Galectin Therapeutics Inc.
Annual Report 2015

Plain-text annual report

Table of Contents UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 FORM 10-K xAnnual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934For the fiscal year ended December 31, 2015 ¨Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. Nevada 04-3562325(State or other jurisdictionof incorporation) (I.R.S. EmployerIdentification No.)4960 Peachtree Industrial Blvd., Suite 240, Norcross, GA 30071(Address of Principal Executive Offices) (Zip Code)(678) 620-3186(Registrant’s Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registeredCommon Stock, $0.001 Par Value Per Share The NASDAQ Capital MarketUnits, each consisting of two shares of Common Stock and one Warrant topurchase one share of Common Stock The NASDAQ Capital MarketCommon Stock Purchase Warrants The NASDAQ Capital MarketSecurities registered pursuant to Section 12(g) of the Act:NoneIndicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ¨ NO xIndicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES ¨ NO xIndicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirementsfor the past 90 days. YES x NO ¨Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required tobe submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit and post such files). YES x NO ¨Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the bestof registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ¨Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See thedefinitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.Large accelerated filer ¨ Accelerated filer x Non-accelerated filer ¨ Smaller reporting company ¨Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ¨ NO xThe aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the commonequity was sold, or the average bid and asked price of such common equity, as of June 30, 2015 was $52.7 million.The number of shares outstanding of the registrant’s common stock as of March 10, 2016 was 28,825,033.DOCUMENTS INCORPORATED BY REFERENCEPortions of the definitive Proxy Statement for the 2016 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report. Table of ContentsINDEX TO FORM 10-KFOR THE YEAR ENDED DECEMBER 31, 2015 PAGE PART 1 ITEM 1. Business 1 ITEM 1A. Risk Factors 12 ITEM 1B. Unresolved Staff Comments 27 ITEM 2. Properties 27 ITEM 3. Legal Proceedings 27 ITEM 4. Mine Safety Disclosure 29 PART II ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 30 ITEM 6. Selected Financial Data 32 ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 32 ITEM 7A. Quantitative and Qualitative Discussions About Market Risk 43 ITEM 8. Financial Statements and Supplementary Data 43 ITEM 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 44 ITEM 9A. Controls and Procedures 44 ITEM 9B. Other Information 45 PART III ITEM 10. Directors, Executive Officers and Corporate Governance 46 ITEM 11. Executive Compensation 46 ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 46 ITEM 13. Certain Relationships, Related Transactions and Director Independence 46 ITEM 14. Principal Accountant Fees and Services 46 PART IV ITEM 15. Exhibits and Financial Statement Schedules 47 SIGNATURES 53 Table of ContentsPART I Item 1.BusinessOverviewWe are a clinical stage biopharmaceutical company engaged in drug research and development to create new therapies for fibrotic disease and cancer. Ourdrug candidates are based on our method of targeting galectin proteins, which are key mediators of biologic and pathologic functions. We use naturally occurring,readily-available plant products as starting material in manufacturing processes to create proprietary complex carbohydrates with specific molecular weights andother pharmaceutical properties. These complex carbohydrate molecules are appropriately formulated into acceptable pharmaceutical formulations. Using theseunique carbohydrate-based candidate compounds that largely bind and inhibit galectin proteins, particularly galectin-3, we are undertaking the focused pursuit oftherapies for indications where galectins have a demonstrated role in the pathogenesis of a given disease. We focus on diseases with serious, life-threateningconsequences to patients and those where current treatment options are limited. Our strategy is to establish and implement clinical development programs that addvalue to our business in the shortest period of time possible and to seek strategic partners when a program becomes advanced and requires significant additionalresources.Our lead galectin-3 inhibitor is GR-MD-02, and has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis. GR-MD-02 has thepotential to treat many diseases due to its involvement in multiple key biological pathways such as cell differentiation, cell growth, and apoptosis (cell death).Galectin Therapeutics Inc. is using this inhibitor to treat advanced liver fibrosis and liver cirrhosis in NASH (non-alcoholic steatohepatitis) patients. We havecompleted Phase 1 clinical studies and currently are engaged in two Phase 2 clinical studies in NASH patients with advanced fibrosis (NASH-FX) and NASHpatients with cirrhosis (NASH-CX). Both disease states are progressive, currently not treatable and ultimately may result in liver failure which has poor prognosisand no effective, approved medical therapies other than liver transplant. Galectin-3 expression is highly increased in patients with liver fibrosis and liver cirrhosis.We believe that our galectin-3 inhibitor, by reducing galectin-3 at the cellular level, ultimately showing a strong anti-fibrotic potential may provide a noveltreatment for various forms of liver fibrosis.We endeavor to leverage our scientific and product development expertise as well as established relationships with outside sources to achieve cost-effectiveand efficient drug development. These outside sources, amongst others, provide us with expertise in preclinical models, pharmaceutical development, toxicology,clinical trial operations, pharmaceutical manufacturing, sophisticated physical and chemical characterization, and commercial development. We also haveestablished several collaborative scientific discovery programs with leading experts in carbohydrate chemistry and characterization. These discovery programs aregenerally aimed at the targeted development of new carbohydrate molecules which bind galectin proteins and offer alternative options to larger market segments inour primary disease indications. We also have established a discovery program aimed at the targeted development of small molecules (non-carbohydrate) whichbind galectin proteins and may afford options for alternative means of drug delivery (e.g., oral) and as a result expand the potential uses of our compounds. We arepursuing a development pathway to clinical enhancement and commercialization for our lead compounds in immune enhancement for cancer therapy as well as inboth liver fibrosis and fatty liver disease. All of our proposed products are presently in development, including pre-clinical and clinical trials.We were founded in July 2000 as Pro-Pharmaceuticals, Inc., a Massachusetts corporation. On April 25, 2001, DTR-Med Pharma Corp. (“DTR”), which wasincorporated in Nevada on January 26, 2001, entered into a stock exchange agreement with Pro-Pharmaceuticals, Inc., whereby DTR acquired all of the outstandingshares of common stock of Pro-Pharmaceuticals, Inc. On May 10, 2001, DTR changed its name to “Pro- Pharmaceuticals, Inc.” and on June 7, 2001, theMassachusetts corporation was merged into the Nevada corporation. On May 26, 2011, Pro-Pharmaceuticals, Inc. changed its name to “Galectin Therapeutics Inc.”In October, 2012, we moved our headquarters to a suburb of Atlanta, GA to be closer to a center of discovery collaboration while maintaining a laboratoryoperation in the Boston area. 1Table of ContentsOur Drug Development ProgramsGalectins are a class of proteins that are made by many cells in the body. As a group, these proteins are able to bind to sugar molecules that are part of otherproteins, glycoproteins, in and on the cells of our body. Galectin proteins act as a kind of molecular glue, bringing together molecules that have sugars on them.Galectin proteins, in particular galectin-3, are known to be markedly increased in a number of important diseases including inflammatory diseases, scarring oforgans (e.g. liver, lung, kidney, and heart) and cancers of many kinds. The increase in galectin protein promotes the disease and is detrimental to the patient.Published data show that mice lacking the galectin-3 gene, and thus unable to produce galectin-3, are incapable of developing liver fibrosis in response to toxicinsult to the liver and in fatty liver disease.We have one new chemical entity (NCE) in development, GR-MD-02, which has shown promise in preclinical and early clinical studies in treatment offibrosis and in cancer therapy. Currently we are focusing on development of GR-MD-02 intended to be used in the treatment of liver fibrosis associated with fattyliver disease (NASH), moderate to severe plaque psoriasis, and in cancer therapy in combination with immune-system modifying agent(s). GR-MD-02 is aproprietary, patented compound derived from natural, readily available, plant-based starting materials, which, following chemical processing, exhibits theproperties of binding to and inhibiting galectin-3 proteins. A second NCE, GM-CT-01 is a proprietary, patented compound that is made from a completely differentstarting source plant material and also binds and inhibits galectin proteins. Previously in clinical development for cancer indications, this compound continues to beexplored in preclinical studies.Our product pipeline is shown below: Indication Drug StatusFibrosis NASH with Advanced Fibrosis: NASH-CX trialand NASH-FX trial GR-MD-02 IND submitted January 2013. Results from the Phase 1 clinical trial were reportedin 2014, with final results reported in January 2015. End of Phase 1 meeting heldwith FDA in 2014. Two Phase 2 clinical trials are being conducted. The NASH CXtrial, is designed for patients with cirrhosis, and the NASH FX trial is designed forpatients with advanced fibrosis but not cirrhosis. The NASH FX trial top line datais expected around end of Q3-2016 and the NASH CX trial top line data isexpected around the end of 2017.Lung Fibrosis GR-MD-02 In pre-clinical developmentKidney Fibrosis GR-MD-02 In pre-clinical developmentCardiac and Vascular Fibrosis GR-MD-02 and GM-CT-01 In pre-clinical developmentCancer Immunotherapy Melanoma GR-MD-02 Investigator IND submitted in December 2013. Phase 1B study in process. Asecond Phase 1B study is planned to begin by April 2016. Investigator IND for thatstudy submitted in September 2015.Psoriasis Moderate to Severe Plaque Psoriasis GR-MD-02 IND submitted March 2015. A phase 2a trial in moderate to severe plaque psoriasispatients began in January 2016. Data is expected around Q3-2016.Fibrosis. GR-MD-02 is our lead product candidate for treatment of fibrotic disease. Our preclinical data show that GR-MD-02 has a significant therapeuticeffect on liver fibrosis as shown in several relevant animal models. In addition, in NASH animal models GR-MD-02 has been shown to reduce liver fat,inflammation, and 2Table of Contentsballooning degeneration or death of liver cells. Therefore, we chose GR-MD-02 as the lead candidate in a development program targeted initially at fibrotic liverdisease associated with non-alcoholic steatohepatitis (NASH, or fatty liver disease). In January 2013, an Investigational New Drug (“IND”) was submitted to theFDA with the goal of initiating a Phase 1 study in patients with NASH and advanced liver fibrosis to evaluate the human safety of GR-MD-02 andpharmacodynamics biomarkers of disease. On March 1, 2013, the FDA indicated we could proceed with a US Phase 1 clinical trial for GR-MD-02 with adevelopment program aimed at obtaining support for a proposed indication of GR-MD-02 for treatment of NASH with advanced fibrosis. The Phase 1 trial wascompleted and demonstrated that GR-MD-02 up to 8 mg/Kg, i.v. was safe and well tolerated and the human pharmacokinetic data defined a drug dose for use in theplanned Phase 2 trials. Additionally, there was evidence of a pharmacodynamic effect of GR-MD-02 at the 8 mg/kg dose with a decrease in alpha 2 macroglobulin,a serum marker of fibrotic activity, and a reduction in liver stiffness as determined by FibroScan . An “End of Phase 1 Meeting” was held with FDA which,amongst other items, provided guidance on the primary endpoint for the Phase 2 clinical trial.Additionally, an open label drug-drug interaction study was completed during the second quarter of 2015, with GR-MD-02 and it showed that with 8 mg/kgdose of GR-MD-02 and 2 mg/kg dose of midazolam there was no drug-drug interaction and no serious adverse events or drug-related adverse events wereobserved. This study was required by the U.S. Food and Drug Administration (FDA) and the primary objective was to determine if single or multiple intravenous(IV) doses of GR-MD-02 affect the pharmacokinetics (PK) of midazolam. The secondary objective was to assess the safety and tolerability of GR-MD-02 whenadministered concomitantly with midazolam. The lack of a drug interaction in this study enables Galectin to expand the number of patients eligible for its Phase 2clinical trial. In addition, should GR-MD-02 be approved for marketing, the success of this study supports a broader patient population for the drug label.Our Phase 2 program in fibrotic disease consists of two separate human clinical trials. The first clinical trial is the NASH-CX study for patients with NASHwith cirrhosis, which began enrolling in June 2015. This study is a randomized, placebo-controlled, double-blind, parallel-group Phase 2 trial to evaluate the safetyand efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH cirrhosis. A total of 156 patients atapproximately 50 sites in the United States will be randomized to receive either 2 mg/kg of GR-MD-02, 8 mg/kg of GR-MD-02 or placebo, with 52 patients in eachgroup. The primary endpoint is a reduction in change in hepatic venous pressure gradient (HVPG). Patients will receive an infusion every other week for one year,total of 26 infusions, and will be evaluated to determine the change in HVPG as compared with placebo. HVPG will be correlated with secondary endpoints offibrosis on liver biopsy as well as with measurement of liver stiffness (FibroScan ) and assessment of liver metabolism ( C-methacetin breath test, Exalenz),which are non-invasive measures of the liver that may be used in future studies. Data readout is expected by the end of 2017.The second clinical trial is the NASH-FX for patients with NASH advanced fibrosis uses a variety of non-invasive fibrosis assessment technologies. The firstpatient in this 30 patient study is was consented in September 2015, and the study is designed for 15 patients receiving 8 mg/kg of GR-MD-02 and 15 receivingplacebo to be treated. That study will evaluate the safety and efficacy of GR-MD-02 for a four month treatment period of bi-weekly infusions of GR-MD-02 onnon-invasive measures on liver stiffness as assessed imaging of liver fibrosis using multi-parametric magnetic resonance imaging (LiverMultiScan , PerspectumDiagnostics), as the primary endpoint, as well as magnetic resonance-elastography and FibroScan score, as secondary endpoints. Top-line data is expected to beavailable in the third quarter of 2016.Our drug candidate provides a promising new approach for the therapy of fibrotic diseases, and liver fibrosis in particular. Fibrosis is the formation of excessconnective tissue (collagen and other proteins plus cellular elements such as myofibroblasts) in response to damage, inflammation or repair. When the fibrotictissue becomes confluent, it obliterates the cellular architecture, leading to scarring and dysfunction of the underlying organ. Given galectin-3’s broad biologicalfunctionality, it has been demonstrated to be involved in cancer, inflammation and fibrosis, heart disease, renal disease and stroke. We have further demonstratedthe broad 3® (R) 13 (R) Table of Contentsapplicability of the actions of our galectin-3 inhibitor’s biological effect in ameliorating fibrosis involving lung, kidney and cardiac tissues in a variety of animalmodels.The focus and goal of the therapeutic program is to stop the progression of and reverse the fibrosis in the liver and, thereby improve liver function andprevent the development of complications of fibrosis/cirrhosis and liver-related mortality in patients.Cancer Immunotherapy. We believe there is potential for galectin inhibition to play a key role in the burgeoning area of cancer immunotherapy. Forexample, there have been several recent approvals of drugs that enhance a patient’s immune system to fight cancer. With many additional vaccines and immunestimulatory agents in development, industry analysts forecast that this market could generate over $35 billion in sales over the next 10 years. It is our goal to use agalectin inhibitor to enhance the immune system function to fight cancer in a way that complements other approaches to this type of therapy. Our drug candidatesprovide a promising new therapeutic approach to enhance the activity of the immune system against cancer cells. Preclinical studies have indicated that GR-MD-02enhances the immune response to cancer cells, increased tumor shrinkage and enhanced survival in immune competent mice with prostate, breast, melanoma andsarcoma cancers when combined with one of the immune checkpoint inhibitors, anti-CTLA-4 or anti-PD-1. These preclinical data led to the filing of anInvestigator-sponsored IND and the initiation of a study of GR-MD-02 in combination with Yervoy (ipilimumab) in a Phase 1B study of patients with metastaticmelanoma. This study is being conducted under the sponsorship of Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI). A study withKeytruda and GRMD-02 is conducted by EACRI is expected to begin enrolling by April 2016.We believe the mechanism of action for GR-MD-02 is based upon interaction with, and inhibition of, galectin proteins, particularly galectin-3, which areexpressed at high levels in certain pathological states including inflammation, fibrosis and cancer. While GR-MD-02 is capable of binding to multiple galectinproteins, we believe that it has the greatest affinity for galectin-3, the most prominent galectin implicated in pathological processes. Blocking galectin in cancer andliver fibrosis has specific salutary effects on the disease process, as discussed below.Psoriasis. During our Phase 1 NASH fibrosis trial with GR-MD-02, a clinical effect on plaque psoriasis was observed in a NASH patient who also hadthis disease. This patient had marked improvement in her psoriasis, with improvement beginning after the third infusion. She reported that her psoriasis was“completely gone” and her skin was “normal” after the fourth infusion. Her skin remained normal for 17 months after the final infusion of study drug. The patientis convinced that the improvement in her psoriasis is related to the study drug.This serendipitous finding, combined with galectin-3 protein being markedly upregulated in the capillary epithelia (small blood vessels) of the psoriaticdermis (plaque lesions), led to a phase 2a trial in patients with moderate to severe plaque psoriasis. GR-MD-02 inhibition of galectin-3 may attenuate capillarychanges in the psoriatic dermis and inflammatory recruitment, perhaps explaining the improvements observed in the NASH fibrosis trial patient. In this open-label,unblinded trial (no placebo, all patients knowingly receive active drug), 10 patients with moderate to severe plaque psoriasis are administered GR-MD-02 everytwo weeks for 12 weeks. We anticipate top line data for this trial by the end of the third quarter of 2016.Liver Fibrosis: New Approach for a Significant Unmet Medical NeedWhen an internal organ is exposed to chronic disease one of the responses is that scar tissue is laid down in the organ (this process is called fibrosis). Thelonger the disease affects the organ, the more fibrous tissue is deposited and this ultimately results in the failure of the organ. This chronic fibrosis of organs mayoccur in the liver, lung, kidney, and heart, as well as others and, as a result, fibrosis of organs has been estimated to account for as much as 45% of all mortality inthe United States. Scientific findings during the last few years indicate that the galectin-3 protein is critically important in this fibrotic process in multiple organs. 4® Table of ContentsIn the liver, fibrosis is the end result of multiple inflammatory conditions and infections. Progressive liver fibrosis leads to cirrhosis, which results inreduction of liver function, multiple medical complications and ultimately death. It is estimated that 1-2 million patients have cirrhosis in the United States withclose to 50,000 losing their lives yearly. Only a fraction of patients’ lives, approximately 6,200 per year, are saved by liver transplantation at a cost ofapproximately $350,000 per transplantation. One condition in particular that frequently leads to cirrhosis is non-alcoholic steatohepatitis, or NASH, a liver diseasecharacterized by the accumulation of fat in the liver with associated inflammation and fibrosis, which can lead to end-stage cirrhosis requiring liver transplantation.The National Institute of Health estimates that 9 to 15 million Americans are affected by NASH, and other sources suggest it may be as many as 30 million peoplehave NASH, and forecasts that the number of Americans affected by this disease is growing due to obesity and diabetes, with the potential to become the leadingcause of liver cirrhosis and liver transplantation in the future. Liver transplantation is currently the only therapeutic approach to NASH or other forms of liverfibrosis as, to the best of our knowledge, there are no drug therapies on the market. Organ transplantation is a difficult, risky and costly procedure as organavailability is scarce and there is the risk of developing cirrhosis in the transplanted liver from the same disease that damaged the patient’s original liver andtherefore, there is a great need for other therapeutic options. All diseases that affect the liver (viral hepatitis, alcoholic liver disease, and fatty liver as examples)lead to the development of scarring of the liver.The primary focus of the Company is to use galectin inhibitors to block galectin-3 and treat organ scarring or fibrosis in the liver. There are no approvedtherapies for treatment of liver fibrosis. We believe that our drug candidates have the potential to treat NASH and other forms of liver fibrosis. Scientific evidencesuggests that galectin-3 is essential for the development of liver fibrosis in animals. Published data show that mice lacking the galectin-3 gene, and thus unable toproduce galectin-3, are essentially incapable of developing liver fibrosis in response to toxic insult to the liver and in fatty liver disease. Moreover, mice that do nothave the galectin-3 gene are resistant to lung and kidney fibrosis. These published data show that galectin-3 is a critical protein for the development of organfibrosis. Our drugs, based on experiments in well characterized animal models, are also potentially useful in scarring or fibrosis of other organs such as lung andkidney which expands the possibilities for future therapeutic indications.We have evaluated the ability of GR-MD-02 to block galectin-3 in animal models of liver fibrosis, the conclusions of which yielded positive results. Our pre-clinical data show that GR-MD-02 may have a therapeutic effect on liver fibrosis as shown in several relevant animal models. Therefore, we chose GR-MD-02 asthe lead candidate in a development program targeted initially at fibrotic liver disease associated with NASH.We evaluated GR-MD-02 in pre-clinical toxicology and pharmacology studies during 2013 and filed an IND with the FDA in January 2013 for initiatinghuman studies in patients with NASH. In February 2013 we entered into an agreement with CTI Clinical Trial Services to assist with the design, development andconduct of one or more clinical research studies, specifically for services with respect to our Phase 1 clinical trials to evaluate safety of GR-MD-02 in patients withNASH. The FDA notified us in March 2013 that we may proceed with a Phase 1 clinical trial for patients with NASH and we began enrolling patients in the Phase1 clinical trial in the third quarter of 2013. In August 2013, GR-MD-02 was granted Fast Track designation by the FDA for NASH with hepatic fibrosis, commonlyknown as fatty liver disease with advanced fibrosis. In January 2014, we completed the enrollment of the first cohort of patients in the Phase 1 trial with no seriousadverse events being reported. We reported initial safety and tolerability results from the first cohort of patients on June 30, 2014. The second cohort of this Phase 1trial began and enrollment was completed in April 2014. In July 2014, we reported the results from the second cohort of patients. Enrollment of the third cohort ofPhase 1 began in July 2014 with interim results presented in November 2014 with the final report on cohort 3 presented in January 2015. The results of the Phase 1study demonstrate that (i) GR-MD-02 was safe and well tolerated by patients with advanced NASH liver fibrosis after IV administration of four doses of 2 mg/kg,4 mg/kg and 8mg/kg lean body weight, (ii) Pharmacokinetics revealed drug exposure in humans at the 8 mg/kg dose that was equivalent to the upper range of thetargeted therapeutic dose determined from effective doses in NASH animal models, (iii) Disease Serum Marker Effect showed there was a statistically significant,dose-dependent reduction in 5Table of ContentsFibroTest scores due to a statistically significant reduction in alpha-2 macroglobulin (A2M) serum levels, and (iv) Liver Stiffness Effect, as measured byFibroScan showed that there was a signal of reduced liver stiffness in patients receiving GR-MD-02. The reduction seen in A2M does not necessarily meanfibrosis got better in this short study, but does suggest changes in the fibrogenic process that might lead to an improvement in fibrosis with longer-term therapy.These Phase 1 results in NASH patients with advanced fibrosis, in addition to completion of further toxicology and drug-drug interaction studies provide a firmfoundation for entry into a Phase 2 development program (described above).GR-MD-02 is a proprietary, patented galactoarabino-rhamnogalacturonan polysaccharide polymer that is comprised predominantly of galacturonic acid,galactose, arabinose, rhamnose, and smaller amounts of other sugars. Structural studies have shown that GR-MD-02 binds to galectin-1 and to galectin-3 withbinding affinity to galectin-3 being significantly greater than binding to galectin-1. With respect to GR-MD-02, we currently have a number of issued US patentsincluding one composition of matter patent, one method of manufacture patent, one method of use patient in patients with NASH, one method of use patent inpatients with liver fibrosis, and one method of use patent in patients with diabetic kidney disease. Additional patent applications are pending with respect to,amongst other uses, cancer immunotherapy, lung fibrotic disease, and inflammatory disease associated with increase in inducible nitric oxide synthase. Patentshave also been granted with respect to liver fibrosis, NASH, and liver fibrosis in combination with other therapeutic agents. Compounds for subcutaneousadministration and oral delivery are currently under pre-clinical development.Galectin Inhibition in Cancer TherapyWe believe the potential exists for galectin inhibition to play an important role in cancer therapy. Galectin proteins, particularly galectin-1 and galectin-3,have been shown to be highly expressed in the majority of cancers and have multiple roles in promoting cancer progression, including tumor cell invasion,metastasis, angiogenesis, and tumor evasion of the immune system.The role of galectins in cancer immunotherapy can be understood through the “Galectin Effect”, a recent discovery of how tumors avoid the body’s ownimmune system, i.e., the tumors secrete galectin proteins that block the body’s efforts to fight tumors. Our current program to block the “Galectin Effect” is basedon the research of Dr. Pierre van der Bruggen (of the Ludwig Institute of Cancer Research in Brussels, Belgium), demonstrating that galectin-3, which is producedby the vast majority of human cancers, binds to and blocks the actions of tumor-infiltrating T-lymphocytes, the major immune cell in the body’s defense againstcancers. In addition, Dr. Will Redmond of the Earl Chiles Cancer Research Institute in Portland Oregon has shown that our galectin inhibitors can enhance the anti-tumor immunogenic effect of other immunotherapies based on targeting lymphocyte checkpoints such as CTLA4. Based on these results, we believe that the body’simmune cells may be unable to attack and kill tumor cells in the presence of galectins. Using this approach, the mechanism of action for our drugs seeks to blockgalectins and, in turn, restore the ability of the T-lymphocytes to kill tumor cells.The Company supported preclinical studies led by tumor immunology expert William L. Redmond, Ph.D., of the Providence Portland Medical Center’sEarle A. Chiles Research Institute (EACRI). The preclinical study found that GR-MD-02 increased tumor shrinkage and enhanced survival in immune competentmice with prostate and breast cancers when combined with one of the immune checkpoint inhibitors, anti-CTLA-4 or anti-PD-1. These findings suggest a role forGR-MD-02 in cancer immunotherapy. These preclinical observations by Dr Redmond provided scientific rationale for proceeding and lead to the filing byProvidence Portland Medical Center of an Investigator-sponsored IND to conduct a Phase 1B study to determine if GR-MD-02 enhances the probability ofmelanoma response with ipilimumab by inducing proliferation, activation and memory function of CD8+ T cells in human patients. The company has licensed theunderlying invention from Providence Portland Medical Center. This study represents a novel approach for patients with metastatic melanoma. The IND wasapproved by FDA in February 2014. This study is being conducted under the sponsorship of Providence Portland Medical Center’s Earle A. Chiles ResearchInstitute (EACRI) and is being supported by the Company. 6® ® Table of ContentsThe study employs a dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of ipilimumab in patients with advanced melanoma forwhom ipilimumab would be considered standard of care. In addition to monitoring for toxicity and clinical response by irRECIST criteria on imaging tests, bloodsamples will be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition. Galectin Therapeutics isproviding its proprietary compound GR-MD-02 to EACRI researchers, as well as supply researchers with supporting analysis of the pharmacokinetics of GR-MD-02 and the right to reference the Company’s open IND on GR-MD-02. To date the first two dosing groups have been completed without serious adverse eventswhich were determined to be related to GR-MD-02. The third dosing group is now enrolling.Similar to the agreement set forth for the ipilimumab (Yervoy )Phase 1B study, Providence Portland Medical Center submitted an IND in September 2015to conduct a Phase 1B study of GR-MD-02 and pembrolizumab (Keytruda ) in patients with metastatic melanoma. The combination of GR-MD-02 and an anti-PD1 (pembrolizumab) has been shown to enhance T-cell activation, memory, and effector function, and promote better antitumor responses in multiple mousestudies. The study will test the hypothesis that galectin-3 antagonism using GR-MD-02 with enhance the probability of melanoma response using penbrolizumab inpatients by inducing proliferation, activation and memory function of CD8+ T cells that recognize melanoma antigens. Similar to the ipilimumab study, the studyemploys a dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of pembrolizumab in patients with metastatic melanoma who have hadprogression of their melanoma after ipilimumab and/or BRAF targeted therapy when a BRAF mutation is present. In addition to monitoring for toxicity and clinicalresponse, blood and tumor samples will be obtained to assess immunologic measures relevant to galectin biology and pembrolizumab T-cell checkpoint inhibition.Patents and Proprietary RightsOur development and commercial viability, and ultimately our competitiveness, depend on our ability to develop and maintain the proprietary aspects of ourtechnology and operate without infringing on the proprietary rights of others. We rely on a combination of patent, trademark, trade secret and copyright law andcontract restrictions to protect the proprietary aspects of our technologies. We seek to limit disclosure of our intellectual property by requiring employees,consultants, and any third parties with access to our proprietary information to execute confidentiality agreements and by restricting access to that information.In August 2015, we received a notice of allowance from the U.S. Patent and Trademark Office for patent application number 13/726,900, titled “Galactose-pronged polysaccharides in a formulation for antifibrotic therapies.” This patent extends coverage of the Company’s pectin-derived compounds (including broadmolecular weight ranges and other sources of pectin) to include treatment of chronic kidney disease associated with the development of fibrosis, established kidneyfibrosis, chronic lung disease associated with the development of fibrosis and established lung fibrosis. Claims in this patent include administering pectin-derivedcompound parenterally to a patient having at least one of the four aforementioned diseases where the established fibrosis or progression of the fibrosis orcirrhosis is inhibited or slowed down. Additional specific claims encompass deriving the compound from citrus pectin, apple pectin, soybean hull pectin or sugarbeet pectin with a molecular weight between 2 kDa and 400kDa. Also covered is the step of administering the modified galacto-rhamnogalacturonan compound inan admixture with a therapeutic agent, where the agent is an antifibrotic compoundIn August 2014, we received a notice of allowance from the U.S. Patent and Trademark Office for patent application number 13/573,442 titled “Compositionof Novel Carbohydrate Drug for Treatment of Human Diseases.” The patent covers composition and chemical structural claims for compounds that includes theCompany’s lead galectin inhibitor compound GR-MD-02 and will expire in December 2031. Claims include multiple routes of administration, includingintravenous, subcutaneous and oral. The application also covers therapeutic formulations for use in the treatment of NASH (fatty liver disease), cancer and fibrotic,inflammatory and autoimmune disorders in which galectin proteins are involved, at least in part, in the pathogenesis. 7® ® Table of ContentsAdditional specific claims encompass liver fibrosis, kidney fibrosis, lung fibrosis or heart fibrosis. The patent, assigned U.S. Patent No. 8,871,925, was issuedOctober 28, 2014.In May 2014, we received notice of allowance from the U.S. Patent and Trademark Office for patent application number 13/998,197 titled “Galactose-Pronged Carbohydrate Compounds for the Treatment of Diabetic Nephropathy and Associated Disorders.” The patent covers both composition claim for and usesof the Company’s carbohydrate-based galectin inhibitor compound GR-MD-02 in patients with diabetic nephropathy, a type of progressive kidney disease thatoccurs in individuals with diabetes. Diabetic nephropathy is the major cause for chronic renal failure in the United States. The patent, assigned U.S. PatentNo. 8,828,971, was issued September 9, 2014.In February 2014, we received notice of issuance that the U.S. Patent and Trademark Office issued patent number 8,658,787 to the Company for itsapplication titled “Galacto-rhamnogalacturonate compositions for the treatment of non-alcoholic steatohepatitis and non-alcoholic fatty liver disease.” The patentcovers the Company’s carbohydrate-based galectin inhibitor compound GR-MD-02 for use in patients with fatty liver disease with or without fibrosis or cirrhosis,providing patent protection through 2031. The major claims are for methods of obtaining galectin inhibitor compounds, obtaining a composition for parenteral orenteral administration in an acceptable pharmaceutical carrier and administering to a subject having at least one of the following: fatty liver, non-alcoholic fattyliver disease, non-alcoholic steatohepatitis, non-alcoholic hepatitis with liver fibrosis, non-alcoholic steatohepatitis with cirrhosis, or non-alcoholic steatohepatitiswith cirrhosis and hepatocellular carcinoma. The use covers reversing or slowing the progression of disease activity or medical consequences of the disease.Applications are pending in multiple countries to extend patent protection globally.In January 2014, we received a notice of allowance from the U.S. Patent and Trademark Office for Patent Application Number 13/550,962 titled “Galactose-Pronged Polysaccharides in a Formulation for Anti-fibrotic Therapies.” The patent covers both composition claim for and uses of the Company’s carbohydrate-based galectin inhibitor compound GR-MD-02 for use in patients with liver fibrosis in combination with other potential therapeutic agents. The patent covers use ofGR-MD-02 with agents directed at multiple targets, some of which are currently in clinical development for fibrotic disorders including monoclonal antibodies toconnective tissue growth factor, integrins, and TGF-ß1. The patent, assigned U.S. Patent No. 8,722,645, was issued May 13, 2014.In July 2012, we received a notice of issuance from the U.S. Patent and Trademark Office for the U.S. Patent number 8,236,780 issued on August 7, 2013titled “Galactose-prolonged polysaccharides in a formulation for antifibrotic therapies”. This methods patent covers key methods of derivation and use for ourcarbohydrate-based galectin inhibitor compound for use in patients with chronic liver disease associated with the development of fibrosis, established liver fibrosisor end-stage scarring, or cirrhosis. The major claim is for a method of obtaining a galacto-rhamnogalacturan compound from an apple pectin, obtaining acomposition for parenteral administration the galacto-rhamnogalacturonan compound in an acceptable pharmaceutical carrier and administering to a subject havingat least one of the following: chronic liver disease associated with the development of fibrosis, established liver fibrosis or cirrhosis. The use covers inhibiting orslowing the progression of fibrosis. GR-MD-02 is covered by this patent and it provides opportunities for development of additional compounds in the class.As of January 31, 2016, we held 14 granted U.S. patents, 15 foreign granted patents (Japan, E.U., New Zealand, and Australia), 56 international patentapplications, and 5 U.S. patent applications. Many of our patents and patent applications cover composition of matter for complex carbohydrate drugs and methodsof use for reducing toxicity and enhancing chemotherapeutic drugs by co-administering a polysaccharide with a chemotherapeutic agent or for use in treatment offibrosis. The scheduled expiration dates of our United States patents span from 2020 to 2033. We have corresponding patent applications pending in Europe, Israel,Australia and Brazil. Additionally, we have patent applications in other areas to utilize our carbohydrate-based compounds to treat disease other than cancer. See“Risk Factors — Risks Related to Our Intellectual Property”. Our competitive position, in part, is contingent upon protection of our intellectual property. 8Table of ContentsResearchOur primary focus is on the design and testing of agents which target galectins in various in vitro and in vivo systems and which demonstrate efficacy intreatment of experimentally induced fibrosis or enhance immune system responsiveness in various tissues and in live animal models. We contract with independentlaboratories and other facilities to conduct our research, which is designed, evaluated and managed by our scientists. While we conduct in house research related toour compounds at SBH laboratories in Massachusetts, we do not anticipate building additional in-house research or development facilities or hiring staff other thanfor purposes of designing and managing our out-sourced research.As we develop products eligible for clinical trials, we contract with independent parties to assist in the design of the clinical trial protocols, arrange for andmonitor the clinical trials, collect data and analyze data. In addition, certain clinical trials for our products may be conducted by government-sponsored agenciesand will be dependent on governmental participation and funding. Our dependence on independent parties and clinical sites involves risks including reducedcontrol over the timing and other aspects of our clinical trials.In February 2013, the Company established a collaborative drug discovery program with Dr. Geert-Jan Boons’ (“Dr. Boons”) laboratory located in theComplex Carbohydrate Research Center at the University of Georgia. This on-going program is focused on the discovery of new carbohydrate molecules that canbe used in the therapy of diseases where galectin proteins play a major role, including cancer, and inflammatory and fibrotic disorders. The aim of this program isto develop a pipeline of drugs that can target galectins. This is an important goal as follow-on compounds for our drugs currently in development and to extend thepotential indications and routes of administration. The Complex Carbohydrate Research Center is a world-class program and Dr. Boons is a world renowned andpre-eminent carbohydrate chemist.In September, 2014, the Company established a collaborative research program with Dr. William Redmonds’ laboratory located at the Providence PortlandMedical Center, Portland, Oregon. This program focuses on combination immunotherapy plus galectin inhibition to augment tumor immunogenicity.During the years ended December 31, 2015, 2014 and 2013, our expenditures for research and development were $13.1 million, $8.4 million, and $5.7million, respectively. We expense all research and development costs as they are incurred.In January, 2014 we created, with SBH Sciences, Inc. (Natick, Ma), Galectin Sciences, LLC, a collaborative joint venture to research and develop smallorganic molecule inhibitors of galectin-3 for oral administration.Using computer molecular modeling techniques coupled with in vitro screening of a variety of compound libraries, SBH Sciences had identified severalsmall organic molecules with promising galectin-3 inhibitory activity in vitro . Galectin Sciences LLC will further develop these unique organic molecule inhibitorsof galectin-3 as drug candidates as well as develop additional candidates. Galectin Sciences LLC will build on the scientific body of knowledge amassed by SBHSciences, coupled with Galectin Therapeutics’ knowledge and expertise of galectins’ pathological role and mechanism of action in inflammation, fibrosis and manycancers. The long-term goal of this effort is to identify and develop drug candidates that are highly specific galectin inhibitors which may be formulated for oraladministration. The intermediate term goal is the development of small molecule inhibitors of galectin-3 which exhibit activity in in vivo preclinical disease modelsof fibrosis and cancer in which galectins play a key role.Because, increased levels of galectin proteins have been implicated in a very large number of inflammatory, fibrotic and neoplastic diseases; the discoveryand development of orally active galectin inhibitors would be a major step towards expanded treatment approaches for these disorders. This early drug discoveryeffort may lead to drugs that would expand our pipeline as follow on compounds to our first in class galectin inhibitors, GR-MD-02 and GM-CT-01. 9Table of ContentsManufacturing and MarketingWe are a development stage Company at this time and do not intend to establish internal facilities for the manufacture of our products for clinical orcommercial production. To have our products manufactured, we have developed and will continue to develop relationships with third-parties that have establishedpharmaceutical manufacturing capabilities and expertise. We are not a party to any long-term agreement with any of our suppliers and, accordingly, we have ourproducts manufactured on a purchase-order basis from one of two primary well-known and established pharmaceutical suppliers that meeting FDA requirements.Because our products are in the development stage, we have not created a sales and marketing staff to commercialize pharmaceutical products. If we developproducts eligible for commercial sale, we will need to develop a sales and marketing capability or rely on third parties such as licensees, collaborators, joint venturepartners or independent distributors to market and sell those products. Our dependence on third-party manufacturers and marketers will involve risks relating to ourreduced control, and other risks including those discussed in “Risk Factors — Risks Related to our Company — There are risks associated with reliance on thirdparties for manufacturing, marketing, sales, managed care and distribution infrastructure channels.”CompetitionMany biotechnology and pharmaceutical companies are developing new technologies for the treatment of cancer and other diseases. Technologies such asmonoclonal antibodies could be competitive with our galectin therapeutic platforms. Other companies are trying to improve the therapeutic profile of widely usedprotein-based drugs. While these companies may broaden the market for our products they may also provide competitive alternatives to our products. We expectincreased competition in the area of galectins will be fueled by a nearly exponential increase in the publication rate of research papers on galectins.See “Risk Factors — Risks Related to Our Company — We face intense competition in the biotechnology and pharmaceutical industries” for additionaldiscussion related to our current and potential competition.Government RegulationThe research, development, testing, manufacture, labeling, promotion, advertising, distribution, and marketing, among other things, of our products areextensively regulated by governmental authorities in the United States and other countries. The FDA regulates drugs under the federal Food, Drug, and CosmeticAct and its implementing regulations. Failure to comply with the applicable U.S. requirements may subject us to administrative or judicial sanctions, such as FDArefusal to approve pending New Drug Applications (“NDAs”), warning letters, product recalls, product seizures, total or partial suspension of production ordistribution, injunctions, and/or criminal prosecution.Drug Approval ProcessDrugs may not be marketed in the U.S. until the FDA has approved them. The steps required before a drug may be marketed in the U.S. include: 1.Pre-clinical laboratory tests, animal studies, and formulation studies, 2.Submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin, 3.Adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug for each indication, 4.Submission to the FDA of a NDA, 5.Satisfactory completion of an FDA inspection of the manufacturing facility or facilities, at which the drug is produced to assess compliance withcurrent good manufacturing procedures (“cGMP”) established by the FDA, 10Table of Contents 6.FDA review and approval of the NDA, and 7.FDA review and approval of a trademark used in connection with a pharmaceutical.Pre-clinical tests include laboratory evaluation of product chemistry, toxicity, and formulation, as well as numerous in vitro and in vivo animal studies. Theresults of the pre-clinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND, which must becomeeffective before human clinical trials may begin and the Company must resolve any outstanding FDA concerns or questions before clinical trials can proceed.There is no certainty that submission of an IND will result in the FDA allowing clinical trials to begin.Clinical trials involve the administration of the investigational drug to human subjects under the supervision of qualified investigators and constant oversightby the FDA or foreign regulatory authorities. Clinical trials are conducted under protocols detailing the objectives of the study, the parameters to be used inmonitoring safety, and the effectiveness criteria to be evaluated. Each protocol must be submitted to the FDA as part of the IND.Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Each trial must be reviewed and approved byan independent Institutional Review Board (“IRB”), before it can begin. Study subjects must sign an informed consent form before participating in a clinical trial.Phase 1 usually involves the initial introduction of the investigational drug into patients to evaluate its safety, dosage tolerance, pharmacodynamics, and, ifpossible, to gain an early indication of its effectiveness. Phase 2 usually involves trials in a limited patient population to (i) evaluate dosage tolerance andappropriate dosage; (ii) identify possible adverse effects and safety risks; and (iii) evaluate preliminarily the efficacy of the drug for specific indications. Phase 3trials usually further evaluate clinical efficacy and test further for safety by using the drug in its final form in an expanded patient population. There is no assurancethat these trials will be completed within a specified period of time, if at all.Assuming successful completion of the required clinical testing, the results of the pre-clinical studies and of the clinical studies, together with other detailedinformation, including information on the manufacture and composition of the drug, are submitted to the FDA in an NDA requesting approval to market theproduct for one or more indications. Before approving an NDA, the FDA usually will inspect the facilities at which the drug is manufactured, and will not approvethe product unless compliance with cGMP is satisfactory. If the FDA evaluates the NDA and the manufacturing facilities as acceptable, the FDA will generallyissue an approval letter. If the FDA evaluates the NDA submission or the manufacturing facilities as not acceptable, the FDA will generally outline the deficienciesin the submission and often will request additional testing or information. Even if an applicant submits the requested additional information, the FDA ultimatelymay decide that the NDA does not satisfy the regulatory criteria for approval. The testing and approval process requires substantial time, effort, and financialresources, and there is no assurance that any approval will be granted on a timely basis, if at all. After approval, certain changes to the approved product, such asadding new indications, manufacturing changes, or additional labeling claims are subject to further FDA review and approval.See “Risk Factors — Risks Related to the Regulation of Our Products — We will need regulatory approvals to commercialize our products” for additionaldiscussion of regulatory risks related to our drug development program.FDA Priority ReviewFDA procedures provide for priority review of an NDA submitted for drugs that, compared to currently marketed products, offer a significant improvementin the treatment, diagnosis, or prevention of a disease. NDAs that are granted priority review are acted upon more quickly than NDAs given standard review. If wewere to seek priority review, there can be no guarantee that the FDA will grant priority review status, that priority review status will affect the time of review, orthat the FDA will approve the NDA submitted for any of our product candidates, whether or not priority review status is granted. 11Table of ContentsPost-Approval RequirementsIf FDA approval of one or more of our products is obtained, we will be required to comply with a number of post-approval requirements. For example,holders of an approved NDA are required to report certain adverse reactions to the FDA and to comply with certain requirements concerning advertising andpromotional labeling for their products. Also, quality control and manufacturing procedures must continue to conform to current Good Manufacturing Practices(“cGMP”) after approval, and the FDA periodically inspects manufacturing facilities to assess compliance with cGMP. Accordingly, manufacturers must continueto expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. In addition, discovery of problems with a productafter approval may result in restrictions on a product, manufacturer, or holder of an approved NDA, including withdrawal of the product from the market. Also,new government requirements may be established that could delay or prevent regulatory approval of our products under development.Regulation Outside the United StatesBefore our products can be marketed outside of the United States, they are subject to regulatory approval similar to that required in the United States,although the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary widely from country to country. No actioncan be taken to market any product in a country until an appropriate application has been approved by the regulatory authorities in that country. The currentapproval process varies from country to country, and the time spent in gaining approval varies from that required for FDA approval. In certain countries, the salesprice of a product must also be approved. The pricing review period often begins after market approval is granted. No assurance can be given that even if a productis approved by a regulatory authority, satisfactory prices will be approved for such product.Environmental RegulationPharmaceutical research and development involves the controlled use of hazardous materials. Biotechnology and pharmaceutical companies must complywith laws and regulations governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials,biological specimens and wastes. We do not anticipate building in-house research, development or manufacturing facilities, and, accordingly, do not expect to haveto comply directly with environmental regulation. However, our contractors and others conducting research, development or manufacturing activities for us may berequired to incur significant compliance cost, and this could in turn could increase our expense or delay our completion of research or manufacturing programs.EmployeesWe currently have seven full-time employees, four of whom are involved primarily in management of our pre-clinical research and development and clinicaltrials and three who were involved primarily in management and administration of our Company. We also utilize contractors who provide product development,manufacture, analytical testing and clinical trial support. Item 1A.Risk FactorsAn investment in our common stock involves a high degree of risk. You should carefully consider the risks described below and the other information beforedeciding to invest in our common stock. The risks described below are not the only ones facing our Company. Additional risks not presently known to us or that wecurrently consider immaterial may also adversely affect our business. We have attempted to identify below the major factors that could cause differences betweenactual and planned or expected results, but we cannot assure you that we have identified all of those factors.If any of the following risks actually happen, our business, financial condition and operating results could be materially adversely affected. In this case, thetrading price of our common stock could decline, and you could lose all or part of your investment. 12Table of ContentsRisks Related to Our CompanyWe have incurred net losses to date and must raise additional capital in order to continue to operate after March 31, 2017.We have incurred net losses in each year of operation since our inception in July 2000. Our accumulated deficit as of December 31, 2015 was $140 million.We had $25.8 million of unrestricted cash as of December 31, 2015. The Company currently believes there is sufficient cash to fund currently planned operationsthrough the first quarter of 2017. We will require more cash to fund our operations after the first quarter of 2017. However, there can be no assurance that we willbe successful in obtaining such new financing or, if available, that such financing will be obtainable on terms favorable to us. If our current clinical trials areunsuccessful or do not produce positive results, it may be particularly difficult for us to raise additional capital. If we do not raise additional cash for operationsafter the first quarter of 2017, we may not be able to continue operations and may be forced to seek bankruptcy protection.We may raise capital through public or private equity financings, partnerships, debt financings, bank borrowings, or other sources. Additional funding maynot be available on favorable terms or at all. If adequate funds are not otherwise available, we may need to significantly curtail operations. To obtain additionalfunding, we may need to enter into arrangements that require us to relinquish rights to certain technologies, products and/or potential markets. To the extent thatadditional capital is raised through the sale of equity, or securities convertible into equity, our equity holders may experience dilution of their proportionateownership of the Company.We are a development stage company and have not yet generated any revenue.We are a development stage company and have not generated any revenues to date. There is no assurance that we will obtain FDA approval of GR-MD-02,GM-CT-01, or any other of our products in development and, even if we do so, that we will generate revenue sufficient to become profitable. Our failure togenerate revenue and profit would likely lead to loss of your investment.Our ability to generate revenue from product sales and achieve profitability will depend upon our ability to successfully commercialize products, includingany of our current product candidates, or other product candidates that we may in-license or acquire in the future. Even if we are able to successfully achieveregulatory approval for these product candidates, we do not know when any of these products will generate revenue from product sales for us, if at all. Our abilityto generate revenue from product sales from our current or future product candidates also depends on a number of additional factors, including our ability to: • successfully complete development activities, including the necessary clinical trials; • complete and submit new drug applications, or NDAs, to the U.S. Food and Drug Administration, or FDA, and obtain regulatory approval forindications for which there is a commercial market; • complete and submit applications to, and obtain regulatory approval from, foreign regulatory authorities; • successfully complete all required regulatory agency inspections; • set a commercially viable price for our products; • obtain commercial quantities of our products at acceptable cost levels; • find suitable distribution partners to help us market, sell and distribute our approved products in other markets; and • obtain coverage and adequate reimbursement from third parties, including government and private payers.In addition, because of the numerous risks and uncertainties associated with product development, including that our product candidates may not advancethrough development or achieve the endpoints of applicable clinical 13Table of Contentstrials, we are unable to predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability. Even if we are able tocomplete the development and regulatory process for any product candidates, we anticipate incurring significant costs associated with commercializing theseproducts.Even if we are able to generate revenues from the sale of our products, we may not become profitable and may need to obtain additional funding to continueoperations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at plannedlevels and be forced to reduce our operations.We are largely dependent on the success of our two lead product candidates, GR-MD-02 and GM-CT-01 and we cannot be certain that these productcandidates will receive regulatory approval or be successfully commercialized.We currently have no products for sale and we cannot guarantee that we will ever have any drug products approved for sale. We and our product candidatesare subject to extensive regulation by the FDA and comparable regulatory authorities in other countries governing, among other things, research, testing, clinicaltrials, manufacturing, labeling, promotion, selling, adverse event reporting and recordkeeping. We are not permitted to market any of our product candidates in oroutside the United States until we receive approval of a new drug application for a product candidate from the FDA or the equivalent approval from a foreignregulatory authority. Obtaining FDA approval is a lengthy, expensive and uncertain process.Before obtaining regulatory approval for the sale of any drug candidate, we must conduct extensive pre-clinical studies and clinical trials to demonstrate thesafety and efficacy of our product candidates in humans.GR-MD-02 our lead product candidate for fibrosis has completed Phase 1 of the human clinical trial phase of drug development in the US and is currently inPhase 2 clinical trials in North America. GR-MD-02 is also currently in an investigator sponsored, human Phase 1B clinical trial being conducted by ProvidencePortland Medical Center in combination with Yervoy (ipilimumab) in patients with metastatic melanoma. We cannot assure you that these trials will yieldsuccessful results, that they will lead to the generation of revenue, or that we will obtain regulatory approval in other countries.There are currently no FDA clinical trials ongoing for GM-CT-01.We filed for an IND with the FDA for GR-MD-02 in January 2013 for initiating human clinical trials in patients with NASH, and the FDA notified us inMarch 2013 that we may proceed with a Phase 1 clinical trial. Our Phase 1 clinical trial began in July 2013 and was completed in 2014. Pre-clinical studies andclinical trials are expensive, time-consuming and ultimately may not be successful. The results of pre-clinical and initial clinical testing of these products may notnecessarily indicate the results that will be obtained from later or more extensive testing. Also, it is possible to suffer significant setbacks in advanced clinical trials,even after obtaining promising results in earlier trials. For example, even though GM-CT-01 progressed successfully through Phase 1 and was progressingsuccessfully through Phase 2 human trials (which were only partially completed due to financing issues in 2010), it may fail in Phase 3 trials or in later stages ofdevelopment. We will engage others to conduct our clinical trials, including clinical research organizations and, possibly, government-sponsored agencies. Pre-clinical studies and clinical trials may not start or be completed as we forecast and may not achieve the desired results. The time required to obtain FDA and otherapprovals is unpredictable but often can take years following the commencement of clinical trials, depending upon the complexity of the drug candidate.Even if we receive regulatory approval, we may be unable to commercialize our product candidates.Even if GR-MD-02, GM-CT-01 and other future product candidates achieve positive results in clinical trials, we may be unable to commercialize them. Theavailability of government and third party payer reimbursement, and pricing, especially compared to competitor products, could affect our ability to 14® Table of Contentscommercialize our product candidates. Our general inability to obtain necessary regulatory approvals and, if obtained, to commercialize our products wouldsubstantially impair our viability.There are risks associated with our reliance on third parties to design trial protocols, arrange for and monitor the clinical trials, and collect and analyzedata.As we develop products eligible for clinical trials, we will contract with independent parties to assist us in the design of the trial protocols, arrange for andmonitor the clinical trials, collect data and analyze data. For instance, in 2015, we entered into an agreement with PPD Development, L.P. (PPD) for the purpose ofassisting us in the design, development and conduct of one or more clinical research studies from time to time. In accordance with this agreement, PPD isconducting the Phase 1 clinical trial for GR-MD-02 to evaluate the drug’s safety in subjects with NASH with advanced hepatic cirrhosis. In addition, certainclinical trials for our products may be conducted by government-sponsored agencies and will be dependent on governmental participation and funding.Additionally, GR-MD-02 is being studied by Providence Portland Medical Center in an Investigator-sponsored IND to conduct a Phase 1B study to determine ifGR-MD-02 enhances the probability of melanoma response with ipilimumab by inducing proliferation, activation and memory function of CD8+ T cells in humanpatients. This study represents a novel approach for patients with metastatic melanoma. The IND was approved by FDA in February 2014.Our dependence on independent parties and clinical sites involves risks including reduced control over the timing and other aspects of our clinical trials.There are risks associated with our reliance on third parties for manufacturing, marketing, sales, managed care and distribution infrastructure andchannels.We do not have, and do not now intend to develop, facilities for the manufacture of any of our products for clinical or commercial production. At this time,we are not a party to any long-term agreement with any of our suppliers, and accordingly, we have our products manufactured on a purchase-order basis from oneof two primary suppliers. We are developing relationships with manufacturers and will enter into collaborative arrangements with licensees or have othersmanufacture our products on a contract basis. We expect to depend on such collaborators to supply us with products manufactured in compliance with standardsimposed by the FDA and foreign regulators.We have limited experience in marketing, sales or distribution, and we do not intend to develop a sales and marketing infrastructure to commercialize ourpharmaceutical products. If we develop commercial products, we will need to rely on licensees, collaborators, joint venture partners or independent distributors tomarket and sell those products. Thus, we expect that we will be required to enter into agreements with commercial partners to engage in sales, marketing anddistribution efforts around our products in development. We may be unable to establish or maintain third-party relationships on a commercially reasonable basis, ifat all. In addition, these third parties may have similar or more established relationships with our competitors. If we do not enter into relationships with third partiesfor the sales and marketing of our proposed products, we will need to develop our own sales and marketing capabilities.Even if engaged, these distributors may: • fail to satisfy financial or contractual obligations to us; • fail to adequately market our products; • cease operations with little or no notice to us; or • offer, design, manufacture or promote competing formulations or products.If we fail to develop sales, managed care, marketing and distribution channels, we would experience delays in generating sales and incur increased costs,which would harm our financial results. 15Table of ContentsWe are exposed to product liability, pre-clinical and clinical liability risks, which could place a financial burden upon us, should we be sued, because we donot currently have product liability insurance beyond our general insurance coverage.Our business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of pharmaceuticalformulations and products; accordingly, claims may be asserted against us. In addition, the use in our clinical trials of pharmaceutical formulations and productsthat our potential collaborators may develop and the subsequent sale of such formulations or products by us or our potential collaborators may cause us to assume aportion of or all of the product liability risks. A successful liability claim or series of claims brought against us could have a material adverse effect on our business,financial condition and results of operations.Because we do not currently have any FDA-approved products or formulations, we do not currently have any product liability insurance coveringcommercialized products. We may not be able to obtain or maintain adequate product liability insurance on acceptable terms, if at all, or such insurance may notprovide adequate coverage against our potential liabilities. Furthermore, our current and potential partners with whom we have collaborative agreements or ourfuture licensees may not be willing to indemnify us against these types of liabilities and may not, themselves, be sufficiently insured or have sufficient liquidity tosatisfy any product liability claims. Claims or losses in excess of any product liability insurance coverage that may be obtained by us could have a material adverseeffect on our business, financial condition and results of operations.We face intense competition in the biotechnology and pharmaceutical industries.The biotechnology and pharmaceutical industries are intensely competitive. We face direct competition from U.S. and foreign companies focusing onpharmaceutical products, which are rapidly evolving. Our competitors include major multinational pharmaceutical and chemical companies, specializedbiotechnology firms and universities and other research institutions. Many of these competitors possess greater financial and other resources, larger research anddevelopment staffs and more effective marketing and manufacturing organizations than we possess. In addition, academic and government institutions areincreasingly likely to enter into exclusive licensing agreements with commercial enterprises, including our competitors, to market commercial products based ontechnology developed at such institutions. Our competitors may succeed in developing or licensing technologies and products that are more effective, or succeed inobtaining FDA or other regulatory approvals for product candidates before we do. Acquisitions of, or investments in, competing pharmaceutical or biotechnologycompanies by large corporations could increase such competitors’ financial, marketing, manufacturing and other resources.The market for our proposed products is rapidly changing and competitive, and new drugs and new treatments which may be developed by others couldimpair our ability to maintain and grow our business and remain competitive.The pharmaceutical and biotechnology industries are subject to rapid and substantial technological change. Developments by others may render our proposedproducts noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors. Technological competition frompharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase.As a pre-revenue company engaged in the development of drug technologies, our resources are limited and we may experience technical challenges inherentin such technologies. Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competition. Someof these technologies may have an entirely different approach or means of accomplishing similar therapeutic effects compared to our proposed products. Ourcompetitors may develop drugs that are safer, more effective and less costly than our proposed products and, therefore, present a serious competitive threat to us. 16Table of ContentsThe potential widespread acceptance of therapies that are alternatives to ours may limit market acceptance of our proposed products, even if commercialized.Many of our targeted diseases and conditions may also be treated by other medications. These treatments may be widely accepted in medical communities and havea longer history of use. The established use of these competitive drugs may limit the potential for our technologies, formulations and products to receivewidespread acceptance even if commercialized.Our lack of operating experience may cause us difficulty in managing our growth.We have limited experience in manufacturing or procuring products in commercial quantities, conducting other later-stage phases of the regulatory approvalprocess, selling pharmaceutical products, or negotiating, establishing and maintaining strategic relationships. Although we have engaged a number of consultants toassist us, any additional growth may require us to expand our management, operational and financial systems and controls. If we are unable to do so, our businessand financial condition would be materially harmed. If rapid growth occurs, it may strain our managerial, operational and financial resources.We depend on key individuals to develop our products and core technologies and pursue collaborative relationships.We are highly dependent on Peter G. Traber, M.D. Dr. Traber is our Chief Executive Officer and our Chief Medical Officer who, among other things,designs and leads our pre-clinical and clinical studies, as well as our U.S. and European regulatory processes. The loss of Dr. Traber or failure to attract or retainother key personnel could prevent us from developing our products and core technologies and pursuing collaborative relationships.We may fail to comply with our reporting and other requirements under federal securities laws.As a publicly traded company, we are subject to the reporting requirements of the Exchange Act. The Exchange Act requires that we file annual, quarterlyand current reports. Our failure to prepare and disclose this information in a timely manner could subject us to penalties under federal securities laws, expose us tolawsuits and restrict our ability to access financing. We may be required to implement additional and expensive finance and accounting systems, procedures andcontrols as we grow our business and organization to satisfy new reporting requirements, which will increase our costs and require additional managementresources.We are a defendant in a consolidated class action and in a consolidated shareholder derivative action, and these lawsuits and any future such lawsuits mayadversely affect our business, financial condition, results of operations and cash flowsWe and certain of our officers and directors are defendants in a consolidated federal securities class action lawsuit and a consolidated shareholder derivativeaction. These lawsuits are described in Part I, Item 3 “Legal Proceedings” in this Form 10-K. These lawsuits were dismissed, with prejudice in January 2016;however, these rulings have been appealed by the plaintiffs. These lawsuits may divert our attention from our ordinary business operations, and we may incursignificant expenses associated with their defense (including, without limitation, substantial attorneys’ fees and other fees of professional advisors and potentialobligations to indemnify current and former officers and directors who are or may become parties to such actions). Depending on the outcome of the class actionlawsuit, we may be required to pay material damages and fines, consent to injunctions on future conduct and/or suffer other penalties, remedies or sanctions.Accordingly, the ultimate resolution of these matters could have a material adverse effect on our business, results of operations, financial condition, liquidity andability to meet our debt obligations and, consequently, could negatively impact the trading price of our common stock. In addition, there is the potential foradditional shareholder litigation and for governmental investigations and/or enforcement actions. Any existing or future shareholder lawsuits and any futuregovernmental investigations and/or enforcement actions could adversely impact our reputation, our relationships with our customers and our ability to generaterevenue. 17Table of ContentsRisks Related to the Regulation of our ProductsWe will need regulatory approvals to commercialize our products.We are required to obtain approval (i) from the FDA in order to sell our products in the U.S. and (ii) from foreign regulatory authorities in order to sell ourproducts in other countries. The FDA’s review and approval process is lengthy, expensive and uncertain. Extensive pre-clinical and clinical data and supportinginformation must be submitted to the FDA for each indication for each product candidate in order to secure FDA approval. Before receiving FDA clearance tomarket our proposed products, we will have to demonstrate that our products are safe on the patient population and effective for the diseases that are to be treated.Clinical trials, manufacturing and marketing of drugs are subject to the rigorous testing and approval process of the FDA and equivalent foreign regulatoryauthorities. The Federal Food, Drug and Cosmetic Act and other federal, state and foreign statutes and regulations govern and influence the testing, manufacture,labeling, advertising, distribution and promotion of drugs and medical devices. As a result, regulatory approvals can take several years to acquire and may furtherrequire the expenditure of substantial financial, managerial and other resources. The FDA could reject an application or, in the alternative, require us to conductadditional clinical or other studies as part of the regulatory review process. Delays in obtaining or failure to obtain FDA approvals would delay or prevent thecommercialization of our product candidates, which would prevent, defer or decrease our receipt of revenues. In addition, should we receive initial regulatoryapproval, our product candidates will be subject to extensive and rigorous ongoing domestic and foreign government regulation.Even if we obtain regulatory approvals, our marketed drugs will be subject to ongoing regulatory review. If we fail to comply with ongoing regulatoryrequirements, we could lose our approvals to market drugs, in which case our business would be materially adversely affected.Following regulatory approval in the United States of any drugs we may develop, we will remain subject to continuing regulatory review, including thereview of adverse drug experiences and clinical results that are reported after our drug products are made available to patients. This would include results from anypost marketing tests or vigilance required as a condition of approval. The manufacturer and manufacturing facilities we use to make any of our drug products willalso be subject to periodic review and inspection by the FDA. The discovery of any new or previously unknown problems with the product, manufacturer or facilitymay result in restrictions on the drug or manufacturer or facility, including withdrawal of the drug from the market. We would continue to be subject to the FDArequirements governing the labeling, packaging, storage, advertising, promotion, recordkeeping, and submission of safety and other post-market information for allof our product candidates, even those that the FDA had approved. If we fail to comply with applicable continuing regulatory requirements, we may be subject tofines, suspension or withdrawal of regulatory approval, product recalls and seizures, operating restrictions and other adverse consequences.The drug development process to obtain FDA approval is very costly and time consuming and if we cannot complete our clinical trials in a cost-effectivemanner, our results of operations may be adversely affected.Costs and timing of clinical trials may vary significantly over the life of a project owing to the following non-exclusive reasons: • the duration of the clinical trial; • the number of sites included in the trials; • the countries in which the trial is conducted; • the length of time required and ability to enroll eligible patients; • the number of patients that participate in the trials; • the number of doses that patients receive; • the drop-out or discontinuation rates of patients; 18Table of Contents • per patient trial costs; • third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner; • our drug product candidates having different chemical and pharmacological properties in humans than in lab testing; • the need to suspend or terminate our clinical trials; • insufficient or inadequate supply or quality of drug product candidates or other necessary materials to conduct our trials; • potential additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory authorities regarding the scope or designof our clinical trials, or other studies requested by regulatory agencies; • problems engaging IRBs to oversee trials or in obtaining and maintaining IRB approval of studies; • the duration of patient follow-up; • the efficacy and safety profile of the product candidate; • the costs and timing of obtaining regulatory approvals; and • the costs involved in enforcing or defending patent claims or other intellectual property rights.Each of the above factors and other unanticipated factors beyond our control could prevent us from gaining approval for our drugs in a cost-effective andtimely manner, which could have a material adverse impact on our business.If users of our proposed products are unable to obtain adequate reimbursement from third-party payers, market acceptance of our proposed products maybe limited and we may not achieve revenues or profits.The continuing efforts of governments, insurance companies, health maintenance organizations and other payers of healthcare costs to contain or reducecosts of health care may affect our future revenues and profitability as well as the future revenues and profitability of our potential customers, suppliers andcollaborative partners in addition to the availability of capital. In other words, our ability to commercialize our proposed products will depend in large part on theextent to which appropriate reimbursement levels for the cost of our proposed formulations, products and related treatments are obtained by the health careproviders of these products and treatments. At this time we cannot predict the precise impact of the Patient Protection and Affordable Care Act of 2010, asamended by the Health Care and Education Affordability Act of 2010, the comprehensive health care reform legislation passed by Congress in March 2010. It ispossible that the adoption of this legislation could harm our business, financial condition and results of operations.Data obtained from clinical trials are not necessarily predictive of future results, may be negative or inconclusive, and are susceptible to varyinginterpretations, which could delay, limit or prevent regulatory clearances.Data already obtained, or in the future obtained, from pre-clinical studies and clinical trials do not necessarily predict the results that will be obtained fromlater pre-clinical studies and clinical trials. Moreover, pre-clinical and clinical data may be negative or inconclusive. In addition, data is susceptible to varyinginterpretations. Negative or inconclusive data, or data interpreted in various ways, could delay, limit or prevent regulatory approval. A number of companies in thepharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after having obtained promising results in earlier trials. Despite theresults reported in earlier clinical trials for GR-MD-02, our clinical trials may not demonstrate sufficient levels of safety and efficacy necessary to obtain therequisite regulatory approvals for our drugs, and thus, our proposed drugs may 19Table of Contentsnot be approved for marketing. If later-stage clinical trials do not produce favorable results, our ability to achieve regulatory approval for any of our productcandidates may be adversely impacted. The failure to adequately demonstrate the safety and effectiveness of a proposed formulation or product under developmentcould delay or prevent regulatory clearance of the potential drug. The resulting delays in commercialization could materially harm our business.Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit thecommercial profile of an approved label, or result in significant negative consequences following any marketing approval.Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result ina more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authority. Although we are not currentlyaware of any undesirable side effects caused by our product candidates, it is possible that they may be identified in the clinical trial process.As a result of undesirable side effects or safety or toxicity issues that we may experience in our clinical trials, we may not receive approval to market anyproduct candidates, which could prevent us from ever generating revenues or achieving profitability. Results of our trials could reveal an unacceptably highseverity and prevalence of side effects. In such an event, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authoritiescould order us to cease further development or deny approval of our product candidates for any or all targeted indications. These side effects could affect patientrecruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims.Additionally, if any of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such product, anumber of potentially significant negative consequences could result, including: • we may be forced to suspend marketing of such product; • regulatory authorities may withdraw their approvals of such product; • regulatory authorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success of suchproducts; • we may be required to conduct post-market studies; • we could be sued and held liable for harm caused to subjects or patients; and • our reputation may suffer.Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved.We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impactour business.A pharmaceutical product cannot be marketed in the U.S. or other countries until it has completed rigorous and extensive regulatory review processes,including approval of a brand name. Any brand names we intend to use for our product candidates will require approval from the FDA regardless of whether wehave secured a formal trademark registration from the U.S. Patent and Trademark Office, or the PTO. The FDA typically conducts a review of proposed productbrand names, including an evaluation of potential for confusion with other product names. The FDA may also object to a product brand name if it believes thename inappropriately implies medical claims. If the FDA objects to any of our proposed product brand names, we may be required to adopt an alternative brandname for our product candidates. If we adopt an alternative brand name, we would lose the 20Table of Contentsbenefit of our existing trademark applications for such product candidate and may be required to expend significant additional resources in an effort to identify asuitable product brand name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. Wemay be unable to build a successful brand identity for a new trademark in a timely manner or at all, which would limit our ability to commercialize our productcandidates.Failure to obtain regulatory approval in international jurisdictions would prevent our product candidates from being marketed abroad.In order to market and sell our products in the European Union and many other jurisdictions, we must obtain separate marketing approvals and comply withnumerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtainapproval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of therisks associated with obtaining FDA approval. In addition, in many countries outside the United States, it is required that the product be approved forreimbursement before the product can be approved for sale in that country. We may not obtain approvals from regulatory authorities outside the United States on atimely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatoryauthority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. We may not be able to filefor marketing approvals and may not receive necessary approvals to commercialize our products in any market. If we are unable to obtain approval of any of ourproduct candidates by regulatory authorities in the European Union or other countries, the commercial prospects of that product candidate may be significantlydiminished and our business prospects could decline.Risks Related to Our Intellectual PropertyOur competitive position is contingent upon the protection of our intellectual property.Development and protection of our intellectual property are critical to our business. All of our intellectual property, patented or otherwise, has been inventedand/or developed by employees or former employees of the Company. Our success depends, in part, on our ability to obtain patent protection for our products orprocesses in the U.S. and other countries, protect trade secrets and prevent others from infringing on our proprietary rights. We will only be able to protect ourproduct candidates from unauthorized making, using, selling, offering to sell or importation by third parties to the extent that we have rights under valid andenforceable patents or trade secrets that cover these activities. If we do not adequately protect our intellectual property, competitors may be able to practice ourtechnologies.The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for whichimportant legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date in theUnited States. The biotechnology patent situation outside the United States is even more uncertain. Changes in either the patent laws or in interpretations of patentlaws in the United States and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may beallowed in our pending patent applications or enforced in our issued patents or in third-party patents.The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect ourrights or permit us to gain or keep our competitive advantage. For example: • others may be able to make compounds that are competitive with our product candidates but are not covered by the claims of our patents; • we might not have been the first to make the inventions covered by our pending patent applications; 21Table of Contents • we might not have been the first to file patent applications for these inventions; • it is possible that our pending patent applications will not result in issued patents; • we may not develop additional proprietary technologies that are patentable; or • the patents of others may have an adverse effect on our business.We also may rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. However,trade secrets are difficult to protect. Although we require our scientific and technical employees and consultants to enter into broad assignment of inventionsagreements, and all of our employees, consultants and corporate partners with access to proprietary information to enter into confidentiality agreements, theseagreements may not be honored. Enforcing a claim that a third party illegally obtained, and is using, our trade secrets is expensive and time consuming, and theoutcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors mayindependently develop equivalent knowledge, methods and know-how.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 toprotect our rights to, or use of, our technology.Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection for our technologiesor products. In addition, patents issued to us or our licensors, if any, may be challenged and subsequently narrowed, invalidated or circumvented. Patent litigation iswidespread in the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent position or to determine the scope andvalidity of third-party proprietary rights.If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company would have the right to ask thecourt to rule that such patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and we may not have the requiredresources to pursue such litigation or to protect our patent rights. In addition, there is a risk that the court will decide that these patents are not valid and that we donot have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of these patents is upheld, the court will refuse tostop the other party on the ground that such other party’s activities do not infringe our rights in these patents.Furthermore, a third party may claim that we are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging inour normal operations and activities, including making or selling our product candidates. These lawsuits are costly and could affect our results of operations anddivert the attention of managerial and technical personnel. There is a risk that a court would decide that we are infringing the third party’s patents and would orderus to stop the activities covered by the patents. In addition, there is a risk that a court will order us to pay the other party treble damages for having violated theother party’s patents. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, whichpatents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not alwaysuniform. If we are sued for patent infringement, we would need to demonstrate that our products or methods of use either do not infringe the claims of the relevantpatent and/or that the patent claims are invalid, and we may not be able to do this. Proving invalidity in the U.S., in particular, is difficult since it requires a showingof clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.Because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States andmany foreign jurisdictions are typically not published until eighteen months after filing, and publications in the scientific literature often lag behind actualdiscoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications or that wewere the first to invent the technology. Our competitors may have filed, and 22Table of Contentsmay in the future file, patent applications covering technology similar to ours. Any such patent application may have priority over our patent applications and couldfurther require us to obtain rights to issued patents covering such technologies. If another party has filed a United States patent application on inventions similar toours, we may have to participate in an interference or other proceeding in the PTO or a court to determine priority of invention in the United States. The costs ofthese proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our United States patent position with respectto such inventions.Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greaterresources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raisethe funds necessary to continue our operations.Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and otherrequirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with theserequirements.The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisionsduring the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial orcomplete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been thecase.Our failure to secure trademark registration could adversely affect our ability to market our product candidates and our business.Our trademark applications in the United States, when filed, and any other jurisdictions where we may file may not be allowed for registration, and ourregistered trademarks may not be maintained or enforced. During trademark registration proceedings, we may receive rejections. Although we are given anopportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the PTO and in comparable agencies in many foreignjurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition orcancellation proceedings may be filed against our applications and/or registrations, and our applications and/or registrations may not survive such proceedings.Failure to secure such trademark registrations in the United States and in foreign jurisdictions could adversely affect our ability to market our product candidatesand our business.Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information andmay not adequately protect our intellectual property, which could impede our ability to compete.Because we operate in the highly technical field of biotechnology and pharmaceutical development, we rely in part on trade secret protection in order toprotect our proprietary trade secrets and unpatented know-how. However, trade secrets are difficult to protect, and we cannot be certain that others will not developthe same or similar technologies on their own. We have taken steps, including entering into confidentiality agreements with all of our employees, consultants andcorporate partners to protect our trade secrets and unpatented know-how. These agreements generally require that the other party keep confidential and not discloseto third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us. We alsotypically obtain agreements from these parties which provide that inventions conceived by the party in the course of rendering services to us will be our exclusiveproperty. However, these agreements may not be honored and may not effectively assign intellectual property rights to us. Enforcing a claim that a party illegallyobtained and is using our trade secrets or know-how is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside theUnited States may be less 23Table of Contentswilling to protect trade secrets or know-how. The failure to obtain or maintain trade secret protection could adversely affect our competitive position.We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other biotechnology orpharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claimsthat these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigationmay be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be adistraction to management.Risks Related to Our Common StockThe market price of our common stock may be volatile and adversely affected by several factors. This could subject us to securities class action litigationand our stockholders could incur substantial losses.The market price of our common stock could fluctuate significantly in response to various factors and events, including but not limited to: • the results of our pre-clinical studies and clinical trials, including interim results, as well as those of our competitors; • regulatory actions with respect to our products or our competitors’ products; • our ability to integrate operations, technology, products and services; • our ability to execute our business plan; • operating results below expectations; • our issuance of additional securities, including debt or equity or a combination thereof, which may be necessary to fund our operating expenses; • announcements of technological innovations or new products by us or our competitors; • the success of competitive products; • loss of any strategic relationship; • industry developments, including, without limitation, changes in healthcare policies or practices or third-party reimbursement policies; • regulatory or legal developments in the United States and other countries; • the level of expenses related to any of our product candidates or clinical development programs; • disputes or other developments related to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for ourtechnologies; • economic and other external factors; • period-to-period fluctuations in our financial results; • sales of our common stock by us, our insiders or our other stockholders; • whether an active trading market in our common stock develops and is maintained; and • engagement and retention of senior management needed for our clinical trials. 24Table of ContentsIn addition, the market price for securities of pharmaceutical and biotechnology companies historically has been highly volatile, and the securities marketshave from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These broadmarket fluctuations may cause the market price of our common stock to decline substantially.In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk isespecially relevant for us because biotechnology and biopharmaceutical companies have experienced significant stock price volatility in recent years. As describedabove, we are currently defending a consolidated federal securities class action lawsuit and a consolidated shareholder derivative action and we may becomeinvolved in additional instances of this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which couldmaterially and adversely affect our business.Additionally, fluctuations in the trading price or liquidity of our common stock may materially and adversely affect, among other things, the interest ofinvestors to purchase our common stock on the open market and, generally, our ability to raise capital.Our board of directors has the power to designate, without stockholder approval, additional series of preferred stock, the shares of which could be senior toour common stock and be entitled to conversion or voting rights that adversely affect the holders of our common stock.Our articles of incorporation authorize the issuance of capital stock including 20,000,000 authorized undesignated shares (8,001,000 designated as ofDecember 31, 2015), and empowers our board of directors to prescribe, by resolution and without stockholder approval, a class or series of undesignated shares,including the number of shares in the class or series and the voting powers, designations, rights, preferences, restrictions and the relative rights in each such class orseries. Accordingly, we may designate and issue additional shares or series of preferred stock that would rank senior to the shares of common stock as to dividendrights or rights upon our liquidation, winding-up, or dissolution.Nevada law and our charter documents could make it more difficult for a third party to acquire us and discourage a takeover, which could depress thetrading price of our common stock.Nevada corporate law and our articles of incorporation and bylaws contain provisions that could discourage, delay, or prevent a change in control of ourCompany or changes in our management that our stockholders may deem advantageous. For example, holders of our common stock do not have cumulative votingrights in the election of directors, meaning that stockholders owning a majority of our outstanding shares of common stock will be able to elect all of our directors.In addition, because we have more than 200 stockholders of record, we are subject to the “business combinations” provisions of the Nevada Revised Statutes, orNRS. These provisions could prohibit or delay a merger or other takeover or change in control attempt and, accordingly, may discourage attempts to acquire ourCompany even though such a transaction may be in our stockholders’ best interest and offer our stockholders the opportunity to sell their stock at a price above theprevailing market price.One investor and certain directors, by virtue of ownership of our securities and related rights, may be able to control the Company.The 10X Fund owns all of our issued and outstanding Series B Preferred Stock, which are convertible into 2,000,000 shares of our common stock. The 10XFund owns related warrants exercisable to purchase an aggregate of 4,000,000 shares of our common stock. As of December 31, 2015, we have issued 1,388,976shares of our common stock as dividends on the Series B Preferred Stock and 2,000,000 shares of our common stock on the exercise of warrants by 10X Fund. Inaddition, James C. Czirr, a managing member of 10X Capital Management, LLC, the general partner of the 10X Fund and one of our directors, owns or controlsapproximately 902,000 shares of our common stock, including shares of Series A on an as converted basis, and has the right to 25Table of Contentsacquire approximately 789,000 additional shares of our common stock upon the exercise of outstanding stock options (approximately 526,000 of which areexercisable as of December 31, 2015. As of December 31, 2015 on a fully diluted basis, assuming conversion of all Series B Preferred Stock and exercise of alloutstanding warrants, the 10X Fund would own approximately 26% of our then outstanding shares of common stock, which, together with the shares of ourcommon stock that would be owned by Mr. Czirr (assuming exercise of all vested options at that date), would constitute approximately 29% of the then outstandingshares.As holder of Series B Preferred Stock, the 10X Fund is entitled to elect two directors in a separate class vote, nominate three directors for election by allshares entitled to vote, and provide or withhold consent to a range of fundamental corporate actions we may wish to undertake, such as recapitalization, sale of ourCompany, and other matters. Such concentration of stock ownership and related rights could have the effect of delaying, deterring or preventing corporate eventsthat our other security holders may desire or consider beneficial to the Company, such as sales of additional securities of the Company needed to fund the ongoingclinical trial program of the Company. In addition to the conversion rights and the right to elect and nominate directors noted above, the 10X Fund, as holder of theSeries B Preferred Stock, has certain approval rights, including the right to approve certain financing transactions, as well as the right to participate in certainfinancing transactions. These rights could negatively impact our ability to raise capital in the future, which could materially and adversely affect our business.We may issue additional common stock, which might dilute the net tangible book value per share of our common stock.Our board of directors has the authority, without action or vote of our stockholders, to issue all or a part of our authorized but unissued shares. Such stockissuances could be made at a price that reflects a discount to, or a premium from, the then-current market price of our common stock. In addition, in order to raisecapital, we may need to issue securities that are convertible into or exchangeable for a significant amount of our common stock. We are currently contemplatingadditional capital raising transactions within the next twelve months, which would likely result in issuances of additional shares which would be dilutive to currentshareholders. These issuances would dilute the percentage ownership interest, which would have the effect of reducing your influence on matters on which ourstockholders vote, and might dilute the net tangible book value per share of our common stock. You may incur additional dilution if holders of stock options,whether currently outstanding or subsequently granted, exercise their options, or if warrant holders exercise their warrants to purchase shares of our common stock.A sale of a substantial number of shares of the common stock may cause the price of our common stock to decline.Our common stock is currently traded on The NASDAQ Capital Market and, despite certain increases of trading volume from time to time, there have beenperiods when it could be considered “thinly-traded,” meaning that the number of persons interested in purchasing our common stock at or near bid prices at anygiven time may be relatively small or non-existent. Finance transactions resulting in a large amount of newly issued shares that become readily tradable, or otherevents that cause current stockholders to sell shares, could place downward pressure on the trading price of our stock. Some of our shareholders have registrationrights to facilitate sales of large blocks of our common stock. We have filed a shelf registration statement to allow registered sales of up to 9.7 million shares bythese shareholders. We may consider additional capital raising transactions within the next twelve months, which would likely result in issuances of additionalshares which would be dilutive to current shareholders. In addition, the lack of a robust resale market may require a stockholder who desires to sell a large numberof shares of common stock to sell the shares in increments over time to mitigate any adverse impact of the sales on the market price of our stock.If our stockholders sell, or the market perceives that our stockholders intend to sell for various reasons, including the ending of restriction on resale or theexpiration of lock-up agreements such as those entered into in 26Table of Contentsconnection with this offering, substantial amounts of our common stock in the public market, including shares issued upon the exercise of outstanding options orwarrants, the market price of our common stock could fall. Sales of a substantial number of shares of our common stock may make it more difficult for us to sellequity or equity-related securities in the future at a time and price that we deem reasonable or appropriate. We may become involved in securities class actionlitigation that could divert management’s attention and harm our business.We have not paid cash dividends in the past and do not expect to pay cash dividends in the foreseeable future.We have never paid cash dividends on our capital stock and do not anticipate paying cash dividends on our capital stock in the foreseeable future. Thepayment of dividends on our capital stock will depend on our earnings, financial condition and other business and economic factors affecting us at such time as theboard of directors may consider relevant. If we do not pay dividends, our common stock may be less valuable because a return on your investment will only occurif the market price of our common stock price appreciates.At times, our shares of common stock and warrants have been thinly traded, so you may be unable to sell at or near ask prices or even at all if you need tosell your shares or warrants to raise money or otherwise desire to liquidate your shares or warrants.We cannot predict the extent to which an active public market for our common stock and warrants will develop or be sustained. Our common stock iscurrently traded on The NASDAQ Capital Market and experiences periods when it could be considered “thinly-traded.” This situation may be attributable to anumber of factors, including the fact that we are a small company which is relatively unknown to stock analysts, stock brokers, institutional investors and others inthe investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk averse and wouldbe reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned andviable. As a consequence, there may be periods of several days, weeks or months when trading activity in our shares is minimal, as compared to a seasoned issuerwhich has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give youany assurance that a broader or more active public trading market for our common stock will be sustained, or that current trading levels will be sustained or notdiminish. Item 1B.Unresolved Staff CommentsNone. Item 2.PropertiesWe lease 3,610 square feet for our executive offices located at 4960 Peachtree Industrial Blvd., Norcross, GA. We also lease on a month-to-month basisapproximately 300 square feet in Natick, MA, for use by research and development consultants and which is collocated with one of our research and developmentservice vendors. We believe these spaces are suitable for our present operations. Item 3.Legal ProceedingsFrom time to time, the Company is exposed to litigation relating to its operations. The Company is not currently engaged in any legal proceedings that areexpected, individually or in the aggregate, to have a material, adverse effect on its financial condition or results of operations, except as noted below:Separation AgreementIn February 2009, the Company entered into a Separation Agreement in connection with the resignation of David Platt, Ph.D., the Company’s former ChiefExecutive Officer and Chairman of the Board of Directors. In July 2014, the Company paid the $1 million severance obligation. 27Table of ContentsShareholder Class Actions and Derivative LawsuitsBetween July 30, 2014, and August 6, 2014, three putative class action complaints were filed in the United States District Court for the District of Nevada(the “Nevada District Court”) against the Company and certain of its officers and directors on behalf of all persons who purchased or otherwise acquired theCompany’s stock between January 6, 2014 and July 28, 2014. The complaints allege that the defendants made false or misleading statements in certain pressreleases and other public statements in violation of the federal securities laws and seek class certification, unspecified monetary damages, costs, and attorneys’ fees.The Company disputes the allegations in the complaints and intends to vigorously defend against the claims. On August 22, 2014, the Nevada District Courtentered an order consolidating the three cases, relieving the defendants of any obligation to respond to the complaints currently on file, and providing thatdefendants may respond to a consolidated amended complaint after it is filed by a lead plaintiff(s) to be appointed pursuant to the Private Securities LitigationReform Act of 1995. On January 5, 2015, the Nevada District Court granted Defendants’ motion to transfer the consolidated putative securities class action to theUnited States District Court for the Northern District of Georgia. On March 24, 2015, the Court appointed a lead plaintiff (“Plaintiff’). Plaintiff filed hisConsolidated Class Action Complaint (the “Complaint”) on May 8, 2015. The Complaint asserts claims on behalf of a putative class of all persons who purchasedor otherwise acquired the Company’s common stock between October 25, 2013 and July 28, 2014. The Complaint alleges that the Company and certain of itsofficers and directors (the “Class Action Individual Defendants”) violated Section 1 O(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and SECRule 10b-5 through allegedly false or misleading statements in certain SEC filings, press releases and other public statements. The Complaint further alleges thatthe Class Action Individual Defendants and one of the Company’s shareholders face liability for the alleged Section 1 O(b) and Rule 10b-5 violations pursuant toSection 20(a) of the Exchange Act. The Complaint seeks class certification, unspecified monetary damages, costs, and attorneys’ fees. The Company disputes theallegations and filed a motion to dismiss the Complaint on June 26, 2015. On December 30, 2015, the Court dismissed the putative class action with prejudice andentered a final judgment in favor of the defendants. Plaintiff has filed a notice of appeal seeking review of the dismissal order and final judgment.On August 1 and 25, 2014, persons claiming to be Galectin shareholders filed putative shareholder derivative complaints in the Nevada District Court,seeking recovery on behalf of the Company against certain of the Company’s directors and officers. On September 10, 2014, the Nevada District Court entered anorder consolidating the two cases, relieving the defendants of any obligation to respond to the initial complaints, and providing that defendants may respond to aconsolidated complaint to be filed by the plaintiffs. On January 5, 2015, the Nevada District Court granted Defendants’ motion to transfer the consolidated putativederivative litigation to the United States District Court for the Northern District of Georgia (hereinafter referred to as the “Georgia Federal Derivative Action.”) Theplaintiffs filed a consolidated complaint on February 27, 2015. On April 6, 2015, the Company and defendants filed motions to dismiss the consolidated complaint.Rather than respond to those motions, the plaintiffs sought and obtained leave to file an amended complaint. Plaintiffs filed their amended complaint (the“Complaint”) on May 26, 2015. The Complaint alleges that certain of the Company’s directors and officers (the “Derivative Action Individual Defendants”)breached their fiduciary duties to the Company’s shareholders by causing or permitting the Company to make allegedly false and misleading public statementsconcerning the Company’s financial and business prospects. The Complaint also alleges that the Derivative Action Individual Defendants violated the federalsecurities laws by allegedly making false or misleading statements of material fact in the Company’s proxy filings, committed waste of corporate assets, wereunjustly enriched, and that certain defendants breached their fiduciary duties through allegedly improper sales of Galectin stock. In addition, the Complaint allegesthat the Derivative Action Individual Defendants and one of the Company’s shareholders aided and abetted the alleged breaches of fiduciary duties. The Complaintseeks unspecified monetary damages on behalf of the Company, corporate governance reforms, disgorgement of profits, benefits and compensation by thedefendants, costs, and attorneys ‘and experts’ fees. The Company and defendants filed motions to dismiss the Complaint on July 8, 2015. On December 30, 2015,the United States District Court for the Northern District of Georgia dismissed the Georgia Federal Derivative Action with 28Table of Contentsprejudice and entered a final judgment in favor of the defendants. Plaintiffs have filed a notice of appeal seeking review of the dismissal order and final judgment.On August 29, 2014, another alleged Galectin shareholder filed a putative shareholder derivative complaint in state court in Las Vegas, Nevada, seekingrecovery on behalf of the Company against the same Galectin directors and officers who are named as defendants in the derivative litigation pending in the GeorgiaFederal Derivative Action. The plaintiff in the Nevada action subsequently filed first and second amended complaints. The second amended complaint allegesclaims for breach of fiduciary duties, unjust enrichment, and waste of corporate assets, based on allegations that are substantially similar to those asserted in theGeorgia Federal Derivative Action (except that the Nevada action does not allege violations of the federal securities laws and does not assert any claim against theGalectin shareholder named as a defendant in the Georgia Federal Derivative Action), and seeks unspecified monetary damages on behalf of the Company,corporate governance reforms, disgorgement of profits, benefits and compensation by the defendants, costs, and attorneys’ and experts’ fees. The Company anddefendants filed motions to dismiss the second amended complaint on April 22, 2015. On April 29, 2015, the plaintiffs in the Georgia Federal Derivative Actionfiled a motion to intervene in the Nevada action which, among other things, raised questions regarding the Nevada plaintiffs standing. Thereafter, the Nevadaplaintiff filed a motion to join additional plaintiffs. At a hearing held on June 11, 2015, the Nevada court: (i) granted the Georgia Federal Derivative Actionplaintiffs’ motion to intervene; (ii) directed the Georgia Federal Derivative Action plaintiffs to file a complaint in intervention; (iii) directed the Nevada plaintiff tofile a motion for leave to file a further amended complaint to add additional plaintiffs; (iv) stated that the defendants’ motions to dismiss the second amendedcomplaint were denied “at this point;” (v) ordered the Nevada action stayed until December 11 , 2015 ; and (vi) directed the parties to submit a status report onDecember 11, 2015, updating the court on the progress and status of the Georgia Federal Derivative Action. On July 9, 2015, pursuant to the Nevada State Court’sinstruction, the Georgia Federal Derivative Action plaintiffs filed a complaint-in-intervention in Nevada State Court, asserting similar claims to the ones theyalleged in the Georgia Federal Derivative Action described above. On December 11, 2015, further to the Nevada State Court’s instruction, the parties submittedstatus reports detailing the status of the Georgia Federal Derivative Action. On January 5, 2016, the Nevada State Court held a status conference during which thedismissal of the Georgia Federal Derivative Action was discussed. Subsequent to that conference, on January 19, 2016, the defendants filed a motion to dismiss theNevada State Court litigation based on the dismissal of the similar Georgia Federal Derivative Action, among other grounds. Defendants’ motion to dismiss wasfully briefed to the Nevada court in February 2016. At a hearing on March 3, 2016, the Nevada State Court granted dismissal of the Nevada State Court litigationpending entry of a final order of dismissal. Once the final order of dismissal is entered, plaintiffs will have 30 days to appeal.Estimating an amount or range of possible losses resulting from litigation proceedings is inherently difficult and requires an extensive degree of judgment,particularly where the matters involve indeterminate claims for monetary damages, are in the early stages of the proceedings, and are subject to appeal. In addition,because most legal proceedings are resolved over extended periods of time, potential losses are subject to change due to, among other things, new developments,changes in legal strategy, the outcome of intermediate procedural and substantive rulings and other parties’ settlement posture and their evaluation of the strengthor weakness of their case against us. For these reasons, we are currently unable to predict the ultimate timing or outcome of, or reasonably estimate the possiblelosses or a range of possible losses resulting from, the matters described above. Based on information currently available, the Company does not believe that anyreasonably possible losses arising from currently pending legal matters will be material to the Company’s results of operations or financial condition. However, inlight of the inherent uncertainties involved in such matters, an adverse outcome in one or more of these matters could materially and adversely affect theCompany’s financial condition, results of operations or cash flows in any particular reporting period. Item 4.Mine Safety DisclosuresNot applicable. 29Table of ContentsPART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity SecuritiesPrice Range of Common StockOur common stock began trading on The NASDAQ Capital Market under the symbol GALT effective March 23, 2012. The high and low sale prices for ourcommon stock as reported on the NASDAQ Capital Market, for the periods indicated as shown below. All share prices reflect the one-for-six reverse split, whichwas effective March 23, 2012. High Low Fiscal Year Ended December 31, 2015 First Quarter $4.50 $3.08 Second Quarter $4.11 $2.50 Third Quarter $3.33 $1.68 Fourth Quarter $3.25 $1.52 Fiscal Year Ended December 31, 2014 First Quarter $19.11 $7.90 Second Quarter $16.02 $9.80 Third Quarter $16.55 $4.28 Fourth Quarter $5.88 $3.00 30Table of ContentsPerformance graphThe following graph shows the value of an investment of $100 on December 31, 2010, in each of Galectin Therapeutics common stock, the Nasdaq BiotechIndex, the Nasdaq Composite Index. All values assume reinvestment of the pretax value of dividends and are calculated as of December 31 of each year. Thehistorical stock price performance of the Company’s common stock shown in the performance graph is not necessarily indicative of future stock price performance. The material in this performance graph is not soliciting material, is not deemed filed with the SEC, and is not incorporated by reference in any filing of theCompany under the Securities Act or the Exchange Act, whether made on, before or after the date of this filing and irrespective of any general incorporationlanguage in such filing.Holders of Common StockAs of February 26, 2016, there were 252 shareholders of record of our common stock. Because shares of our common stock are held by depositaries, brokersand other nominees, the number of beneficial holders of our shares is substantially larger than the number of record holders. Based on information available to us,we believe there are approximately 8,900 non-objecting beneficial owners of our shares of our common stock in addition to the record holders. 31Table of ContentsDividendsThere have been no cash dividends declared on our common stock since our Company was formed. Dividends are declared at the sole discretion of ourBoard of Directors. Our intention is not to declare cash dividends and retain all cash for our operations. Item 6.Selected Financial Data Years ended December 31, Consolidated Statement of Income Data: 2015 2014 2013 2012 2011 (in thousands, except per share data) Operating expenses: Research and development $13,114 $8,425 $5,688 $4,527 $3,552 General and administrative 6,965 7,005 6,416 5,372 6,857 Other income (expense) 52 (358) 16 224 (506) Net loss (20,027) (15,788) (12,088) (9,675) (10,915) Preferred stock dividends (868) (943) (867) (976) (1,568) Preferred stock accretion (229) (229) (229) (230) (230) Warrant modification — — (8,763) — — Net loss applicable to common stockholders (21,124) (16,960) (21,947) (10,881) (12,713) Basic and diluted loss per share $(0.88) $(0.78) $(1.30) $(0.72) $(1.06) Dividends paid per share — — — — — As of December 31, Consolidated Balance Sheet Data: 2015 2014 2013 2012 2011 (in millions) Total assets $26,408 $29,677 $10,713 $9,561 $6,612 Total debt — — — — — Total stockholders’ equity (deficit) 18,040 21,195 1,481 1,165 (2,125) See Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations and the Consolidated Financial Statements andaccompanying notes and previously filed Annual Reports on Form 10-K for further information regarding our consolidated results of operations and financialposition for periods reported therein and for known factors that will impact comparability of future results. Item 7.Management’s Discussion and Analysis of Financial Condition and Results of OperationsForward-Looking StatementsIn addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of Operations containsforward-looking statements as defined under Section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created therein forforward-looking statements. Such statements include, but are not limited to, statements concerning our anticipated operating results, research and development,clinical trials, regulatory proceedings, and financial resources, and can be identified by use of words such as, for example, “anticipate,” “estimate,” “expect,”“project,” “intend,” “plan,” “believe” and “would,” “should,” “could” or “may.” All statements, other than statements of historical facts, included herein thataddress activities, events, or developments that the Company expects or anticipates will or may occur in the future, are forward-looking statements, includingstatements regarding: plans and expectations regarding clinical trials; plans and expectations regarding regulatory approvals; our strategy and expectations forclinical development and commercialization of our products; potential strategic partnerships; expectations regarding the effectiveness of our products; plans forresearch and development and related costs; statements about accounting assumptions and estimates; expectations regarding liquidity and the sufficiency of cash tofund currently planned operations through March 31, 2017; our commitments and contingencies; and our 32Table of Contentsmarket risk exposure. Forward-looking statements are based on current expectations, estimates and projections about the industry and markets in which GalectinTherapeutics operates, and management’s beliefs and assumptions. These statements are not guarantees of future performance and involve certain known andunknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Such risks and uncertaintiesare related to and include, without limitation, • our early stage of development, • we have incurred significant operating losses since our inception and cannot assure you that we will generate revenue or profit, • our dependence on additional outside capital, • we may be unable to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed productcandidates, • uncertainties related to any litigation, including shareholder class actions and derivative lawsuits filed, • uncertainties related to our technology and clinical trials, including expected dates of availability of clinical data, • we may be unable to demonstrate the efficacy and safety of our developmental product candidates in human trials, • we may be unable to improve upon, protect and/or enforce our intellectual property, • we are subject to extensive and costly regulation by the U.S. Food and Drug Administration (FDA) and by foreign regulatory authorities, which mustapprove our product candidates in development and could restrict the sales and marketing and pricing of such products, • competition and stock price volatility in the biotechnology industry, • limited trading volume for our stock, concentration of ownership of our stock, and other risks detailed herein and from time to time in our SEC reports,andWe caution investors that actual results or business conditions may differ materially from those projected or suggested in forward-looking statements as aresult of various factors including, but not limited to, those described above and in the Risk Factors section of this annual report on Form 10-K. We cannot assureyou that we have identified all the factors that create uncertainties. Moreover, new risks emerge from time to time and it is not possible for our management topredict all risks, nor can we assess the impact of all risks on our business or the extent to which any risk, or combination of risks, may cause actual results to differfrom those contained in any forward-looking statements. Readers should not place undue reliance on forward-looking statements. We undertake no obligation topublicly release the result of any revision of these forward-looking statements to reflect events or circumstances after the date they are made or to reflect theoccurrence of unanticipated events.OverviewWe are a clinical stage biopharmaceutical company engaged in drug research and development to create new therapies for fibrotic disease and cancer. Ourdrug candidates are based on our method of targeting galectin proteins, which are key mediators of biologic and pathologic functions. We use naturally occurring,readily-available plant materials as starting material in manufacturing processes to create proprietary complex carbohydrates with specific molecular weights andother pharmaceutical properties. These complex carbohydrate molecules are appropriately formulated into acceptable pharmaceutical formulations. Using theseunique carbohydrate-based candidate compounds that largely bind and inhibit galectin proteins, particularly galectin-3, we are undertaking the focused pursuit oftherapies for indications where galectins have a demonstrated role in the pathogenesis of a given disease. We focus on diseases with serious, life-threateningconsequences to patients and those where current treatment options are limited. Our strategy is to establish and implement clinical 33Table of Contentsdevelopment programs that add value to our business in the shortest period of time possible and to seek strategic partners when a program becomes advanced andrequires additional resources.We endeavor to leverage our scientific and product development expertise as well as established relationships with outside sources to achieve cost-effectiveand efficient development. These outside sources, amongst others, provide us with expertise in preclinical models, pharmaceutical development, toxicology,clinical development, pharmaceutical manufacturing, sophisticated physical and chemical characterization, and commercial development. We also have establishedseveral collaborative scientific discovery programs with leading experts in carbohydrate chemistry and characterization. These discovery programs are generallyaimed at the targeted development of new carbohydrate molecules which bind galectin proteins and offer alternative options to larger market segments in ourprimary disease indications, such as subcutaneous or oral administration. We also have established a discovery program aimed at the targeted development of smallmolecules (non-carbohydrate) which bind galectin proteins and may afford options for alternative means of drug delivery (e.g., oral) and as a result expand thepotential uses of our compounds. We are pursuing a development pathway to clinical enhancement and commercialization for our lead compounds in immuneenhancement for cancer therapy as well as in both liver fibrosis and fatty liver disease. All of our proposed products are presently in development, including pre-clinical and clinical trials.Our Drug Development ProgramsGalectins are a class of proteins that are made by many cells in the body. As a group, these proteins are able to bind to sugar molecules that are part of otherproteins, glycoproteins, in and on the cells of our body. Galectin proteins act as a kind of molecular glue, bringing together molecules that have sugars on them.Galectin proteins, in particular galectin-3, are known to be markedly increased in a number of important diseases including inflammatory diseases, scarring oforgans (e.g. liver, lung, kidney, and heart) and cancers of many kinds. The increase in galectin protein promotes the disease and is detrimental to the patient.Published data show that mice lacking the galectin-3 gene, and thus unable to produce galectin-3, are incapable of developing liver fibrosis in response to toxicinsult to the liver and in fatty liver disease.We have one new chemical entity (NCE) in development, GR-MD-02, which has shown promise in preclinical and early clinical studies in treatment offibrosis and in cancer therapy. Currently we are focusing on development of GR-MD-02 intended to be used in the treatment of liver fibrosis associated with fattyliver disease (NASH), moderate to severe plaque psoriasis, and in cancer therapy in combination with immune-system modifying agent(s). GR-MD-02 is aproprietary, patented compound derived from natural, readily available, plant-based starting materials, which, following chemical processing, exhibits theproperties of binding to and inhibiting galectin-3 proteins. A second NCE, GM-CT-01 is a proprietary, patented compound that is made from a completely differentstarting source plant material and also binds and inhibits galectin proteins. Previously in clinical development for cancer indications, this compound continues to beexplored in preclinical studies. 34Table of ContentsOur product pipeline is shown below: Indication Drug StatusFibrosis NASH with Advanced Fibrosis: NASH-CX trial and NASH-FX trial GR-MD-02 IND submitted January 2013. Results from the Phase 1 clinicaltrial were reported in 2014, with final results reported in January2015. End of Phase 1 meeting held with FDA in 2014. TwoPhase 2 clinical trials are being conducted. The NASH CX trial,is designed for patients with cirrhosis, and the NASH FX trial isdesigned for patients with advanced fibrosis but not cirrhosis.The NASH FX trial top line data is expected around end of Q3-2016 and the NASH CX trial top line data is expected around theend of 2017.Lung Fibrosis GR-MD-02 In pre-clinical developmentKidney Fibrosis GR-MD-02 In pre-clinical developmentCardiac and Vascular Fibrosis GR-MD-02 and GM-CT-01 In pre-clinical developmentCancer Immunotherapy Melanoma GR-MD-02 Investigator IND submitted in December 2013. Phase 1B studyin process. A second Phase 1B study is planned to begin in1Q-2016 2016. Investigator IND for that study submitted inSeptember 2015.Psoriasis Moderate to Severe Plaque Psoriasis GR-MD-02 IND submitted March 2015. A phase 2a trial in moderate tosevere plaque psoriasis patients began in January 2016. Data isexpected around Q3-2016.Fibrosis. GR-MD-02 is our lead product candidate for treatment of fibrotic disease. Our preclinical data show that GR-MD-02 has a significant therapeuticeffect on liver fibrosis as shown in several relevant animal models. In addition, in NASH animal models GR-MD-02 has been shown to reduce liver fat,inflammation, and ballooning degeneration or death of liver cells. Therefore, we chose GR-MD-02 as the lead candidate in a development program targetedinitially at fibrotic liver disease associated with non-alcoholic steatohepatitis (NASH, or fatty liver disease). In January 2013, an Investigational New Drug (“IND”)was submitted to the FDA with the goal of initiating a Phase 1 study in patients with NASH and advanced liver fibrosis to evaluate the human safety of GR-MD-02and pharmacodynamics biomarkers of disease. On March 1, 2013, the FDA indicated we could proceed with a US Phase 1 clinical trial for GR-MD-02 with adevelopment program aimed at obtaining support for a proposed indication of GR-MD-02 for treatment of NASH with advanced fibrosis. The Phase 1 trial wascompleted and demonstrated that GR-MD-02 up to 8 mg/Kg, i.v. was safe and well tolerated and the human pharmacokinetic data defined a drug dose for use in theplanned Phase 2 trials. Additionally, there was evidence of a pharmacodynamic effect of GR-MD-02 at the 8 mg/kg dose with a decrease in alpha 2 macroglobulin,a serum marker of fibrotic activity, and a reduction in liver stiffness as determined by FibroScan . An “End of Phase 1 Meeting” was held with FDA which,amongst other items, provided guidance on the primary endpoint for the Phase 2 clinical trial.Additionally, an open label drug-drug interaction study was completed during the second quarter of 2015 with GR-MD-02 and it showed that with 8 mg/kgdose of GR-MD-02 and 2 mg/kg dose of midazolam there was 35® Table of Contentsno drug-drug interaction and no serious adverse events or drug-related adverse events were observed. This study was required by the U.S. Food and DrugAdministration (FDA) and the primary objective was to determine if single or multiple intravenous (IV) doses of GR-MD-02 affect the pharmacokinetics (PK) ofmidazolam. The secondary objective was to assess the safety and tolerability of GR-MD-02 when administered concomitantly with midazolam. The lack of a druginteraction in this study enables Galectin to expand the number of patients eligible for its Phase 2 clinical trial. In addition, should GR-MD-02 be approved formarketing, the success of this study supports a broader patient population for the drug label.Our Phase 2 program in fibrotic disease consists of two separate human clinical trials. The first clinical trial is the NASH-CX study for patients with NASHwith cirrhosis, which began enrolling in June 2015. This study is a randomized, placebo-controlled, double-blind, parallel-group Phase 2 trial to evaluate the safetyand efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH cirrhosis. A total of 156 patients atapproximately 50 sites in the United States will be randomized to receive either 2 mg/kg of GR-MD-02, 8 mg/kg of GR-MD-02 or placebo, with 52 patients in eachgroup. The primary endpoint is a reduction in change in hepatic venous pressure gradient (HVPG). Patients will receive an infusion every other week for one year,total of 26 infusions, and will be evaluated to determine the change in HVPG as compared with placebo. HVPG will be correlated with secondary endpoints offibrosis on liver biopsy as well as with measurement of liver stiffness (FibroScan ) and assessment of liver metabolism ( C-methacetin breath test, Exalenz),which are non-invasive measures of the liver that may be used in future studies. Data readout is expected by the end of 2017.The second clinical trial is the NASH-FX for patients with NASH advanced fibrosis uses a variety of non-invasive fibrosis assessment technologies. The firstpatient in this 30 patient study is was consented in September 2015, and the study is designed for 15 patients receiving 8 mg/kg of GR-MD-02 and 15 receivingplacebo to be treated. That study will evaluate the safety and efficacy of GR-MD-02 for a four month treatment period of bi-weekly infusions of GR-MD-02 onnon-invasive measures on liver stiffness as assessed imaging of liver fibrosis using multi-parametric magnetic resonance imaging (LiverMultiScan , PerspectumDiagnostics), as the primary endpoint, as well as magnetic resonance-elastography and FibroScan score, as secondary endpoints. Top-line data is expected to beavailable in the third quarter of 2016.Our drug candidate provides a promising new approach for the therapy of fibrotic diseases, and liver fibrosis in particular. Fibrosis is the formation of excessconnective tissue (collagen and other proteins plus cellular elements such as myofibroblasts) in response to damage, inflammation or repair. When the fibrotictissue becomes confluent, it obliterates the cellular architecture, leading to scarring and dysfunction of the underlying organ. Given galectin-3’s broad biologicalfunctionality, it has been demonstrated to be involved in cancer, inflammation and fibrosis, heart disease, renal disease and stroke. We have further demonstratedthe broad applicability of the actions of our galectin-3 inhibitor’s biological effect in ameliorating fibrosis involving lung, kidney and cardiac tissues in a variety ofanimal models.The focus and goal of the therapeutic program is to stop the progression of and reverse the fibrosis in the liver and, thereby improve liver function andprevent the development of complications of fibrosis/cirrhosis and liver-related mortality in patients.Cancer Immunotherapy. We believe there is potential for galectin inhibition to play a key role in the burgeoning area of cancer immunotherapy. Forexample, there have been several recent approvals of drugs that enhance a patient’s immune system to fight cancer. With many additional vaccines and immunestimulatory agents in development, industry analysts forecast that this market could generate over $35 billion in sales over the next 10 years. It is our goal to use agalectin inhibitor to enhance the immune system function to fight cancer in a way that complements other approaches to this type of therapy. Our drug candidatesprovide a promising new therapeutic approach to enhance the activity of the immune system against cancer cells. Preclinical studies have indicated that GR-MD-02enhances the immune response to cancer cells, increased tumor shrinkage and enhanced survival in immune competent mice with prostate, breast, melanoma andsarcoma cancers when 36(R) 13 (R) Table of Contentscombined with one of the immune checkpoint inhibitors, anti-CTLA-4 or anti-PD-1. These preclinical data led to the filing of an Investigator-sponsored IND andthe initiation of a study of GR-MD-02 in combination with Yervoy (ipilimumab) in a Phase 1B study of patients with metastatic melanoma. This study is beingconducted under the sponsorship of Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI). A study with Keytruda and GRMD-02 isconducted by EACRI is expected to begin enrolling by April 2016.We believe the mechanism of action for GR-MD-02 is based upon interaction with, and inhibition of, galectin proteins, particularly galectin-3, which areexpressed at high levels in certain pathological states including inflammation, fibrosis and cancer. While GR-MD-02 is capable of binding to multiple galectinproteins, we believe that it has the greatest affinity for galectin-3, the most prominent galectin implicated in pathological processes. Blocking galectin in cancer andliver fibrosis has specific salutary effects on the disease process, as discussed below.Psoriasis. During our Phase 1 NASH fibrosis trial with GR-MD-02, a clinical effect on plaque psoriasis was observed in a NASH patient who also hadthis disease. This patient had marked improvement in her psoriasis, with improvement beginning after the third infusion. She reported that her psoriasis was“completely gone” and her skin was “normal” after the fourth infusion. Her skin remained normal for 17 months after the final infusion of study drug. The patientis convinced that the improvement in her psoriasis is related to the study drug.This serendipitous finding, combined with galectin-3 protein being markedly upregulated in the capillary epithelia (small blood vessels) of the psoriaticdermis (plaque lesions), led to a phase 2a trial in patients with moderate to severe plaque psoriasis. GR-MD-02 inhibition of galectin-3 may attenuate capillarychanges in the psoriatic dermis and inflammatory recruitment, perhaps explaining the improvements observed in the NASH fibrosis trial patient. In this open-label,unblinded trial (no placebo, all patients knowingly receive active drug), 10 patients with moderate to severe plaque psoriasis are administered GR-MD-02 everytwo weeks for 12 weeks. We anticipate top line data for this trial by the end of the third quarter of 2016.Results of Operations from the Years Ended December 31, 2015 and 2014Research and Development Expense Year ended December 31, 2015 as Compared to 2014 2015 2014 $ Change % Change (in thousands, except %) Research and development $13,114 $8,425 $4,689 56% We generally categorize research and development expenses as either direct external expenses, comprised of amounts paid to third party vendors forservices, or all other research and development expenses, comprised of employee payroll and general overhead allocable to research and development. We considera clinical program to have begun upon acceptance by the FDA, or similar agency outside of the United States, to commence a clinical trial in humans, at which timewe begin tracking expenditures by the product candidate. Clinical program expenses comprise payments to vendors related to preparation for, and conduct of, allphases of the clinical trial, including costs for drug manufacture, patient dosing and monitoring, data collection and management, oversight of the trials and reportsof results. Pre-clinical expenses comprise all research and development amounts incurred before human trials begin, including payments to vendors for servicesrelated to product experiments and discovery, toxicology, pharmacology, metabolism and efficacy studies, as well as manufacturing process development for adrug candidate.We have two product candidates, GR-MD-02 and GM-CT-01; however only GR-MD-02 is in active development. We filed for an IND for GR-MD-02 inJanuary 2013 and in February 2013 we entered into an agreement with CTI to conduct a Phase 1 clinical trial of GR-MD-02. In March 2013, the FDA indicated we 37® Table of Contentscould proceed with a Phase 1 human clinical trial of GR-MD-02, and we began enrolling patients in the third quarter of 2013. In January 2014, we completed theenrollment of the first cohort of patients in the Phase 1 trial with no serious adverse events being reported. We reported initial safety and tolerability results fromthe first cohort of patients on March 31, 2014. The second cohort of this Phase 1 trial began and enrollment was completed in April 2014. In July 2014, we reportedthe results from the second cohort of patients. Enrollment of the third cohort of Phase 1 began in July 2014 with interim results presented in November 2014 withthe final report on cohort 3 presented in January 2015. The results of the Phase 1 study demonstrate that (i) GR-MD-02 was safe and well tolerated by patients withadvanced NASH liver fibrosis after IV administration of four doses of 2 mg/kg, 4 mg/kg and 8mg/kg lean body weight, (ii) Pharmacokinetics revealed drugexposure in humans at the 8 mg/kg dose that was equivalent to the upper range of the targeted therapeutic dose determined from effective doses in NASH animalmodels, (iii) Disease Serum Marker Effect showed there was a statistically significant, dose-dependent reduction in FibroTest scores due to a statisticallysignificant reduction in alpha-2 macroglobulin (A2M) serum levels, and (iv) Liver Stiffness Effect, as measured by FibroScan showed that there was a signal ofreduced liver stiffness in patients receiving GR-MD-02. The reduction seen in A2M does not necessarily mean fibrosis got better in this short study, but doessuggest changes in the fibrogenic process that might lead to an improvement in fibrosis with longer-term therapy. These Phase 1 results in NASH patients withadvanced fibrosis provide a firm foundation for entry into a Phase 2 development program.The Company held an “End of Phase 1 meeting” with the FDA and, amongst other things, received guidance on the primary endpoints for a Phase 2 trial. InPhase 2 we are exploring two indications, NASH cirrhosis and NASH with advanced fibrosis. The NASH-CX trial is designed to target a patient population withcirrhosis due to NASH. The study endpoints will include those that are closely associated with outcomes in patients with cirrhosis with the primary endpoint:chosen as hepatic venous pressure gradient (HVPG). HVPG is reflective of portal pressure and portal hypertension is responsible for most of the complicationsresulting from cirrhosis; a reduction in HVPG is associated with a reduction in complications of cirrhosis and reduced mortality. Planned secondary endpointsinclude: morphometric analysis of collagen on liver biopsies, a change in histopathological stage, and other secondary endpoints will include non-invasive tests toevaluate for correlation with HVPG and liver collagen. We have awarded the contract for the NASH-CX trial to a CRO, PPD Development, L.P., and enrollmentbegan in June 2015 to assess the efficacy of GR-MD-02 in patients with NASH cirrhosis. On March 11, 2016, we entered into a Project Addendum Modificationwith PPD Development, L.P. (“PPD”) amending our Project Addendum to Master Services Agreement for clinical management services, which we entered into onMarch 6, 2015. Pursuant to the Project Addendum Modification, the parties have revised the timeline, the budget and payment schedule for the trial. Under therevised budget, Galectin will pay PPD to a sum anticipated not to exceed approximately $22,746,691 (increased from $14,941,804), consisting of direct fees of$9,084,692 (increased from $8,866,490) and pass through costs estimated at $13,661,998 (increased from $6,075,313). The primary reasons for the increase are toreflect actual costs related to the treatment of the patients which were estimated in the original Project Addendum and for costs related to the evaluation of theendpoints in the trial which were not determined at the time of and therefore not included in the original Project Addendum. The foregoing description of theProject Addendum Modification is a summary only and is qualified by reference to the full text of the Project Addendum. The Project Addendum Modification isattached hereto as Exhibit 10.50 and is incorporated herein by reference. The timing of initial results from the NASH-CX are dependent upon the rate of patientenrollment, amongst other factors, but we anticipate top line results around the end of 2017. In the indication of NASH with advanced fibrosis, we are conducting asingle site, placebo controlled, randomized clinical trial (NASH-FX) to evaluate 4 months of treatment on patients with stage 3 bridging fibrosis. This trial wasinitiated in the third quarter of 2015 with top line results expected to be available around the end of the third quarter of 2016. Our Phase 2 clinical program isdesigned to position the Company for a strong Phase 3 clinical trial program.Additionally, during the Phase 1 clinical trial, there appeared to be a potential beneficial effect on at least one patient’s moderate to severe psoriasis. As aresult, we are conducting a single site, 10 patient, open label clinical trial with GR-MD-02 to determine whether more extensive studies in this indication arewarranted. Enrollment of patients in this trial began in January 2016. 38® ® Table of ContentsAn open label drug-drug interaction study was completed with GR-MD-02 and it showed that with 8 mg/kg dose of GR-MD-02 and 2 mg/kg dose ofmidazolam there was no drug-drug interaction and no serious adverse events or drug-related adverse events were observed. This study was required by the FDAand the primary objective was to determine if single or multiple intravenous (IV) doses of GR-MD-02 affect the pharmacokinetics (PK) of midazolam. Thesecondary objective was to assess the safety and tolerability of GR-MD-02 when administered concomitantly with midazolam. The lack of a drug interaction in thisstudy enables Galectin to expand the number of patients eligible for its Phase 2 clinical trial. In addition, should GR-MD-02 be approved for marketing, the successof this study supports a broader patient population for the drug label.Based on guidance from FDA and in furtherance of its understanding of the GR-MD-02 molecule, we continue to enhance its chemistry, manufacturing andcontrol procedures on GR-MD-02 active pharmaceutical ingredient (API) as well as on the finished, sterile, pharmaceutical dosage form. Various state of the artand cutting-edge analytical technologies are being utilized, for example, to characterize and quantify the backbone vs. side-chain constituents and their quantitation,use of sophisticated linkage analysis with 2-D NMR to provide both qualitative and quantitative information on the proportion of oligomers, degree of methylation,as well as other monoclonal specific antibody techniques to map GR oligomer integrity and distribution. The Company has also characterized how the GR moleculebehaves under conditions of forced degradation.Our research and development expenses were as follows: Year Ended December 31, 2015 2014 (in thousands) Direct external expenses: Clinical programs $9,177 $3,572 Pre-clinical activities 1,531 2,499 Other research and development expenses: Payroll and other including stock based compensation 2,406 2,354 $13,114 $8,425 Clinical programs expenses increased primarily due to costs related to our Phase 2 clinical trials during the year ended December 31, 2015 as compared tothe same period in 2014. As we continue enroll patients in the Phase 2 trials we expect our clinical activities costs will increase and may fluctuate from quarter toquarter as the trial progresses. Pre-clinical activities decreased primarily because we have completed pre-clinical work directly related to our Phase 2 clinical trialprogram. Payroll and other expenses increased in 2015 over 2014 primarily due to the hiring of the executive director of clinical development in 2015 offset bylower stock based compensation expense in 2015.Both the time required and costs we may incur in order to commercialize a drug candidate that would result in material net cash inflow are subject tonumerous variables, and therefore we are unable at this stage of our development to forecast useful estimates. Variables that make estimates difficult include thenumber of clinical trials we may undertake, the number of patients needed to participate in the clinical trial, patient recruitment uncertainties, trial results as to thesafety and efficacy of our products, and uncertainties as to the regulatory agency response to our trial data prior to receipt of marketing approval. Moreover, theFDA or other regulatory agencies may suspend clinical trials if we or an agency believes patients in the trial are subject to unacceptable risks, or find deficiencies inthe conduct of the clinical trial. Delays or rejections may also occur if governmental regulation or policy changes during our clinical trials or in the course of reviewof our clinical data. Due to these uncertainties, accurate and meaningful estimates of the ultimate cost to bring a product to market, the timing of costs andcompletion of our program and the period during which material net cash inflows will commence are unavailable at this time. 39Table of ContentsGeneral and Administrative Expense Year ended December 31, 2015 as Compared to 2014 2015 2014 $ Change % Change (in thousands, except %) General and administrative $6,965 $7,005 $(40) (1)% General and administrative expenses consist primarily of salaries including stock based compensation, legal and accounting fees, insurance, investorrelations, business development and other office related expenses. The primary reasons for the decrease for the year ended December 31, 2015 as compared to thesame period for 2014 are due to, decreased legal expenses of $340,000, decreased stock based compensation of $457,000 offset by increases in investor relationsactivities of $278,000 and increases in insurance of $194,000.Other Income and ExpenseDuring the year ended December 31, 2015, other income and expense consisted of interest income.Results of Operations from the Years Ended December 31, 2014 and 2013Research and Development Expense Year ended December 31, 2014 as Compared to 2013 2014 2013 $ Change % Change (in thousands, except %) Research and development $8,425 $5,688 $2,737 48% Our research and development expenses were as follows: Year Ended December 31, 2014 2013 (in thousands) Direct external expenses: Clinical programs $3,572 $2,235 Pre-clinical activities 2,499 1,701 Other research and development expenses: Payroll and other, including stock based compensation 2,354 1,752 $8,425 $5,688 Clinical programs and pre-clinical expenses cost increases for the year ended December 31, 2014, compared to the same period in 2013, were due toincreases in costs related to our Phase 1 clinical trial of $367,000 and drug manufacturing costs of $970,000. Pre-clinical activities increase is related to activities tosupport our planned Phase 2 program. We have completed our Phase 1 trial for GR-MD-02 and are preparing for our Phase 2 program, and expect our clinical andpre-clinical program costs will increase substantially.Both the time required and costs we may incur in order to commercialize a drug candidate that would result in material net cash inflow are subject tonumerous variables, and therefore we are unable at this stage of our development to forecast useful estimates. Variables that make estimates difficult include thenumber of clinical trials we may undertake, the number of patients needed to participate in the clinical trial, patient recruitment uncertainties, trial results as to thesafety and efficacy of our product, and uncertainties as to the regulatory agency response to our trial data prior to receipt of marketing approval. Moreover, theFDA or other regulatory 40Table of Contentsagencies may suspend clinical trials if we or an agency believes patients in the trial are subject to unacceptable risks, or find deficiencies in the conduct of theclinical trial. Delays or rejections may also occur if governmental regulation or policy changes during our clinical trials or in the course of review of our clinicaldata. Due to these uncertainties, accurate and meaningful estimates of the ultimate cost to bring a product to market, the timing of costs and completion of ourprogram and the period during which material net cash inflows will commence are unavailable at this time. However, we expect to continue to have substantialresearch and development expenses for the foreseeable future as we continue to develop our products.General and Administrative Expense Year ended December 31, 2014 as Compared to 2013 2014 2013 $ Change % Change (in thousands, except %) General and administrative $7,005 $6,416 $589 9% General and administrative expenses consist primarily of salaries including stock based compensation, legal and accounting fees, insurance, investorrelations, business development and other office related expenses. The primary reasons for the increase for the year ended December 31, 2014 as compared to thesame period for 2013 are due to, increased legal expenses of $407,000 related to our arbitration with Dr. Platt which was settled in 2014 and includes the $150,000retention of legal fees we paid in connection with the shareholder suits filed in 2014 and increased insurance expense of $115,000.Other Income and ExpenseDuring the year ended December 31, 2014, other income and expense consisted primarily of the $400,000 loss on equity method investment in GalectinSciences LLC.Liquidity and Capital ResourcesAs described above in the Overview and elsewhere in this Annual Report on Form 10-K, we are in the development stage and have not generated anyrevenues to date. Since our inception on July 10, 2000, we have financed our operations from proceeds of public and private offerings of debt and equity. As ofDecember 31, 2015, we raised a net total of $122.5 million from these offerings. At December 31, 2015, the Company had $25.8 of unrestricted cash and cashequivalents available to fund future operations. The Company currently believes there is sufficient cash to fund currently planned operations through March 31,2017. We will require more cash to fund our operations after March 31, 2017 and believe we will be able to obtain additional financing. However, there can be noassurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us. If we are unsuccessful inraising additional capital to fund operations before March 31, 2017, we may be required to cease operations or seek bankruptcy protection.2015 compared to 2014Net cash used in operations increased by $4,557,000 to $16,983,000 for 2015, as compared to $12,426,000 for 2014. Cash operating expenses increasedprincipally due to increased research and development activities primarily related to our Phase 2 clinical programs.There were no equipment purchases or other investing activities in 2015.Net cash provided by financing activities was $13,701,000 during 2015 as compared to $31,465,000 during 2014, due primarily to the transactions describedbelow.In 2015, we completed an offering of common stock and warrants for net proceeds of $9,129,000 and $4,572,000 from sales of our common stock throughAt the Market issuances. In 2014, we received $2,128,000 from the exercise of stock options and warrants. Additionally, in 2014, we received $29,337,000 fromsales of our common stock through At the Market issuances. 41Table of Contents2014 compared to 2013Net cash used in operations increased by $4,942,000 to $12,426,000 for 2014, as compared to $7,484,000 for 2013. Cash operating expenses increasedprincipally due to increased research and development activities primarily related to our fibrosis development and Phase 1 clinical trial for GR-MD-02 begun in2013.There were no equipment purchases or other investing activities in 2014.Net cash provided by financing activities was $31,465,000 during 2014 as compared to $8,609,000 during 2013, due primarily to the transactions describedbelow.In 2014, we received $2,128,000 from the exercise of stock options and warrants. Additionally, in 2014, we received $29,337,000 from sales of our commonstock through At the Market issuances. In 2013, we received $4,776,000 from the exercise of stock options and warrants. Additionally, in 2013, we received$3,000,000 from a private placement of unregistered common stock and received $833,000 in net proceeds from our at the market stock issuance program.Operating leases.In September 2012, the Company entered into an operating lease for office space in Norcross, GA for a term of twenty-six months, beginning on October 1,2012 and ending November 30, 2014 at a rate of approximately $3,000 per month. In June 2014, the Company signed an amendment to the lease extending theterm through November 30, 2017 with a base monthly rental of approximately $3,300 through the extended term. The original lease provided for free rent for thefirst two months of the lease and required a security deposit of $6,000. In addition to base rental payments included in the contractual obligations table above, theCompany is responsible for our pro-rata share of the operating expenses for the building.In October 2012, the Company entered into an operating lease for office space collocated with lab space for research and development activities. The lease isfor a period of one year, beginning on October 1, 2012, for a rate of $15,000 for the term, payable in equal monthly increments. This lease was continued on amonth to month basis from October 1, 2013.Other . We have engaged outside vendors for certain services associated with our clinical trials. These services are generally available from severalproviders and, accordingly, our arrangements are typically cancellable on 30 days notice.Off-Balance Sheet ArrangementsWe have not created, and are not a party to, any special-purpose or off-balance sheet entities for the purpose of raising capital, incurring debt or operatingparts of our business that are not consolidated into our financial statements. We do not have any arrangements or relationships with entities that are notconsolidated into our financial statements that are reasonably likely to materially affect our liquidity or the availability of capital resources.Contractual Obligations and CommitmentsThe following table summarizes contractual obligations and commitments as of December 31, 2015: Contractual Obligations Payments due by period (in thousands) Total Less than1 year 1-3 years 3-5 years More than5 yearsOperating Leases $81 $40 $41 Total $81 $40 $41 Critical Accounting Policies and EstimatesOur significant accounting policies are more fully described in Note 2 to our consolidated financial statements included elsewhere in this annual report onForm 10-K. Certain of our accounting policies, however, 42Table of Contentsare critical to the portrayal of our financial position and results of operations and require the application of significant judgment by our management, which subjectsthem to an inherent degree of uncertainty. In applying our accounting policies, our management uses its best judgment to determine the appropriate assumptions tobe used in the determination of certain estimates. Our more significant estimates include stock option and warrant liability valuations and performance vestingfeatures of certain of these instruments, useful lives and potential impairment of property and equipment and intangible assets, accrued liabilities, deferred incometaxes and cash flow. These estimates are based on our historical experience, terms of existing contracts, our observance of trends in the industry, informationavailable from other outside sources, and on various other factors that we believe to be appropriate under the circumstances. We believe that the critical accountingpolicies discussed below involve more complex management judgment due to the sensitivity of the methods, assumptions and estimates necessary in determiningthe related asset, liability, revenue and expense amounts.Accrued Expenses . As part of the process of preparing our consolidated financial statements, we are required to estimate accrued expenses. This processinvolves identifying services that third parties have performed on our behalf and estimating the level of service performed and the associated cost incurred on theseservices as of each balance sheet date in our consolidated financial statements. Examples of estimated accrued expenses include contract service fees in conjunctionwith pre-clinical and clinical trials, professional service fees, such as those arising from the services of attorneys and accountants and accrued payroll expenses. Inconnection with these service fees, our estimates are most affected by our understanding of the status and timing of services provided relative to the actual servicesincurred by the service providers. In the event that we do not identify certain costs that have been incurred or we under- or over-estimate the level of services orcosts of such services, our reported expenses for a reporting period could be understated or overstated. The date on which certain services commence, the level ofservices performed on or before a given date, and the cost of services are often subject to our judgment. We make these judgments based upon the facts andcircumstances known to us in accordance with accounting principles generally accepted in the U.S.Research and Development Expenses. Costs associated with research and development are expensed as incurred. Research and development expensesinclude, among other costs, salaries and other personnel-related costs, and costs incurred by outside laboratories and other accredited facilities in connection withclinical trials and preclinical studies.Stock-Based Compensation . Stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expenseover the service period, which generally represents the vesting period. For awards that have performance based vesting conditions the Company recognizes theexpense over the estimated period that the awards are expected to be earned. The Company generally uses the Black-Scholes option-pricing model to calculate thegrant date fair value of stock options. For options that only vest upon the achievement of market conditions, the Company values the options using a Monte Carlomodel to calculate the grant date fair value of the stock options. The expense related to options that vest based on market conditions is not reversed should thoseoptions not ultimately vest. The expense recognized over the service period is required to include an estimate of the awards that will be forfeited. Stock optionsissued to non-employees are accounted for in accordance with the provisions of ASC Subtopic 505-50, Equity-Based Payments to Non-employees, which requiresvaluing the stock options using an option pricing model (the Company uses Black-Scholes) and measuring such stock options to their current fair value when theyvest. Item 7A.Quantitative and Qualitative Disclosures About Market RiskDue to the nature of our operations, assets and absence of debt, we are not exposed to any significant market risks at December 31, 2015 and 2014. Item 8.Financial Statements and Supplementary DataThe financial statements required by this item are attached to this Annual Report on Form 10-K beginning on Page F-1. 43Table of ContentsItem 9.Changes in and Disagreements With Accountants on Accounting and Financial DisclosureNone. Item 9A.Controls and Procedures(a) Evaluation of Disclosure Controls and ProceduresAs required by Rule 13a-15 under the Securities Exchange Act of 1934, (the “Exchange Act”) as of the end of the period covered by this Annual Report, wecarried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness ofour disclosure controls and procedures as of December 31, 2015. Our management has concluded, based on their evaluation, that our disclosure controls andprocedures were effective as of December 31, 2015 to ensure that information required to be disclosed by us in the reports we file or submit under the ExchangeAct is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.(b) Management’s Annual Report on Internal Control Over Financial ReportingManagement of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. As defined in Rule 13a-15(f)under the Exchange Act, internal control over financial reporting is a process designed by, or under the supervision of, a company’s principal executive andprincipal financial officers and effected by a company’s board of directors, management and other personnel, to provide reasonable assurance regarding thereliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Itincludes those policies and procedures that:a) Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company;b) Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generallyaccepted accounting principles, and that receipts and expenditures of a company are being made only in accordance with authorizations of management and theboard of directors of the Company; andc) Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that couldhave a material effect on its financial statements.Because of the inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance withthe policies or procedures may deteriorate.The Company’s management has used the criteria established in “Internal Control-Integrated Framework” issued by the Committee of SponsoringOrganizations of the Treadway Commission (2013 framework), or COSO, to evaluate the effectiveness of the Company’s internal control over financial reporting.Management has selected the COSO 2013 framework for its evaluation as it is a control framework recognized by the SEC and the Public Company AccountingOversight Board, that is free from bias, permits reasonably consistent qualitative and quantitative measurement of the Company’s internal controls, is sufficientlycomplete so that relevant controls are not omitted, and is relevant to an evaluation of internal controls over financial reporting.Management conducted an evaluation of internal controls based on the COSO 2013 framework. The evaluation included a full scale, documented riskassessment, based on the principles described in the framework, 44Table of Contentsand included identification of key controls. Management completed documentation of its testing to verify the effectiveness of the key controls. Based on theevaluation, management concluded that our internal control over financial reporting was effective as of December 31, 2015.The effectiveness of the Company’s internal control over financial reporting has been audited by our independent registered public accounting firm, as statedin their attestation report appearing below, which expresses an unqualified opinion on the effectiveness of the Company’s internal control over financial reportingas of December 31, 2015.(c) Changes in Internal Control Over Financial ReportingThere was no change in our internal control over financial reporting that occurred during the fourth quarter of 2015 that has materially affected, or isreasonably likely to materially affect, our internal control over financial reporting. Item 9B.Other InformationNone. 45Table of ContentsPART III Item 10.Directors, Executive Officers and Corporate GovernanceThe information required by this Item will be contained in our definitive Proxy Statement to be filed with the Securities and Exchange Commission, or SEC,in connection with our Annual Meeting of Stockholders (the “2016 Proxy Statement”) under the captions “Election of Directors,” “Board of Directors Meetingsand Committees of the Board,” “Executive Officers” and “Section 16(a) Beneficial Ownership Reporting Compliance” and is incorporated herein by reference.We have adopted a Code of Ethics that applies to all our directors, officers and employees. The Code of Ethics is publicly available on our website atwww.galectintherapeutics.com. Amendments to the Code of Ethics and any grant of a waiver from a provision of the Code of Ethics requiring disclosure underapplicable SEC rules will be disclosed on our website.On March 11, 2016, our Board of Directors adopted amendments to Article II, Section 2.13(i) of the Amended and Restated Bylaws of the Company,effective immediately, regarding the stockholder vote required in connection with the election of directors. Section 2.13(i) of the Bylaws was amended in order toprovide that directors will be elected by a majority of the votes cast by each of the holders of the shares of capital stock present and entitled to vote at the meeting.Previously, the Bylaws provided that directors would be elected by a plurality of the votes cast by each of the holders of the shares of capital stock present andentitled to vote at the meeting. Section 2.13(i) of the Bylaws was further amended in order to provide that in the event the number of directors receiving a majorityvote of the shares cast exceeds the number of available director positions, then, of the directors with a majority of the votes cast, those directors with a plurality ofthe votes cast would be elected as the directors of the Board. Previously, the Bylaws were silent on this issue. Item 11.Executive CompensationThe information required by this Item will be incorporated by reference from the information under the caption “Compensation of Named ExecutiveOfficers” contained in our 2016 Proxy Statement. Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder MattersThe information required by this item will be incorporated by reference from the information under the caption “Security Ownership of Certain BeneficialOwners and Management” contained in our 2016 Proxy Statement. Item 13.Certain Relationships, Related Transactions and Director IndependenceThe information required by this item will be incorporated by reference from the information under the caption “Certain Relationships and RelatedTransactions” contained in our 2016 Proxy Statement. Item 14.Principal Accountant Fees and ServicesThe information required by this item will be incorporated by reference from the information under the captions “Audit Fees”, “Audit-Related Fees,” “TaxFees,” “All Other Fees” and “Pre-Approval Policies and Procedures” contained in our 2016 Proxy Statement. 46Table of ContentsPART IV Item 15.Exhibits and Financial Statement Schedules (a) 1.Consolidated Financial Statement SchedulesThe Consolidated Financial Statements are filed as part of this report. 2.Consolidated Financial Statement Schedules All schedules are omitted because of the absence of conditions under which they are required or because the required information is included in theConsolidated Financial Statements or notes thereto. 3.Exhibits Exhibit Number Description of Document 3.1 Amended and Restated Articles of Incorporation of Galectin Therapeutics Inc. (Incorporated by reference to the Company’s Current Report onForm 8-K filed with the Commission on May 30, 2012.) 3.2* Amended and Restated Bylaws of Galectin Therapeutics Inc., as amended. 3.3 Certificate of Designation of Preferences, Rights and Limitations of Series A 12% Convertible Preferred Stock of Pro Pharmaceuticals, Inc., asfiled with the Secretary of State of the State of Nevada on October 5, 2007. (Incorporated by reference to the Company’s Current Report onForm 8-K filed with the Commission on October 9, 2007.) 3.4 Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Convertible Preferred Stock and Series B-2 ConvertiblePreferred Stock of Pro Pharmaceuticals, Inc., as filed with the Secretary of State of the State of Nevada on February 11, 2009. (Incorporatedby reference to the Company’s Current Report on Form 8-K filed with the Commission on February 18, 2009.) 3.5 Certificate of Amendment to the Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Convertible Preferred Stockand Series B-2 Convertible Preferred Stock of Pro-Pharmaceuticals, Inc., as filed with the secretary of State of the State of Nevada onAugust 12, 2009. (Incorporated by reference to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2009 as filedwith the Commission on August 14, 2009.) 3.6 Certificate of Amendment No. 2 to the Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Convertible PreferredStock and Series B-2 Convertible Preferred Stock, as filed with the State of Nevada, on February 17, 2010. (Incorporated by reference to theCompany’s Current Report on Form 8-K as filed with the Commission on February 17, 2010.) 3.7 Certificate of Amendment with respect to the Amended and Restated Certificate of Designation of Preferences, Rights and Limitation of SeriesB-1 Convertible Preferred Stock and Series B-2 Convertible Preferred Stock of Pro-Pharmaceuticals, Inc., as filed with the Secretary ofState of the State of Nevada on January 26, 2011. (Incorporated by reference to the Company’s Current Report on Form 8-K as filed with theCommission on January 27, 2011.) 3.8 Certificate of Designation of Preferences, Rights and Limitation of Series C Super Dividend Convertible Preferred Stock of Pro-Pharmaceuticals, Inc., as filed with the Secretary of State of Nevada on December 30, 2010. (Incorporated by reference to the Company’sCurrent Report on Form 8-K as filed with the Commission on January 6, 2011.) 3.9 Certificate of Change as filed with the Nevada Secretary of State on March 1, 2012. (Incorporated by reference to the Company’s CurrentReport on Form 8-K as filed with the Commission on March 23, 2012.) 47Table of ContentsExhibit Number Description of Document 4.1 Form of Class A-1 Common Stock Purchase Warrant (Incorporated by reference to the Company’s Current Report on Form 8-K filed with theCommission on February 18, 2009.) 4.2 Form of Class A-2 Common Stock Purchase Warrant (Incorporated by reference to the Company’s Current Report on Form 8-K filed with theCommission on February 18, 2009.) 4.3 Form of Class B Common Stock Purchase Warrant (Incorporated by reference to the Company’s Current Report on Form 8-K filed with theCommission on February 18, 2009.) 4.4 Amended Form of Class A-1 Common Stock Purchase Warrant (Incorporated by reference to the Company’s Current Report on Form 8-K asfiled with the Commission on January 27, 2011.) 4.5 Amended Form of Class A-2 Common Stock Purchase Warrant (Incorporated by reference to the Company’s Current Report on Form 8-K asfiled with the Commission on January 27, 2011.) 4.6 Amended Form of Class B Common Stock Purchase Warrant (Incorporated by reference to the Company’s Current Report on Form 8-K as filedwith the Commission on January 27, 2011.) 4.7 Form of Warrant Agreement between Galectin Therapeutics Inc. and Continental Stock Transfer and Trust Company, as warrant agent (includingform of warrant certificate) (Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission onMarch 23, 2012.) 4.8 Form of Common Stock Purchase Warrant (Incorporated by reference to the Company’s Current Report on Form 8-K as filed with theCommission on November 20, 2015.)10.1† Pro-Pharmaceuticals, Inc. 2001 Stock Incentive Plan. (Incorporated by reference to the Company’s Quarterly Report on Form 10-QSB for thequarter ended September 30, 2001 filed with the Commission on November 14, 2001.)10.2† Pro-Pharmaceuticals, Inc. 2003 Non-employee Director Stock Incentive Plan. (Incorporated by reference to the Company’s RegistrationStatement on Form S-8, as filed with the Commission on October 22, 2003.)10.3† Employment Agreement, effective January 2, 2004, between Pro Pharmaceuticals, Inc. and David Platt. (Incorporated by reference to theCompany’s Annual Report on Form 10-K for the fiscal year ended December 31, 2003, as filed with the Commission on March 30, 2004.)10.4† Form of Incentive Stock Option Agreement (under the 2001 Stock Incentive Plan). (Incorporated by reference to the Company’s QuarterlyReport on Form 10-Q for the period ended September 30, 2004 as filed with the Commission on November 19, 2004.)10.5† Form of Non-Qualified Stock Option Agreement (under the 2001 Stock Incentive Plan). (Incorporated by reference to the Company’s QuarterlyReport on Form 10-Q for the period ended September 30, 2004 as filed with the Commission on November 19, 2004.)10.6† Form of Non-Qualified Stock Option Agreement (under the 2003 Non-Employee Director Stock Incentive Plan). (Incorporated by reference tothe Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2004 as filed with the Commission on November 19,2004.)10.7 Form of Common Stock Purchase Warrant. (Incorporated by reference to the Company’s Current Report on Form 8-K as filed with theCommission on February 15, 2008.)10.8 Promissory Note dated February 12, 2009 issued by Pro Pharmaceuticals, Inc. in favor of 10X Fund, L.P. (Incorporated by reference to theCompany’s Current Report on Form 8-K filed with the Commission on February 18, 2009.)10.9 Security Agreement dated February 12, 2009 between Pro Pharmaceuticals, Inc. and 10X Fund, L.P. (Incorporated by reference to theCompany’s Current Report on Form 8-K filed with the Commission on February 18, 2009.) 48Table of ContentsExhibit Number Description of Document10.10 Escrow Agreement dated February 12, 2009 among Pro Pharmaceuticals, Inc., 10X Fund, L.P. and Investment Law Group of Gillett, Mottern &Walker, LLP, as Escrow Agent. (Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Commission onFebruary 18, 2009.)10.11 Registration Rights Agreement dated February 12, 2009 between Pro Pharmaceuticals, Inc. and 10X Fund, L.P. (Incorporated by reference to theCompany’s Current Report on Form 8-K filed with the Commission on February 18, 2009.)10.12† Separation Agreement dated February 12, 2009 between Pro Pharmaceuticals, Inc. and David Platt, Ph.D. (Incorporated by reference to theCompany’s Current Report on Form 8-K filed with the Commission on February 18, 2009.)10.13† Pro-Pharmaceuticals, Inc. 2009 Incentive Compensation Plan. (Incorporated by reference to the Company’s Current Report on Form 8-K filedwith the Commission on February 18, 2009.)10.14† Form of Restricted Stock Grant Agreement (under the 2009 Incentive Compensation Plan). (Incorporated by reference to the Company’s AnnualReport on Form 10-K as filed with the Commission on March 30, 2009.)10.15† Form of Non-Qualified Stock Option Grant Agreement (under the 2009 Incentive Compensation Plan). (Incorporated by reference to theCompany’s Annual Report on Form 10-K as filed with the Commission on March 30, 2009.)10.16† Form of Incentive Stock Option Grant Agreement (under the 2009 Incentive Compensation Plan). (Incorporated by reference to the Company’sAnnual Report on Form 10-K as filed with the Commission on March 30, 2009.)10.17 Agreement with the 10X Fund L.P., dated February 11, 2010. (Incorporated by reference to the Company’s Current Report on Form 8-K as filedwith the Commission on February 17, 2010.)10.18† Common Stock Purchase Warrant dated August 3, 2010 issued to Peter Traber. (Incorporated by reference to the Company’s Quarterly Report onForm 10-Q as filed with the Commission on August 13, 2010.)10.19 Letter Agreement Between 10X Fund, L.P. and Pro-Pharmaceuticals, Inc. (Incorporated by reference to the Company’s Quarterly Report onForm 10-Q as filed with the Commission on August 13, 2010.)10.20 Form of Securities Purchase Agreement for Series C Super Dividend Convertible Preferred Stock (Incorporated by reference to the Company’sCurrent Report on Form 8-K as filed with the Commission on January 6, 2011.)10.21 Agreement dated January 21, 2011, between Pro-Pharmaceuticals, Inc. and 10X Fund L.P. (Incorporated by reference to the Company’s CurrentReport on Form 8-K as filed with the Commission on January 27, 2011.)10.22† Non-Qualified Stock Option Agreement dated March 7, 2011 (Incorporated by reference to the Company’s Current Report on Form 8-K as filedwith the Commission on March 9, 2011.)10.23† Amended Employment Agreement dated March 8, 2011 between Anthony D. Squeglia, and Pro-Pharmaceuticals, Inc. (Incorporated by referenceto the Company’s Current Report on Form 8-K as filed with the Commission on March 14, 2011.)10.24† Amended Employment Agreement dated March 8, 2011 between Maureen Foley, and Pro-Pharmaceuticals, Inc. (Incorporated by reference to theCompany’s Current Report on Form 8-K as filed with the Commission on March 14, 2011.) 49Table of ContentsExhibit Number Description of Document10.25† Amended Employment Agreement dated March 31, 2011 between Anatole Klyosov, and Pro-Pharmaceuticals, Inc. (Incorporated by reference tothe Company’s Current Report on Form 8-K as filed with the Commission on April 6, 2011.)10.26† Employment Agreement dated March 31, 2011 between Eli Zomer and Pro-Pharmaceuticals, Inc. (Incorporated by reference to the Company’sCurrent Report on Form 8-K as filed with the Commission on April 6, 2011.)10.27† Separation Agreement dated March 31, 2011 between Pro-Pharmaceuticals, Inc. and Theodore D. Zucconi (Incorporated by reference to theCompany’s Current Report on Form 8-K as filed with the Commission on April 6, 2011.)10.28 Agreement dated April 22, 2011, between Pro-Pharmaceuticals, Inc. and Sigma-Aldrich, Inc. (Incorporated by reference to the Company’sCurrent Report on Form 8-K as filed with the Commission on April 28, 2011.)10.29† Employment Agreement dated March 31, 2011 between Peter Traber, and Galectin Therapeutics Inc. (Incorporated by reference to theCompany’s Current Report on Form 8-K as filed with the Commission on June 2, 2011.)10.30† Employment Agreement dated June 28, 2011 between James C. Czirr, and Galectin Therapeutics Inc. (Incorporated by reference to theCompany’s Current Report on Form 8-K as filed with the Commission on July 5, 2011.)10.31† Non-Qualified Stock Option Agreement for Peter G. Traber, M.D. (Incorporated by reference to the Company’s Current Report on Form 8-K asfiled with the Commission on August 15, 2011.)10.32† Non-Qualified Stock Option Agreement for James C. Czirr (Incorporated by reference to the Company’s Current Report on Form 8-K as filedwith the Commission on August 15, 2011.)10.33† Consulting Agreement, dated March 2, 2012 between Galectin Therapeutics Inc. and Thomas A. McGauley (Incorporated by reference to theCompany’s Quarterly Report on Form 10-Q as filed with the Commission on May 11, 2012.)10.34† Independent Consulting Agreement dated April 30, 2012, between Scott L. Friedman, M.D. and Galectin Therapeutics Inc. (Incorporated byreference to the Company’s Quarterly Report on Form 10-Q as filed with the Commission on November 9, 2012.)10.35† Amended Employment Agreement dated July 19, 2012 between Maureen Foley and Galectin Therapeutics Inc. (Incorporated by reference to theCompany’s Quarterly Report on Form 10-Q as filed with the Commission on November 9, 2012.)10.36† Amended and Restated Employment Agreement dated December 11, 2014 between Harold H. Shlevin and Galectin Therapeutics Inc.(Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on December 12, 2014.)10.37† Independent Consulting Agreement dated September 19, 2012 between Thomas A. McGauley and Galectin Therapeutics Inc. (Incorporated byreference to the Company’s Quarterly Report on Form 10-Q as filed with the Commission on November 9, 2012.)10.38 Amended and Restated Master Services Agreement dated February 1, 2013 between Galectin Therapeutics Inc. and CTI Clinical Trial Services,Inc. and CTI Clinical Consulting Services Inc. (Incorporated by reference to the Company’s Quarterly Report on Form 10-Q as filed with theCommission on May 10, 2013.)10.39 Amended Form of Class A-2 Common Stock Purchase Warrant (Incorporated by reference to the Company’s Quarterly Report on Form 10-Q asfiled with the Commission on August 14, 2013.) 50Table of ContentsExhibit Number Description of Document10.40 Amended Form of Class B Common Stock Purchase Warrant (Incorporated by reference to the Company’s Quarterly Report on Form 10-Q asfiled with the Commission on August 14, 2013.)10.41† Employment Agreement dated June 20, 2013 between Jack W. Callicutt and Galectin Therapeutics Inc. (Incorporated by reference to theCompany’s Quarterly Report on Form 10-Q as filed with the Commission on August 14, 2013.)10.42† Amendment to Independent Consulting Agreement dated June 19, 2013 between Thomas A. McGauley and Galectin Therapeutics Inc.(Incorporated by reference to the Company’s Quarterly Report on Form 10-Q as filed with the Commission on August 14, 2013.)10.43† Stock Option Agreement with Thomas A. McGauley dated June 19, 2013 (Incorporated by reference to the Company’s Quarterly Report on Form10-Q as filed with the Commission on August 14, 2013.)10.44 At Market Issuance Sales Agreement, dated October 25, 2013, by and between Galectin Therapeutics Inc. and MLV & Co. LLC (Incorporated byreference to the Company’s Current Report on Form 8-K as filed with the Commission on October 25, 2013.)10.45 Amendment No. 1 to At Market Issuance Sales Agreement, dated March 21, 2014, by and between Galectin Therapeutics Inc. and MLV & Co.LLC (Incorporated by reference to the Company’s Registration Statement on Form S-3 as filed with the Commission on March 21, 2014.)10.46 Project Addendum (with Master Services Agreement), dated March 6, 2015, by and between Galectin Therapeutics Inc. and PPD Development,L.P. (Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on March 12, 2015.)***10.47 Securities Purchase Agreement, dated November 19, 2015, by and among Galectin Therapeutics Inc. and the Purchasers identified therein(Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on November 20, 2015.)10.48 Placement Agency Agreement, dated November 19, 2015, by and between Galectin Therapeutics Inc. and Roth Capital Partners, LLC(Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on November 20, 2015.)10.49 Registration Rights Agreement, dated November 19, 2015, by and between Galectin Therapeutics Inc. and the Purchasers signatory thereto(Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on November 20, 2015.)10.50* Project Addendum Modification, dated March 11, 2016, by and between Galectin Therapeutics, Inc. and PPD Development, L.P.***16.1 Letter of McGladrey LLP dated September 9, 2015 (Incorporated by reference to the Company’s Current Report on Form 8-K as filed with theCommission on September 11, 2015.)21.1* Subsidiaries of Galectin Therapeutics Inc.23.1* Consent of McGladrey LLP, an independent registered public accounting firm.31.1* Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.31.2* Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.32.1*# Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.32.2*# Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 51Table of ContentsExhibit Number Description of Document101.INS* XBRL Instance document.101.SCH* XBRL Taxonomy Extension Schema Document.101.CAL* XBRL Taxonomy Calculation Linkbase Document.101.DEF* XBRL Taxonomy Definition Linkbase Document.101.LAB* XBRL Taxonomy Label Linkbase Document.101.PRE* XBRL Taxonomy Presentation Linkbase Document. *Filed herewith.#Furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.***Galectin Therapeutics, Inc. has requested confidential treatment with respect to portions of this exhibit. Those portions have been omitted from the exhibitand filed separately with the U.S. Securities and Exchange Commission.†Executive Compensation Arrangement pursuant to 601(b)(10)(iii)(A) of Regulation S-K 52Table of ContentsSIGN ATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf bythe undersigned, thereunto duly authorized, on March 15, 2016. GALECTIN THERAPEUTICS INC.By: /s/ P ETER G. T RABER Name: Peter G. Traber, M.D. Title: Chief Executive Officer and PresidentPursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and inthe capacities and on the dates indicated. Signature Title Date/ S / P ETER G. T RABERPeter G. Traber, M.D. Chief Executive Officer, President and Director(principal executive officer) March 15, 2016/ S / J ACK W. C ALLICUTTJack W. Callicutt Chief Financial Officer(principal financial and accounting officer) March 15, 2016/ S / M ARC R UBINMarc Rubin, M.D. Director and Chairman of the Board March 15, 2016/ S / J AMES C. C ZIRRJames C. Czirr Director March 15, 2016/ S / G ILBERT F. A MELIOGilbert F. Amelio Director March 15, 2016/ S / A RTHUR R. G REENBERGArthur R. Greenberg Director March 15, 2016/ S / K EVIN D. F REEMANKevin D. Freeman Director March 15, 2016/ S / J OHN M AULDINJohn Mauldin Director March 15, 2016/ S / G ILBERT S. O MENNGilbert S. Omenn, M.D, Ph.D. Director March 15, 2016/ S / S TEVEN P RELACKSteven Prelack Director March 15, 2016 53Table of ContentsGalectin Therapeutics Inc. and subsidiariesTable of Contents 1. Reports of Independent Registered Public Accounting Firms F-1 2. Consolidated Balance Sheets as of December 31, 2015 and 2014 F-4 3. Consolidated Statements of Operations for the years ended December 31, 2015, 2014 and 2013 F-5 4. Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’Equity for the years ended December 31, 2015, 2014 and 2013 F-6 5. Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2014 and 2013 F-9 6. Notes to Consolidated Financial Statements F-10 Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Board of Directors and Stockholders of Galectin Therapeutics, Inc.We have audited the accompanying consolidated balance sheet of Galectin Therapeutics, Inc. and subsidiaries (the “Company) as of December 31, 2015, and therelated consolidated statements of operations, changes in redeemable convertible preferred stock and stockholders’ equity, and cash flows for the year then ended.The Company’s management is responsible for these financial statements. Our responsibility is to express an opinion on these financial statements based on ouraudit.We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we planand perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on atest basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used andsignificant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basisfor our opinion.In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as ofDecember 31, 2015, and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted in theUnited States of America. Also, in our opinion, the related consolidated financial statement schedule for the year ended December 31, 2015, when considered inrelation to the basic consolidated financial statements taken as a whole, presents fairly, in all material respects, the information set forth therein.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control overfinancial reporting as of December 31, 2015, based on criteria established in Internal Control — Integrated Framework issued by the Committee of SponsoringOrganizations of the Treadway Commission (COSO) in 2013, and our report dated March 14, 2016, expressed an unqualified opinion./s/ CHERRY BEKAERT LLPAtlanta, GeorgiaMarch 14, 2016 F-1Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Board of Directors and Stockholders ofGalectin Therapeutics, Inc.We have audited the accompanying consolidated balance sheet of Galectin Therapeutics, Inc. and subsidiaries as of December 31, 2014, and the relatedconsolidated statements of operations, changes in redeemable convertible preferred stock and stockholders’ equity, and cash flows for each of the two years in theperiod ended December 31, 2014. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion onthese financial statements based on our audits.We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that weplan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, ona test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made bymanagement, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Galectin Therapeutics, Inc. asof December 31, 2014, and the results of its operations and cash flows for each of the two years in the period ended December 31, 2014, in conformity with U.S.generally accepted accounting principles./s/ RSM US LLPCharlotte, North CarolinaMarch 18, 2015 F-2Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Board of Directors and Stockholders ofGalectin Therapeutics, Inc.We have audited Galectin Therapeutic Inc. and subsidiaries’ (“the Company”) internal control over financial reporting as December 31, 2015, based on criteriaestablished in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in 2013. TheCompany’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internalcontrol over financial reporting included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is toexpress an opinion on the company’s internal control over financial reporting based on our audit.We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we planand perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Ouraudit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a materialweakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performingsuch other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and thepreparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financialreporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactionsand dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financialstatements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance withauthorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorizedacquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance withthe policies or procedures may deteriorate.In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2015, based on criteriaestablished in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in 2013.We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States of America), the consolidated balancesheet as of December 31, 2015 and the related consolidated statements of operations, changes in redeemable convertible preferred stock and stockholders’ equity,and cash flows of the Company for the year then ended, and our report dated March 14, 2016, expressed an unqualified opinion. Also, in our opinion, the relatedconsolidated financial statement schedule for the year ended December 31, 2015, when considered in relation to the basic consolidated financial statements taken asa whole, presents fairly, in all material respects, the information set forth therein./s/ CHERRY BEKAERT LLPAtlanta, GeorgiaMarch 14, 2016 F-3Table of ContentsGALECTIN THERAPEUTICS INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS December 31, 2015 2014 (in thousands) ASSETS Current assets: Cash and cash equivalents $25,846 $29,128 Prepaid expenses and other current assets 554 533 Total current assets 26,400 29,661 Property and equipment, net — 1 Intangible assets, net 8 15 Total assets $26,408 $29,677 LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $448 $906 Accrued expenses 845 729 Accrued dividends payable 67 68 Total current liabilities 1,360 1,703 Total liabilities 1,360 1,703 Commitments and contingencies (Note 9) Series B-1 12% redeemable convertible preferred stock; 900,000 shares authorized, issued and outstanding at December 31,2015 and 2014, redemption value and liquidation value: $1,800,000, at December 31, 2015 1,748 1,731 Series B-2 12% redeemable convertible preferred stock; 2,100,000 shares authorized, issued and outstanding at December 31,2015 and 2014, redemption value and liquidation value: $4,200,000, at December 31, 2015 3,537 3,325 Series C super dividend convertible preferred stock; 1,000 shares authorized, 176 issued and outstanding at December 31, 2015and 2014, redemption value: $6,487,000, liquidation value: $1,786,000 at December 31, 2015 1,723 1,723 Stockholders’ equity: Undesignated stock, $0.01 par value; 20,000,000 shares authorized at December 31, 2015 and 2014, 8,001,000shares designated at December 31, 2015 and 2014 — — Series A 12% convertible preferred stock; 5,000,000 shares authorized, 1,377,500 and 1,452,500 issued andoutstanding at December 31, 2015 and 2014, respectively, liquidation value $1,418,000 at December 31, 2015, 557 567 Common stock, $0.001 par value; 50,000,000 shares authorized at December 31, 2015 and 2014, 28,825,033 and22,277,283 issued and outstanding at December 31, 2015 and 2014, respectively 28 22 Additional paid-in capital 157,504 139,531 Retained deficit (140,049) (118,925) Total stockholders’ equity 18,040 21,195 Total liabilities, redeemable convertible preferred stock and stockholders’ equity $26,408 $29,677 See notes to consolidated financial statements. F-4Table of ContentsGALECTIN THERAPEUTICS INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS Year Ended December 31, 2015 2014 2013 (in thousands, except per share amounts) Operating expenses: Research and development $13,114 $8,425 $5,688 General and administrative 6,965 7,005 6,416 Total operating expenses 20,079 15,430 12,104 Total operating loss (20,079) (15,430) (12,104) Other income (expense): Interest income 52 42 16 Loss from equity method investment in Galectin Sciences, LLC — (400) — Total other income (expense) 52 (358) 16 Net loss $(20,027) $(15,788) $(12,088) Preferred stock dividends (868) (943) (867) Preferred stock accretion (229) (229) (229) Warrant modification — — (8,763) Net loss applicable to common stockholders $(21,124) $(16,960) $(21,947) Basic and diluted net loss per share $(0.88) $(0.78) $(1.30) Shares used in computing basic and diluted net loss per share 24,120 21,849 16,874 See notes to consolidated financial statements. F-5Table of ContentsGALECTIN THERAPEUTICS INC. AND SUBSIDIARIESCONSOLIDATED STATEMENT OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITYFor the Years Ended December 31, 2015, 2014 and 2013(amounts in thousands except share data) Stockholders’ Deficit Series B-1 12% Redeemable Convertible Preferred Stock Series B-2 12% Redeemable Convertible Preferred Stock Series C Super Dividend Convertible Preferred Stock Series A 12% Convertible Preferred Stock Common Stock Number ofShares Amount Number ofShares Amount Number ofShares Amount Number ofShares Amount Number ofShares Amount AdditionalPaid-In Capital Retained Deficit Total Stockholders’Deficit Balance at December 31, 2012 900,000 $1,698 2,100,000 $2,900 220 $2,154 1,562,500 $632 16,060,853 $16 $80,535 $(80,018) $1,165 Accretion of Series B redeemableconvertible preferred stock 17 158 (175) (175) Accretion of beneficial conversionfeature for Series B-2 54 (54) (54) Series A 12% convertible preferredstock dividend 25,062 148 (148) Series B-1 12% redeemableconvertible preferred stockdividend 36,106 178 (178) Series B-2 12% redeemableconvertible preferred stockdividend 84,553 418 (418) Series C super dividend convertiblepreferred stock dividend 23,848 123 (123) Issuance of common stock uponexercise of warrants 1.284.948 1 4,504 4,505 Issuance of common stock uponexercise of options 213,008 271 271 Issuance of common stock, net ofissuance costs of $111 599,942 1 3,832 3,833 Conversion of Series A to commonstock (110,000) (45) 18,387 45 Conversion of Series C superdividend convertible preferredstock to common stock (24) (235) 40,193 235 235 Modification of warrants 8,763 (8,763) Stock-based compensation expense 3,789 3,789 Net loss (12,088) (12,088) Balance at December 31, 2013 900,000 $1,715 2,100,000 $3,112 196 $1,919 1,452,500 $587 18,386,900 $18 $102,841 $(101,965) $1,481 See notes to consolidated financial statements. F-6Table of ContentsGALECTIN THERAPEUTICS INC. AND SUBSIDIARIESCONSOLIDATED STATEMENT OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY —(Continued)For the Years Ended December 31, 2015, 2014 and 2013(amounts in thousands except share data) Stockholders’ Deficit Series B-1 12% Redeemable Convertible Preferred Stock Series B-2 12% Redeemable Convertible Preferred Stock Series C Super Dividend Convertible Preferred Stock Series A 12% Convertible Preferred Stock Common Stock Number ofShares Amount Number ofShares Amount Number ofShares Amount Number ofShares Amount Number ofShares Amount AdditionalPaid-In Capital Retained Deficit Total Stockholders’Equity Accretion of Series B redeemableconvertible preferred stock 16 157 (173) (173) Accretion of beneficial conversionfeature for Series B-2 56 (56) (56) Series A 12% convertible preferredstock dividend 19,490 154 (154) Series B-1 12% redeemableconvertible preferred stockdividend 32,043 206 (206) Series B-2 12% redeemableconvertible preferred stockdividend 74,764 480 (480) Series C super dividend convertiblepreferred stock dividend 13,152 103 (103) Issuance of common stock uponexercise of warrants 572,148 1 1,675 1,676 Issuance of common stock uponexercise of options 246,445 452 452 Issuance of common stock 2,881,269 3 29,334 29,337 Conversion of Series A to commonstock (50,000) (20) 8,350 20 Conversion of Series C superdividend convertible preferredstock to common stock (20) (196) 33,756 196 196 Issuance of common stock toconsultants 8,966 100 100 Stock-based compensation expense 3,970 3,970 Net loss (15,788) (15,788) Balance at December 31, 2014 900,000 $1,731 2,100,000 $3,325 176 $1,723 1,402,500 $567 22,277,283 $22 $139,531 $(118,925) $21,195 See notes to consolidated financial statements. F-7Table of ContentsGALECTIN THERAPEUTICS INC. AND SUBSIDIARIESCONSOLIDATED STATEMENT OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY —(Continued)For the Years Ended December 31, 2015, 2014 and 2013(amounts in thousands except share data) Stockholders’ Deficit Series B-1 12% Redeemable Convertible Preferred Stock Series B-2 12% Redeemable Convertible Preferred Stock Series C Super Dividend Convertible Preferred Stock Series A 12% Convertible Preferred Stock Common Stock Number ofShares Amount Number ofShares Amount Number ofShares Amount Number ofShares Amount Number ofShares Amount AdditionalPaid-In Capital Retained Deficit Total Stockholders’Equity Accretion of Series B redeemableconvertible preferred stock 17 156 (173) (173) Accretion of beneficial conversionfeature for Series B-2 56 (56) (56) Series A 12% convertible preferredstock dividend 28,000 80 (80) Series B-1 12% redeemableconvertible preferred stockdividend 88,195 208 (208) Series B-2 12% redeemableconvertible preferred stockdividend 205,788 479 (479) Series C super dividend convertiblepreferred stock dividend 36,910 101 (101) Issuance of common stock uponexercise of options 95,574 Issuance of common stock 6,059,116 6 13,695 13,701 Issuance of common stock toconsultants 30,000 71 71 Conversion of Series A to commonstock (25,000) (10) 4,167 10 Stock-based compensation expense 3,329 3,329 Net loss (20,027) (20,027) Balance at December 31, 2015 900,000 $1,748 2,100,000 $3,537 176 $1,723 1,377,500 $557 28,825,033 $28 $157,504 $(140,049) $18,040 See notes to consolidated financial statements. F-8Table of ContentsGALECTIN THERAPEUTICS INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF CASH FLOWS Year Ended December 31, 2015 2014 2013 (in thousands) CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(20,027) $(15,788) $(12,088) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 7 10 12 Stock-based compensation expense 3,400 4,070 3,789 Loss from equity method investment in Galectin Sciences LLC — 400 — Changes in operating assets and liabilities: Prepaid expenses and other assets (21) (335) (39) Accounts payable and accrued expenses (342) (783) 848 Other long-term liabilities — — (6) Net cash used in operating activities (16,983) (12,426) (7,484) CASH FLOWS FROM INVESTING ACTIVITIES: Equity method investment in Galectin Sciences LLC — (400) — Purchases of property and equipment — — — Change in restricted cash and security deposit — — — Net cash used in investing activities — (400) — CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from issuance of common stock and warrants 13,701 29,337 3,833 Net proceeds from exercise of common stock warrants and options — 2,128 4,776 Net cash provided by financing activities 13,701 31,465 8,609 NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (3,282) 18,639 1,125 CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 29,128 10,489 9,364 CASH AND CASH EQUIVALENTS, END OF PERIOD $25,846 $29,128 $10,489 NONCASH FINANCING ACTIVITIES: Payment of preferred stock dividends in common stock $868 $943 $867 See notes to consolidated financial statements. F-9Table of ContentsGALECTIN THERAPEUTICS INC. AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1.Nature of Business and Basis of PresentationGalectin Therapeutics Inc. (the “Company”) is a clinical stage biopharmaceutical company that is applying its leadership in galectin science and drugdevelopment to create new therapies for fibrotic disease and cancer. These candidates are based on the Company’s targeting of galectin proteins which arekey mediators of biologic and pathologic function. These compounds also may have application for drugs to treat other diseases and chronic healthconditions.The Company was founded in July 2000, was incorporated in the State of Nevada in January 2001 under the name “Pro-Pharmaceuticals, Inc.,” and changedits name to “Galectin Therapeutics Inc.” on May 26, 2011. On March 23, 2012, the Company effected a one-for-six reverse stock split. All common shareand per share amounts in these financial statements have been adjusted to reflect the effect of the reverse split.The Company has operated at a loss since its inception and has had no revenues. The Company anticipates that losses will continue for the foreseeablefuture. At December 31, 2015, the Company had $25,846,000 of unrestricted cash and cash equivalents available to fund future operations. The Companybelieves there is sufficient cash to fund currently planned operations through March 31, 2017.The Company is subject to a number of risks similar to those of clinical stage companies, including dependence on key individuals, uncertainty of productdevelopment and generation of revenues, dependence on outside sources of capital, risks associated with clinical trials of products, dependence on third-partycollaborators for research operations, need for regulatory approval of products, risks associated with protection of intellectual property, and competition withlarger, better-capitalized companies. Successful completion of the Company’s development program and, ultimately, the attainment of profitable operationsis dependent upon future events, including obtaining adequate financing to fulfill its development activities and achieving a level of revenues adequate tosupport the Company’s cost structure. There are no assurances that the Company will be able to obtain additional financing on favorable terms, or at all, orsuccessfully market its products. 2.Summary of Significant Accounting PoliciesThe accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States(“GAAP”).Basis of Consolidation. The consolidated financial statements include the accounts of the Company and Galectin Therapeutics Security Corp., its wholly-owned subsidiary, which was incorporated in Delaware on December 23, 2003 and Galectin Sciences LLC (see Note 10). All intercompany transactions havebeen eliminated.Use of Estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of Americarequires management to make estimates and judgments that may affect the reported amounts of assets, liabilities, equity, revenue, expenses and relateddisclosure of contingent assets and liabilities. Management’s estimates and judgments include assumptions used in stock option and warrant liabilityvaluations, useful lives of property and equipment and intangible assets, accrued liabilities, deferred income taxes and various other assumptions that arebelieved to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions.Fair Value Measurements . The Company has certain financial assets and liabilities recorded at fair value. Fair values determined by Level 1 inputs utilizeobservable data such as quoted prices in active markets. F-10Table of ContentsFair values determined by Level 2 inputs utilize data points other than quoted prices in active markets that are observable either directly or indirectly. Fairvalues determined by Level 3 inputs utilize unobservable data points in which there is little or no market data, which require the reporting entity to developits own assumptions. The estimated value of accounts payable and accrued expenses approximates their carrying value due to their short-term nature. Therewere no Level 2 or 3 assets or liabilities at December 31, 2015 or 2014.Cash and Cash Equivalents. The Company considers all highly-liquid investments with original maturities of 90 days or less at the time of acquisition tobe cash equivalents. The Company had no cash equivalents at December 31, 2015 or 2014.Prepaid Expenses and Other Current Assets. Prepaid expenses and other assets consist principally of prepaid insurance.Property and Equipment. Property and equipment, including leasehold improvements, are stated at cost, net of accumulated depreciation and amortization,and are depreciated or amortized using the straight-line method over the estimated useful lives of the related assets of generally three years for computers andoffice equipment, five years for furniture and fixtures and the shorter of the useful life or life of the lease for leasehold improvements.Security Deposit. At December 31, 2015 and 2014, the Company had a security deposit of $6,000 for leased office space included in Prepaid Expenses andOther Current Assets.Intangible Assets. Intangible assets include patent costs, consisting primarily of related capitalized legal fees, which are amortized over an estimated usefullife of five years from issuance. Amortization expense in 2015, 2014 and 2013 was approximately $6,000, $8,000, and $7,000 respectively. Gross intangibleassets at December 31, 2015 and 2014 totaled $78,000 each year, and accumulated amortization at December 31, 2015 and 2014 totaled $69,000 and$63,000, respectively.Long-Lived Assets. The Company reviews all long-lived assets for impairment whenever events or circumstances indicate the carrying amount of suchassets may not be recoverable. Recoverability of assets to be held or used is measured by comparison of the carrying value of the asset to the futureundiscounted net cash flows expected to be generated by the asset. If such asset is considered to be impaired, the impairment recognized is measured by theamount by which the carrying value of the asset exceeds the discounted future cash flows expected to be generated by the asset.Accrued Expenses . As part of the process of preparing our consolidated financial statements, we are required to estimate accrued expenses. This processinvolves identifying services that third parties have performed on our behalf and estimating the level of service performed and the associated cost incurred onthese services as of each balance sheet date in our consolidated financial statements. Examples of estimated accrued expenses include contract service fees inconjunction with clinical trials, professional service fees, such as those arising from the services of attorneys and accountants and accrued payroll expenses.In connection with these service fees, our estimates are most affected by our understanding of the status and timing of services provided relative to the actualservices incurred by the service providers. In the event that we do not identify certain costs that have been incurred or we under- or over-estimate the level ofservices or costs of such services, our reported expenses for a reporting period could be understated or overstated. The date on which certain servicescommence, the level of services performed on or before a given date, and the cost of services are often subject to our judgment. We make these judgmentsbased upon the facts and circumstances known to us in accordance with accounting principles generally accepted in the U.S.Warrants Modification. The Company has issued common stock warrants in connection with the execution of certain equity and debt financings. Certainwarrants were accounted for as derivative liabilities at fair value. Such warrants did not meet the accounting criteria that a contract should not be considereda F-11Table of Contentsderivative instrument if it is (1) indexed to its own stock and (2) classified in stockholders’ equity. Changes in fair value of derivative liabilities are recordedin the consolidated statement of operations under the caption “Change in fair value of warrant liabilities.” Warrants that are not considered derivativeliabilities are accounted for at fair value at the date of issuance in additional paid-in capital. The fair value of warrants was determined using the Black-Scholes option-pricing model using assumptions regarding volatility of our common share price, remaining life of the warrant, and risk-free interest rates ateach period end. There were no warrant liabilities as of December 31, 2015 or 2014.Research and Development Expenses. Costs associated with research and development are expensed as incurred. Research and development expensesinclude, among other costs, salaries and other personnel-related costs, and costs incurred by outside laboratories and other accredited facilities in connectionwith clinical trials and preclinical studies.Income Taxes. The Company accounts for income taxes in accordance with the accounting rules that requires an asset and liability approach to accountingfor income taxes based upon the future expected values of the related assets and liabilities. Deferred income tax assets and liabilities are determined based onthe differences between the financial reporting and tax bases of assets and liabilities and for tax loss and credit carry forwards, and are measured using theexpected tax rates estimated to be in effect when such basis differences reverse. Valuation allowances are established, if necessary, to reduce the deferred taxasset to the amount that will, more likely than not, be realized.Concentration of Credit Risk. Financial instruments that subject the Company to credit risk consist of cash and cash equivalents and certificates of deposit.The Company maintains cash and cash equivalents and certificates of deposit with well-capitalized financial institutions. At times, those amounts mayexceed federally insured limits. The Company has no significant concentrations of credit risk.Stock-Based Compensation. Stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expenseover the service period, which generally represents the vesting period. For awards that have performance based vesting conditions the Company recognizesthe expense over the estimated period that the awards are expected to be earned. The Company generally uses the Black-Scholes option-pricing model tocalculate the grant date fair value of stock options. For options that only vest upon the achievement of market conditions, the Company values the optionsusing a Monte Carlo model to calculate the grant date fair value of the stock options. The expense related to options that vest based on market conditions isnot reversed should those options not ultimately vest. The expense recognized over the service period is required to include an estimate of the awards thatwill be forfeited. Stock options issued to non-employees are accounted for in accordance with the provisions of ASC Subtopic 505-50, Equity-BasedPayments to Non-employees , which requires valuing the stock options using an option pricing model (the Company uses Black-Scholes) and measuring suchstock options to their current fair value when they vest.New Accounting Pronouncements. The Company adopted Financial Accounting Standards Board (FASB), Accounting Standards Update No. 2014-10“Development Stage Entities (Topic 915)” as of June 30, 2014. This new standard modifies financial statement presentation to eliminate the requirement toinclude inception-to-date information in the statements of operations and cash flows, among other provisions.In August 2014, the FASB issued Accounting Standard Update No. 2014-15, Disclosure of Uncertainties About an Entity’s Ability to Continue as a GoingConcern. The amendments require management to perform interim and annual assessments of an entity’s ability to continue as a going concern and providesguidance on determining when and how to disclose going concern uncertainties in the financial statements. The standard applies to all entities and iseffective for annual and interim reporting periods ending after December 15, 2016, with early adoption permitted. The Company is currently evaluating theimpact that this new guidance will have on its financial statements. F-12Table of Contents3.Property and EquipmentProperty and equipment consists of the following at December 31: 2015 2014 (in thousands) Leasehold improvements $2 $2 Computer and office equipment 13 13 Furniture and fixtures 59 59 Total 74 74 Less accumulated depreciation and amortization (74) (73) Property and equipment—net $— $1 Depreciation and amortization expense for the years ended December 31, 2015, 2014 and 2013 was $1,000, $2,000 and $3,000, respectively. 4.Accrued ExpensesAccrued expenses consist of the following at December 31: 2015 2014 (in thousands) Legal and accounting fees $123 $118 Accrued compensation 626 604 Accrued research and development costs and other 96 7 Total $845 $729 5.Stockholders’ EquityAt December 31, 2015, the Company had 50,000,000 shares of common stock and 20,000,000 undesignated shares authorized. As of December 31, 2015,5,000,000 shares have been designated for Series A 12% Convertible Preferred Stock, 900,000 shares have been designated for Series B-1 ConvertiblePreferred Stock, 2,100,000 shares have been designated for Series B-2 Convertible Preferred Stock, 1,000 shares have been designated for Series C SuperDividend Convertible Preferred Stock and 11,999,000 remain undesignated.2013 Private Placement of Common StockOn August 16, 2013, the Company issued 500,000 unregistered shares of its common stock for proceeds of $3,000,000 to a single investor pursuant to aprivate placement. There were no warrants or placement fees associated with this transaction.At Market Issuances of Common StockOn October 25, 2013, the Company entered into an At Market Issuance Sales Agreement (the “2013 At Market Agreement”) with a sales agent under whichthe Company may issue and sell shares of its common stock having an aggregate offering price of up to $30.0 million from time to time through the salesagent. Sales of the Company’s common stock through the sales agent, if any, will be made by any method that is deemed an “at the market” offering asdefined by the U.S. Securities and Exchange Commission. The Company will pay to the sales agent a commission rate equal to 3.0% of the gross proceedsfrom the sale of any shares of common stock sold through the sales agent under the 2013 At Market Agreement. As of F-13Table of ContentsDecember 31, 2013, the Company had issued 99,942 shares of its common stock through its 2013 At Market Agreement resulting in gross proceeds ofapproximately $944,000. The Company incurred one time, initial legal and accounting costs of approximately $82,000 and commissions of $29,000 resultingin net proceeds of $833,000 as of December 31, 2013. In January and February 2014, the Company issued 2,663,647 shares of common stock for netproceeds of approximately $28,178,000 which completed the 2013 At Market Agreement.On March 30, 2014, the Company entered into an At Market Issuance Sales Agreement (the “2014 At Market Agreement”) with a sales agent under whichthe Company may issue and sell shares of its common stock having an aggregate offering price of up to $30.0 million from time to time through the salesagent. Sales of the Company’s common stock through the sales agent, if any, will be made by any method that is deemed an “at the market” offering asdefined by the U.S. Securities and Exchange Commission. The Company will pay to the sales agent a commission rate equal to 3.0% of the gross proceedsfrom the sale of any shares of common stock sold through the sales agent under the 2014 At Market Agreement. As of December 31, 2014, the Company hadissued 217,622 shares of its common stock through its 2014 At Market Agreement at an average price of $5.49 per share resulting in gross proceeds ofapproximately $1,196,000. The Company incurred commissions of approximately $36,000 resulting in net proceeds of approximately $1,159,000 as ofDecember 31, 2014. In 2015, the Company issued 1,297,216 shares of common stock for net proceeds of approximately $4,571,000 under the 2014 AtMarket Agreement.2015 Registered Direct OfferingOn November 25, 2015, the Company completed an offering of 4,761,900 shares of common stock to three institutional investors at $2.06 per share for netproceeds of approximately $9,130,000. The Company also issued, to the three investors, warrants to purchase 3,571,425 shares of common stock at $2.50 pershare. The warrants have an expiration date of May 25, 2021. The warrants are exercisable beginning on May 25, 2016. The warrants provide for cashlessexercise if at any time during the term of the warrants if there is no effective registration statement for the issuance or resale of the underlying warrant shares.The exercise price of each warrant is adjustable in the event of a stock split or stock combination, capital reorganization, merger or similar event. Thewarrants were valued at $5,893,000 as of the issuance date of November 25, 2015, using the closing price of $2.28, a life of 5.5 years, a volatility of 93% anda risk free interest rate of 1.84%. Based upon the Company’s analysis of the criteria contained in ASC Topic 815-40, “Derivatives and Hedging — Contractsin Entity’s Own Equity” the Company has determined that warrants issued in connection with this financing transaction were not derivative liabilities andtherefore, were recorded as additional paid-in capital.Series A 12% Convertible Preferred Stock — February 4, 2008 Private PlacementOn February 4, 2008, the Company closed a private placement begun in October 2007 of its Series A 12% Convertible Preferred Stock (“Series A”) andrelated warrants. In this transaction, the Company sold units of securities at $6.00 per unit, each unit comprised of (i) one share of Series A Preferred, (ii) awarrant to purchase one share of common stock for $9.00, and (iii) a warrant to purchase one share of common stock for $12.00. Each share of the Series Ais entitled to dividends at the rate of 12% per annum payable at the Company’s option in cash or shares of common stock valued at the higher of $6.00 pershare or 100% of the value weighted average price of the Company’s share price for the 20 consecutive trading days prior to the applicable dividend paymentdate. Dividends are payable semi-annually on March 30 and September 30. The dividend paid on the initial dividend payment date is calculated from thedate the Company deposited each subscription advance.The shares of Series A are entitled to vote as a class with the Company’s common stock and each share of Series A is convertible at any time to one-sixth ofa share of common stock, subject to adjustment in the event of a stock dividend, stock split or combination, reclassification or similar event. The Companyhas the F-14Table of Contentsright to require conversion if the closing price of the common stock exceeds $18.00 for 15 consecutive trading days and a registration statement covering theresale of the shares of common stock issuable upon conversion of the Series A is then in effect. Each warrant is exercisable solely for cash beginningAugust 3, 2008 and expired on February 4, 2012. The exercise price of each warrant is adjustable in the event of a stock split or stock combination, capitalreorganization, merger or similar event.As of December 31, 2007, the Company had received subscription advances of $1,667,500 for Series A. In 2008, the Company received additionalsubscription advances of $75,000 resulting in total gross proceeds of $1,742,500. On February 4, 2008 the Company closed the private placement. TheCompany incurred $52,000 of cash transaction costs resulting in net cash proceeds of $1,691,000. In addition, the Company incurred $3,000 of costs for1,400 warrants exercisable at $9.00 issued to placement agents. Proceeds of $984,000 were allocated to investor warrants using the Black-Scholes methodwith the following assumptions as of February 4, 2008: risk free interest rate 2.51%, volatility 95%, fair market value of the Company’s common stock onFebruary 4, 2008, and the share price on the closing date of the transaction of $3.54. The warrants were originally accounted for as freestanding derivativeinstruments in the consolidated balance sheet formerly under the caption “Warrant Liabilities”. These warrants were originally classified as a liabilitybecause the February 2006 warrants contain an anti-dilution provision in the event of a subsequent dilutive issuance and the potential number of sharesissuable exceeded the Company’s authorized shares. Changes in fair value were recognized as either a gain or loss in the consolidated statement ofoperations under the caption “Change in fair value of warrant liabilities”. In the second quarter of 2008, the warrants were reclassified to equity as a result ofan amendment to the Company’s articles of incorporation approved at the May 21, 2008 annual meeting of shareholders increasing the Company’sauthorized common. Through May 21, 2008, these warrants were marked to market resulting in a reduction in warrant liabilities in the balance sheet and anoffsetting credit to change in fair value of warrant liabilities in the statement of operations in the amount of $100,000. The remaining fair value of $502,000was credited to additional paid-in capital in the balance sheet.In 2015, 2014 and 2013, 25,000, 50,000 and 110,000 shares of Series A were converted into 4,167, 8,334 and 18,387 shares of common stock, respectively.Prior to 2013, a total of 180,000 shares of Series A had been converted into 30,000 shares of common stock.Series B Redeemable Convertible Preferred StockOn February 12, 2009, the Company entered into a securities purchase agreement (the “10X Agreement”) pursuant to which it agreed to issue and sell to 10XFund LP, at two or more closings, up to: (i) 3,000,000 shares its Series B convertible preferred stock (“Series B redeemable convertible preferred stock” or“Series B”) with an aggregate stated value of $6.0 million and convertible into 2,000,000 shares of common stock at December 31, 2011 and (ii) warrants topurchase 6,000,000 shares of common stock.Through a series of closings from February 2009 through May 2010, the Company issued and sold, pursuant to the 10X Agreement, a total of (i) 900,000shares of Series B-1 convertible preferred stock (“Series B-1 redeemable convertible preferred stock” or “Series B-1”) and related common stock warrantsfor 1,800,000 shares of common stock and (ii) 2,100,000 shares of Series B-2 convertible preferred stock (“Series B-2 redeemable convertible preferredstock” or “Series B-2”) and related warrants for 4,200,000 shares of common stock for total net proceeds of $5,483,000.The terms of the Series B are as follows:Dividends . Holders of the Series B will be entitled to receive cumulative dividends at the rate of 12% per share per annum (compounding monthly)payable quarterly which may, at the Company’s option, be paid in cash or common stock. Pursuant to an agreement with the holder of all shares of Series B,on January 26, 2011, the Company amended and restated the Certificate of Designation of Preferences, Rights and F-15Table of ContentsLimitations for the Series B-1 and Series B-2, to provide that dividends are payable in cash or shares of Common Stock valued at 100% of the volumeweighted average price of the Common Stock for the 20 consecutive trading days prior to the dividend payment date on and after September 30, 2011. If theCompany does not pay any dividend on the Series B, dividends will accrue at the rate of 15% per annum (compounding monthly).Conversion Rights . Each share of Series B is convertible into two-thirds (approximately 0.667) shares of common stock at the conversion price of $3.00per share at the option of (i) the holder, at any time and (ii) the Company, at any time after February 12, 2010 (and upon 10 days notice) if the common stockis quoted at or above $9.00 for 15 consecutive trading days and an effective registration statement regarding the underlying shares of common stock is ineffect (subject to certain monthly volume limits). Pursuant to an agreement with the holder of all shares of Series B, on January 26, 2011, the Companyamended and restated the Certificate of Designation of Preferences, Rights and Limitations for the Series B-1 and Series B-2, to remove the Company’s rightto compel conversion of the Series B Preferred Stock to shares of its Common StockRedemption Rights . Pursuant to an agreement with the holder of all shares of Series B, on January 26, 2011, the Company amended and restated theCertificate of Designation of Preferences, Rights and Limitations for the Series B-1 and Series B-2, to provide that, upon notice of not less than 30 tradingdays, a holder of Series B may require the Company to redeem, in whole or in part at any time on or after the earlier of (a) February 12, 2019 or (b) the dateof issuance of a promissory note to David Platt (see Note 11) in connection with the achievement of certain milestones under his separation agreement.The redemption price will be equal to the sum of the stated value of the Series B, plus all accrued but unpaid dividends thereon, as of the redemption date. Ifthe Company fails to pay the redemption price in cash on the redemption date, then the holders of the Series B requesting redemption may, at their soleoption, automatically convert their shares of Series B into a promissory note bearing interest at the rate of 15% per year and secured by a lien on all of theCompany’s assets. So long as any shares of the Series B remain outstanding, the Company is also subject to restrictions limiting, among other things,amendments to the Company’s organizational documents; the purchase or redemption of the Company’s capital stock; mergers, consolidations, liquidationsand dissolutions; sales of assets; dividends and other restricted payments; investments and acquisitions; joint ventures, licensing agreements, exclusivemarketing and other distribution agreements; issuances of securities; incurrence of indebtedness; incurrence of liens and other encumbrances and issuancesof any common stock equivalents. Pursuant to a letter agreement with the 10X Fund, the holder of all of the Series B shares, the 10X Fund will consent to anamendment to Certificate of Designation of Preferences, Rights and Limitations for the Series B-1 and Series B-2 to eliminate the redemption right.Liquidation Rights . In the event of any liquidation, dissolution or winding up of the Company, either voluntarily or involuntarily, the holders of Series Bwill receive $2 per share plus accrued and unpaid dividends, payable prior and in preference to any distributions to the holders of Common Stock but paripassu with the holders of the Series A 12% Convertible Preferred Stock.Voting Rights . Except as noted below, the holder of each share of Series B shall be entitled to the number of votes equal to the number of shares ofCommon Stock into which such share of Series B would be convertible, and shall otherwise have voting rights and powers equal to the voting rights andpowers of the Common Stock. With respect to the election of directors, the holders of the Series B shall vote together as a separate class to elect two(2) members of the Board of Directors (the “Series B Directors”), and the Company shall take all reasonably necessary or desirable actions within its control(including, without limitation, calling special meetings of the Board of Directors, nominating such persons designated by the holders of the Series B asdirectors on the applicable proxy statements and recommending their election) to permit the holders of the Series B to appoint two additional (2) members ofthe Board of Directors (the F-16Table of Contents“Series B Nominees”), who shall be subject to election by all shares of voting stock of the Company voting together as a single group, until such time as allauthorized shares of Series B have been issued and sold, after which the number of Series B Nominees shall be three (3), and shall remain three (3) untilthere are no longer any shares of Series B outstanding. The holders of Series B shall vote together with the holders of Common Stock and other votingcapital stock of the Company to elect all other members of the Board of Directors.Other Restrictions . So long as any shares of the Series B remain outstanding, the Company may not, without the approval of the holders of a majority ofthe shares of Series B outstanding, among other things, (i) change the size of the Company’s Board of Directors; (ii) amend or repeal the Company’s Articlesof Incorporation or Bylaws or file any articles of amendment designating the preferences, limitations and relative rights of any series of preferred stock, thatwould alter or change the preferences, rights, privileges or powers of, or restriction provided for the benefit of the Series B; (iii) create or increase theauthorized amount of any additional class or series of shares of stock that is equal to or senior to Series B; (iv) increase or decrease the authorized number ofshares of the Series B; (v) purchase, redeem or otherwise acquire for value any shares of any class of capital stock; (vi) merge or consolidate the Companyinto or with any other corporation or sell, assign, lease, pledge, encumber or otherwise dispose of all or substantially all of the Company’s assets or those ofany subsidiary; (vii) voluntarily or involuntarily liquidate, dissolve or wind up the Company or the Company’s business; (viii) pay or declare dividends onany capital stock other than the Preferred Stock, unless the Series B share ratably in such dividend and all accrued dividends payable with respect to theSeries B have been paid prior to the payment or declaration of such dividend; (ix) acquire an equitable interest in, or the assets or business of any other entityin any form of transaction; (x) create or commit us to enter into a joint venture, licensing agreement or exclusive marketing or other distribution agreementwith respect to the Company’s products, other than in the ordinary course of business; (xi) permit the Company or any subsidiary to sell or issue any securityof such subsidiary to any person or entity other than the Company; (xii) enter into, create, incur, assume or guarantee any indebtedness for borrowed moneyof any kind (other than indebtedness existing on the initial closing date and approved by Series B shareholders); (xiii) enter into, create, incur or assume anyliens of any kind (other than certain permitted liens); (xiv) issue any common stock or common stock equivalents; (xv) increase the number of shares of theCompany’s common stock that may be issued pursuant to options, warrants or rights to employees, directors, officers, consultants or advisors above 250,000.Warrants . Each Class A-1 warrant, Class A-2 warrant and Class B warrant is exercisable at $3.00 per share of common stock at any time on or after thedate of issuance until the fifth anniversary of the respective issue date. The Company may, upon 30 days’ notice and so long as an effective registrationstatement regarding the underlying shares of common stock is in effect, issue a termination notice with respect to (i) each Class A-1 warrant on any tradingday on which the market value of the common stock for each of the 15 previous trading days exceeded $7.50 per share and (ii) each Class A-2 warrant onany trading day on which the market value of the common stock for each of the 15 previous trading days exceeded $10.50 per share. All Class A-1 warrantswere exercised for cash proceeds of $3,000,000 in 2011 and 500,000 of the Class A-2 warrants were exercised for cash proceeds of $1,500,000 in 2013.Subsequently, in January 2014, the remaining 500,000 Class A-2 warrants were exercised for cash proceeds of $1,500,000.The fair value of the warrants issued in connection with the Series B-1 was $1,296,000 at the date of issuance based on the following assumptions: anexpected life of 5 years, volatility of 118%, risk free interest rate of 1.79% and zero dividends. The Company allocated the gross proceeds based on therelative fair value of the Series B-1 and the related warrants, resulting in $1,105,000 of the proceeds being allocated to additional paid-in capital. TheCompany analyzed the Series B-1, post-allocation of the gross proceeds, and determined that there was no beneficial conversion feature at the date ofissuance. The issuance costs of the Series B-1 and the amounts allocated to warrants were recorded as a reduction to the carrying value of the Series B-1when issued, and are accreted to the redemption value of the Series B-1 through the earliest F-17Table of Contentsredemption date. Due to the redemption feature, the Company has presented the Series B-1 outside of permanent equity, in the mezzanine of the consolidatedbalance sheets at December 31, 2015 and 2014.The fair value of the warrants issued during the year ended December 31, 2010 in connection with the Series B-2 was $4,148,000 at the dates of issuancebased on the following assumptions: an expected life of 5 years, volatility of 126% to 129%, risk free interest rates of 2.27% to 2.43% and zero dividends.The fair value of the warrants issued during the year ended December 31, 2009 in connection with the Series B-2 was $5,333,000 at the dates of issuancebased on the following assumptions: an expected life of 5 years, volatility of 124% to 127%, risk free interest rates of 1.98% to 2.70% and zero dividends.The Company allocated the gross proceeds based on the relative fair value of the Series B-2 and the related warrants, resulting in $1,028,000 and $1,732,000of the proceeds being allocated to additional paid-in capital for the years ended December 31, 2010 and 2009, respectively. The issuance costs of the SeriesB-2 and the amounts allocated to warrants were recorded as a reduction to the carrying value of the Series B-2 when issued, and are accreted to theredemption value of the Series B-2 through the earliest redemption dates. Due to the redemption feature, the Company has presented the Series B-2 outsideof permanent equity, in the mezzanine of the consolidated balance sheets at December 31, 2015 and 2014.The Company analyzed the Series B-2, post-allocation of the gross proceeds, and determined that there was a beneficial conversion feature at the dates ofissuance. Because the closing price of the common stock on the closing date was greater than the effective conversion price, $388,000 and $628,000 of theproceeds (limited to the allocation of the proceeds) during the years ended December 31, 2010 and 2009, respectively, were allocated to an embeddedbeneficial conversion feature of the Series B-2. The amount allocated to the beneficial conversion feature was recorded as a discount to the Series B-2 isbeing accreted, with such accretion being charged through the earliest redemption dates.Series C 6% Super Dividend Convertible Preferred StockOn December 29, 2010, the Company designated and authorized the sale and issuance of up to 1,000 shares of Series C Super Dividend ConvertiblePreferred Stock (“Series C”) with a par value of $0.01 and a stated value equal to $10,000 (the “Stated Value”).On December 30, 2010, the Company sold and issued 212 shares of Series C at a price of $10,000 per share for gross proceeds of $2,120,000. The Companyincurred $47,000 of cash transaction costs resulting in net cash proceeds of $2,073,000. In addition, the Company issued 500 warrants exercisable at $7.20 toa placement agent which had a de minimis value. Additionally, in January 2011, the Company sold and issued 13 shares of Series C at a price of $10,000 pershare for gross proceeds of $130,000.The terms of the Series C are as follows:Conversion Rights . Each holder of Series C may convert all, but not less than all, of his Series C shares plus accrued and unpaid dividends into CommonStock at the price of $6.00 per share of Common Stock (“Conversion Price”), such that approximately 1,667 shares of Common Stock will be issued per eachconverted share of Series C (accrued and unpaid dividends will be issued as additional shares). At December 31, 2015, the 176 outstanding shares of Series Cwere convertible into a total of approximately 293,340 shares of Common Stock.Subject to the continuing obligation to pay post conversion dividends, the Company may convert all, but not less than all, of the Series C (plus all accruedand unpaid dividends) into Common Stock, at the Conversion Price, upon such time that the closing price of the Common Stock is no less than $18.00 pershare for 15 consecutive trading days.Dividends . Holders of Series C shall be entitled to receive cumulative non-compounding dividends at the rate per share of Series C equal to the greater of(i) 6% per annum of the Stated Value (also defined as the F-18Table of Contents“Floor”) or (ii) 2.5% of net sales until the total dividends paid is equal to the initial investment and 1.25% of net sales thereafter. The maximum amount eachSeries C shareholder will receive in dividend payments is equal to $100,000 (the “Maximum Payout”). For purposes of this dividend calculation, net salesshall mean gross revenues actually received by the Company, from the sale or licensing of the product DAVANAT (GM-CT-01), less chargebacks, returns,expenses attributable to product recalls, duties, customs, sales tax, freight, insurance, shipping expenses, allowances and other customary deductions.The dividend shall be payable in arrears semiannually on March 31 and September 30, beginning with the first such date after the original issue date;provided, however, that all dividends and all other distributions shall cease, and no further dividends or other distributions shall be paid, in respect of eachshare of Series C from and after such time that the Maximum Payout has been paid in respect of such share of Series C. Such dividends shall be payable atthe Company’s option either in cash or in duly authorized, fully paid and non-assessable shares of Common Stock valued at the higher of (i) $3.00 per shareor (ii) the average of the Common Stock trading price for the ten (10) consecutive trading days ending on the trading day that is immediately prior to thedividend payment date.Series C Post Conversion Dividend Right . In the event that any share of Series C is converted into Common Stock before the Maximum Payout is paid inrespect of such converted share of Series C, then the holder shall have the right to continue to receive dividends in respect of such converted share of SeriesC equal to the remaining payout (the “Series C Preferred Stock Post Conversion Dividend Right”) which shall be equal to the Maximum Payout less thecumulative dividends received through the conversion date. One share of Series C Preferred Stock Post Conversion Dividend Right shall be issued for eachsuch converted share of Series C. The holder of each Series C Preferred Stock Post Conversion Dividend Right shall receive the remaining payout on anequal basis and in conjunction with the then outstanding shares of Series C and all the other then outstanding Series C Post Conversion Dividend Rights, inthe same manner and subject to the same terms and conditions as applicable to the payment of dividends on each share of Series C, except that for purposesof calculating the dividend the Floor shall not apply. The Series C Preferred Stock Post Conversion Dividend Right shall have no stated value, liquidationpreference or right to any dividends or distributions other than the remaining payout. The Series C Preferred Stock Post Conversion Right is subject toredemption in the same manner as outstanding Series C shares.At the date of issuance, the Series C have an embedded dividend right to continue to receive dividend payments after conversion to common stock (theSeries C Post Conversion Dividend Right) which requires bifurcation. The value of this post conversion dividend right on the date of issuance wasdetermined to be de minimis due to the fact that the payment of a dividend stream other than the 6% dividend and conversion of Series C prior to theCompany achieving sales of GM-CT-01 was deemed improbable at that time. Upon a conversion of the Series C, the Company will be required to record aliability and the related expense during the period of conversion.In July 2011, 5 shares of Series C were converted into 8,334 shares of common stock and 5 Series C Post Conversion Dividend Rights (Dividend Rights)were issued. In 2013, 24 shares of Series C were converted into 40,193 shares of common stock and 24 Dividend Rights were issued. In 2014, 20 shares ofSeries C were converted into 33,756 shares of common stock and 20 Dividend Rights were issued. Per the terms of the Series C, these Dividend Rights shallcontinue to participate in dividends, however the Floor shall not apply. At December 31, 2015 and 2014, these Dividend Rights were determined to have a deminimis value, as the payment of a dividend is considered improbable at this time. The Company will continue to evaluate and assess the Series C PostConversion Dividend Right for each reporting period.Liquidation Rights . In the event of any liquidation, dissolution or winding up of the Company, either voluntarily or involuntarily, the holders of Series Cwill receive $10,000 per share plus accrued and unpaid dividends, payable prior and in preference to any distributions to the holders of Common Stock butafter and subordinate to the Series A 12% Convertible Preferred Stock (“Series A”), Series B-1 and Series B-2, subject to the Maximum Payout. F-19® Table of ContentsRedemption . Upon a sale of the Company, the Company shall redeem all of the then outstanding shares of Series C and Series C Preferred Stock PostConversion Rights within thirty (30) days after the transaction constituting the sale of the Company is closed and such closing is fully funded. The price toredeem a share of Series C and each redeemed Series C Preferred Stock Post Conversion Redemption Right shall be equal to (i) (A) the applicable return oninvestment (“ROI”) percentage, multiplied by (B) $10,000, minus (ii) the cumulative dividends received through the redemption date. The redemption priceshall be payable at the Company’s option either in cash or in shares of common stock valued at the higher of (i) $3.00 per share or (ii) the average marketprice for the ten consecutive trading days ending immediately prior to the date of redemption. The ROI Percentage shall mean the percentage that applies asof the redemption date, as follows: ROI Percentage 200% before the second anniversary of the date of issuance;250% on or after the second anniversary of the date of issuance, but before the third anniversary of the date of issuance;300% on or after the third anniversary of the date of issuance, but before the fourth anniversary of the date of issuance;350% on or after the fourth anniversary of the date of issuance, but before the fifth anniversary of the date of issuance;400% on or after the fifth anniversary of the date of issuance, but before the sixth anniversary of the date of issuance;450% on or after the sixth anniversary of the date of issuance, but before the seventh anniversary of the date of issuance;500% on or after the seventh anniversary of the date of issuance, but before the eighth anniversary of the date of issuance; and550% on or after the eighth anniversary of the date of issuance, but before the ninth anniversary of the date of issuance.Due to the redemption feature, the Company has presented the Series C outside of permanent equity, in the mezzanine of the consolidated balance sheets atDecember 31, 2015 and 2014. At December 31, 2015, the Series C redemption value was $6,487,000.Voting Rights . The Series C shares have no voting rights. 6.WarrantsWarrant activity is summarized as follows: Outstanding at December 31, 2013 6,035,229 Issued 20,000 Cancelled (7,500) Exercised (576,734) Outstanding at December 31, 2014 5,470,995 Issued 3,571,425 Cancelled (133,834) Exercised — Outstanding at December 31, 2015 8,908,586 F-20Table of ContentsThe following table summarizes information with regard to outstanding warrants issued in connection with equity and debt financings and consultants as ofDecember 31, 2015. Issued in Connection With Number Issued Exercise Price Exercisable Date Expiration Date February 12, 2009 Series B-1 Transaction $0.50 Investor Warrants—Class B 1,200,000 $3.00 February 12, 2009 February 12, 2019 May 13, 2009 Series B-2 Transaction $0.50 Investor Warrants—Class B 600,000 $3.00 May 13, 2009 May 13, 2019 June 30, 2009 Series B-2 Transaction $0.50 Investor Warrants—Class B 333,333 $3.00 June 30, 2009 June 30, 2019 August 12, 2009 Series B-2 Transaction $0.50 Investor Warrants—Class B 200,000 $3.00 August 12, 2009 August 12, 2019 September 30, 2009 Series B-2 Transaction $0.50 Investor Warrants—Class B 216,666 $3.00 September 30, 2009 September 30, 2019 November 4, 2009 Series B-2 Transaction $0.50 Investor Warrants—Class B 206,666 $3.00 November 4, 2009 November 4, 2019 December 8, 2009 Series B-2 Transaction $0.50 Investor Warrants—Class B 216,667 $3.00 December 8, 2009 December 8, 2019 January 29, 2010 Series B-2 Transaction $0.50 Investor Warrants—Class B 216,667 $3.00 January 29, 2010 January 29, 2020 March 8, 2010 Series B-2 Transaction $0.50 Investor Warrants—Class B 223,334 $3.00 March 8, 2010 March 8, 2020 April 30, 2010 Series B-2 Transaction $0.50 Investor Warrants—Class B 206,667 $3.00 April 30, 2010 April 30, 2020 May 10, 2010 Series B-2 Transaction $0.50 Investor Warrants—Class B 380,000 $3.00 May 10, 2010 May 10, 2020 March 28, 2012 Offering Warrants 1,317,161 $5.63 March 28, 2012 March 28, 2017 October 30, 2014 Consultant Warrants 20,000 $5.45 October 30, 2014 October 30, 2017 November 25, 2015 Offering Warrants 3,571,425 $2.50 May 25, 2016 May 25, 2021 Total outstanding warrants 8,908,586 Consultant WarrantsIn October 2014, the Company granted warrants to a consultant for the purchase of 20,000 shares of common stock at an exercise price of $5.45 per share.The warrants were valued at $76,000 on issuance based on the following assumptions: an expected life of 3 years, volatility of 117%, risk free interest rate of0.91% and zero dividends. The warrants vested immediately and the Company recognized an expense of $76,000 related to these warrants during the yearended December 31, 2014. These warrants remain outstanding at December 31, 2015.Offering WarrantsOn March 28, 2012, the Company sold and issued 1,333,361 Units (2,666,722 shares of common stock and related $5.63 warrants to purchase 1,333,361shares of common stock) for gross proceeds of $12.0 million (net cash proceeds of $10,403,000 after the underwriting discount and offering costs). Thewarrants were valued at $4,445,000 as of the issuance date of March 28, 2012, using the closing price of $4.20, a life of 5 years, a volatility of 119% and arisk free interest rate of 1.05%. Based upon the Company’s analysis of the criteria contained in ASC Topic 815-40, “Derivatives and Hedging — Contractsin Entity’s Own Equity” the Company has determined that warrants issued in connection with this financing transaction were not derivative liabilities andtherefore, were recorded as additional paid-in capital. At December 31, 2015, 1,317,161 of these warrants remain outstanding.Warrants ModificationOn May 6, 2013, the Company modified the terms of the Class A-2 and Class B warrants that were originally issued to the 10X Fund with the Series BPreferred Stock offering. The Class B warrants were F-21Table of Contentsmodified to allow for the cashless exercise of all 4,000,000 outstanding Class B warrants. Previously, only half of the Class B warrants allowed for cashlessexercise. The Class A-2 warrants for the purchase of 1,000,000 shares of common and all of the Class B warrants had their exercisable life extended by anadditional five years. In exchange for these modifications, the 10X Fund agreed to a future amendment of the Company’s Series B certificate of designationto remove the redemption provision such that the Series B Preferred Stock will no longer be redeemable, if and when the Company will no longer berequired to issue Dr. Platt a promissory note as may currently be required under the separation agreement (see Note 11). Should the Company amend theirSeries B certificate of designation in the future as described above, the Company will be required at that time to evaluate whether such amendment is to beaccounted for as a modification or an extinguishment of the Company’s Series B Preferred Stock. The Company has accounted for the modified terms of theClass A-2 and Class B warrants pursuant to ASC 718, Stock Compensation, whereby the Company has recognized a charge for the change in fair value ofthe warrants immediately before and immediately after the modification. In the second quarter of 2013, the Company recognized a one-time charge of$8,763,000 related to the extension of the 5,000,000 warrants. The following assumptions were used to value the extension of the warrants immediatelybefore and immediately after the modification: a) immediately before the modification — an expected life range of 0.77 to 2.01 years, volatility range of77% to 96%, risk free interest rate range of 0.11% to 0.22% and zero dividends and; b) immediately following the modification — an expected life range of5.78 to 7.02 years, volatility range of 113% to 122%, risk free interest rate range of 0.74% to 1.19% and zero dividends. 7.Stock-Based CompensationSummary of Stock-Based Compensation PlansAt December 31, 2015, the Company has a stock-based compensation plan where the Company’s common stock has been made available for equity-basedincentive grants as part of the Company’s compensation programs. In February 2009, the Company adopted the 2009 Incentive Compensation Plan (the“2009 Plan”) which originally provided for the issuance of up to 3,333,334, which was subsequently increased to 4,733,334 in May 2014, shares of theCompany’s common stock in the form of options, stock appreciation rights, restricted stock and other stock-based awards to employees, officers, directors,consultants and other eligible persons. At December 31, 2015, 1,314,729 shares were available for future grant under the 2009 Plan.In addition, the Company has awarded 1,477,379 non-plan stock option grants to employees and non-employees. These non-plan grants have vesting periodsand expiration dates similar to those options granted under the Incentive Plans. At December 31, 2015, 1,416,669 non-plan grants were outstanding.Stock-Based CompensationFollowing is the stock-based compensation expense related to common stock options, restricted common stock and common stock warrants: Year Ended December 31, 2015 2014 2013 Research and development $1,018 $1,302 $991 General and administrative 2,382 2,768 2,798 Total stock-based compensation expense $3,400 $4,070 $3,789 F-22Table of ContentsThe fair value of the options granted is determined using the Black-Scholes option-pricing model. The following weighted average assumptions were used: 2015 2014 2013 Risk-free interest rate 1.65% 1.58% 1.17% Expected life of the options 6 years 6 years 5.29 years Expected volatility of the underlying stock 101% 114% 115% Expected dividend rate 0% 0% 0% As noted above, the fair value of stock options is determined by using the Black-Scholes option pricing model. For all options granted since January 1, 2006the Company has generally used option terms of between 5 to 10 years, generally with 5 to 6 years representing the estimated life of options granted toemployees. The volatility of the common stock is estimated using historical volatility over a period equal to the expected life at the date of grant. The risk-free interest rate used in the Black-Scholes option pricing model is determined by reference to historical U.S. Treasury constant maturity rates with termsequal to the expected terms of the awards. An expected dividend yield of zero is used in the option valuation model, because the Company does not expect topay any cash dividends in the foreseeable future. At December 31, 2015, the Company does not anticipate any option awards will be forfeited in thecalculation of compensation expense due to the limited number of employees that receive stock option grants and the Company’s historical employeeturnover.The following table summarizes the stock option activity in the stock based compensation plans: Number of Shares WeightedAverage Exercise Price Weighted Average Remaining ContractualLife (in years) Aggregate Intrinsic Value(in thousands) Outstanding, December 31, 2012 3,539,961 $5.66 Granted 425,426 3.89 Forfeited/Cancelled (403,674) 14.19 Exercised (213,008) 2.18 Outstanding, December 31, 2013 3,348,705 $4.70 Granted 354,823 12.72 Forfeited/Cancelled (124,466) 3.80 Exercised (246,445) 1.97 Outstanding, December 31, 2014 3,332,617 $5.79 Granted 454,000 3.23 Forfeited/Cancelled (348,718) 4.42 Exercised (95,574) 1.80 Outstanding, December 31, 2015 3,342,325 $5.70 6.30 $0 Exercisable, December 31, 2015 2,541,299 $5.68 5.95 $0 The aggregate intrinsic value in the table above represents the total pre-tax amount, net of exercise price, which would have been received by option holdersif all option holders had exercised all options with an exercise price lower than the market price on December 31, 2015, based on the closing price of theCompany’s common stock of $1.64 on that date.The weighted-average grant-date fair values of options granted during 2015, 2014 and 2013 were $2.57, $10.75 and $3.17, respectively. As of December 31,2015 and December 31, 2014, there were unvested options to purchase 801,026 and 888,140 shares of common stock, respectively. Total expectedunrecognized compensation cost related to such unvested options is $2,440,000 at December 31, 2015, which is expected to be recognized over a weighted-average period of 1.62 years. F-23Table of ContentsDuring the years ended December 31, 2015, 2014 and 2013, the Company issued shares totaling 95,574, 246,445, and 213,008, respectively, upon theexercise of options valued at $146,000, $411,000 and $378,000, respectively. During the years ended December 31, 2015, 2014 and 2013, the Companyreceived $0, $394,000, and $271,000, respectively, for the exercise of stock options. During 2015, 2014 and 2013, 212,501, 35,734, and 173,669 optionswere exercised on a cashless basis resulting in the issuance of 95,574, 26,109, and 81,591 shares, respectively. The intrinsic value of options exercisedduring the years ended December 31, 2015, 2014 and 2013 was $313,000, $2,677,000, and $1,498,000, respectively.During the years ended December 31, 2015, 2014 and 2013, 535,692, 676,335, and 614,041 options became vested, respectively. The total grant date fairvalue of options vested during the years ended December 31, 2015, 2014 and 2013 was $2,753,000, $3,711,000, and $2,406,000 respectively.The following table summarizes additional information regarding outstanding and exercisable options under our stock based compensation plans atDecember 31, 2015: Options Outstanding Options Exercisable ExercisePrice (Range) Number of Shares Weighted Average Remaining ContractualLife WeightedAverage Exercise Price Number of Shares WeightedAverage Exercise Price (in years) $1.80 – 1.83 64,168 5.4 $1.81 64,168 $1.81 $2.08 – 2.88 911,667 6.3 2.35 729,667 2.25 $3.45 – 4.41 564,517 8.3 3.82 331,202 3.87 $6.24 – 7.56 1,485,473 5.2 6.99 1,185,471 7.00 $13.38 316,500 8.1 13.38 230,791 13.38 3,342,325 6.3 $5.70 2,541,299 $5.68 The following table summarizes the restricted stock grant activity in the Company’s equity incentive plans from December 31, 2014 through December 31,2015: Shares Outstanding, December 31, 2014 416,670 Granted 337,935 Exercised — Options forfeited/cancelled — Outstanding, December 31, 2015 754,605 On March 12, 2015, the Company granted 81,352 shares of restricted stock to non-employee directors as a component of their compensation. A total of77,784 shares were issued to seven directors representing non-cash compensation cost of $280,000 which will be recognized on a straight-line basis from thegrant date through May 21, 2016, when the restricted shares will vest in full. A total of 3,568 shares were issued to two directors, who were not nominatedfor reelection, representing non-cash compensation cost of $12,845 that will be recognized on a straight-line basis from the grant date through May 21, 2016,when the restricted shares will vest in full.On April 8, 2015, the Company granted 177,618 shares of restricted stock to non-employee directors in exchange for cancelation of 222,615 stock options.As the exchange was made at fair value, there was no additional non-cash compensation expense recorded in accordance with FASB ASC 718-20.Additionally, on April 8, 2015, the Company granted 71,378 shares of restricted stock to one non-employee director representing $236,975 of non-cashcompensation expense which will be recorded on a straight-line basis F-24Table of Contentsfrom grant date to May 21, 2016, when the restricted shares will vest in full. Also, in April and May 2015, the Company granted a total of 7,587 shares ofrestricted stock to four non-employee directors for service as committee chairs or lead independent director representing $23,500 of non-cash compensationexpense which will be recorded on a straight-line basis from grant date to May 21, 2016, when the restricted shares will vest in full.Other Stock Based Compensation TransactionsIn September 2013, the Company modified certain vested stock options held by a former member of the Company’s board of directors. The individual leftthe board on May 23, 2013. The modification extended the contractual period of exercise of 103,158 stock options until the end of their original termsinstead of such options expiring 3 months after service on the board ended. As a result, the Company recorded a one-time, non-cash charge of $930,000 ingeneral and administrative expenses related to the modification in for the year ended December 31, 2013.In June 2013, the Company issued 25,000 options to a consultant for consulting services, which vested in August 2013. The options are exercisable at $3.97per share. These options were valued using the Black-Scholes option-pricing model based on a grant date fair value of the Company’s common stock rangingfrom $3.97 per share upon grant to $7.25 per share at completion of vesting. The Company recorded a $173,000 charge to stock compensation expense overthe vesting period of the options.In January 2014, the Company entered into an agreement with a consultant that provided for the grant of 8,966 shares of common stock. The Companyrecognized an expense of $100,000, representing the fair value of the common stock at issuance, during the year ended December 31, 2014.In October 2015, the Company entered into an agreement with a consultant that provided for the grant of 30,000 shares of common stock. The Companyrecognized an expense of $71,000, representing the fair value of the common stock at issuance, during the fourth quarter of 2015. 8.Loss Per ShareBasic net loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of common sharesoutstanding during the period. Diluted net loss per common share is computed by dividing the net loss available to common stockholders by the weightedaverage number of common shares and other potential common shares then outstanding. Potential common shares consist of common shares issuable uponthe assumed exercise of in-the-money stock options and warrants and potential common shares related to the conversion of the preferred stock. Thecomputation of diluted net loss per share does not assume the issuance of common shares that have an anti-dilutive effect on net loss per share. Year Ended December 31, (in thousands, except share and per share amounts) 2015 2014 2013 Net loss $(20,027) $(15,788) $(12,088) Preferred stock dividends (868) (943) (867) Preferred stock accretion (229) (229) (229) Warrant modification — — (8,763) Net loss applicable to common stockholders $(21,124) $(16,960) $(21,947) Basic and diluted net loss per share $(0.88) $(0.78) $(1.30) Shares used in computing basic and diluted net loss per share 24,120 21,849 16,874 F-25Table of ContentsDilutive shares which could exist pursuant to the exercise of outstanding stock instruments and which were not included in the calculation because theiraffect would have been anti-dilutive are as follows: Year Ended December 31, 2015 (Shares) 2014 (Shares) 2013 (Shares) Warrants to purchase shares of common stock 8,908,586 5,470,995 6,035,229 Options to purchase shares of common stock 3,342,325 3,332,617 3,348,705 Shares of common stock issuable upon conversion preferred stock 2,522,936 2,527,103 2,568,771 14,807,681 11,330,715 11,952,705 9.Commitments and ContingenciesLease CommitmentsIn September 2012, the Company entered into an operating lease for office space in Norcross, GA for a term of twenty-six months, beginning on October 1,2012 and ending November 30, 2014 at a rate of approximately $3,000 per month. In June 2014, the Company signed an amendment to the lease extendingthe term through November 30, 2017 with a base monthly rental of approximately $3,300 through the extended term. The original lease provided for freerent for the first two months of the lease and required a security deposit of $6,000. In addition to base rental payments included in the contractual obligationstable above, the Company is responsible for our pro-rata share of the operating expenses for the building.Rent expense under this operating lease was $47,000, $44,000 and $39,000 for the years ended December 31, 2015, 2014 and 2013, respectively.Future minimum payments under this lease as of December 31, 2015 are as follows (in thousands): Year ended December 31, 2016 40 2017 41 Total $81 Separation AgreementIn February 2009, the Company entered into a Separation Agreement in connection with the resignation of David Platt, Ph.D., the Company’s former ChiefExecutive Officer and Chairman of the Board of Directors. In July 2014, the Company paid the $1 million severance obligation.Shareholder Class Actions and Derivative LawsuitsBetween July 30, 2014, and August 6, 2014, three putative class action complaints were filed in the United States District Court for the District of Nevada(the “Nevada District Court”) against the Company and certain of its officers and directors on behalf of all persons who purchased or otherwise acquired theCompany’s stock between January 6, 2014 and July 28, 2014. The complaints allege that the defendants made false or misleading statements in certain pressreleases and other public statements in violation of the federal securities laws and seek class certification, unspecified monetary damages, costs, and attorneys’ fees.The Company disputes the allegations in the complaints and intends to vigorously defend against the claims. On August 22, 2014, the Nevada District Courtentered an order consolidating the three cases, relieving the defendants of any obligation F-26Table of Contentsto respond to the complaints currently on file, and providing that defendants may respond to a consolidated amended complaint after it is filed by a lead plaintiff(s)to be appointed pursuant to the Private Securities Litigation Reform Act of 1995. On January 5, 2015, the Nevada District Court granted Defendants’ motion totransfer the consolidated putative securities class action to the United States District Court for the Northern District of Georgia. On March 24, 2015, the Courtappointed a lead plaintiff (“Plaintiff’). Plaintiff filed his Consolidated Class Action Complaint (the “Complaint”) on May 8, 2015. The Complaint asserts claims onbehalf of a putative class of all persons who purchased or otherwise acquired the Company’s common stock between October 25, 2013 and July 28, 2014. TheComplaint alleges that the Company and certain of its officers and directors (the “Class Action Individual Defendants”) violated Section 1 O(b) of the SecuritiesExchange Act of 1934 (the “Exchange Act”) and SEC Rule 10b-5 through allegedly false or misleading statements in certain SEC filings, press releases and otherpublic statements. The Complaint further alleges that the Class Action Individual Defendants and one of the Company’s shareholders face liability for the allegedSection 1 O(b) and Rule 10b-5 violations pursuant to Section 20(a) of the Exchange Act. The Complaint seeks class certification, unspecified monetary damages,costs, and attorneys’ fees. The Company disputes the allegations and filed a motion to dismiss the Complaint on June 26, 2015. On December 30, 2015, the Courtdismissed the putative class action with prejudice and entered a final judgment in favor of the defendants. Plaintiff has filed a notice of appeal seeking review of thedismissal order and final judgment.On August 1 and 25, 2014, persons claiming to be Galectin shareholders filed putative shareholder derivative complaints in the Nevada District Court,seeking recovery on behalf of the Company against certain of the Company’s directors and officers. On September 10, 2014, the Nevada District Court entered anorder consolidating the two cases, relieving the defendants of any obligation to respond to the initial complaints, and providing that defendants may respond to aconsolidated complaint to be filed by the plaintiffs. On January 5, 2015, the Nevada District Court granted Defendants’ motion to transfer the consolidated putativederivative litigation to the United States District Court for the Northern District of Georgia (hereinafter referred to as the “Georgia Federal Derivative Action.”) Theplaintiffs filed a consolidated complaint on February 27, 2015. On April 6, 2015, the Company and defendants filed motions to dismiss the consolidated complaint.Rather than respond to those motions, the plaintiffs sought and obtained leave to file an amended complaint. Plaintiffs filed their amended complaint (the“Complaint”) on May 26, 2015. The Complaint alleges that certain of the Company’s directors and officers (the “Derivative Action Individual Defendants”)breached their fiduciary duties to the Company’s shareholders by causing or permitting the Company to make allegedly false and misleading public statementsconcerning the Company’s financial and business prospects. The Complaint also alleges that the Derivative Action Individual Defendants violated the federalsecurities laws by allegedly making false or misleading statements of material fact in the Company’s proxy filings, committed waste of corporate assets, wereunjustly enriched, and that certain defendants breached their fiduciary duties through allegedly improper sales of Galectin stock. In addition, the Complaint allegesthat the Derivative Action Individual Defendants and one of the Company’s shareholders aided and abetted the alleged breaches of fiduciary duties. The Complaintseeks unspecified monetary damages on behalf of the Company, corporate governance reforms, disgorgement of profits, benefits and compensation by thedefendants, costs, and attorneys ‘and experts’ fees. The Company and defendants filed motions to dismiss the Complaint on July 8, 2015. On December 30, 2015,the United States District Court for the Northern District of Georgia dismissed the Georgia Federal Derivative Action with prejudice and entered a final judgmentin favor of the defendants. Plaintiffs have filed a notice of appeal seeking review of the dismissal order and final judgment.On August 29, 2014, another alleged Galectin shareholder filed a putative shareholder derivative complaint in state court in Las Vegas, Nevada, seekingrecovery on behalf of the Company against the same Galectin directors and officers who are named as defendants in the derivative litigation pending in the GeorgiaFederal Derivative Action. The plaintiff in the Nevada action subsequently filed first and second amended complaints. The second amended complaint allegesclaims for breach of fiduciary duties, unjust enrichment, and waste of corporate assets, based on allegations that are substantially similar to those asserted in theGeorgia Federal Derivative Action (except that the Nevada action does not allege violations of the federal securities laws and does not assert any claim against theGalectin shareholder named as a defendant in the Georgia Federal F-27Table of ContentsDerivative Action), and seeks unspecified monetary damages on behalf of the Company, corporate governance reforms, disgorgement of profits, benefits andcompensation by the defendants, costs, and attorneys’ and experts’ fees. The Company and defendants filed motions to dismiss the second amended complaint onApril 22, 2015. On April 29, 2015, the plaintiffs in the Georgia Federal Derivative Action filed a motion to intervene in the Nevada action which, among otherthings, raised questions regarding the Nevada plaintiffs standing. Thereafter, the Nevada plaintiff filed a motion to join additional plaintiffs. At a hearing held onJune 11, 2015, the Nevada court: (i) granted the Georgia Federal Derivative Action plaintiffs’ motion to intervene; (ii) directed the Georgia Federal DerivativeAction plaintiffs to file a complaint in intervention; (iii) directed the Nevada plaintiff to file a motion for leave to file a further amended complaint to add additionalplaintiffs; (iv) stated that the defendants’ motions to dismiss the second amended complaint were denied “at this point;” (v) ordered the Nevada action stayed untilDecember 11 , 2015 ; and (vi) directed the parties to submit a status report on December 11, 2015, updating the court on the progress and status of the GeorgiaFederal Derivative Action. On July 9, 2015, pursuant to the Nevada State Court’s instruction, the Georgia Federal Derivative Action plaintiffs filed a complaint-in-intervention in Nevada State Court, asserting similar claims to the ones they alleged in the Georgia Federal Derivative Action described above. On December 11,2015, further to the Nevada State Court’s instruction, the parties submitted status reports detailing the status of the Georgia Federal Derivative Action. OnJanuary 5, 2016, the Nevada State Court held a status conference during which the dismissal of the Georgia Federal Derivative Action was discussed. Subsequentto that conference, on January 19, 2016, the defendants filed a motion to dismiss the Nevada State Court litigation based on the dismissal of the similar GeorgiaFederal Derivative Action, among other grounds. Defendants’ motion to dismiss was fully briefed to the Nevada court in February 2016. At a hearing on March 3,2016, the Nevada State Court granted dismissal of the Nevada State Court litigation pending entry of a final order of dismissal. Once the final order of dismissal isentered, plaintiffs will have 30 days to appeal.Estimating an amount or range of possible losses resulting from litigation proceedings is inherently difficult and requires an extensive degree of judgment,particularly where the matters involve indeterminate claims for monetary damages, are in the early stages of the proceedings, and are subject to appeal. In addition,because most legal proceedings are resolved over extended periods of time, potential losses are subject to change due to, among other things, new developments,changes in legal strategy, the outcome of intermediate procedural and substantive rulings and other parties’ settlement posture and their evaluation of the strengthor weakness of their case against us. For these reasons, we are currently unable to predict the ultimate timing or outcome of, or reasonably estimate the possiblelosses or a range of possible losses resulting from, the matters described above. Based on information currently available, the Company does not believe that anyreasonably possible losses arising from currently pending legal matters will be material to the Company’s results of operations or financial condition. However, inlight of the inherent uncertainties involved in such matters, an adverse outcome in one or more of these matters could materially and adversely affect theCompany’s financial condition, results of operations or cash flows in any particular reporting period.Other Legal ProceedingsThe Company records accruals for such contingencies to the extent that the Company concludes that their occurrence is probable and the related damages areestimable. There are no other pending legal proceedings except as noted above. 10.Galectin Sciences LLCIn January 2014, we created Galectin Sciences, LLC (the “LLC” or “Investee”), a collaborative joint venture co-owned by SBH Sciences, Inc. (“SBH”), toresearch and develop small organic molecule inhibitors of galectin-3 for oral administration. The LLC was initially capitalized with a $400,000 cashinvestment to fund future research and development activities, which was provided by the Company, and specific in-process research and development(“IPR&D”) contributed by SBH. The estimated fair value of the IPR&D contributed by SBH, on the date of contribution, was $400,000. Initially, theCompany and SBH have a 50% F-28Table of Contentsequity ownership interest in the LLC, with neither party having control over the LLC. Accordingly from inception through the fourth quarter of 2014, theCompany accounted for its investment in the LLC using the equity method of accounting. Under the equity method of accounting, the Company’s investmentwas initially recorded at cost with subsequent adjustments to the carrying value to recognize additional investments in or distributions from the Investee, aswell as the Company’s share of the Investee’s earnings, losses and/or changes in capital. The estimated fair value of the IPR&D contributed to the LLC wasimmediately expensed upon contribution as there was no alternative future use available at the point of contribution. The operating agreement provides that ifeither party does not desire to contribute its equal share of funding required after the initial capitalization, then the other party, providing all of the funding,will have its ownership share increased in proportion to the total amount contributed from inception. In the fourth quarter of 2014, after the LLC hadexpended the $400,000 in cash, SBH decided not to contribute its share of the funding required. As a result, the Company contributed the $73,000 needed forthe fourth quarter of 2014 expenses of the LLC. As a result, the Company’s ownership percentage in the LLC was 54.2% at December 31, 2014. TheCompany contributed $687,000 for the LLC expenses in 2015 adjusting the Company’s ownership percentage to 74.7% at December 31, 2015. TheCompany accounts for the interest in the LLC as a consolidated, less than wholly owned subsidiary. Because the LLC’s equity is immaterial, the value of thenon-controlling interest is also deemed to be immaterial. The Company’s portion of the LLC’s net loss for 2014, prior to the change in accounting discussedpreviously, was $400,000, which includes the Company’s proportionate share of the non-cash charge associated with the contributed IPR&D of $200,000. 11.Income TaxesThe components of the net deferred tax assets are as follows at December 31: 2015 2014 (in thousands) Operating loss carryforwards $37,152 $30,578 Tax credit carryforwards 1,195 645 Other temporary differences 5,048 4,689 43,395 35,912 Less valuation allowance (43,395) (35,912) Net deferred tax asset $— $— The primary factors affecting the Company’s income tax rates were as follows: 2015 2014 2013 Tax benefit at U.S. statutory rates (34%) (34%) (34%) State tax benefit (5%) (5.3%) (5.3%) Permanent differences 2.6% 5.4% 0.9% Expiring state NOL’s 0.9% 1.4% 1.8% Changes in valuation allowance 35.5% 32.5% 36.6% 0% 0% 0% As of December 31, 2015, the Company has federal and state net operating loss carryforwards totaling $99,642,000 and $60,459,000 respectively, whichexpire through 2034. The net operating losses include Federal and State excess benefits related to stock options of $707,000 that will be charged to additionalpaid-in capital when utilized. In addition, the Company has federal and state research and development credits of $998,000 and $196,000, respectively,which expire through 2034. Ownership changes, as defined by Section 382 of the Internal Revenue Code, may have limited the amount of net operating losscarryforwards that can be utilized annually to offset future taxable income. Subsequent ownership changes F-29Table of Contentscould further affect the limitation in future years. Because of the Company’s limited operating history and its recorded losses, management has provided, ineach of the last two years, a 100% valuation allowance against the Company’s net deferred tax assets.The Company is subject to taxation in the U.S. and various states. Based on the history of net operating losses all jurisdictions and tax years are open forexamination until the operating losses are utilized or the statute of limitations expires. As of December 31, 2015 and 2014, the Company does not have anysignificant uncertain tax positions. 12.Subsequent EventsOn January 6, 2016, the Company’s Board of Directors terminated the employment of its executive chairman in connection with electing a new non-executive chairman of the Board. Accordingly in January 2016, the Company recorded the severance obligation of $250,000 and non-cash stockcompensation due to the acceleration of stock options of $578,000. 13.Quarterly financial data (unaudited) 2015 Quarters ended (In thousands except per share data) December 31 September 30 June 30 March 31 Net loss $(4,671) $(5,887) $(4,643) $(4,826) Net loss applicable to common stockholders (4,967) (6,152) (4,931) (5,074) Basic and diluted net loss per share $(0.19) $(0.26) $(0.21) $(0.22) 2014 Quarters ended (In thousands except per share data) December 31 September 30 June 30 March 31 Net loss $(3,731) $(3,518) $(3,429) $(5,110) Net loss applicable to common stockholders (3,968) (3,853) (3,731) (5,408) Basic and diluted net loss per share $(0.17) $(0.17) $(0.17) $(0.27) F-30Exhibit 3.2AMENDED AND RESTATED BYLAWSOFGALECTIN THERAPEUTICS INCARTICLE 1OFFICESSection 1.1 Principal Office . Galectin Therapeutics Inc (the “ Corporation ”) will maintain its principal office within or without the State of Nevada as theBoard of Directors (the “ Board ”) may determine from time to time.Section 1.2 Registered Office and Other Offices . The registered office of the Corporation in Nevada shall be that of its registered agent most recentlyappointed in the Articles (as defined in Section 1.3), or as evidenced by a certificate of acceptance executed by a registered agent and filed with the Secretary ofState of Nevada in the manner prescribed by the Nevada Revised Statutes (“ NRS ”). The Corporation may also maintain offices at such other place or places,either within or without the State of Nevada, as may be designated from time to time by the Board, where the business of the Corporation may be transacted withthe same effect as though done at the principal office.Section 1.3 Records . The Corporation will keep and maintain at its registered office a certified copy of its articles of incorporation and all amendmentsthereto (the “ Articles ”) and a certified copy of these bylaws and all amendments hereto (the “ Bylaws ”). The Corporation will also keep at its registered office astock ledger or duplicate stock ledger, revised annually, containing the names, alphabetically arranged, of all stockholders of the Corporation, showing their placesof residence, if known, and the number of shares held by them respectively, or a statement setting out the name of the custodian of the stock ledger or duplicatestock ledger, and the present and complete post office address, including street and number, if any, where such stock ledger or duplicate ledger is kept.ARTICLE 2STOCKHOLDERSSection 2.1 Stockholders’ Meetings . All meetings of stockholders will be held at such places as may be fixed from time to time by the Board, or in theabsence of direction by the Board, by the President or Secretary, either within or without the State of Nevada, as will be stated in the notice of the meeting or in aduly executed waiver of notice thereof. If authorized by the Board, in its sole discretion and subject to such guidelines and procedures as the Board may adopt,stockholders may participate in a meeting of stockholders, whether annual or special, through electronic communications, videoconferencing, teleconferencing, orother available technology which allows the stockholders to communicate simultaneously or sequentially. Such participation in a meeting will constitute presencein person at the meeting.Section 2.2 Annual Meetings . Annual meetings of stockholders will be held each year on a date and at a time to be designated by the Board. Stockholderswill, at the annual meeting, elect the directors to serve on the Board and transact such other business as properly may be brought before the meeting.Section 2.3 Special Meetings of Stockholders . Special meetings of the stockholders, for any purpose or purposes, unless otherwise prescribed by statute orby the Articles, may be called by the President and will be called by the President or Secretary at the request in writing of a majority of the Board. Such request willstate the purpose or purposes of the proposed meeting.Section 2.4 List of Stockholders . The Transfer Agent (as defined in Section 6.4) or, if a Transfer Agent has not been appointed, the Secretary, will prepare,and make, at least ten (10) days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabeticalorder, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list is not required to includestockholders’ electronic email addresses or facsimile numbers. Such list will be open to the examination of any stockholder, for any purpose germane to themeeting, during ordinary business hours, for a period of at least ten (10) days prior to the meeting, either at a place within the city where the meeting is to be held,which place will be specified in the notice of the meeting, or, if not so specified, at the place where the meeting is to be held. The list will also be produced and keptat the time and place of the meeting during the whole time thereof and may be inspected by any stockholder who is present.Section 2.5 Notice of Meetings .(a) Written notice stating the time and place of any meeting of the stockholders will be delivered to each stockholder of record entitled to vote at suchmeeting not less than ten (10) nor more than sixty (60) days before the date of the meeting.(b) In the case of an annual meeting, the notice of meeting need not specifically state the purpose or purposes for which the meeting is called. In the case of aspecial meeting, the notice of meeting shall specifically state the purpose or purposes for which the meeting is called.(c) If a meeting is adjourned for sixty (60) days or more after the date fixed for the original meeting, notice of the adjourned meeting will be given as in thecase of an original meeting. When a meeting is adjourned for a period of less than sixty (60) days in any one adjournment, it is not necessary to give any notice ofthe date, time, or place of the adjourned meeting other than by announcement at the meeting at which the adjournment is taken, unless a new record date is set forthe meeting.(d) If mailed, such notice shall be deemed to be delivered when deposited in the United States mail, addressed to the stockholder at his, her, or its address asit appears on the record of stockholders of the Corporation, with postage prepaid.(e) Without limiting the manner by which notice otherwise may be given to stockholders, any notice to a stockholder may be given by a form of electronictransmission consented to by the stockholder to whom the notice is given and in the manner prescribed in NRS Section 78.370, as amended. Any such consent maybe revoked by the stockholder by written or electronic notice to the Corporation. Any such consent will be deemed revoked if: (i) the Corporation is unable todeliver two (2) consecutive electronic transmissions given by the Corporation in accordance with such consent; and (ii) such inability becomes known to theSecretary or the Transfer Agent or other person responsible for giving of notice or other communications; provided , however , that the inadvertent failure to treatsuch inability as a revocation shall not invalidate any meeting or other action. For purposes of this Section 2.5(e), “electronic transmission” means facsimiletransmission,electronic mail, posting on an electronic network, or any form of communication, not directly involving the physical transmission of paper or other tangiblemedium, which is suitable for the retention, retrieval, and reproduction of information by the recipient, and which is retrievable and reproducible in paper form bythe recipient through an automated process used in conventional commercial practice. An affidavit of the Secretary or the Transfer Agent or any other agent of theCorporation that the notice has been given, whether by a form of electronic transmission or otherwise, shall, in the absence of fraud, be prima facie evidence of thefacts stated therein.Section 2.6 Waiver of Notice . Attendance of a stockholder at a meeting, in person or by proxy, will constitute waiver of notice of such meeting, except whenthe stockholder attends the meeting for the express purpose of objecting to the transaction of any business because the meeting is not lawfully called or convenedand so objects at the beginning of the meeting. Any stockholder may waive notice of any annual or special meeting of stockholders by executing a written waiver ofnotice either before or after the time of the meeting.Section 2.7 Fixing of Record Date .(a) For the purpose of determining the stockholders entitled to notice of and to vote at any meeting of stockholders or any adjournment thereof, or entitled toreceive payment of any distribution or the allotment of any rights, or entitled to exercise any rights in respect of any change, conversion, or exchange of stock or forthe purpose of any other lawful action, the directors may fix, in advance, a record date, which shall not be more than sixty (60) days nor less than ten (10) daysbefore the date of such meeting, if applicable. When a determination of stockholders entitled to vote at any meeting of stockholders has been made as provided inthis Section 2.7, such determination will, unless otherwise provided by the Board, also apply to any adjournment thereof.(b) If no record date is fixed, the record date for determining stockholders: (i) entitled to notice of and to vote at a meeting of stockholders shall be at theclose of business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day onwhich the meeting is held; and (ii) for any other purpose shall be at the close of business on the day on which the Board adopts the resolution relating thereto. Adetermination of stockholders of record entitled to notice of or to vote at any meeting of stockholders shall apply to any adjournment of the meeting; provided ,however , that the Board may fix a new record date for the adjourned meeting and must fix a new record date if the meeting is adjourned to a date more than sixty(60) days later than the date set for the original meeting.Section 2.8 Quorum and Adjournment . The holders of at least one-third (1/3) of the voting power of all classes and series of stock entitled to vote at themeeting, present in person or by proxy, regardless of whether the proxy has authority to vote on all matters, will constitute a quorum at all meetings of thestockholders for the transaction of business except as otherwise provided by the NRS or by the Articles. Once a quorum is established at any meeting of thestockholders, the voluntary withdrawal of any stockholder from the meeting shall not affect the authority of the remaining stockholders to conduct any businesswhich properly comes before the meeting. If, however, such quorum is not present or represented at any meeting of the stockholders, the stockholders entitled tovote at the meeting, present in person or represented by proxy, will have the power to adjourn the meeting from time to time, without notice other thanannouncement at the meeting, until a quorum is present or represented by proxy. At such adjourned meeting at which a quorum is present or represented by proxyany business may be transacted which might have been transacted at themeeting as originally notified. If the adjournment is for more than sixty (60) days, or if after the adjournment a new record date is fixed for the adjourned meeting,a notice of the adjourned meeting will be given to each stockholder of record entitled to vote at the meeting.Section 2.9 Nominations for Director .(a) Only persons who are nominated in accordance with the procedures set forth in this Section 2.9 will be eligible for election to the Board. Nominations ofpersons for election to the Board at a meeting of the stockholders at which directors are being elected may be made (i) by or at the direction of the Board or (ii) byany stockholder of the Corporation entitled to vote for the election of directors at such meeting who complies with the procedures set forth in this Section 2.9. Suchnominations by any stockholder must be made pursuant to timely notice in proper written form to the Secretary.(b) To be timely, a stockholder’s notice must be delivered to or mailed to and received by the Secretary at the principal office of the Corporation not less thanninety (90) days nor more than one hundred twenty (120) days in advance of the first anniversary of the preceding year’s annual meeting; provided , however , thatin the event that (i) no annual meeting was held in the previous year or (ii) the date of the annual meeting has been changed by more than thirty (30) days from thedate of the previous year’s meeting, or in the event of a special meeting of stockholders called for the purpose of electing directors, not later than the close ofbusiness on the 10 day following the day on which notice of the date of the meeting was mailed or public disclosure of the date of the meeting was made,whichever occurs first. In no event will the public disclosure of an adjournment or postponement of a stockholders meeting commence a new time period for thegiving of a stockholders notice as described above.(c) To be in proper written form, a stockholder’s notice to the Secretary must set forth in writing: (i) as to each person whom such stockholder proposes tonominate for election or re-election as a director, all information relating to such person that is required to be disclosed in solicitations of proxies for election ofdirectors, or is otherwise required, in each case pursuant to Regulation 14A under the Securities Exchange Act of 1934, as amended (the “ Exchange Act ”),including, without limitation, such person’s written consent to being named in the proxy statement as a nominee and to serving as director if elected as well as (A)such person’s name, age, business address and residence address, (B) his or her principal occupation or employment, (C) the class and number of shares of theCorporation that are beneficially owned by such person, and (D) a description of all arrangements or understandings between the stockholder and each nominee andany other person or persons (naming such person or persons) pursuant to which the nominations are to be made by the stockholder; and (ii) as to such stockholder(A) the name and address, as they appear on the Corporation’s books, of such stockholder and the beneficial owner, if any, on whose behalf the nomination ismade, and (B) the class and number of shares of the Corporation which are beneficially owned by such stockholder and the beneficial owner, if any, on whosebehalf the nomination is made, and any material interest of such stockholder and owner. At the request of the Board, any person nominated by the Board forelection as a director will furnish to the Secretary the information required to be set forth in a stockholder’s notice of nomination which pertains to the nominee.(d) No person will be eligible for election by the stockholders as a director unless nominated in accordance with the procedures set forth in this Section 2.9.The chairman of the meeting will, if the facts warrant, determine and declare at the meeting that a nomination was not made in accordance with the proceduresprescribed in this Section 2.9, and if he or she so determines, he or she will so declare at the meeting that the defective nomination will be disregarded.th Section 2.10 Stockholder Proposals .(a) At any special meeting of the stockholders, only such business will be conducted as has been brought before the meeting by or at the direction of theBoard.(b) At any annual meeting of the stockholders, only such business will be conducted as has been brought before the meeting (i) specified in the notice ofmeeting (or any supplement thereto) given by or at the direction of the Board, (ii) otherwise properly brought before the meeting by or at the direction of the Board,or (iii) by any stockholder who complies with the procedures set forth in this Section 2.10.(c) For business to be properly brought before an annual meeting by a stockholder, the stockholder must give timely notice thereof in proper written form tothe Secretary and such business must otherwise be a proper matter for stockholder action.(d) To be timely, a stockholder’s notice must be delivered to or mailed to and received by the Secretary at the principal office of the Corporation not less thanninety (90) days nor more than one hundred twenty (120) days in advance of the first anniversary of the preceding year’s annual meeting; provided , however , thatin the event that (i) no annual meeting was held in the previous year or (ii) the date of the annual meeting has been changed by more than thirty (30) days before orafter the date of the previous year’s meeting, not later than the close of business on the 10 day following the day on which notice of the date of the meeting wasmailed or public disclosure of the date of the meeting was made, whichever occurs first. In no event will the public disclosure of an adjournment or postponementof a stockholders meeting commence a new time period for the giving of a stockholders notice as described above.(e) To be in proper written form, a stockholder’s notice to the Secretary must set forth in writing as to each matter such stockholder proposes to bring beforethe annual meeting: (i) a brief description of the business desired to be brought before the meeting; (ii) the name and address, as they appear on the Corporation’sbooks, of the stockholder proposing such business, and the beneficial owner, if any, on whose behalf the proposal is made; (iii) the text of the proposal or business(including the text of any resolutions proposed for consideration) and the reasons for conducting such business at the meeting; (iv) the class and number of sharesof the Corporation which are owned beneficially by such stockholder and the beneficial owner, if any, on whose behalf the proposal is made; (v) any materialinterest in such business of the stockholder or the beneficial owner, if any, on whose behalf the proposal is made; (vi) any other information that is required to beprovided by the stockholder pursuant to Regulation 14A under the Exchange Act in such stockholder’s capacity as a proponent of a stockholder proposal; (vii) arepresentation that the stockholder is a holder of record of stock of the Corporation entitled to vote at such meeting and intends to appear in person or by proxy atthe meeting to propose such business; and (viii) a representation whether the stockholder or the beneficial owner, if any, intends or is part of a group which intends(A) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital stock required to approve oradopt the proposal or (B) otherwise to solicit proxies from stockholders in support of such proposal. The foregoing notice requirements will be deemed satisfied bya stockholder if the stockholder has notified the Corporation of his, her, or its intention to present a proposal at an annual meeting in compliance withth Rule 14a-8 (or any successor thereof) promulgated under the Exchange Act and such stockholder’s proposal has been included in a proxy statement that has beenprepared by the Corporation to solicit proxies for such annual meeting.(f) No business will be conducted at an annual meeting except in accordance with the procedures set forth in this Section 2.10. The chairman of an annualmeeting will, if the facts warrant, determine and declare at the meeting that business was not properly brought before the meeting in accordance with the provisionsof this Section 2.10, and, if he or she should so determine, he or she shall so declare at the meeting that any such business not properly brought before the meetingwill not be transacted.Section 2.11 Public Disclosure; Conduct of Nominations, and Proposals by Stockholders .(a) For purposes of Sections 2.9 and 2.10, “public disclosure” means disclosure in a press release reported by the Dow Jones News Service, Associated Press,Reuters or any comparable national news service or in a document publicly filed or furnished by the Corporation with the Securities and Exchange Commissionpursuant to Section 13, 14, or 15(d) of the Exchange Act.(b) Notwithstanding Sections 2.9 and 2.10, if the stockholder (or a representative of the stockholder) does not appear at the annual meeting to present anomination or proposal, such nomination and proposal will be disregarded, notwithstanding that proxies in respect of such vote may have been received by theCorporation.(c) Without limiting Sections 2.9 and 2.10, a stockholder will also comply with all applicable requirements of the Exchange Act and the rules and regulationsthereunder with respect to the matters set forth in Sections 2.9 and 2.10. Nothing in Sections 2.9 or 2.10 will affect any rights of stockholders to request inclusion ofproposals in the Corporation’s proxy statement pursuant to Rule 14a-8 under the Exchange Act.Section 2.12 Conduct of Meetings . The President, or any person so designated by the President, or if the President is absent, did not so designate, orotherwise is unable to so serve, any Vice President, will chair all meetings of the stockholders. The Secretary or, in his or her absence, such other person as thechairman of the meeting may designate, will serve as secretary of the meeting. The chairman of the meeting will conduct all meetings of the stockholders inaccordance with the best interests of the Corporation and will have the authority and discretion to establish reasonable procedural rules for the conduct of suchmeetings, including such regulation of the manner of voting and the conduct of discussion as he or she deems appropriate.Section 2.13 Voting; Proxies .(a) Each stockholder entitled to vote at any meeting may vote either in person or by proxy. Unless otherwise specified in the Articles or in resolutions of theBoard providing for the issuance of different classes or series of shares, each stockholder entitled to vote will be entitled to one (1) vote for each share of capitalstock registered in his, her, or its name on the transfer books or records of the Corporation.(b) Except as otherwise provided herein, all votes with respect to shares standing in the name of an individual at the close of business on the record date(including pledged shares) shall be cast only by that individual or such individual’s duly authorized proxy. With respect to shares held by a representative of theestate of a deceased stockholder, or a guardian, conservator, custodian ortrustee, even though the shares do not stand in the name of such holder, votes may be cast by such holder upon proof of such representative capacity. In the case ofshares under the control of a receiver, the receiver may cast votes carried by such shares even though the shares do not stand of record in the name of the receiver;provided, that the order of a court of competent jurisdiction which appoints the receiver contains the authority to cast votes carried by such shares. If shares stand ofrecord in the name of a minor, votes may be cast by the duly appointed guardian of the estate of such minor only if such guardian has provided the Corporationwith written proof of such appointment.(c) With respect to shares standing of record in the name of another corporation, partnership, limited liability company or other legal entity on the recorddate, votes may be cast: (i) in the case of a corporation, by such individual as the bylaws of such other corporation prescribe, by such individual as may beappointed by resolution of the Board of Directors of such other corporation or by such individual (including, without limitation, the officer making theauthorization) authorized in writing to do so by the chairman of the board, if any, president, chief executive officer, if any, or any vice president of suchcorporation; and (ii) in the case of a partnership, limited liability company or other legal entity, by an individual representing such stockholder upon presentation tothe Corporation of satisfactory evidence of his or her authority to do so.(d) Notwithstanding anything to the contrary contained herein and except for the Corporation’s shares held in a fiduciary capacity, the Corporation shall notvote, directly or indirectly, shares of its own stock owned by it; and such shares shall not be counted in determining the total number of outstanding shares entitledto vote.(e) Any holder of shares entitled to vote on any matter may cast a portion of the votes in favor of such matter and refrain from casting the remaining votes orcast the same against the proposal, except in the case of elections of directors. If such holder entitled to vote does vote any of such stockholder’s sharesaffirmatively and fails to specify the number of affirmative votes, it will be conclusively presumed that the holder is casting affirmative votes with respect to allshares held.(f) With respect to shares standing of record in the name of two (2) or more persons, whether fiduciaries, members of a partnership, joint tenants, tenants incommon, husband and wife as community property, tenants by the entirety, voting trustees or otherwise and shares held by two (2) or more persons (includingproxy holders) having the same fiduciary relationship in respect to the same shares, votes may be cast in the following manner: (i) if only one (1) person votes, thevote of such person binds all; (ii) if more than one (1) person casts votes, the act of the majority so voting binds all; and (iii) if more than one (1) person casts votes,but the vote is evenly split on a particular matter, the votes shall be deemed cast proportionately, as split.(g) Each stockholder entitled to vote may authorize another person or persons to act for his, her, or it by proxy. All proxies must be in writing, signed by thestockholder or by his, her, or its duly authorized attorney-in-fact, and will be filed with the Secretary before being voted; provided , that no proxy will be valid aftersix (6) months from the date of its execution unless the person executing it specifies in it the length of time for which it is to continue in force, which in no eventwill exceed seven (7) years. A duly executed proxy is not revoked and will continue in full force and effect until another instrument or transmission revoking it or aproperly created proxy bearing a later date is filed with or transmitted to the Secretary. The mere attendance at a meeting by a stockholder who has previouslygiven a proxy applicable to such meeting will not constitute a revocation of such proxy.(h) Except for the election of directors or as otherwise provided by applicable law, the Articles, or these Bylaws, at all meetings of stockholders, action bythe stockholders on a matter is approved if the number of votes cast in favor of the action exceeds the number of votes cast in opposition to the action.(i) Except as otherwise required by applicable law or the Articles, a director will be elected to the Board only if such director receives the affirmative vote ofthe majority of shares of capital stock present in person or represented by a proxy at the meeting and entitled to vote for the election of directors. In the event thenumber of directors receiving the affirmative vote of such majority of shares at such meeting exceeds the number of then available director positions, then, of suchdirectors receiving the affirmative vote of such majority of shares at such meeting, those directors with a plurality of the votes cast shall be elected to theBoard. Cumulative voting for directors will not be required or permitted.Section 2.14 Inspectors of Election . In advance of any meeting of stockholders, the Board will appoint one (1) or more persons, other than officers,directors, or nominees for office, as inspectors of election to act at such meeting or any adjournment thereof. Such appointment will not be altered at the meeting. Ifinspectors of election are not so appointed, the chairman of the meeting will make such appointment at the meeting. If any person appointed as inspector fails toappear or fails or refuses to act at the meeting, the vacancy so created may be filled by appointment by the Board in advance of the meeting or at the meeting by thechairman of the meeting. The duties of the inspectors of election will include determining the number of shares outstanding and the voting power of each;determining the shares represented at the meeting; determining the existence of a quorum; determining the validity and effect of proxies; receiving votes, ballots, orconsents; hearing and deciding all challenges and questions arising in connection with the right to vote; counting and tabulating all votes, ballots, or consents;determining the results of any election, vote, or other determination; and doing such acts as are proper to the conduct of the election or the vote with fairness to allstockholders. Any report or certificate made by them will be prima facie evidence of the facts stated and of the vote as certified by them. Each inspector will beentitled to a reasonable compensation for his or her services, to be paid by the Corporation.Section 2.15 Action Without Meeting . Any action required or permitted to be taken at any meeting of stockholders may be taken without a meeting, withoutprior notice, and without a vote, if a consent in writing, setting forth the action so taken, is signed by the holders of a majority of the voting power of all classes andseries of stock entitled to vote with respect to the subject matter of the action, except that if any greater proportion of voting power is required for such an action ata meeting, then the greater proportion of written consents is required. Such written consents will be delivered to the Secretary. Every written consent must bear thedate of signature of each stockholder who signs the consent. No written consent will be effective unless it is delivered, with signatures of stockholders holdingsufficient shares to authorize or take such action, to the Secretary within sixty (60) days after the earliest dated signature on such consent. In no instance whereaction is authorized by written consent need a meeting of stockholders be called or notice given.ARTICLE 3BOARD OF DIRECTORSSection 3.1 General Powers . The business and affairs of the Corporation shall be managed under the direction of the Board except as otherwise provided bythe Articles or by applicable law.Section 3.2 Number, Term, and Qualification . The number of directors on the Board will be determined from time to time by resolution adopted by theBoard. In the absence of such resolution, the number of directors elected at the meeting shall constitute the number of directors of the Corporation until the nextannual meeting of stockholders, unless the number is changed prior to such meeting by action of the Board. Unless otherwise required or permitted by applicablelaw, a majority of the members of the Board must be Independent Directors (as defined in Section 4.4). Each director’s term shall expire at the annual meeting nextfollowing the director’s election as a director; provided , that, notwithstanding the expiration of the term of the director, the director shall continue to hold officeuntil a successor is elected and qualifies or until his death, resignation, retirement, removal, or disqualification or until there is a decrease in the number ofdirectors. Directors need not be residents of the State of Nevada or stockholders of the Corporation. No decrease in the number of directors constituting the Boardshall shorten the term of any incumbent directors.Section 3.3 Removal . Directors may be removed from office with or without cause, at an annual or special meeting of the stockholders upon a vote ofstockholders holding at least two-thirds (2/3) of the voting power of all classes and series of stock entitled to vote at such meeting. The notice of the stockholders’meeting at which such action is to be taken must state that a purpose of the meeting is removal of the director.Section 3.4 Vacancies . A vacancy occurring on the Board, including, without limitation, a vacancy resulting from death, resignation, retirement, removal,disqualification, an increase in the number of directors, or from the failure by the stockholders to elect the full authorized number of directors, may be filled by amajority vote of the remaining directors or by the sole director remaining in office, in either case though less than a quorum.Section 3.5 Compensation . The Corporation may compensate directors for their service on the Board as such and may provide for the payment of expensesincurred by the directors in connection with such services. Any director may serve the Corporation in any other capacity and receive compensation therefor.Section 3.6 Chairman and Vice Chairman of the Board . The chairman of the Board (the “ Chairman of the Board ”) and vice chairman of the Board (the “Vice Chairman of the Board ”) will be elected by the Board, the Chairman of the Board, or if the Chairman of the Board is unable to attend the meeting or if theChairman of the Board is not then an Independent Director and a meeting on the Independent Directors is called, the Vice Chairman of the Board, will preside atmeetings of the Board, and each shall have such other authority and perform such other duties as the Board may designate.Section 3.7 Place of Meetings; Meetings by Telephone . The Board may hold meetings, both regular and special, either within or outside the State of Nevada.Members of the Board or any committee designated by the Board may participate in a meeting of the Board or committee through electronic communications,videoconferencing, teleconferencing or other available technology which allows the stockholders to communicate simultaneously or sequentially. Suchparticipation in a meeting will constitute presence in person at the meeting.Section 3.8 Regular Meetings . Regular meetings of the Board may be held without notice at such date, time, and place as the Board will determine fromtime to time.Section 3.9 Special Meetings; Notice . Special meetings of the Board may be called at any time by the Chairman of the Board, the President, or any two (2)directors. Notice of the date, time, and place of special meetings of the Board will be delivered personally, by first class mail, overnight courier, telephone,facsimile, or electronic mail to each director at that director’s address as shown on the records of the Corporation.Section 3.10 Waiver of Notice . Notice of the date, time, place, and purpose of any meeting of directors may be waived in writing, signed by the personentitled to notice, either before or after such meeting, and a director’s attendance at a meeting waives objection to lack of notice or defective notice of the meeting,unless the director at the beginning of the meeting objects to holding the meeting or transacting business at the meeting because the meeting is not lawfully calledor convened. Neither of the business to be transacted at, nor the purpose of, any regular or special meeting of the directors, or members of a committee of directors,need to be specified in a written waiver of notice.Section 3.11 Quorum; Vote . Except as otherwise provided by applicable law, at all meetings of the Board, a majority of the authorized number of directorswill constitute a quorum for the transaction of business and the vote of a majority of the directors present at any meeting at which there is a quorum will be the actof the Board. If a quorum is present at the call of a meeting, the directors may continue to transact business until adjournment notwithstanding the withdrawal ofenough directors to leave less than a quorum. In the event of a tie vote of the Board and one (1) or more directors is absent from the meeting, the matter will bedeferred until the next meeting of the Board. In the event of a tie vote and all directors have participated in the meeting and have voted or abstained from voting,the Chairman of the Board will cast an additional vote and the matter will be approved or disapproved based upon such vote. In the event the Chairman of theBoard has abstained from voting on the issue, the matter will be deemed disapproved due to the matter failing to obtain a majority of affirmative votes.Section 3.12 Adjourned Meeting; Notice . If a quorum is not present at any meeting of the Board, then the directors present at the meeting may adjourn themeeting from time to time without notice other than announcement at the meeting, until a quorum is present, but may not transact business.Section 3.13 Conduct of Business . Meetings of the Board will be presided over by the Chairman of the Board, if any, or in his or her absence by thePresident, or in his or her absence by a chairman chosen at the meeting. The Secretary will act as secretary of the meeting, but in his or her absence the chairman ofthe meeting may appoint any person to act as secretary of the meeting. The chairman of the meeting will determine the order of business and the procedures at themeeting.Section 3.14 Action by Written Consent . Any action required or permitted to be taken at any meeting of the Board, or of any committee thereof, may betaken without a meeting if all members of the Board or committee, as the case may be, consent thereto in writing and the writing or writings are filed with theminutes of proceedings of the Board or committee.ARTICLE 4COMMITTEESSection 4.1 Audit Committee . The Board by resolution will designate an audit committee (the “ Audit Committee ”) consisting of at least three (3)members. All of the members of the Audit Committee must be Independent Directors. The Audit Committee will review the internal financial controls of theCorporation, and the integrity of its financial reporting, and have such other powers and duties as the Board determines. The Board will adopt a charter, which maybe amended from time to time, setting forth the powers and duties of the Audit Committee. The Board will designate by resolution a member of the AuditCommittee as a “financial expert” within the meaning of Item 401 of Regulation S-K under the Exchange Act.Section 4.2 Compensation Committee . The Board by resolution will designate a compensation committee (the “ Compensation Committee ”) consisting ofat least two (2) members. All members of the Compensation Committee must be Independent Directors. The Compensation Committee will administer theCorporation’s compensation plans and have such other powers and duties as the Board determines. The Board will adopt a charter, which may be amended fromtime to time, setting forth the powers and duties of the Compensation Committee.Section 4.3 Nominating and Corporate Governance Committee . The Board by resolution will designate a nominating and corporate governance committee(the “ Nominating and Corporate Governance Committee ”) consisting of at least two (2) members. All members of the Nominating and Corporate GovernanceCommittee must be Independent Directors. The Nominating and Corporate Governance Committee will nominate candidates for election to the Board, formulatecorporate governance principles, and have such other powers and duties as the Board determines. The Board will adopt a charter, which may be amended from timeto time, setting forth the powers and duties of the Nominating and Corporate Governance Committee.Section 4.4 Independent Directors . For purposes of this Article 4, “ Independent Director ” means a director who is not an officer or employee of theCorporation or its affiliates and who does not have any other relationship with the Corporation which, in the opinion of the Board, would interfere with the exerciseof independent judgment in carrying out the responsibilities of a director. Without limiting the foregoing, all Independent Directors must satisfy the requirementsset forth in the applicable rule concerning director independence of the national securities exchange on which the Corporation’s common stock or other equitysecurity is then listed, and if not listed then the requirements set forth in Rule 5605(a)(2) of the NASDAQ Listing Rules.Section 4.5 Other Committees . The Board, by resolution adopted by a majority of the entire Board, may designate other committees of directors of one (1)or more directors, which shall serve at the Board’s pleasure and have such powers and duties as the Board determines.Section 4.6 Meetings and Action of Committees .(a) The members of all committees will serve at the pleasure of the Board. The Board may designate one (1) or more directors as alternate members of anycommittee, who may replace any absent or disqualified member at any meeting of the committee; provided , that such alternate members of the Audit Committee,Compensation Committee, and Nominating and Corporate Governance Committee must be Independent Directors. Each committee will keep regular minutes of itsmeetings and report the same to the Board at its next meeting. Each committee may adopt rules of procedure and shall meet as provided by those rules or byresolutions of the Board. Subject to the provisions requiring Independent Directors, any director may serve simultaneously on multiple committees.(b) Except as otherwise provided in resolutions or charters adopted by the Board, all meetings and actions of committees will be governed by, and held andtaken in accordance with, the provisions of Sections 3.7 through 3.14, with such changes in the context of those Bylaws as are necessary to substitute the committeeand its members for the Board and its members; provided , however , that (i) the time of regular meetings of committees may be determined either by resolution ofthe Board or by resolution of the committee; (ii) special meetings of committees may also be called by resolution of the Board; (iii) notice of special meetings ofcommittees will also be given to all alternate members, who will have the right to attend all meetings of the committee; (iv) a majority of the members of acommittee will constitute a quorum for the transaction of business at any meeting; and (v) the affirmative vote of a majority of the members of a committee will berequired to take action in respect of any matter presented to or requiring the approval of the committee.ARTICLE 5OFFICERSSection 5.1 Designation . The officers of the Corporation will be chosen by the Board and will be a President, a Secretary, and a Treasurer. The Board mayalso choose one (1) or more vice presidents, assistant secretaries, and assistant treasurers, and such other officers as may be deemed necessary. Any person mayhold two (2) or more offices.Section 5.2 Appointment of Officers . The Board at its first meeting after each annual meeting of stockholders will choose a President, a Secretary, aTreasurer, and a Chief Financial Officer and may choose a Chairman of the Board, each of whom will serve at the pleasure of the Board. The Board at any timemay appoint such other officers as it deems necessary who will hold their offices at the pleasure of the Board and who will exercise such powers and perform suchduties as will be determined from time to time by the Board.Section 5.3 Compensation . The compensation of the officers will be fixed from time to time by the Board, upon recommendation from the CompensationCommittee, and no officer will be prevented from receiving such compensation by reason of the fact that he or she is also a director of the Corporation. Thecompensation of the officers or the method by which compensation is set will be set forth in the minutes of the meetings of the Board.Section 5.4 Vacancies . A vacancy in any office because of death, resignation, removal, disqualification, or otherwise may be filled by the Board at any time.Section 5.5 Resignation and Removal . Any officer may resign at any time by giving written notice to the President. Any resignation will take effect on thedate the President receives such notice or at any later time specified in such notice; and, unless otherwise specified in such notice, acceptance of the resignation willnot be necessary to make it effective. Any resignation is without prejudice to the rights, if any, of the Corporation under any contract to which the officer is a party,or of the Board to remove an officer at any time as provided in this Section 5.5. Subject to the rights, if any, of an officer under any contract of employment, theBoard may remove any officer, either with or without cause, at any regular or special meeting of the Board.Section 5.6 Chairman of the Board . The Chairman of the Board, if one is appointed and serving, or if the Chairman of the Board is unable to attend themeeting or the Chairman of theBoard is not then an Independent Director and a meeting of the Independent Directors is called, the Vice Chairman of the Board, will preside at all meetings of theBoard and will perform such other duties as may be from time to time assigned to him or her by the Board.Section 5.7 President . The President will serve as the chief executive officer (the “ Chief Executive Officer ”) of the Corporation may be designated as theChief Executive Officer if determined by the Board, and will, subject to the control of the Board, be responsible for the general supervision, direction, and controlof the business and affairs and supervision of the other officers of the Corporation. The President will have the general powers and duties of management usuallyvested in the president or chief executive officer of a corporation and will have such other powers and duties as may be from time to time prescribed by the Board.Section 5.8 Vice Presidents . There will be as many vice presidents (each a “ Vice President ”) as may be determined from time to time and they willperform such duties as may be from time to time assigned to them by the Board or the President. Any one of the vice presidents, as authorized by the Board, willhave all the powers and perform all the duties of the President in case of the President’s temporary absence or inability to act. In case of the President’s permanentabsence or inability to act, the office will be declared vacant by the Board and a successor chosen by the Board.Section 5.9 Secretary . The secretary (the “ Secretary ”) will see that the minutes of all meetings of the Board and of any standing committees are kept. TheSecretary will be the custodian of the corporate seal, if any, and will affix it to all proper instruments when deemed advisable. The Secretary will give or cause tobe given required notices of all meetings of the Board. The Secretary will have charge of all the books and records of the Corporation except the books of accountand in general will perform all the duties incident to the office of secretary of a corporation and such other duties as may be assigned to him or her by the Board orthe President.Section 5.10 Treasurer . The treasurer (the “ Treasurer ”) will have general custody of all of the funds and securities of the Corporation except such as maybe required by applicable law to be deposited with any state official. The Treasurer will see to the deposit of the funds of the Corporation in such bank or banks asthe Board may designate. If required by the Board, the Treasurer will give the Corporation such fidelity bond as may be required, and the premium therefor will bepaid by the Corporation as an operating expense.Section 5.11 Chief Financial Officer . The chief financial officer (the “ Chief Financial Officer ”) shall keep or cause to be kept the books of account of theCorporation in a thorough and proper manner and shall render statements of the financial affairs of the Corporation in such form and as often as required by theBoard or the President. The Chief Financial Officer shall perform other duties commonly incident to the office and shall perform such other duties and have suchothers powers as the Board or the President may from time to time delegate.Section 5.12 Assistant Secretaries . There may be such number of assistant secretaries (each an “ Assistant Secretary ”) as the Board may from time to timedetermine, and such persons will perform such functions as may be from time to time assigned to them.Section 5.13 Assistant Treasurers . There may be such number of assistant treasurers (each an “ Assistant Treasurer ”) as the Board may from time to timedetermine, and such persons will perform such functions as may be from time to time assigned to them.ARTICLE 6CAPITAL STOCKSection 6.1 Issuance . Shares of the Corporation’s authorized stock shall, subject to any provisions or limitations of the laws of the State of Nevada, theArticles, or any contracts or agreements to which the Corporation may be a party, be issued in such manner, at such times, upon such conditions and for suchconsideration as shall be prescribed by the Board.Section 6.2 Stock Certificates and Uncertificated Shares .(a) Every holder of stock in the Corporation shall be entitled to have a certificate signed by or in the name of the Corporation by two (2) officers or agents soauthorized by the Board, certifying the number of shares of stock owned by him, her, or it in the Corporation; provided , however , that the Board may authorize theissuance of uncertificated shares of some or all of the Corporation’s stock. Any such issuance of uncertificated shares shall have no effect on existing certificatesfor shares until such certificates are surrendered to the Corporation, or on the respective rights and obligations of the stockholders. Whenever such certificate iscountersigned or otherwise authenticated by a Transfer Agent, or a transfer clerk and by a registrar (other than the Corporation), then a facsimile of the signaturesof any corporate officers or agents, the Transfer Agent, transfer clerk, or the registrar of the Corporation may be printed or lithographed upon the certificate in lieuof the actual signatures. In the event that any officer or officers who have signed, or whose facsimile signatures have been used on any certificate or certificates forstock cease to be an officer or officers because of death, resignation, or other reason, before the certificate or certificates for stock have been delivered by theCorporation, the certificate or certificates may nevertheless be adopted by the Corporation and be issued and delivered as though the person or persons who signedthe certificate or certificates, or whose facsimile signature or signatures have been used thereon, had not ceased to be an officer or officers of the Corporation.(b) Within a reasonable time after the issuance or transfer of uncertificated shares, the Corporation shall send to the registered owner thereof a writtenstatement certifying the number of shares owned by him, her, or it in the Corporation and, at least annually thereafter, the Corporation shall provide to suchstockholders of record holding uncertificated shares, a written statement confirming the information contained in such written statement previously sent. Except asotherwise expressly provided by applicable law, the rights and obligations of the stockholders shall be identical whether or not their shares of stock are representedby certificates.(c) Certificates of stock shall be in such form consistent with applicable law and the Articles as shall be prescribed by the Board. All certificates evidencingshares of the Corporation’s stock or other securities issued by the Corporation shall contain such legend or legends as may from time to time be required by theBoard, the NRS, or such other federal, state, or local laws or regulations then in effect.6.3 Transfer of Shares . Shares shall be transferable in the manner prescribed by applicable law, the Articles, and in these Bylaws. Transfers of Shares shallbe made on the books of the Corporation only by the person named in the certificate or by his, her, or its attorney lawfully constituted inwriting and, if such Shares are certificated, upon the surrender of the certificate therefore properly endorsed, and payment of all necessary transfer taxes, whichcertificate shall be canceled before a new certificate shall be issued; or, in the case of uncertificated Shares, upon receipt of proper transfer instructions from theregistered holder of the Shares or by such person’s attorney lawfully constituted in writing, and upon payment of all necessary transfer taxes and compliance withappropriate procedures for transferring Shares in uncertificated form. Any transfer shall be accompanied by proper evidence of succession, assignment, or authorityand, upon receipt of such evidence and compliance with the other applicable provisions of these Bylaws and applicable law; it shall be the duty of the Corporationto record the transaction in its books. The Corporation may treat, as the absolute owner of Shares, the person or persons in whose name or names the Shares areregistered on the books of the Corporation.Section 6.4 Transfer Agent . The Board may appoint one (1) or more transfer agents (each a “ Transfer Agent ”) for the transfer and registration ofcertificates of stock of any class and may require that stock certificates be countersigned and registered by one (1) or more of such Transfer Agents. The TransferAgent will keep the stock transfer records of the Corporation, which will reflect the name and address of each stockholder of record, the number and class or seriesof shares issued to each stockholder of record and the date of issue of each such share.Section 6.5 Lost, Stolen, or Destroyed Certificates . The Board may authorize the issuance of a new certificate in place of a certificate alleged to have beenlost, stolen, or destroyed, upon receipt of: (a) an affidavit from the person explaining the loss, theft, or destruction; and (b) a bond or other security from the owneror legal representative of the owner in a sum as the Corporation may reasonably direct to indemnify the Corporation against any claim with respect to the certificateclaimed to have been lost, stolen, or destroyed. The Board may, in its discretion, waive the affidavit and bond or other security and authorize the issuance of a newcertificate in place of a certificate claimed to have been lost, stolen, or destroyed.ARTICLE 7INDEMNIFICATION OF DIRECTORS AND OFFICERSSection 7.1 Indemnification of Directors and Officers .(a) For purposes of this Article, (A) “ Indemnitee ” shall mean each director or officer who was or is a party to, or is threatened to be made a party to, or isotherwise involved in, any Proceeding (as hereinafter defined), by reason of the fact that he or she is or was a director or officer of the Corporation or member,manager, or managing member of a predecessor limited liability company or affiliate of such limited liability company, or is or was serving in any capacity at therequest of the Corporation as a director, officer, employee, agent, partner, member, manager, or fiduciary of, or in any other capacity for, another corporation orany partnership, joint venture, limited liability company, trust, or other enterprise or affiliate; (B) “ Proceeding ” shall mean any threatened, pending, or completedaction, suit, or proceeding (including, without limitation, an action, suit, or proceeding by or in the right of the Corporation), whether civil, criminal, administrative,or investigative; and (C) “ Liabilities ” shall mean any and all expenses, liabilities, and losses (including, without limitation, attorneys’ fees, judgments, fines,taxes, penalties, and amounts paid or to be paid in settlement).(b) Each Indemnitee shall be indemnified and held harmless by the Corporation to the fullest extent permitted by Nevada law, against Liabilities actually andreasonably incurred or suffered by the Indemnitee in connection with any Proceeding; provided , that such Indemnitee either is not liable pursuant to NRS 78.138or acted in good faith and in a manner such Indemnitee reasonably believed to be in or not opposed to the best interests of the Corporation and, with respect to anyProceeding that is criminal in nature, had no reasonable cause to believe that his or her conduct was unlawful. The termination of any Proceeding by judgment,order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, does not, of itself, create a presumption that the Indemnitee is liable pursuant toNRS 78.138 or did not act in good faith and in a manner in which he or she reasonably believed to be in or not opposed to the best interests of the Corporation, orthat, with respect to any criminal Proceeding he or she had reasonable cause to believe that his or her conduct was unlawful.(c) With regard solely to a Proceeding that is an action or suit by or in the right of the Corporation to procure a judgment in the Corporation’s favor, theCorporation shall not indemnify an Indemnitee against Liabilities for any claim, issue, or matter as to which the Indemnitee has been adjudged by a court ofcompetent jurisdiction, after exhaustion of all appeals therefrom, to be liable to the Corporation or for any amounts paid in settlement to the Corporation, unless andonly to the extent that the court in which the Proceeding was brought or other court of competent jurisdiction determines upon application that in view of all thecircumstances of the case, the Indemnitee is fairly and reasonably entitled to indemnity for such amounts as the court deems proper.(d) Except as so ordered by a court and for advancement of expenses pursuant to this Article 7, indemnification may not be made to or on behalf of anIndemnitee if a final adjudication establishes that his or her acts or omissions involved intentional misconduct, fraud, or a knowing violation of law and wasmaterial to the cause of action.(e) The expenses of Indemnitees must be paid by the Corporation or through insurance purchased and maintained by the Corporation or through otherfinancial arrangements made by the Corporation, as they are incurred and in advance of the final disposition of the Proceeding, upon receipt of an undertaking by oron behalf of the director or officer to repay the amount if it is ultimately adjudged by a court of competent jurisdiction, after exhaustion of all appeals therefrom,that he or she is not entitled to be indemnified by the Corporation.(f) Notwithstanding anything to the contrary herein, to the extent that a director or officer of the Corporation is successful on the merits or otherwise indefense of any Proceeding, including in the defense of any claim, issue, or matter arising out of an action or suit by or in the right of the Corporation to procure ajudgment in the Corporation’s favor, the Corporation shall indemnify him or her against Liabilities actually and reasonably incurred by him or her in connectionwith the defense.Section 7.2 Enforcement . Without the necessity of entering into an express contract, all rights to indemnification and advances to persons under this Article7 will be deemed to be contractual rights and be effective to the same extent and as if provided for in a contract between the Corporation and the Indemnitee. anIndemnitee may enforce any right to indemnification or advances under this Article 7 in any court of competent jurisdiction if: (a) the Corporation denies the claimfor indemnification or advances, in whole or in part; or (b) the Corporation does not dispose of such claim within ninety (90) days of request therefor. The claimantin such enforcement action, if successful in whole or in part, will be entitled to be paid also the expense of prosecuting his claim.The burden of proof is on the claimant to substantiate that he is entitled to be indemnified under this Article 7. The Corporation will be entitled to raise as a defenseto any such action that the claimant has not met the standard of conduct that makes it permissible under NRS Section 78.7502 for the Corporation to indemnify theclaimant for the amount claimed. Neither the failure of the Corporation (including the Board, independent legal counsel, or the stockholders) to have, prior to thecommencement of such action, made a determination that indemnification of the claimant is proper in the circumstances because the claimant has met theapplicable standard of conduct set forth in NRS Section 78.7502, nor an actual determination by the Corporation (including the Board, independent legal counsel,or the stockholders) that the claimant has not met such applicable standard of conduct, will be a defense to the action or create a presumption that claimant has notmet the applicable standard of conduct.Section 7.3 Non Exclusivity of Rights . The rights conferred on any person by this Article 7 will not be exclusive of any other right which such person mayhave or hereafter acquire under any statute, provision of the Articles, Bylaws, agreement, vote of stockholders, or disinterested directors or otherwise, both as toaction in the person’s official capacity and as to action in another capacity while serving the Corporation. The Corporation is specifically authorized to enter intoindividual contracts with any or all of its directors, officers, employees, or agents respecting indemnification and advances, to the fullest extent not prohibited byapplicable law.Section 7.4 Survival of Rights . Indemnification pursuant to this Section shall continue as to an Indemnitee who has ceased to be a director or officer of theCorporation or member, manager, or managing member of a predecessor limited liability company or affiliate of such limited liability company, or a director,officer, employee, agent, partner, member, manager, or fiduciary of, or to serve in any other capacity for, another corporation or any partnership, joint venture,limited liability company, trust, or other enterprise or affiliate and shall inure to the benefit of his or her heirs, executors, and administrators.Section 7.5 Insurance; Other Financial Arrangements .(a) To the fullest extent permitted by NRS Section 78.752, the Corporation, upon approval by the Board, may purchase and maintain insurance or make otherfinancial arrangements on behalf of any person required or permitted to be indemnified pursuant to this Article 7 for any liability asserted against him or her andliability and expenses incurred by him or her in his or her capacity as a director, officer, employee, member, manager, managing member, or agent, or arising out ofhis or her status as such, whether or not the Corporation has the authority to indemnify him or her against such liability and expenses.(b) The other financial arrangements which may be made by the Corporation may include the following (i) the creation of a trust fund; (ii) the establishmentof a program of self-insurance; (iii) the securing of its obligation of indemnification by granting a security interest or other lien on any assets of the Corporation;and/or (iv) the establishment of a letter of credit, guarantee or surety. No financial arrangement made pursuant to this subsection may provide protection for aperson adjudged by a court of competent jurisdiction, after exhaustion of all appeals therefrom, to be liable for intentional misconduct, fraud, or a knowingviolation of law, except with respect to advancement of expenses or indemnification ordered by a court.(c) Any insurance or other financial arrangement made on behalf of a person pursuant to this Article 7 may be provided by the Corporation or any otherperson approved by the Board, even if allor part of the other person’s stock or other securities is owned by the Corporation. In the absence of fraud (i) the decision of the Board as to the propriety of theterms and conditions of any insurance or other financial arrangement made pursuant to this Article 7 and the choice of the person to provide the insurance or otherfinancial arrangement is conclusive; and (ii) the insurance or other financial arrangement is not void or voidable and does not subject any director approving it topersonal liability for his action; even if a director approving the insurance or other financial arrangement is a beneficiary of the insurance or other financialarrangement.Section 7.6 Indemnification of Employees and Other Persons . The Corporation may, by action of its Board and to the extent provided in such action,indemnify employees and other persons as though they were Indemnitees.Section 7.7 Amendment . The provisions of this Article 7 relating to indemnification shall constitute a contract between the Corporation and each of itsdirectors and officers which may be modified as to any director or officer only with that person’s consent or as specifically provided in this Section 7.7.Notwithstanding any other provision of these Bylaws relating to their amendment generally, any repeal or amendment of this Article 7 which is adverse to anydirector or officer shall apply to such director or officer only on a prospective basis, and shall not limit, eliminate, or impair the rights of an Indemnitee toindemnification with respect to any action or failure to act occurring prior to the time of such repeal or amendment. Notwithstanding any other provision of theseBylaws (including, without limitation, Section 8.8 below), no repeal or amendment of these Bylaws shall affect any or all of this Article 7 so as to limit or reducethe indemnification in any manner unless adopted by the unanimous vote of the directors of the Corporation then serving; provided , that no such amendment shallhave a retroactive effect inconsistent with the preceding sentence.ARTICLE 8MISCELLANEOUSSection 8.1 Corporate Seal . The Board may, but is not require to, adopt a corporate seal, which shall be in the form of a circle and shall bear theCorporation’s name and the year and state in which it was incorporated.Section 8.2 Fiscal Year . The Board may by resolution determine the Corporation’s fiscal year. Until changed by the Board, the Corporation’s fiscal yearshall be the calendar year.Section 8.3 Voting of Shares in Other Corporations . Unless another person is designated by the Board, shares in other corporations which are held by theCorporation may be represented and voted by the President or a Vice President of the Corporation or by proxy or proxies appointed by one of them.Section 8.4 Checks; Drafts; Evidences of Indebtedness . From time to time, the Board will determine by resolution which person or persons may sign orendorse all checks, drafts, other orders for payment of money, notes, or other evidences of indebtedness that are issued in the name of or payable to theCorporation, and only the persons so authorized shall sign or endorse those instruments.Section 8.5 Corporate Contracts and Instruments; How Executed . The Board may authorize any officers or agents to enter into any contract or execute anyinstrument in the name of and on behalf of the Corporation. Such authority may be general or confined to specific instances.Section 8.6 Provisions Additional to Provisions of Law . All restrictions, limitations, requirements, and other provisions of these Bylaws shall be construed,insofar as possible, as supplemental and additional to all provisions of law applicable to the subject matter thereof and shall be fully complied with in addition tothe said provisions of law unless such compliance shall be illegal.Section 8.7 Provisions Contrary to Law . Any article, section, subsection, subdivision, sentence, clause, or phrase of these Bylaws which is contrary to orinconsistent with any applicable provisions of law, shall not apply so long as said provisions of law shall remain in effect, but such result shall not affect thevalidity or applicability of any other portions of these Bylaws.Section 8.8 Amendments . The Board may make the Bylaws of the Corporation. Unless otherwise prohibited by applicable law, the Board may adopt,amend, or repeal these Bylaws, or any portion hereof, including any bylaw adopted by the stockholders. Whenever an amendment or new Bylaws are adopted, theamendment or the new Bylaws will be copied in the Corporation’s minute book with the original Bylaws.Section 8.9 Changes in Nevada Law . References in these Bylaws to Nevada law or the NRS or to any provision thereof shall be to such law as it existed onthe date these Bylaws were adopted or as such law thereafter may be changed; provided , that (a) in the case of any change which expands the liability of directorsor officers or limits the indemnification rights or the rights to advancement of expenses which the Corporation may provide in Article 7 hereof, the rights to limitedliability, to indemnification and to the advancement of expenses provided in the Articles and/or these Bylaws shall continue as theretofore to the extent permittedby applicable law; and (b) if such change permits the Corporation, without the requirement of any further action by stockholders or directors, to limit further theliability of directors or limit the liability of officers or to provide broader indemnification rights or rights to the advancement of expenses than the Corporation waspermitted to provide prior to such change, then liability thereupon shall be so limited and the rights to indemnification and the advancement of expenses shall be sobroadened to the extent permitted by applicable law.Exhibit 10.50CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT (INDICATED BY **) HAS BEEN OMITTED AND FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.Modification Number: 1PROJECT ADDENDUM MODIFICATION Effective Date: April 15, 2015 Sponsor: Galectin Therapeutics, Inc.Protocol No: GT-026(Project #NASH-CX) Sponsor Contact: Jack CallicuttPPD ProjectManager: ** Bus Dev Director: **The Project Addendum by and between PPD Development, L.P., a Delaware limited partnership and successor-in-interest to PPD Development, LLC, (“PPD”) andGalectin Therapeutics, Inc. (“Sponsor”) effective as of January 10, 2015 regarding the above-referenced Protocol shall be modified as follows:General: • The timeline is being extended by approximately seven (7) months, where the PPD end of Involvement date has been revised from 01 July 2017 to01 February 2018. • Inflationary costs associated with this timeline extension have been captured as a line item in the study budget. • New activities have been added in North America (NA) to capture the additional labor needed for Protocol Amendment 1. • New activities have been added to capture the Direct and Pass Through Costs for Central Reader Site Evaluation, Interim Monitoring, and SiteCloseout Visits for Hepatic Venous Pressure Gradient (HPVG) and Liver Biopsy. • New activity has been added to capture the labor associated with the mapping of raw data to the Study Data Tabulation Module (SDTM). • The Site Country Mix has been revised as detailed below: Country Number of sites perProject Addendum Number of sites perProject Addendum Modification #1** ** **** ** ** • All tasks associated with **, where work has not already occurred, have been removed as the study has left the country entirely. Estimated costs associated with this Project Addendum Modification: $ 218,201.92 Direct Fees $7,586,684.89 Pass Through Costs $7,804,886.80 Total Costs **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. Page 1 of 31Modification Number: 1PROJECT ADDENDUM MODIFICATION Cumulative Budget NA Budget EMEA Total Budget TOTAL DIRECT COSTS $9,059,751.07 $24,941.56 $9,084,692.63 TOTAL PASS THROUGH COSTS $13,293,084.54 $368,913.80 $13,661,998.34 TOTAL STUDY COSTS $22,352,835.61 $393,855.36 $22,746,690.97 Prior TOTAL DIRECT COSTS $8,842,785.02 $23,705.69 $8,866,490.71 TOTAL PASS THROUGH COSTS $5,738,284.26 $337,029.19 $6,075,313.45 TOTAL STUDY COSTS $14,581,069.28 $360,734.88 $14,941,804.16 Incremental TOTAL DIRECT COSTS $216,966.05 $1,235.87 $218,201.92 TOTAL PASS THROUGH COSTS $7,554,800.28 $31,884.61 $7,586,684.89 TOTAL STUDY COSTS $7,771,766.33 $33,120.47 $7,804,886.80 A revised estimated study timeline is attached hereto as Exhibit A and which replaces the estimated study timeline set forth in section 1.16 of Exhibit A to theProject Addendum.A detailed explanation of the changes to the budget is attached hereto as Exhibit B. A revised Central Labs budget is attached hereto as Exhibit C. A revised studybudget is attached hereto at Exhibit D, and which replaces the budget set forth in Exhibit B to the Project Addendum.Payment of such costs shall be made in accordance with the Revised Payment Schedule attached hereto as Exhibit E which shall replace the payment schedule setforth in Exhibit C to the Project Addendum.All Exhibits attached hereto and incorporated herein by reference.This Project Addendum Modification may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one andthe same instrument. Each party may execute this Project Addendum Modification by facsimile transmission or in Adobe Portable Document Format (PDF) sent byelectronic mail. Facsimile or PDF signatures of authorized signatories of the parties will be deemed to be original signatures, will be valid and binding, and, upondelivery, will constitute due execution of this Project Addendum Modification.Upon execution by the parties, this Project Addendum Modification will be made a part of the Project Addendum and incorporated by reference therein. Except asexpressly provided herein or in any other mutual written agreement by the parties, all terms and conditions contained in the Project Addendum shall remain in fullforce and effect. In the event of any conflict between the terms of this Project Addendum Modification and the Project Addendum, the terms of this ProjectAddendum Modification shall govern and control. All capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in theProject Addendum.SIGNATURES FOLLOW ON NEXT PAGE Page 2 of 31Modification Number: 1PROJECT ADDENDUM MODIFICATIONACCEPTED AND AGREED: PPD Development, L.P.By: PPD GP, LLCIts General Partner Galectin Therapeutics, Inc.By: /s/ Patti McNamara By: /s/ Peter G. TraberName: Patti McNamara Name: Peter G. TraberTitle: VP Finance Title: CEO and CMODate: March 11, 2016 Date: March 11, 2016Remainder of Page Intentionally Left Blank Page 3 of 31Modification Number: 1PROJECT ADDENDUM MODIFICATIONExhibit ARevised Estimated Study Timeline Activity As of Project Addendum As of Project AddendumModification #1 Duration in MonthsPre-Study Activities ** **Enrollment Period ** **Treatment Period ** **Close-Down Period ** **Total PPD Commitment ** **Remainder of Page Intentionally Left Blank **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. Page 4 of 31Modification Number: 1PROJECT ADDENDUM MODIFICATIONExhibit BDetailed Explanation of ChangeThe Detailed Explanation of Change follows this cover page **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. Page 5 of 31 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Incremental Budget as of Project Addendum Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Department/Activity Project Management Unit Type Unit Cost NA Total Hours NA # of Units NA Budget NA Total Hours NA ft of Units NA Budget NA Total Hours NA # of Units NA Budget NA Justification Develop Country Budget and Payment Schedule Template ** ** ** ** ** ** ** ** ** ** ** longer projected to be achieved, due to the study leaving, Canada. ICF Local Customized—Review and Approve ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada ICF Local Customization—Review and Approve -Amendments ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Project Management—Start-up ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Project Management—Enrollment ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Project Management—Protocol Amendment 1 ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the additional labor needed for Protocol Amendment 1. ** ** ** ** ** ** ** ** ** ** ** ICF Local Customization ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Management of Translation of Protocol, Investigator Brochure, ICF & Technical Documents ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Review of Translation of ICF ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Client Teleconferences ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Internal Team Meetings ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Site Intelligence and Activation Management ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Hepatic Venous Pressure Gradient (HVPG) Vendor Site Evaluation Visit Prep/Follow-up ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with Hepatic Venous Pressure Gradient (HVPG) Site Evaluation Visits for Central Reader. HVPG Vendor Site Evaluation Visit—Time On Site ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with HVPG Site Evaluation Visits for Central Reader. HVPG Vendor Site Evaluation Visit—Travel ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with HVPG Site Evaluation Visits for Central Reader. Subtotal ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Cumulative Study Budget as of Project Addendum Incremental Budget as of Project Addendum Modification #1 Department/Activity Unit Type Unit Cost NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Justification Clinical Management ICF Local Customization—Amendments ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Amendments—Management of Translation of Protocol, Investigator Brochure, ICF & Technical Documents ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Amendments—Review of Translation of ICF ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada- Site Initiation Visits—Prep/Admin/Follow-up ** ** ** ** ** ** ** ** ** ** ** Activity i increased due to additional unit needed, as sponsor requested an additional site. Site Initiation Visits—Time on Site ** ** ** ** ** ** ** ** ** ** ** Activity increased due to additional unit needed, as sponsor requested an additional site Site Initiation Visits—Travel ** ** ** ** ** ** ** ** ** ** ** Activity increased due to additional unit needed, as sponsor requested an additional site Site Management ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Annual Investigator File Audits ** ** ** ** ** ** ** ** ** ** ** Activity increased due to Protocol Amendment 1. Site Closeout Visits—Prep/Admin/Follow-up ** ** ** ** ** ** ** ** ** ** ** Activity increased due to additional unit needed, as sponsor requested an additional site. Site Closeout Visits—Time on Site ** ** ** ** ** ** ** ** ** ** ** Activity increased due to additional unit needed, as sponsor requested an additional site. Site Closeout Visits—Travel ** ** ** ** ** ** ** ** ** ** ** Activity increased due to additional unit needed, as sponsor requested an additional site. Unblended Investigator Meeting ** ** ** ** ** ** ** ** ** ** ** Activity decreased due to the inability to identify unblended Clinical Research Associates (CRAs) in time to attend meeting. CRA Team Meetings ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved. Unblended CRA Team Meetings ** ** ** ** ** ** ** ** ** ** ** Activity increased due to Protocol Amendment 1. Clinical Team Management ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Clinical Management—Protocol Amendment 1 ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the additional labor needed for Protocol Amendment 1 HVPG Vendor Interim Monitoring Visits—Prep/Follow-Up ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with HVPG Interim Monitoring Visits (IMVs) for Central Reader. HVPG Vendor Interim Monitoring Visits—Time On Site ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with HVPG IMVs for Central Reader. HVPG Vendor Interim Monitoring Visits—Travel ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with HVPG IMVs for Central Reader. PPD Pmnnrfan; and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budgetas of Project Addendum Modification #1 Cumulative Study Budget as of Project Addendum Incremental Budget as of Project Addendum Modification #1 Department/Activity Unit Type Unit Cost NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Justification HVPG Vendor Site Closeout Visit—Prep/Follow-Up ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with HVPG Closeout Visits (COVs) for Central Reader. HVPG Vendor Site Closeout Visit—Time On Site ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with HVPG COVs for Central Reader. HVPG Vendor Site Closeout Visit—Travel ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with HVPG COVs for Central Reader. Liver Biopsy Vendor Interim Monitoring Visits -Prep/Follow-Up ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with Liver Biopsy IMVs for Central Reader. Liver Biopsy Vendor Interim Monitoring Visits—Time On S:te ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with Liver Biopsy IMVs for Central Reader. Liver Biopsy Vendor Interim Monitoring Visits—Travel ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with Liver Biopsy IMVs for Central Reader. Liver Biopsy Vendor Site Closeout Visits—Prep/Follow-Up ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with Liver Biopsy COVs for Central Reader. Liver Biopsy Vendor Site Closeout Visits—Time On Site ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with Liver Biopsy COVs for Central Reader. Liver Biopsy Vendor Site Closeout Visits—Travel ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with Liver Biopsy COVs for Central Reader. Subtotal ** ** ** ** ** ** ** ** ** ** ** Identify, Select and Negotiate Contracts with Clinical Supply Vendors ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved. Label Text Development ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved. Label Text Translation Coordination ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Clinical Supply Forecasting ** ** ** ** ** ** ** ** ** ** ** Activity increased due to Protocol Amendment 1. Monitor/Track Study Progress, Inventory Levels and Communication with Team/Sponsor ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Depot Management ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Distribution Management ** ** ** ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved. Investigators Meeting ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the labor associated with attending the Investigators Meeting. Global Clinical Supplies—Protocol Amendment 1 ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the additional labor needed for Protocol Amendment 1. Subtotal ** ** ** ** ** ** ** ** ** ** ** IVRS Investigational Product (IP) Accountability Module ** ** ** ** ** ** ** ** ** ** ** New activity added to capture labor associated with Investigational Product (IP) Accountability Module. Subtotal ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Cumulative Study Budget as of Project Addendum Incremental Budget as of Project Addendum Modification #1 Department/Activity/ Unit Type Unit Cost NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Justification Data Management Client Teleconferences ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Internal Team Meetings ** ** Activity increased due to the seven (7) month timeline extension. Quality Management ** ** ** Activity increased due to the seven (7) month timeline extension. DM Project Management ** ** ** ** Activity increased due to the seven (7) month timeline extension. Data Management—Protocol Amendment 1 ** ** ** ** ** ** New activity added to capture the additional labor needed for Protocol Amendment 1. Subtotal ** ** ** ** ** ** Pharmacovigilance Data Safety Monitoring Board Set-up Retired and rebuilt this activity as the new activity below in order increase the labor per unit due to Protocol Amendment. Revised—Data Safety Monitoring Board Set-up ** ** ** New activity added per above in order to capture the labor associated with DSMB Set-up. Analysis of Similar Events ** ** ** Activity decreased as unit is no longer projected to be achieved. Development Safety Update Report (DSUR) Preparation ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Senior Medical Officer for Canada Maintenance—Monthly ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Senior Medical Officer Review of Canadian CTA ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Senior Medical Officer Review of Canadian CTA Amendment ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Data Safety Monitoring Board Face-to-Face Meeting Retired and rebuilt this activity as the new activity below in order increase the labor per unit due to Protocol Amendment. Revised—Data Safety Monitoring Board Face to Face Meeting New activity added per above in order to capture the labor associated with Data Safety Monitoring Board (DSMB) Face to Face meetings. Data Safety Monitoring Board Teleconference Meeting Retired and rebuilt this activity as the new activity below in order increase the labor per unit due to Protocol Amendment. Revised—Data Safety Monitoring Board Teleconference Meeting New activity added per above in order to capture the labor associated with DUMB Teleconferences. Pharmacovigilance Team Management ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. PPD Pmnnrfan; and Confidential PPD BC#: 58004-01 Date Issued: February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Cumulative Study Budget as of Project Addendum Incremental Budget as of Project Addendum Modification #1_ Department/Activity Unit Type Unit Cost NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Justification Unblinded Medical Monitor ** ** ** ** ** ** ** ** New activity added to capture labor associated with an Unblinded Medical Monitor. PVG—Protocol Amendment 1 ** ** ** New activity added to capture the additional labor needed for Protocol Amendment 1. Subtotal ** ** ** ** Biostats Team Management Activity increased due to the seven (7) month timeline extension. Mapping Raw Data to Study Data Tabulation Model (SDTM) New activity added to capture labor associated with the mapping of raw data to the Study Data Tabulation Module (SDTM). Biostatistics—Protocol Amendment 1 ** ** ** ** ** New activity added to capture the additional labor needed for Protocol Amendment 1. Subtotal ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Review CRF ** ** ** ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved. Medical Writing—Protocol Amendment 1 ** ** ** ** ** ** New activity added to capture the additional labor needed for Protocol Amendment 1. Subtotal ** ** ** ** Information Governance & Compliance—Country File Set-up Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Information Governance & Compliance—Country File Archiving and Transfer ** ** ** ** ** Activity decreased as unit is no longer projected to be achieved, due to the study leaving Canada. Clinical Supplies OA—Project Agreements *. * *. ** » Activity decreased as unit is no longer projected to be achieved. Clinical Supplies QA—Project Support „ ** ** *. Activity decreased as unit is no longer projected to be achieved. Subtotal ** ** ** ** Registration of Clinical Trials—Maintenance Activity increased due to the seven (7) month timeline extension. ** ** ** ** ** ** Pharmacokinetics—Protocol Amendment 1 New activity added to capture the additional labor needed for Protocol Amendment 1. Subtotal Inflation: Added a line item inflation adjustment to capture inflationary increases associated with the seven (7) month increase to the study duration. Timeline Extension Services Discount (CM1): ** ** ** ** PPD is providing a one-time discount associated with services performed in regards to the seven (7) month timeline extension. PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Cumulative Study Budget as of Project Addendum Incremental Budget as of Project Addendum Modification #1 Department/Activity Unit Type Unit Cost NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Total Hours NA # of Units NA Budget NA Justification Pass Through Costs Central Laboratory Fees ** ** ** ** ** ** ** ** ** ** ** Activity increased due to the seven (7) month timeline extension. Investigator Fees ** ** ** ** ** ** ** ** ** ** ** Activity increased due to Protocol Amendment Site Closeout Visits—Travel ** ** ** ** ** ** ** ** ** ** ** Activity increased due to additional unit needed, as sponsor requested an additional site. Site Initiation Visits—Travel ** ** ** ** ** ** ** ** ** ** ** Activity increased due to additional unit needed, as sponsor requested an additional site. Central Reader—HVPG ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the costs projected through the duration of the study. Central Reader—Liver Biopsy ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the costs projected through the duration of the study. Data Safety Monitoring Board Member Honoraria ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the costs needed to include payments for three (3) members, which will cover the contracted caps for each member. Site Evaluation Visits—HVPG—Central Reader ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the costs needed to do a site evaluation visit for HVPG Central Reader. Site Closeout Visits—HVPG—Central Reader ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the costs needed to do a site closeout visit for HVPG Central Reader. Site Closeout Visits—Liver Biopsy—Central Reader ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the costs needed to do a site closeout visit for Liver Biopsy Central Reader. Intenm Monitoring Visits- HVPG—Central Reader ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the costs needed to do a interim monitoring visit for HVPG Central Reader. Interim Monitoring Visits—Liver Biopsy—Central Reader ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the costs needed to do a interim monitoring visit for Liver Biopsy Central Reader. Investigator Meeting Travel—Clinical Supplies Project Manager ** ** ** ** ** ** ** ** ** ** ** New activity added to capture the cost for Clinical Supplies Project Manager to attend the Investigator Meeting. Total Pass Throughs ** ** ** $7,554,800.28 Total Study Costs ** $7,771,786.33 Subtotals and Totals included in the Cumulative and Prior sections are for reference to the budget grid only and do no represent totaling of the numbers included in this document. The Discrete Subtotals and Totals are representative of the numbers in this document. PPD Proprietary and Confidential PPD BC#: 58D04-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Cumulative Study Budget as of Project Addendum Incremental Budget as of Project Addendum Modification #1 Department/Activity Unit Type Unit Cost EMEA Total Hours EMEA # of Units EMEA Budget EMEA Total Hours EMEA # of Units EMEA Budget EMEA Total Hours EMEA # of Units EMEA Budget EMEA Justification Pharmacovigilance Pharmacovigilance Team Management ** ** *. ** ** ** ** M Activity increased due to the seven (7) month timeline extension. _Subtotal ** ** ** ** ** ** Total Direct Costs ** ** ** ** ** ** Inflation: Added a line item inflation adjustment to capture inflationary increases associated with the seven (7) month increase to the study duration. Total Discounted Direct Costs ** ** ** ** ** ** Pass Through Costs Central Labs Quote EMEA ** ** M ** m ** m Activity increased due to the seven (7) month timeline extension. Total Pass Throughs ** ** ** ** ** ** Total Study Costs ** ** ** ** ** ** Subtotals and Totals included in the Cumulative an d Prior sections are for reference to the budget grid only and do not represent totaling of the numbers included in (his document. The Discrete Subtotals an d Totals are representative of the numbers in this d ocument. PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016Modification Number: 1PROJECT ADDENDUM MODIFICATIONExhibit CRevised Central Labs BudgetThe Revised Central Labs Budget follows this cover page Page 13 of 31 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PPD’s Central Lab, LLC Budget Estimate PPD Central Labs 09-Jul-2015 Galectin Therapeutics, Inc. GT-025 BC: 58004-01 Sc2 M1 Central Lab BC: 58004-02 mod #1 Budget Summary Total Charge (USD) GT-025 Laboratory Testing ** Sample Management ** Kits and Supplies ** Clinical Trial Services Fees ** Direct Costs Estimate: ** _Logistics (Pass-Through) Estimate: ** Total Estimate: ** Original Contract (Rev 2) Budget Summary Total Charge {USD) Differences GT-025 Laboratory Testing ** ** Sample Management ** ** Kits and Supplies ** ** Clinical Trial Services Fees ** ** Direct Costs Estimate: ** ** Logistics (Pass-Through) Estimate: ** ** Total Estimate: ** ** Regional Budget Summary GT-025 NA & LA Region EMEA Region AsiaPac Region China Laboratory Testing ** ** ** ** Sample Management ** ** ** ** Kits and Supplies ** ** ** ** Clinical Trial Services Fees ** ** ** ** Regional Direct Costs Estimate: ** ** ** ** Regional Logistics (Pass-Through) Estimate: ** ** ** ** Regional Total Estimate: ** ** ** ** Countries Sites Screened Subjects Enrolled Subjects Completed Subjects % United States ** ** ** ** ** Canada ** ** ** ** ** North America ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PPD’s Central Labs, LLC Budget Estimate # Patients: 260 260 26 156 156 156 156 156 156 156 156 156 156 156 156 156 156 16 0% SV1 SV2 5V3 Ml NDV1 HDV2 Visit 2 V3 V4 NDV3 V7 VII V13 V20 V26 14-26 Day After 14 Days After NA& Shipping Screen in g Random nation LeOo ret -Dry Test i ng As sumptions Frequency ipment IWeek Screening Screening ^elM)’”” Week 13 Week 51 Week 53-55 Week 57 ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Sample Management |B| SV1 SV2 SV3 VI m NDV2 V>sit2 V, V4 N0V3 V7 v„ V20 V26 14-28 Dtiy After 14 Days After Toh NA& ?S3 Final Dots LATAM ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PPD’s Central Labs, LLC Budget Estimate PPD Estimate Subjects: US EU M0D#1 NA & LATAM EMEA region fx rate=EUR/USD 1.41 14 Laboratory Testing Assumptions UOM NAM A Unit Charge (USD) Total Charge (USD) EU Unit Charge (Euro) No. Units Total Charge (EUR) Total Charge (USD) ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Sample Management Assumptions UOM NA & LA Unit Charge (USD) Total Charge (USD) EU Unit Charge (Euro) No. Units Total Charge (EUR) Total Charge (USD) ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** NA & LATAM region fx rate=USD/EUR 0.7944 EMEA region fx rate=EUR/USD 1.4144 Previous Total Charge (USD) Explanation Difference Previous Total Charge (USD) Explanation Difference ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Previous Total Charge (USD) Explanation Difference Previous Total Charge (USD) Explanation Difference ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidentia PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PPD’s Central Labs, LLC Budget Estimate PPD Estimate Subjects: Kits and Supplies Assumptions UOM NA & LA Unit Charge (USD) No. Units Total Charge (USD) EU Unit Charge (Euro) No. Units Total Charge (EUR) Total Charge (USD) Previous Total Charge (USD) Explanation Difference Previous Total Charge (USD) Explanation Difference ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Clinical Trial Services Fees Assumptions UOM NA & LA Unit Charge (USD) No. Units Total Charge (USD) EU Unit Charge (Euro) NO. Units Total Charge (EUR) Total Charge (USD) Previous Total Charge (USD) Explanation Difference Previous Total Charge (USD) Explanation Difference ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PPD’s Central Labs, LLC Budget Estimate Exchange Rates: Global Logistics (Pass-Through} Outbound, supplies to sites Inbound, Ambient/Refrig ., sites to PPD Inbound, Frozen, sites to PPD Total Charge Country Sites Unit Type Courier Unit Cost (Euro) Unit Cost (USD) # of Units Sub-total Courier Unit Cost (Euro) Unit Cost (USD) #of Units Sub-total Courier Unit Cost (Euro) Unit Cost (USD) # of Unite Sub-total Dry ice and shippers (USD) ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** * ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Referral lab courier costs Frequency Courier Unit Type Unit Cost (Euro) Unit Cost (USD) # of Units Su b-total Comments Total Charge (USD) TOTAL PASS THROUGH COSTS TOTAL PASS THROUGH COSTS NA/LA region (USD) MEA gion USD) AsiaPac region (USD) China (USD) Total Differences TOTAL PASS THROUGH COSTS NA/LA region (USD) $31,287.91 EMEA region (USD) $0.00 AsiaPac region (USD) $0.00 China (USD) $0.00 $31,287.91 * Transportation costs do not include Saturday delivery charges, taxes, tariffs, duties and fuel surcharge. This will be invoiced at the prevailing rate.Transportation fees are estimates only and based on primary cities.Client will be invoiced based on actual fees incurred.* Laboratory kits may accommodate more than one patient visit/per inbound shipping box. For purposes of the estimate, 1 visit per inbound box has been assumed as average. * Drive-away and trans-shipment to international port of departure may apply. Applicable customs fees charged as pass through cost.Inbound transport costs are based on Weekday priority overnight shipments.* Outbound kits have standard transit time of 2-5 days. Overnight priority shipping provided with sponsor approval at additional shipping cost. PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PPD’s Central Labs, LLC Budget Estimate Terms and Conditions Study sst up will commence upon written acceptance of Contract and Central Laboratory Specifications (CLS). The costs contained within this Proposal are valid for ** from date of proposal. The prices contained within this Proposal are estimates based upon information provided by Sponsor. Cost will be revised if the Sponsor provides an amended protocol or updated information. *** no charge, regardless of number of users. All protocol materials will be archived for ** from the end of PPD involvement. Requests for protocol materials will be shipped at the expense of the Sponsor/CRO. *PPD Global Central Labs requires ** from signed CLS for study initiation Study initiation is defined as the first Investigational site to receive specimen collection kits. Sponsor requested changes ** will result in additional charges to be determined based upon the complexity of the revisions. *PPD Global Central Labs has one global database that supports all regions within the study. Global set-up fees will be invoiced upon project initiation once database set-up activities are complete. TRAINING/TRAVEL If requested to attend a Kick off meeting or Investigator meeting, ** Central Labs presenter at one meeting including preparation, excluding travel expenses billed as pass through. This cost assumes a one day meeting with one day for travel. **. Sponsor request of technical attendees will be charged additional fees of Attendance at the investigator meeting via WebEx will be charged **, *Site training via conference call for protocol specific laboratory procedures is available at sponsor’s request. This will be invoiced at **. •On site training visits to outline protocol specific laboratory procedures at the sponsor’s request, will be invoiced at a rate of **. TRANSPORTATION MODIFICATIONS Any services requested by Sponsor (or sites) and not included in this cost estimate will be charged separately. Services rendered will be invoiced as performed and a Contract Modification will be issued. Out of protocol testing will be invoiced per the unit price with an additional **” Project Management fee, per request. Additional charges will apply for any off-cycle or expedited testing. Specimens requiring off-hour technician/processing time, will be invoiced with an added service charge of ** Any sample that is UTP (Unable To Perform) will be charged a Sample Handling fee. A sample destruction fee will be invoiced for any sample that is required to be destroyed. This fee will be charged per sample destroyed. Expedited shipping fees will be applied at ** with less then notice, plus shipping costs. Additional label sets provided at an additional fee of **. Additional requisition forms provided at an additional fee of*, Additional collection flow charts (CFC) provided at an additional fee of ** *Set up of additional sites will incur additional site initiation fees and other applicable charges. Database modifications will be invoiced at ** Non-Standard Services for Data Management and Custom programming will be supplied upon request and billed at a programming rate of ** for services included but not limited to: a. Custom data file formats b. Custom data management reports c.Data reconciliation requirements Returned kit fee of ** (break-down and disposal of kit contents) plus return shipping charges. Hard copy reports will be invoiced at **. Translation costs reflect the average cost to translate a typical manual Translation costs for other documents besides the manual, will be charged ** Lab Manuals will be supplied to all sites upon initiation as part of the study set-up. Amended or revised manuals will be supplied at ** If adjustments to kits are required, the kit tier may be revised and billed at the following rates: This budget for centrai laboratory services is based upon protocol requirements provided at the time of the RFP and is an estimate only. PPD Central Labs will invoice Sponsor for actual services rendered and testing performed. Invoices may, therefore, differ from the Budget due to differences in actual services rendered versus those contained within this Budget. PPD Proprietary and Confidential PPDBC#: 5S004-Q1 Date Issued: 17 February 2016 to the omitted portions. Kit Tier NA & LATAM EMEA AsiaPac ** ** ** ** ** ** ** ** ** ** **Modification Number: 1PROJECT ADDENDUM MODIFICATIONExhibit DRevised Study BudgetThe Revised Study Budget follows this cover page Page 20 of 31 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulativs Study Budget as of Project Addendum _Modification #1_ Cumulative Study Budget as of Project Addendum Incremental Budget as of Project Addendum _Modification #1_ Department/Activity Budget NA Budget EMEA Total Budget Budget NA Budget EMEA Total Budget Budget NA Budget EMEA Total Budget Project Management ** ** ** ** ** ** ** ** ** Study Start-Up ** ** ** ** ** ** ** ** ** Clinical Management ** ** ** ** ** ** ** ** ** Global Clinical Supplies ** ** ** ** ** ** ** ** ** IVRS ** ** ** ** ** ** ** ** ** Data Management ** ** ** ** ** ** ** ** ** Pharmacovigilance ** ** ** ** ** ** ** ** ** Biostatistics ** ** ** ** ** ** ** ** ** Medical Writing ** ** ** ** ** ** ** ** ** Quality Assurance ** ** ** ** ** ** ** ** ** Regulatory Affairs ** ** ** ** ** ** ** ** ** Clinical Pharmacology (PK) ** ** ** ** ** ** ** ** ** Electronic Data Capture ** ** ** ** ** ** ** ** ** TOTAL DIRECT COSTS ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** TOTAL DISCOUNTED DIRECT COSTS ** ** ** ** ** ** ** ** ** TOTAL PASS THROUGH COSTS ** ** ** ** ** ** ** ** ** TOTAL STUDY COSTS $22,352,835.61 $393,855.36 $22,746,690.97 $14,581,069.28 $360,734.88 $14,941,804.16 $7,771,766.33 $33,120.47 $7,804,886.80 PPD Proprietary and Confidential PPD BC#. 58004-01 Date Issued. 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Department/Activity Unit Type Total Hours NA Unit Cost NA # of Units NA Budget NA Total Hours EMEA Unit Cost EMEA # of Units EMEA Budget EMEA Total Budget Project Management ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Study Start-Up ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued. 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Department/Activity Unit Type Total Hours NA Unit Cost NA # of Units NA Budget NA Total Hours EMEA Unit Cost EMEA # of Units EMEA Budget EMEA Total Budget ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Clinical Management ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued. 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Department/Activity Unit Type Total Hours NA Unit Cost NA # of Units NA Budget NA Total Hours EMEA Unit Cost EMEA # of Units EMEA Budget EMEA Total Budget ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Global Clinical Supplies ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** IVRS ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Department/Activity Unit Type Total Hours NA Unit Cost NA # of Units NA Budget NA Total Hours EMEA Unit Cost EMEA # of Units EMEA Budget EMEA Total Budget ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Data Management ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Pharmacovigilance ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#. 58004-01 Date Issued. 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Department/Activity Unit Type Total Hours NA Unit Cost NA # of Units NA Budget NA Total Hours EMEA Unit Cost EMEA # of Units EMEA Budget EMEA Total Budget ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Biostatistics ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued. 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Department/Activity Unit Type Total Hours NA Unit Cost NA # of Units NA Budget NA Total Hours EMEA Unit Cost EMEA # of Units EMEA Budget EMEA Total Budget *” ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Medical Writinq ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Quality Assurance ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004 01 Date Issued. 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Department/Activity Unit Type Total Hours NA Unit Cost NA # of Units NA Budget NA Total Hours EMEA Unit Cost EMEA # of Units EMEA Budget EMEA Total Budget ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Regulatory Affairs ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Clinical Pharmacoloqv (PK) ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Electronic Data Capture ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Total Direct Costs ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Total Discounted Direct Costs ** ** ** ** ** ** ** ** ** ** PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PROJECT ADDENDUM MODIFICATION Modification #1 Cumulative Study Budget as of Project Addendum Modification #1 Department/Activity Unit Type Total Hours NA Unit Cost NA # of Units NA Budget NA Total Hours EMEA Unit Cost EMEA # of Units EMEA Budget EMEA Total Budget Pass Throuqh Costs ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Total Study Costs $22,352,835.61 $393,855.36 $22,746,690.97 PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016Modification Number: 1PROJECT ADDENDUM MODIFICATIONExhibit ERevised Payment ScheduleThe Revised Payment Schedule follows this cover page Page 30 of 31 **Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to theomitted portions. PPD Payment Schedule Sponsor: Galectin BC Number: 58004-01 Protocol :GT-026 Direct Costs: Execution of Contract ** Monthly ** Project Management Fee ** ** ** Milestones: ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** Total Direct Costs ** Indirect Costs: ** ** ** Total Clinical Grants ** ** ** Total Pass Through Costs ** Project Grand Total 22,746,690.97 ** ** ** *** **PPD Proprietary and Confidential PPD BC#: 58004-01 Date Issued: 17 February 2016Exhibit 21.1SUBSIDIARIES OF REGISTRANTThe following is a list of the Corporation’s subsidiaries as of December 31, 2015. The Corporation owns, directly or indirectly, 100% of the voting securitiesof each subsidiary, unless noted otherwise. NAME STATE OR JURISDICTIONOF ORGANIZATIONGalectin Therapeutics Security Corp. DelawareGalectin Sciences LLC GeorgiaExhibit 23.1Consent of Independent Registered Public Accounting FirmWe hereby consent to the incorporation by reference in Registration Statement Nos. 333-208674, 333-116629, 333-109893, 333-159247, 333-198070, 333-176306, and 333-176305 on Form S-8, and Registration Nos. 333-194747, 333-172849, 333-150898, 333-148911, 333-132459, 333-118907, 333-115118, 333-111650 and 333-109887 on Form S-3, of our reports dated March 14, 2016 included in this Annual Report on Form 10-K of Galectin Therapeutics, Inc. andsubsidiaries (the “Company”) relating to the consolidated balance sheet of the Company as of December 31, 2015, and the related consolidated statements ofoperations, changes in redeemable convertible preferred stock and stockholders’ equity, and cash flows and the related financial statement schedules for the yearthen ended, and the effectiveness of internal control over financial reporting for the Company as of December 31, 2015./S/ CHERRY BEKAERT LLPAtlanta, GeorgiaMarch 14, 2016Exhibit 23.2Consent of Independent Registered Public Accounting FirmWe consent to the incorporation by reference in Registration Statement Nos. 333-208674, 333-116629, 333-109893, 333-159247, 333-198070, 333-176306,and 333-176305 on Form S-8, and Registration Nos. 333-194747, 333-172849, 333-150898, 333-148911, 333-132459, 333-118907, 333-115118, 333-111650 and333-109887 on Form S-3 of Galectin Therapeutics, Inc. of our report dated March 18, 2015, relating to our audit of the consolidated financial statements whichappears in this Annual Report on Form 10-K of Galectin Therapeutics, Inc. for the year ended December 31, 2015./S/ RSM US LLPCharlotte, North CarolinaMarch 15, 2016Exhibit 31.1Certification pursuant to Rule 13a-14(a) of the Securities Act of 1934I, Peter G. Traber, certify that: 1.I have reviewed this annual report on Form 10-K of Galectin Therapeutics Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statementsmade, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financialcondition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange ActRules 13a-15(e) and 15d-15(e)) for the registrant and we have: a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensurethat material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,particularly during the period in which this report is being prepared; b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes inaccordance with generally accepted accounting principles; c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectivenessof the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likelyto adversely affect the registrant’s ability to record, process, summarize and report financial information; and b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting. March 15, 2016 /s/ Peter G. Traber Name: Peter G. Traber, M.D. Title: Chief Executive Officer and President(principal executive officer)Exhibit 31.2Certification pursuant to Rule 13a-14(a) of the Securities Act of 1934I, Jack W. Callicutt, certify that: 1.I have reviewed this annual report on Form 10-K of Galectin Therapeutics Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statementsmade, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financialcondition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange ActRules 13a-15(e) and 15d-15(e)) for the registrant and we have: a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensurethat material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,particularly during the period in which this report is being prepared; b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes inaccordance with generally accepted accounting principles; c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectivenessof the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, theregistrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likelyto adversely affect the registrant’s ability to record, process, summarize and report financial information; and b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting. March 15, 2016 /s/ Jack W. Callicutt Name: Jack W. Callicutt Title: Chief Financial Officer(principal financial and accounting officer)Exhibit 32.1CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report of Galectin Therapeutics Inc. (the “Company”) on Form 10-K for the period ended December 31, 2015 as filed withthe Securities and Exchange Commission on the date hereof (the “Report”), I, Peter G. Traber, Chief Executive Officer and President of the Company, certify,pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge: (1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. March 15, 2016 /s/ Peter G. Traber Name: Peter G. Traber, M.D. Title: Chief Executive Officer and President(principal executive officer)Exhibit 32.2CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report of Galectin Therapeutics Inc. (the “Company”) on Form 10-K for the period ended December 31, 2015 as filed withthe Securities and Exchange Commission on the date hereof (the “Report”), I, Jack W. Callicutt, Chief Financial Officer of the Company, certify, pursuant to 18U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge: (1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. March 15, 2016 /s/ Jack W. Callicutt Name: Jack W. Callicutt Title: Chief Financial Officer(principal financial and accounting officer)

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