| ☒ | Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
| ☐ | Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
of Norcross, GA
620-3186and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation (§232.05and post such files). ☒ Yes ☐ NoLarge Accelerated Filer ☐ Accelerated Filer ☐ ☐ (Do not check if a smaller reporting company)☒ Smaller reporting company ☒ Emerging growth company ☐
59,275,031.
ASSETS Current assets: Cash and cash equivalents Prepaid expenses and other current assets Total current assets Intangible assets, net Total assets LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable Accrued expenses Accrued dividends payable Total current liabilities Total liabilities Commitments and contingencies (Note 8) Series C super dividend convertible preferred stock; 1,000 shares authorized, 176 shares issued and outstanding at September 30, 2017 and December 31, 2016, redemption value: $7,130,000, liquidation value: $1,760,000 at September 30, 2017 Stockholders’ equity: Undesignated stock, $0.01 par value; 20,000,000 shares authorized, 20,000,000 and 14,001,000 designated at September 30, 2017 and December 31, 2016, respectively Series A 12% convertible preferred stock; 1,742,500 shares authorized, 1,377,500 issued and outstanding at September 30, 2017 and December 31, 2016, liquidation value $1,377,500 at September 30, 2017 SeriesB-1 12% convertible preferred stock; 900,000 shares authorized, issued and outstanding at September 30, 2017 and December 31, 2016, liquidation value $1,800,000 at September 30, 2017 SeriesB-2 12% convertible preferred stock; 2,100,000 shares authorized, issued and outstanding at September 30, 2017 and December 31, 2016, liquidation value $4,200,000 at September 30, 2017 SeriesB-3 8% convertible preferred stock; 2,508,000 shares authorized, 2,508,000 issued and outstanding at September 30, 2017 and December 31, 2016, liquidation value $2,508,000 at September 30, 2017 Common stock, $0.001 par value; 50,000,000 shares authorized at September 30, 2017 and December 31, 2016, 35,638,698 and 32,912,942 issued and outstanding at September 30, 2017 and December 31, 2016, respectively Additionalpaid-in capital Retained deficit Total stockholders’ equity Total liabilities, redeemable convertible preferred stock and stockholders’ equity Operating expenses: Research and development General and administrative Total operating expenses Total operating loss Other income (expense): Interest income Total other income (expense) Net loss Preferred stock dividends Preferred stock accretion Net loss applicable to common stockholders Net loss per common share — basic and diluted Weighted average common shares outstanding — basic CASH FLOWS FROM OPERATING ACTIVITIES: Net loss Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization Stock-based compensation expense Issuance of common stock for services Changes in operating assets and liabilities: Prepaid expenses and other assets Accounts payable and accrued expenses Net cash used in operating activities CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from issuance of SeriesB-3 preferred stock and warrants Net proceeds from issuance of common stock and warrants Net cash provided by financing activities NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD CASH AND CASH EQUIVALENTS, END OF PERIOD NONCASH FINANCING ACTIVITIES: Payment of preferred stock dividends in common stock 2020. and Other Legal and accounting fees Accrued compensation Accrued research and development costs and other Total Research and development General and administrative Total stock-based compensation expense warrants and deferred stock units: Outstanding, December 31, 2016 Granted Exercised Options forfeited/cancelled Outstanding, September 30, 2017 2021: issuance of 109,201 shares of common stock. Outstanding, December 31, 2016 Granted Exercised Forfeited/cancelled Outstanding, September 30, 2017 Warrants to purchase shares of common stock Options to purchase shares of common stock Shares of common stock issuable upon conversion of preferred stock Unvested shares of restricted common stock Furthermore, in this Quarterly Report on Form tissues. Psoriasis tolerated. Further details on this hepatic impairment study can be found on multicenter Phase 2 study. 2020 Research and development Direct external expenses: Clinical programs Pre-clinical activities All other research and development expenses 2021. General and administrative $95,000 partially offset by decrease in legal fees expense of $192,000. us. belapectin. ATM.SEPTEMBERJUNE 30, 20172021 September 30,
2017 December 31,
2016 (in thousands) $ 6,958 $ 15,362 53 432 7,011 15,794 — 1 $ 7,011 $ 15,795 $ 166 $ 910 4,175 2,802 — 68 4,341 3,780 4,341 3,780 1,723 1,723 — — 557 557 1,761 1,761 3,697 3,697 1,224 1,224 36 33 172,053 166,721 (178,381 ) (163,701 ) 947 10,292 $ 7,011 $ 15,795
2021
2020 $ 31,598 $ 27,142 1,736 2,323 33,334 29,465 71 135 $ 33,405 $ 29,600 $ 924 $ 1,292 5,065 4,042 65 65 6,054 5,399 9,643 0 592 0 0 8 16,289 5,407 0 0 1,723 1,723 0— 0— 527 527 59 56 269,657 261,883 (254,850 ) (239,996 ) 15,393 22,470 $ 33,405 $ 29,600 Three Months Ended
September 30, Nine Months Ended
September 30, 2017 2016 2017 2016 (in thousands, except
per share data) (in thousands, except
per share data) $ 3,503 $ 3,289 $ 10,719 $ 11,892 911 1,248 3,155 4,990 4,414 4,537 13,874 16,882 (4,414 ) (4,537 ) (13,874 ) (16,882 ) 6 11 21 37 6 11 21 37 $ (4,408 ) $ (4,526 ) $ (13,853 ) $ (16,845 ) (254 ) (63 ) (827 ) (466 ) — (56 ) — (173 ) $ (4,662 ) $ (4,645 ) $ (14,680 ) $ (17,484 ) $ (0.13 ) $ (0.16 ) $ (0.42 ) $ (0.60 )
and diluted 35,165 29,282 34,600 29,045
June 30,
June 30, $ 6,450 $ 4,681 $ 11,349 $ 6,825 1,743 1,421 3,161 2,861 8,193 6,102 14,510 9,686 (8,193 ) (6,102 ) (14,510 ) (9,686 ) 1 9 2 59 (85 ) (21 ) (107 ) (43 ) (172 ) 0 (172 ) 0 (256 ) (12 ) (277 ) 16 $ (8,449 ) $ (6,114 ) $ (14,787 ) $ (9,670 ) (65 ) (66 ) (67 ) (60 ) $ (8,514 ) $ (6,180 ) $ (14,854 ) $ (9,730 ) $ (0.15 ) $ (0.11 ) $ (0.26 ) $ (0.17 ) 58,312 57,035 57,725 56,995 Nine Months Ended
September 30, 2017 2016 (in thousands) $ (13,853 ) $ (16,845 ) 1 5 829 2,001 27 — 379 501 629 2,794 (11,988 ) (11,544 ) — 1,500 3,584 257 3,584 1,757 (8,404 ) (9,787 ) 15,362 25,846 $ 6,958 $ 16,059 $ 894 $ 534
June 30, $ (14,787 ) $ (9,670 ) 835 824 20 17 107 43 172 0 587 377 707 1,434 (12,359 ) (6,975 ) 10,000 0 6,815 263 16,815 263 4,456 (6,712 ) 27,142 47,480 $ 31,598 $ 40,768 $ 67 $ 60 420 0 60 0
Dividend Redeemable
Convertible
Preferred Stock
Shares
Convertible
Preferred Stock
of
Shares
of
Shares
Capital
Deficit
Stockholders’
Equity
(Deficit) (40 ) (40 ) (26 ) (26 ) 14,452 44 44 394 394 (6,114 ) (6,114 ) (38 ) (38 )
stock dividend 845,214 1 3,863 3,864 1,243,162 2 2,949 2,951 581 581 (8,449 ) (8,449 )
Convertible
Preferred Stock
of
Shares
of
Shares
Capital
Deficit
Stockholders’
Equity
(Deficit) 13,275 26 (26 ) 17,600 34 (35 ) (1 ) 14,452 44 44 84,624 219 219 19,068 824 824 (9,670 ) (9,670 ) 13,025 28 (28 ) 17,600 39 (39 ) 845,214 1 3,863 3,864 1,289,444 2 2,949 2,951 32,693 895 895 (14,787 ) (14,787 ) skin diseases and cancer. These candidates are based on the Company’s targeting of galectin proteins which are key mediators of biologic and pathologic function. These compounds also may have application for drugs to treat other diseases and chronic health conditions.SeptemberJune 30, 20172021 and the results of its operations for the three and ninesix months ended SeptemberJune 30, 20172021 and 20162020 and its cash flows for the ninethree and six months ended SeptemberJune 30, 20172021 and 2016.2020. All adjustments made to the interim financial statements include all those of a normal and recurring nature. Amounts presented in the condensed consolidated balance sheet as of December 31, 20162020 are derived from the Company’s audited consolidated financial statements as of that date, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated through the date these financial statements are available to be issued. The results for interim periods are not necessarily indicative of results whichthat may be expected for any other interim period or for the full year. The unaudited condensed consolidated financial statements of the Company should be read in conjunction with its Annual Report on Form2016.significant revenues. The Company anticipates that losses will continue for the foreseeable future. At SeptemberJune 30, 2017,2021, the Company had $7.0 million$31,598,000 of unrestricted cash and cash equivalents available to fund future operations. The Company believes that with the cash on hand at September 30, 2017, there is sufficient cash, including availability of the line of credit (see Note 3), to fund currently planned operations at least through February 2018 which creates uncertainty aboutSeptember 30, 2022. We will require more cash to fund our operations after September 30, 2022 and believe we will be able to obtain additional financing. The currently planned operations include costs related to our adaptively designed NAVIGATE Phase 2b/3 clinical trial. Currently, we expect to require an additional approximatelyCompany’s abilitytrial to continue as a going concern. The Company’s abilityreach the planned interim analysis estimated to occur in the second half of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs. However, there can be no assurance 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 in raising additional capital to fund operations after its current cash resources are exhausted depends on its abilitybefore September 30, 2022, we may be required to obtain additional financing or achieve profitable operations, as to which no assurances can be given.cease operations. Accordingly, based on the forecasts and estimates underlying the Company’sour current operating plan, substantial doubt exists about the ability for the Company to continue as a going concern. The financial statements do not currently include any adjustments that might be necessary if the Company iswe are unable to continue as a going concern. September 30,
2017 December 31,
2016 (in thousands) $ 115 $ 14 361 614 3,699 2,174 $ 4,175 $ 2,802 June 30,
2021 December 31,
2020 (in thousands) $ 94 $ 122 370 789 31 44 4,570 3,087 $ 5,065 $ 4,042 common stock, restricted common stock, and common stock warrants: Three Months Ended
September 30, Nine Months Ended
September 30, 2017 2016 2017 2016 $ 109 $ 165 $ 407 $ 598 121 211 422 1,403 $ 230 $ 376 $ 829 $ 2,001
June 30,
June 30, $ 89 $ 83 $ 156 $ 240 492 311 679 584 $ 581 $ 394 $ 835 $ 824 20162020 through SeptemberJune 30, 2017: Shares Weighted Average
Exercise Price 4,656,888 $ 4.30 — — — — — — 4,656,888 $ 4.30 Shares Weighted Average
Exercise Price 3,987,575 $ 4.29 2,065,000 2.20 (252,500 ) 2.19 (880,350 ) 5.52 4,919,725 $ 3.30 SeptemberJune 30, 2017,2021, there was $366,000$3,532,185 of unrecognized compensation related to 907,4892,413,751 unvested options, which is expected to be recognized over a weighted-averageweighted–average period of approximately 0.582.15 years. The weighted-average grant date fair value for options granted during the ninesix months ended SeptemberJune 30, 20162021 was $1.05.$1.63. The Company granted 277,5002,065,000 stock options during the ninesix months ended SeptemberJune 30, 2016, of which 69,375 options vested upon grant with2021. During the remaining 208,125 options vesting over 3 years. Approximately $73,000 ofnon-cash, stock-based compensation expense was recorded during the ninesix months ended SeptemberJune 30, 2016 related to2021, 252,500 stock options were exercised on a net basis resulting in the options granted during the quarter that were vested upon the grant date.NineMonths EndedSeptember 30,2016Risk-free interest rate1.7% Expected life of the options6.0 yearsExpected volatility of the underlying stock94% Expected dividend rate0% The following table summarizes the Six
Months Ended
June 30, Six
Months Ended
June 30, 2021 2020 0.57 % 1.55 % 6 years 6 years 91 % 100 % 0 % 0 % grant activitygrants in the Company’s equity incentive plans from December 31, 2016 through September 30, 2017:SharesOutstanding, December 31, 2016754,605Granted— Exercised— Options forfeited/cancelled— Outstanding, September 30, 2017754,605On March 12, 2015, the Company granted 81,352lieu of cash retainers for 2020. A total of 32,693 shares of restricted stock tonon-employee directors as a component of their compensation. A total of 77,784 shares were issuedvalued at approximately $93,500 was amortized to seven directors representingnon-cash compensation cost of $280,000 which was recognizedexpense on a straight-line basis from the grant date through December 15, 2016,until January 9, 2021 when the restricted sharesstock vested in full.3,56816,588 shares were issuedof restricted stock valued at approximately $35,000 is being amortized to two directors, who were not nominated for reelection, representingnon-cash compensation cost of $12,845 that was recognizedexpense on a straight-line basis fromuntil December 31, 2021 when the stock vests in full.through May 21, 2016, whenfair value of $2.70 per share. Also, Mr. Lewis’ bonus for the restrictedyear ended December 31, 2020 of $60,000 (which was included in accrued compensation at December 31, 2020) was approved in March 2021 and represents 27,027 shares vestedof common stock to be issued under the DSU agreement with a grant date fair value of $2.22 per share. The $60,000 was reclassified from accrued compensation to additional paid in full.4.capital in March 2021. There is 0 unrecognized compensation expense related to the DSUs.20162020 through SeptemberJune 30, 2017: Shares Weighted Average
Exercise Price 13,488,296 $ 3.44 78,455 5.00 — — (1,317,161 ) 5.63 12,249,590 $ 3.22 5.2021: Shares Weighted Average
Exercise Price 12,538,204 $ 4.22 0— 0— (1,180,240 ) 2.50 0— 0— 11,357,964 $ 4.40 September 30, 2017 or December 31, 2016.6.2020. Level 1 Level 2 Level 3 Total $ 592,000 $ 592,000 $ 2.19 $ 3.20 $ 5.00 $ 5.00 4 years 3.8 years 0.59 % 0.67 % 7.60 % 7.11 % 88 % 91 % 0 % 0 $ 0 420,000 172,000 $ 592,000 September 30, 2017
(shares) September 30, 2016
(shares) 12,249,590 10,452,844 4,656,888 3,499,638 4,312,282 3,415,285 — 337,935 21,218,760 17,705,702 7. June 30, 2021
(shares) June 30, 2020
(shares) 11,357,964 12,538,204 4,919,725 3,737,575 510,424 514,602 18,837,541 16,790,381 2014March 30, 2014,May 11, 2020, the Company entered into an At Market Issuance Sales Agreement (the “2014“2020 At Market Agreement”) with a sales agent under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $30.0$40.0 million from time to time through the sales agent. 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 as defined 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 proceeds from the sale of any shares of common stock sold through the sales agent under the 2014 At Market Agreement. In three months ended June 30, 2016, the Company issued 176,950 shares of common stock for net proceeds of approximately $257,000 under the 2014 At Market Agreement. In three months ended March 31, 2017, the Company issued 1,496,797 shares of common stock for net proceeds of approximately $1,946,000 under the 2014 At Market Agreement. The 2014 At Market Agreement expired in March 2017.2017 At Market Issuance of Common StockOn May 19, 2017, the Company entered into an At Market Issuance Sales Agreement (the “2017 At Market Agreement”) with a sales agent under which the 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 sales agent. 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 as defined 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 proceeds from the sale of any shares of common stock sold through the sales agent under the 20172020 At Market Agreement. During the ninesix months ended SeptemberJune 30, 2017,2021, the Company issued 716,563845,214 shares of common stock under the 2020 At Market Agreement for net proceeds of approximately $1,438,000 under$3,864,000.2017 At Market Agreement.2017 Private PlacementOn February 28, 2017, the Company closed a transaction with five individual investors through a private placement of common stocksix months ended June 30, 2021 and warrants. In total,2020, the Company issued 102,368a total of 30,625 and 30,875 shares of common stock, for proceeds of $200,000. The Company also issued, to the five investors, warrants to purchase 76,776 shares of common stock at $5.00 per share. The warrants have an expiration date of February 28, 2024. The exercise price of each warrant is adjustable in the event of a stock split or stock combination, capital reorganization, merger or similar event. The warrants were valued at approximately $101,000 as of the issuance, using the closing price of $1.86, a life of 7 years, a volatility of 97% and a risk-free interest rate of 1.92%. Based upon the Company’s analysis of the criteria contained in ASC Topic815-40, “Derivatives and Hedging — Contracts in Entity’s Own Equity” the Company has determined that warrants issued in connection with this financing transaction were not derivative liabilities and therefore, were recorded as additionalpaid-in capital.OtherIn 2017, the Company entered an agreement with a vendor whereby the Company will issue common stock to vendor in lieu of paying in cash in amount up to $100,000 for the year. Through September 30, 2017, the Company has issued 16,793 shares of common stock and 1,680 warrants to purchase shares of common stock pursuant to this agreement and the value of such shares has been recorded as research and development expense.Through September 30, 2017, the Company has issued a total of 393,235 shares of common stockrespectively, for dividends on Series A Series B and Series C Preferred Stock for 2017.8.Stock.Shareholder Class Actions and Derivative LawsuitsOn 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 an order consolidating the two cases, relieving the defendants of any obligation to respond to the initial complaints, and providing that defendants may respond to a consolidated complaint to be filed by the plaintiffs. On January 5, 2015, the Nevada District Court granted Defendants’ motion to transfer the consolidated putative derivative litigation to the United States District Court for the Northern District of Georgia (hereinafter referred to as the “Georgia Federal Derivative Action.”). The plaintiffs 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 statements concerning the Company’s financial and business prospects. The Complaint also alleges that the Derivative Action Individual Defendants violated the federal securities laws by allegedly making false or misleading statements of material fact in the Company’s proxy filings, committed waste of corporate assets, were unjustly enriched, and that certain defendants breached their fiduciary duties through allegedly improper sales of Galectin stock. In addition, the Complaint alleges that the Derivative Action Individual Defendants and one of the Company’s shareholders aided and abetted the alleged breaches of fiduciary duties. The Complaint 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 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 judgment in favor of the defendants. Plaintiffs filed a notice of appeal seeking review of the dismissal order and final judgment. On July 7, 2016, the United States Court of Appeals for the Eleventh Circuit dismissed the appeal as the Plaintiffs failed to timely file their appeal brief. In September 2016, the Board received a demand letter from one of the plaintiffs in the Georgia Federal Derivative Action. The demand letter, among other things, requests that the Board investigate the conduct alleged in the Complaint and implement certain remedial measures purportedly designed to address the alleged conduct. It is expected that the Board will consider the demand letter in due course and in light of the related pending shareholder litigation described herein.On August 29, 2014, another alleged Galectin shareholder filed a putative shareholder derivative complaint in state court in Las Vegas, Nevada, seeking recovery on behalf of the Company against the same Galectin directors and officers who are named as defendants in the derivative litigation pending in the Georgia Federal Derivative Action. The plaintiff in the Nevada action subsequently filed first and second amended complaints. The second amended complaint alleges claims for breach of fiduciary duties, unjust enrichment, and waste of corporate assets, based on allegations that are substantially similar to those asserted in the Georgia Federal Derivative Action (except that the Nevada action does not allege violations of the federal securities laws and does not assert any claim against the Galectin 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 and defendants filed motions to dismiss the second amended complaint on April 22, 2015. On April 29, 2015, the plaintiffs in the Georgia Federal Derivative Action (the “Intervenor Plaintiffs”) filed a motion to intervene in the Nevada action which, among other things, raised questions regarding the Nevada plaintiff’s standing. Thereafter, the Nevada plaintiff filed a motion to join additional plaintiffs. At a hearing held on June 11, 2015, the Nevada court: (i) granted the Intervenor Plaintiffs’ motion to intervene; (ii) directed the Intervenor 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 additional plaintiffs; (iv) stated that the defendants’ motions to dismiss the second amended complaint 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 on December 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’s instruction, the Intervenor Plaintiffs filed acomplaint-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. On January 5, 2016, the Nevada State Court held a status conference during which the dismissal of the Georgia Federal Derivative Action was discussed. Subsequent to 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 Georgia Federal Derivative Action, among other grounds. Following full briefing and a hearing on March 3, 2016, the Nevada State Court granted dismissal of the Nevada State Court litigation. Notice of Entry of the Nevada State Court’s order dismissing the Nevada State Court litigation was docketed on June 21, 2016. The Nevada plaintiff and Intervenor Plaintiffs (“Appellants”) filed notices of appeal seeking review of the Nevada State Court’s order and judgment dismissing the claims. The appeal is now fully briefed and awaiting a decision from the Nevada Supreme Court.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 strength or 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 possible losses or a range of possible losses resulting from, the matters described above. Based on information currently available, the Company does not believe that any reasonably possible losses arising from currently pending legal matters will be material to the Company’s results of operations or financial condition. However, in light of the inherent uncertainties involved in such matters, an adverse outcome in one or more of these matters could materially and adversely affect the Company’s financial condition, results of operations or cash flows in any particular reporting period.othersignificant pending legal proceedings exceptproceedings.noted above.9.of June 30, 2021 in thousands: 24 8 32 1 $ 31 As a result,Since then, the Company has contributed thea total of $2,529,000, including $73,000 needed for the fourth quarter of 2014three months ended June 30, 2021, for expenses of the LLC. The CompanySince the end of 2014, SBH has contributed $659,000 and $687,000$158,000 for the LLC expenses in 2016 and 2015, respectively, and SBH contributed $50,000 in 2016. The Company contributed $45,000, $29,000 and $30,000 during the quarters ended March 31, 2017,LLC. As of June 30, 2017, and September 30, 2017, respectively. As of September 30, 2017,2021, the Company’s ownership percentage in the LLC was 81.2%84%. The Company 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 theFebruary 2018;at least September 30, 2022; our commitments and contingencies; and our market risk exposure. Forward-looking statements are based on current expectations, estimates and projections about the industry and markets in which Galectin Therapeutics operates, and management’s beliefs and assumptions. These statements are not guarantees of future performance and involve certain known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Such risks and uncertainties are related to and include, without limitation,certain severe skin diseases,cancer and cancer.selected other diseases. Our drug 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, patented complex carbohydrates with specific molecular weights and other pharmaceutical properties. These complex carbohydrate molecules are appropriately formulated into acceptable pharmaceutical formulations. Using these unique carbohydrate-based candidate compounds that largely bind and inhibit galectin proteins, particularlygalectinsgalectin proteins have a demonstrated role in the pathogenesis of a given disease. We focus on diseases with serious, life-threatening consequences to patients and those where current treatment options, are limited.limited specifically in NASHa programone of our programs becomes advanced and requires significant additional resources.GR-MD-02, belapectinGR-MD-02 Belapectin has the potential to treat many diseases due toGalectin Therapeutics Inc.The importance ofthis our(non-alcoholic steatohepatitis) patients. We have completed two Phase 1 clinical studies, onea Phase 2 clinical study in NASH patients with advanced fibrosishave oneongoinga second Phase 22b clinical studytrial in NASH patients with well compensated cirrhosis. TheNASH-CX trial patients have completed all infusions/dosing and final HVPG and liver biopsy results have been obtained on all patients. The trial is expected to complete with 151 patients and to report top line data in December 2017. NASH cirrhosis is a progressive disease, currently not treatable and ultimately may result in liver failure that has poor prognosis and no effective, approved medical therapies other than liver transplant.Galectin-3 expression is highly increased in liver fibrosisliver cirrhosis. We believe that ourgalectin-3 inhibitor, by reducinggalectin-3 atproviding guidance on various aspects of the extra-cellular level, ultimately showingongoing NAVIGATE trial.strong anti-fibrotic potential may provide a novel treatment for various formsstudy protocol entitled “A Single-dose, Open-label, Pharmacokinetic Study of liver fibrosis.several collaborative scientific discovery programs with leading experts in carbohydrate chemistry and characterization. These discovery programs are generally aimed at the targeted development of new carbohydrate molecules that bind galectin proteins and offer alternative options to larger market segments inthrough our primary disease indications. We also have establishedmajority-owned joint venture subsidiary, Galectin Sciences LLC, a discovery program aimed at the targeted development of small molecules(non-carbohydrate) (generally,immune enhancementimmuno-oncology for cancer therapy and certain severe skin diseases including moderate to severe plaque psoriasis and severe atopic dermatitis. Ourin collaboration with Providence Portland Cancer Center. However, our clinical development efforts are primarily focused on both liver fibrosis and fatty liver disease as represented by a Phase 2 clinical trial in NASH-cirrhosis which will report top line data in December 2017.NASH. All of our proposed products are presently in development, includingshow that mice lackingsubstantiating the importance ofdisease; they are also incapabledisease as well as development of developing fibrosis in other tissues such as lung, kidney and cardiac.GR-MD-02, belapectin, which has shown promise in preclinical and early clinical studies in treatment of fibrosis, certain severe skin diseases,disease, and in cancer therapy. Currently we are focusing on development ofGR-MD-02 belapectin intended to be used in the treatment of liver fibrosis associated with fatty liver disease (NASH) and more specifically onin NASH cirrhosis. We have also leveraged our relationships with well-known investigators to demonstrate clinical effects ofGR-MD-02 belapectin in treating moderate to severe plaque psoriasis, severe atopic dermatitis, and in cancer therapy in combination with immune-system modifying agent(s).GR-MD-02 Belapectin is a proprietary, patented compound derived from natural, readily available, plant-based starting materials, which, following chemical processing, exhibits the properties of binding to and inhibiting this continues to behas been explored in limited other preclinical studies. GR-MD-02belapectin End of1 meeting held with FDA in 2014. Two Phase 2 clinical trials were designed. The NASH CX trial, was designed for patients with cirrhosis, and the NASH FX trial was designed for patients with advanced fibrosis but not cirrhosis. Its principal purpose was to evaluate various imaging modalities. The NASH FX trial top line data was reported in September 2016 and theThe Phase 2 NASH CX trial, was designed for patients with well compensated cirrhosis. The NASH CX trial top line data is expectedwas reported in December 2017.2017 and was published inNASH NAVIGATE Lung Fibrosis GR-MD-02belapectin In Kidney Fibrosis GR-MD-02belapectin In Cardiac and Vascular Fibrosis GR-MD-02belapectin and In GR-MD-02belapectin Investigator IND submitted in December 2013. Phase 1B study in process. A second Phase 1B study began in Investigator IND for that study submitted in September 2015. Early data was reported in February 2017 and studies will continue.additional data were reported in September 2018. A further expansion cohort of patients with melanoma and HNSCC was reported in July 2021. GR-MD-02belapectin IND submitted March 2015. A phasePhase 2a trial in moderate to severe plaque psoriasis patients began in January 2016. Interim data on the first four patients were positive and were reported in May 2016. Further positive data was reported in September 2016. Investigator initiated IND submitted for treatment of three patients with severe atopic dermatitis, with positive preliminary data presented in February 2017. StudiesFurther studies are now completed.dependent on finding a suitable strategic partner which is unlikely. GR-MD-02GR-MD-02 belapectin has a significant therapeutic effect on liver fibrosis as shown in several relevant animal models. In addition, in NASH animal models,GR-MD-02 belapectin has been shown to reduce liver fat, inflammation, and ballooning degeneration or death(death of liver cells.cells). Therefore, we choseGR-MD-02(NASH, or fatty liver disease)(NASH). 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 ofGR-MD-02 belapectin and pharmacodynamics biomarkers of disease. On March 1, 2013, the FDA indicated we could proceed with a US Phase 1 clinical trial forGR-MD-02 belapectin with a development program aimed at obtaining support for a proposed indication ofGR-MD-02 belapectin for treatment of NASH with advanced fibrosis. The Phase 1 trial was completed and demonstrated thatGR-MD-02 belapectin up to 8 mg/kg Lean Body Mass (LBM), i.v. was safe and well tolerated and the human pharmacokinetic data defined a drug dose for use in the planned Phase 2 trials. Additionally, there was evidence of a pharmacodynamic effect ofGR-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.GR-MD-02 belapectin and it showed that with 8 mg/kg LBM dose ofGR-MD-02 belapectin and 2 mg/kg LBM dose of midazolam there was no 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 Drug Administration (FDA) and the primary objective was to determine if single or multiple intravenous (IV) doses ofGR-MD-02 affect the pharmacokinetics (PK) of midazolam. The secondary objective was to assess the safety and tolerability ofGR-MD-02 belapectin when administered concomitantly with midazolam. The lack of a drug interaction in this study enabled Galectin to expand the number of patients eligible for its Phase 2 clinical trial. In addition, shouldGR-MD-02 be approved for marketing, the success of this study supports a broader patient population for the drug label.consistsconsisted of two separate human clinical trials. The firstprimary clinical trial iswas the Phase 2biswas the primary focus of our program and iswas a randomized, placebo-controlled, double-blind, parallel-group Phase 22b trial to evaluate the safety and efficacy ofGR-MD-02 belapectin for treatment of liver fibrosis and resultant portal hypertension in NASH patients with compensated cirrhosis. A smaller, exploratoryGR-MD-02, belapectin, 8 mg/kg LBM ofGR-MD-02 belapectin or placebo, with approximately 54 patients in each group. Approximately 50% of patients at baseline had esophageal varices (a complication of portal hypertension). The primary endpoint iswas a reduction in change in hepatic venous pressure gradient (HVPG). Patients are receivingreceived an infusion of belapectin or placebo every other week for one year, a total of 26 infusions, and will bewere evaluated to determine the change in HVPG as compared with placebo. HVPG will be correlated with secondarySecondary or exploratory endpoints ofincluded fibrosis on liver biopsy, as well as with measurement of liver stiffness (FibroScan, which arenon-invasive measures. Top line data readout was reported in December 2017. The study demonstrated a favorable safety profile and clinically meaningful efficacy results in patients without esophageal varices at baseline demonstrated by a prevention of development of varices when compared to placebo.liver that may be used in future studies. A late-breaking abstract on screening data results correlating clinicallytotal population), there was a statistically significant portal hypertension and methacetin breath test results was presented at The International Liver Congress™ in Amsterdam on April 20, 2017. The DSMB concluded its third and final revieweffect of the safety and conduct2 mg/kg LBM dose of belapectin on thein-life phase of ourNASH-CX trial and indicated it concurrence with continuation absolute change in HVPGtrial8 mg/Kg LBM dose of belapectin on absolute or percent change in HVPG from baseline to week 54 was not significant.‘clean’ safety profile.8 mg/kg LBM, respectively) vs placebo (18%). As esophageal varices can lead to hemorrhagic complication, which can be fatal, we believe the prevention of the timeesophageal varices may represent a clinically relevant measure of their evaluation, therapy had been completedclinical efficacy in 68% of subjects in theNASH-CX trial. As of September 30, 2017, 151 patients (100%) have completed all 52 weeks of infusions in this Phase 2b clinical trial. All of the doses have already been administered and end of study HVPG and liver biopsies have been completed. The dropout rate remains at approximately 7%, which is well below expectations, which may increase the power of the trial. We currently expect approximately 151 subjects will complete the trial in November 2017. This trial was designed, and is being conducted, with a primary endpoint that the U.S. Food and Drug Administration views may be a surrogate for outcomes for registration trials in this patient population. After completion of study endpoints and initial analysis of data, the Company remains on track to report top line data from theNASH-CX trial in early December 2017.The second trial, our Phase 2a pilot trialNASH-FX for patients with NASH advanced fibrosis that explored usecirrhosis.shorter, single site, four-month trialstatistically significant reduction (p=0.02) in 30 NASHthe development of new esophageal varices in drug-treated patients with advanced fibrosis, but not cirrhosis, randomized 1:1compared to either 9bi-weekly doses ofplacebo. We believe that this is a clinically relevant endpoint related to patient outcomes, (iv) While there was a drug effect in both the 2 mg/kg LBM and 8 mg/kg LBM groups on the development ofGR-MD-02 or placebo. The trial did not meet its primary biomarker endpoint as measured using multi-parametric magnetic resonance imaging (LiverMultiScan(R), Perspectum Diagnostics). The trial also did not meet secondary endpoints that measure varices and liver stiffness asbiopsy there was a surrogate for fibrosis using, magnetic resonance-elastographyconsistently greater and FibroScan score. After analysisstatistically significant effect of the data, we do not believe that a four-month treatment period was likely long enough in the NASH population to show efficacy results. This small study was not powered for the secondary endpoints and thus, not surprisingly did not meet the secondary endpoints. In the trial,GR-MD-02 was found2 mg/kg LBM dose of belapectin, (v) belapectin appears to be safe and well tolerated amongin this one year clinical trial, a feature that is of prime importance for a cirrhotic population and (vi) We believe this is the patient population with no serious adverse events.Although there was no apparentfirst large, randomized clinical trial to demonstrate a clinically meaningful improvement in portal hypertension or liver biopsy in patients with compensated NASH cirrhosis who have not yet developed esophageal varices.threenon-invasive tests SEC and in a peer reviewed publication inassessmentthe prevention of esophageal varices in patient withfibrosisfailure, and (iii) During the first 18 months, two belapectin dose levels (2 mg/kg LBM and 4 mg/kg LBM) will be compared to placebo (phase 2b). Then, at the interim analysis (IA), one belapectin dose will be selected based on efficacy and safety, for continued evaluation (Phase 3). The belapectin dose selected for the phase 2b/3 are based on the analysis of thefour-monthNASH-FX trial,protocol, the principal investigatorprimary endpoint remain the development of theNASH-FX trial has stated that the inhibitionvarices. Secondary endpoints include a composite clinical outcomes endpoint, including varices requiring treatment (development ofgalectin-3 large varices or varices withGR-MD-02 remains promising for the treatment a red wale), decompensating events,NASH fibrosis. Of note is thatGR-MD-02 has demonstrateddeveloping esophageal varices, patient selection will be based on clinical signs of portal hypertension, including, a low platelet count, an improved clinical effect inmoderate-to-severe psoriasis and inmoderate-to-severe atopic dermatitis patients, suggesting the compound has activity in an immune-mediated inflammatory human disease that can occur in association with NASH and in whichgalectin-3 is believed to play a role. We believe our drug candidate provides a promising new approach for the therapyincreased spleen size and/or evidence of fibrotic diseases, and liver fibrosis in particular. Fibrosis is the formationcollaterals circulation.andand/or reverse the fibrosis in the liverportal hypertension and thereby improve liver function and prevent the development of complicationsvarices, potentially one of fibrosis/the most immediately life-threatening complication of cirrhosis. Based on the results of theliver-related mortality as such, are at a greater health risk of complications fromGR-MD-02 belapectin enhances the immune response to cancer cells, increased tumor shrinkage and enhanced survival in immune competent mice with prostate, breast, melanoma and sarcoma cancers when combined with one of the immune checkpoint inhibitors, andGR-MD-02 belapectin in combination with YervoyData on this combination immunotherapy program was presented on February 7, 2017 at the 9th GTCBio Immunotherapeutics & Immunomonitoring Conference in San Diego, CA by Dr. William L. Redmond, Providence Cancer Center. Preclinical results in mouse models of multiple types of cancers showed important anti-tumor and increased survival effects of combiningGR-MD-02 with different types of immune modulators, providing a case for progressing studies into human patients with cancer. Seven patients were treated in theGR-MD-02 in combination with Yervoy trial, with no safety concerns in these low dose cohorts. Due to changes in the standard of care for metastatic melanoma (i.e., approval ofanti-PD-1), recruitment has been slowed significantly in this trial. GR-MD-02 belapectin with pembrolizumab (KEYTRUDA)(KEYTRUDAneck)neck cancer) with one partial response and one mixed response in 5the melanoma patients. There was a rapid and marked tumor response after 3 doses of combinedGR-MD-02 belapectin and pembrolizumab in the one partial response patient who had failed high-dose This Phase 1b clinical trial that combinesGR-MD-02 with pembrolizumab (KEYTRUDA®) continues to enroll patients and recently completed the second cohort, which used 4 mg/kgGR-MD-02. The third cohort, which will start 85 days following the final patient enrollment in the second cohort, will enroll 10 patients at a dose of 8 mg/kgGR-MD-02. There will likely be additional data reported in early 2018. The study is ongoing and progression to further development will be based on response rate as compared to historical response rates to pembrolizumab alone.Severe skin diseases.Psorasis. During our Phase 1 NASH fibrosis trial In September 2018 we announced additional preliminary clinical data from cohort 3 of this investigator-initiated trial. When aggregated withGR-MD-02, cohorts previously reported, the data shows a clinical effect on plaque psoriasis was observed50% objective response rate in advanced melanoma with belapectin in combination with KEYTRUDA, and a NASH patient who also had this disease. This patient had marked improvementsignificant decrease in her psoriasis, with improvement beginning after the third infusion. She reported that her psoriasis was “completely gone”frequency of suppressive myeloid-derived suppressor cells following treatment in the responding patients (on day 85 post-treatment). Fourteen advanced melanoma patients across three dose cohorts now have Objective Response Rate (ORR) and her skin was “normal” after the fourth infusion. Her skin remained normal for 17 months after the final infusion of study drug. The patient is convinced that the improvementDisease Control Rate (DCR) data. Six patients completed in her psoriasis is relatedcohort 3 (8 mg/kg LBM) have now been added to the study drug.This serendipitous finding, combined withgalectin-3 protein being markedly upregulatedthree patients completed in the capillary epithelia (small blood vessels)cohort 2 (4 mg/kg LBM) and five patients completed in cohort 1 (2 mg/kg LBM). Cohorts 1 and 3moderate to severe plaque psoriasis.GR-MD-02 inhibition ofgalectin-3 may attenuate capillary changes 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), 5 patients with moderate to severe plaque psoriasis were administeredGR-MD-02 every two weeks for 24 weeks. In May 2016, we reported positive results on the first four patients after 12 weeks of therapy. Based on these results, we modified the trial to include 24 weeks of therapy. In August 2016, we reported on four patients after 24 weeks of therapy and one patient after 12 weeks of therapy. The four patients who received 24 weeks of therapy experienced an average of 48% improvement in their plaque psoriasis. At this time, the average response in all five patients remains at 50% with one patient having an 82% improvement. However, there are existing drugs on the market in this disease that produce 75% and higher improvements in60-90% of patients. While we are encouraged that this study has demonstrated clinically meaningful results in a human disease withGR-MD-02, the next steps would entail a controlled, does-ranging clinical trial which we do not expect to conduct absent a strategic partnership. The results of this Phase 2a clinical trial was presented at the Maui Derm for Dermatologists meeting in March 2017. The results have been published in the Journal of the American Academy of Dermatology in October 2017.Atopic Dermatitis. Atopic Dermatitis (AD) is a chronic pruritic (itching), immune-mediated, inflammatory skin disease that for some adult patients can be severe and debilitating. There is an important unmet medical need in adults with severe disease who are not adequately treated with topical medicines. Our findings in psoriasis led to an interest in exploring the potential utility of the compound in treatment of AD. A Phase 2a open label trial was initiated in 3 adult patients who were treated withGR-MD-02 at 8 mg/Kg every other week for 12 weeks, and dosage could be increased to 12 mg/Kg for weeks12-24 if an incomplete response was observed. The response was objectively evaluated using two validated scores: the EASI (eczema area and severity index) and SCORAD (severity scoring of atopic dermatitis index).objective response. All three patients showed clinical responsesin cohort 2 had an objective response. In addition to the fourteen advanced melanoma patients, six patients with head and neck cancer were enrolled in this trial with a 33% ORR and 67% DCR. These data, taken together with the observed favorable safety and tolerability of the combination, in the view of the principal investigator, provide compelling rationale to move forward. Given that all three melanoma patients were responders at the 4 mg/kg dose, the investigators plan to continue the trial with the expansion of the 4 mg/Kg cohort to include additional advanced melanoma patients and additional head and neck cancer patients.determined by reductionwell as surgery and radiation therapies (external and radio-labeled). Patients also had a high burden of EASImetastasis, with the lungs, soft tissues, and SCORAD during the study. but no subject achievedliver being the most frequently involved organs. Four of the nine melanoma patients had a choroidal (ocular) tumor as a primary endpoint. Upon completionsite of the24-weektheir cancer and had also developed liver metastasis. The treatment phase subjectconsisted of Belapectin 4 mg/Kg of lean body mass administered every three weeks by infusion, after the infusion of pembrolizumab. Pembrolizumab was administered according to its label. Patients’ response was evaluated at day 85, according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The median number of treatment cycles was four (rangemet both secondary endpoints(mild) pruritus (itching), a known and labeled side-effect ofSCORAD-50 andEASI-50, and subject pembrolizumab. The second most frequent adverse event related to pembrolizumab was grade 2 met one secondary endpoint(EASI-50)fatigue in three patients. All other adverse events were mild (grade 1). Subject 3 approached a secondary endpoint with an EASI reduction of 49% at week 24. There were no druggrade 3 or above adverse events. Similar to the initial phase 1 study results, the frequency and severity of toxicities related to pembrolizumab, notably immune-mediated adverse events, during this trial. These initial findingswas less than anticipated. No adverse event was deemed related to belapectin.believed to suggestongoing about the planning and feasibility of a clinically relevant effect. Additionally, the 12 mg/Kg dosage was administered safely in this patient population.We believe the mechanism of action forGR-MD-02 in moderate to severe skin diseases is based upon interaction with, and inhibition of, galectin proteins, particularlygalectin-3, which are expressed at high levels in certain pathological states including inflammation, fibrosis, skin diseases and cancer. WhileGR-MD-02 is capable of binding to multiple galectin proteins, we believe that it has the greatest affinity forgalectin-3, the most prominent galectin implicated in pathological processes. Blocking galectin in cancer and liver fibrosis has specific salutary effects on the disease process.NineSix Months Ended SeptemberJune 30, 20172021 Compared to Three and Six Months Ended SeptemberJune 30, 2016 Three Months Ended
September 30, Nine Months Ended
September 30, 2017 as Compared to 2016 Three Months Nine Months 2017 2016 2017 2016 $ Change % Change $ Change % Change (In thousands, except %) $ 3,503 $ 3,289 $ 10,719 $ 11,892 $ 214 7 % $ (1,173 ) (10 %) Three Months Ended Six Months Ended 2021 as Compared to 2020 June 30, June 30, Three Months Six Months 2021 2020 2021 2020 $ Change % Change $ Change % Change (In thousands, except %) $ 6,450 $ 4,681 $ 11,349 $ 6,825 $1,769 38 % $ 4,524 66 % We have two product candidates,GR-MD-02 andGM-CT-01; however onlyGR-MD-02 is in active development. We filed for an IND forGR-MD-02 in January 2013 and in February 2013 we entered into an agreement with CTI to conduct a Phase 1 clinical trial Three Months Ended
September 30, Nine Months Ended
September 30, 2017 2016 2017 2016 (in thousands) $ 2,945 $ 2,499 $ 8,973 $ 9,272 39 213 105 787 519 577 1,641 1,833 $ 3,503 $ 3,289 $ 10,719 $ 11,892 Three Months Ended
June 30, Six Months Ended
June 30, 2021 2020 2021 2020 (in thousands) $ 5,878 $ 3,779 $ 10,161 $ 4,798 70 121 181 363 502 781 1,007 1,664 $6,450 $4,681 $11,349 $6,825 SeptemberJune 30, 2017 as compared to the prior year and decreased during nine months ended September 30, 2017 as compared to the same period in 2016 primarily due to timing of costs incurred in theNASH-CX clinical trial. As we continue our Phase 2 trial, we expect our clinical activities costs will increase although they may fluctuate from quarter to quarter as the trials progress. Clinical activities expenses primarily decreased due to reduced expenses associated with drug manufacturing and preparation.Pre-clinical activities decreased primarily because we have completedpre-clinical work directly related to our Phase 2 clinical trial program. Other research and development expense decreased in the nine months ended September 30, 2017 compared to 2016 primarily due to a decrease innon-cash stock-based compensation expense of approximately $191,000. Three Months Ended
September 30, Nine Months Ended
September 30, 2017 as Compared to 2016 Three Months Nine Months 2017 2016 2017 2016 $ Change % Change $ Change % Change (In thousands, except %) $ 911 $ 1,248 $ 3,155 $ 4,990 $ (337 ) (27 %) $ (1,835 ) (37 )% 2021 as Compared to 2020 Three Months
Ended June 30, Six Months
Ended June 30, Three Months Six Months 2021 2020 2021 2020 $ Change % Change $ Change % Change (In thousands, except %) $ 1,743 $ 1,421 $ 3,161 $ 2,861 $ 322 23 % $ 300 10 % stock basedstock-based compensation, legal and accounting fees, insurance, investor relations, business development and other office related expenses. The primary reasons for the decreaseincrease in general and administrative expenses for the three months ended SeptemberJune 30, 20172021 as compared to the same period in 20162020 are reduced legal expensesdue to increases in insurance expense of approximately $163,000$130,000, investor relations/business development expense of $209,000 and decreasedapproximately $90,000.$181,000 partially offset by decrease in legal fees expense of $174,000. The primary reasons for the decreaseincrease in general and administrative expenses for the ninesix months ended SeptemberJune 30, 20172021 as compared to the same period in 2016 is2020 are due to recording of severance of $300,000, acceleration ofnon-cash, stock-based compensationincreases in insurance expense of $578,000 related to the termination$254,000, investor relations/business development expense of the Company’s executive chairman in January 2016, a decrease in investor relations expenses of approximately $335,000, a decrease in legal expenses of $248,000,$135,000 and a decrease in$403,000.SeptemberJune 30, 2017,2021, we raised a net total of $132$214.5 million from these offerings. We have operated at a loss since our inception and have had no significant revenues. We anticipate that losses will continue for the foreseeable future. At SeptemberJune 30, 2017, we2021, the Company had $7.0$31.6 million of unrestricted cash and cash equivalents available to fund future operations. We believe thatThe Company also has a $10 million unsecured line of credit facility with stockholder and director, Richard E. Uihlein. The Company has not drawn under the cash on hand at September 30, 2017,line of credit. The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through February 2018 which creates uncertainty about the Company’s ability to continue as a going concern. Our abilitySeptember 30, 2022. We will require more cash to fund our operations after our current cash resources are exhausted depends on our abilitySeptember 30, 2022 and believe we will be able to obtain additional financing. The currently planned operations include costs related to our adaptively designed NAVIGATE Phase 2b/3 clinical trial. Currently, we expect to require an additional approximatelyachieve profitable operations, asif available, that such financing will be on terms favorable to which no assurances can be given. Accordingly, based on the forecasts and estimates underlying the Company’s current operating plan, substantial doubt exists about the ability for the Company to continue as a going concern. The financial statements do not currently include any adjustments that might be necessary if the Company is unable to continue as a going concern.$444,000$5,384,000 to $11,988,000$12,359,000 for the ninesix months ended SeptemberJune 30, 2017,2021, as compared to $11,544,000$6,975,000 for the ninesix months ended SeptemberJune 30, 2016.2020. Cash operating expenses increased principally just due to timing of payments for researchthe preparations and development activitiesexpenses related to our NAVIGATE clinical trial activity withGR-MD-02.ninesix months ended SeptemberJune 30, 20172021, of $16,815,000 represents proceeds of $10,000,000 from a convertible note payable, $2,951,000 from the exercise of common stock warrants and 2016, of $3,584,000 and $1,757,000, respectively, represents$3,864,000 in net proceeds from the saleissuance of common shares under our ATM. Net cash provided by financing activities for the six months ended June 30, 2020, of $263,000 represents proceeds of $219,000 from the exercise of common stock options and preferred stock and warrants.Other.We have engaged outside vendors for certain services associated with$44,000 in net proceeds from issuance of common shares under our clinical trials. These services are generally available from several providers and, accordingly, our arrangements are typically cancellable on 30 days notice. intangible assets, accrued expenses, stock-based compensation, contingencies and litigation. We base our estimates on historical experience, terms of existing contracts, our observance of trends in the industry, information available from other outside sources and on various other factors that we believe to be appropriate under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.20162020 Annual Report on FormSeptemberJune 30, 2017,2021, our disclosure controls and procedures were effective ateffective.reasonablecontrol system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance level. that all control issues and instances of fraud, if any, within the Company have been detected.SeptemberJune 30, 2017,2021, no change in our internal control over financial reporting has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.2016,2020, which could materially impact our business, financial condition or future results.Item 6.Exhibits 31.1* Certification Pursuant to Rule13a-14(a) of the Securities Exchange Act of 1934 31.2* Certification Pursuant to Rule13a-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 theSarbanes-Oxley Act of 2002 32.2** 101.INS Inline XBRL Instance Document** 101.INS XBRL Instance Document* 101.SCH Inline XBRL Taxonomy Extension Schema Document* 101.CAL Inline XBRL Taxonomy Calculation Linkbase Document* 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document* 101.LAB Inline XBRL Taxonomy Label Linkbase Document* 101.PRE Inline XBRL Taxonomy Presentation Linkbase Document* 104 Cover Page Interactive Data File (the cover page XBRL tags are embedded in the Inline XBRL document and included in Exhibit 101)* * **Furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.November 7, 2017.August 16, 2021. Peter G. TraberJoel Lewis Peter G. Traber, M.D. 23