UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 15, 2023
(Exact name of registrant as
specified in its charter)
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive office) (zip code)
Registrant’s telephone number, including area code: (678 ) 620-3186
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this
chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b) of
the Act:
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Title of each class
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Trading Symbol
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Name of each exchange on which registered
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SECTION 2 – FINANCIAL INFORMATION
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Results of Operations and Financial Condition.
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On May 15, 2023, Galectin Therapeutics Inc. (“Galectin Therapeutics”) issued a
press release announcing its results of operations and financial condition as of and for the year ended December 31, 2022 and provided a business update. Galectin hereby incorporates by reference herein the information set forth in its press
release dated May 15, 2023 (the “Press Release”), a copy of which is attached hereto as Exhibit 99.1.
Except for the historical information contained in this report, the statements made by Galectin Therapeutics are forward looking statements
that involve risks and uncertainties. All such statements are subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. Galectin Therapeutics’ future financial performance could differ significantly from the
expectations of management and from results expressed or implied in the Press Release. Forward-looking statements in the Press Release are subject to certain risks and uncertainties described in the Press Release. For further information on other
risk factors, please refer to the “Risk Factors” contained in Galectin Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission, and its subsequent filings with the SEC.
The information in this Item 2.02 is being furnished, not filed, pursuant to Item 2.02 of Form 8-K. Accordingly, the information in Item 2.02
of this report, including the Press Release attached hereto as Exhibit 99.1, will not be incorporated by reference into any registration statement filed by Galectin under the Securities Act of 1933, as amended, unless specifically identified
therein as being incorporated therein by reference.
SECTION 9 – FINANCIAL STATEMENTS AND EXHIBITS
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Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits.
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Exhibit Number
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Description
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Press Release dated May 15, 2023
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- 2 -
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, Galectin Therapeutics Inc. has duly caused this report to be signed
on its behalf by the undersigned hereunto duly authorized.
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Galectin Therapeutics Inc.
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Date: May 15, 2023
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By:
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/s/ Jack W. Callicutt
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Jack W. Callicutt
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Chief Financial Officer
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Exhibit 99.1
Galectin Therapeutics Reports Financial Results for the Quarter Ended March 31, 2023 and Provides Business Update
NORCROSS, Georgia, May 15, 2023 (GLOBE NEWSWIRE) – Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended March 31, 2023. These results are included in
the Company's Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said:
“Our entire team is actively engaged in oversight and management of our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of
esophageal varices in patients with NASH cirrhosis, which completed randomization of 357 patients in February 2023. Our stated target remains obtaining interim analysis results from the Phase 2b portion in the fourth quarter of 2024. The Company’s
results will be the first, and as of now, the only late-stage trial in compensated cirrhosis that has advanced to include portal hypertension caused by NASH. Currently, this patient population has no therapeutic option, other than liver
transplantation.
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Additionally, we are continuing to evaluate options and develop plans for a potential Phase 2 clinical trial of belapectin in combination
with Keytruda in patients with advanced head and neck cancers. Our team is fully committed to maximizing the value of our company for the stockholders by advancing our programs for patients.”
Dr. Pol Boudes, Chief Medical Officer stated: “Joel and I were pleased to
discuss our innovative NAVIGATE trial for the prevention of esophageal varices with Ed Arce, managing director of equity research at H.C. Wainwright on May 2, 2023. A replay of that discussion is available in the Investor Relations section of
our website, www.galectintherapeutics.com. As we
reiterated in that discussion, as compared to NASH pre-cirrhotic stages, cirrhosis of the liver is characterized by a distinct pathophysiology, with activated macrophages, the target of belapectin, playing a central role in the progression to
portal hypertension and, ultimately, liver failure. We continue to be encouraged by the apparent high level of safety and tolerance of belapectin in the NAVIGATE patient population, and we remain optimistic that the NAVIGATE results can one day
bring a therapy to patients with NASH cirrhosis that currently can only contemplate liver transplantation as a therapeutic option.”
Financial Results
For the three months ended March 31, 2023, the Company reported a net loss applicable to common stockholders of $11.5 million, or ($0.19) per share, compared to
a net loss applicable to common stockholders of $9.9 million, or ($0.17) per share for the three months ended March 31, 2022. The increase is largely due to an increase in 2023 research and development expenses related to the Company’s NAVIGATE
trial.
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Research and development expenses for the three months ended March 31, 2023, was $8.8 million compared with $8.1 million for the three months ended March 31,
2022. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended March 31, 2023, were $1.5 million, compared to $1.9 million for the
three months ended March 31, 2022. The decrease was primarily due to non-cash stock-based compensation expense.
As of March 31, 2023, the Company had $17.8 million of cash and cash equivalents. Additionally, the Company has $40 million remaining available under a $60
million line of credit provided by its chairman to fund operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least December 31, 2024.
The Company expects that it will require more cash to fund operations after December 31, 2024, and believes it will be able to obtain additional financing as
needed. 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.
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About Belapectin
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in
diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart, and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has
robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial.
The NAVIGATE trial (www.NAVIGATEnash.com), titled “A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of
Esophageal Varices in NASH Cirrhosis,” completed randomization of 357 patients in February 2023 with top-line data expected from the Phase 2b portion in the fourth quarter of 2024, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3
has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and Keytruda in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a
Company-sponsored Phase 2 development program, which the company is exploring.
About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity and other metabolic
diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over
time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver
transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.
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About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug
belapectin (formerly known as GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S.
Food and Drug Administration. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH-related fibrosis. This is the most common liver disease and one of the largest drug development
opportunities available today. Additional development programs are in treatment of combination immunotherapy for advanced melanoma and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable
partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.
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Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These
statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could
cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of fatty liver
disease with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in
the forward-looking statements include, among others, that trial endpoints required by the FDA may not be achieved; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin
or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical
studies as modified to meet the requirements of the FDA may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and
marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be
unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to
successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. Global factors such as coronavirus may continue to impact NASH patient populations around the globe and slow trial enrollment
and prolong the duration of the trial and significantly impact associated costs. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and
subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
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Company Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name
for Galectin Therapeutics’ galectin-3 inhibitor belapectin (GR-MD-02).
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Condensed Consolidated Statements of Operations
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Three Months Ended
March 31,
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2023
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2022
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Operating expenses:
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Research and development
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$
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8,799
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$
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8,058
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General and administrative
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1,543
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1,877
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Total operating expenses
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10,342
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9,935
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Total operating loss
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(10,342
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(9,935
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Other income (expense):
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Interest income
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44
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1
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Interest expense
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(460
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(227
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Change in fair value of derivatives
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(769
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229
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Total other income
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(1,185
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3
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Net loss
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$
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(11,527
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$
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(9,932
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Preferred stock dividends
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0
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16
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Net loss applicable to common stock
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$
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(11,527
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$
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(9,916
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Basic and diluted net loss per share
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$
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(0.19
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$
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(0.17
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Shares used in computing basic and diluted net loss per share
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59,480
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59,354
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Condensed Consolidated Balance Sheet Data
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March 31, 2023
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December 31, 2022
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(in thousands)
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Cash and cash equivalents
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$
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17,799
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$
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18,592
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Total assets
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20,225
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21,285
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Total current liabilities
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11,533
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13,012
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Total liabilities
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62,871
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53,479
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Total redeemable, convertible preferred stock
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1,723
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1,723
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Total stockholders’ equity (deficit)
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$
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(44,369
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$
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(33,917
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# # #
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