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Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update NORCROSS, Ga.

Key Takeaway: Galectin Therapeutics has announced its 2023 financial results and provided an update on its business progress, particularly regarding the belapectin program targeting liver cirrhosis. The CEO highlighted the completion of enrollment for the NAVIGATE Phase 2b/3 trial, which is expected to provide its interim analysis in Q4 2024. The company has received a $10 million credit facility to support its continued operations as it develops new treatment options for patients with metabolic dysfunction-associated steatohepatitis. Despite achieving operational milestones, the company faces ongoing financial challenges and risks associated with clinical trials.

Market Sentiment Analysis

POSITIVE FACTORS

  • Galectin Therapeutics reports an encouraging safety profile for belapectin.
  • The company has secured a $10 million credit facility extending its cash runway.
  • The recent FDA approval of resmetirom may reignite interest in MASH treatments.

CONCERNS & RISKS

  • The company continues to incur significant operating losses.
  • Dependence on the successful execution of future trials remains a concern.
  • Limited access to liver transplantation impacts the patient population's treatment options.

Full Press Release Details

Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update
NORCROSS, Ga., March 29, 2024 (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 year ended December 31, 2023.
Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said "We have been focused on advancing our Metabolic Dysfunction-Associated Steatohepatitis
(MASH, formerly known as NASH) cirrhosis program. We completed enrollment and randomization for the NAVIGATE Phase 2b/3 trial in 2023, and belapectin has consistently shown an encouraging safety profile, which was determined by our independent Data
and Safety Monitoring Board on multiple reviews.
We are pleased with the recent addition of Khurram Jamil, M.D., to our team. Dr. Jamil's extensive experience in advanced liver disease, specifically for late-stage
cirrhotic patients, is a tremendous asset to our program. Echoing Dr. Boudes' comments from early March, Dr. Jamil's breadth of expertise in clinical development and regulatory interactions will be critical for the Company as we continue to execute
the trial. We look forward to sharing the top-line interim analysis readout from NAVIGATE in Q4 2024.
Finally, we are pleased to report that, once again, our Chairman, Mr. Richard Uihlein, has provided significant financing for the Company via an additional $10 million
credit facility to the Company. This funding extends our cash runway through March 2025. On behalf of the Board and management I want to thank Mr. Uihlein for his confidence in our team and our program."
Pol Boudes, M.D., Chief Medical Officer added, "We were pleased by the very recent U.S. Food and Drug Administration approval of resmetirom for the treatment of patients
with MASH with moderate to advanced liver fibrosis; this will bring renewed attention to the field. However, the population of patients in our NAVIGATE trial of belapectin have progressed beyond advanced liver fibrosis, to liver cirrhosis and
portal hypertension and have the most pressing medical need. Currently, for them, the only curative treatment is liver transplantation, a process whose access is severely limited, highly complex and very costly. Our hope is that our belapectin MASH
program, which has a Fast Track Designation, will for the first time offer a new medical treatment option for the increasing number of patients affected with MASH associated liver cirrhosis. We look forward to the upcoming interim analysis of the
adaptive Phase 2b/3 NAVIGATE study which, we believe, has the potential to demonstrate belapectin's ability to stop the progression of portal hypertension in cirrhotic patients and prevent the development of esophageal varices, which are a leading
cause of morbidity and mortality in this population."
Q4 2023 Belapectin Program Highlights
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis.
Full Year 2023 Financial Highlights
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
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 metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most
advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need and a significant drug development opportunity . Additional development programs are in treatment of combination immunotherapy for advanced head and
neck cancers 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.
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", "look forward", "believe", "hope" 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 MASH, formerly known as NASH, 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 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. 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, 2023, 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
Jack Callicutt, Chief Financial Officer
Investors Relations Contacts:
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.
Condensed Consolidated Statements of Operations
Year Ended December 31,
2023 2022
Operating expenses:
Research and development $ 32,130 $ 31,737
General and administrative 5,942 6,615
Total operating expenses 38,072 38,352
Total operating loss (38,072 ) (38,352 )
Other income (expense):
Interest income 230 52
Interest expense (2,792 ) (1,033 )
Change in fair value of derivatives (432 ) 557
Total other income (2,994 ) (424 )
Net loss $ (41,066 ) $ (38,776 )
Preferred stock dividends (120 ) (97 )
Warrant modification (3,619 )
Net loss applicable to common stock $ (44,805 ) $ (38,873 )
Basic and diluted net loss per share $ (0.74 ) $ (0.65 )
Shares used in computing basic and diluted net loss per share 60,159 59,391
Condensed Consolidated Balance Sheet Data
December 31, 2023 December 31, 2022
(in thousands)
Cash and cash equivalents $ 25,660 $ 18,592
Total assets 28,200 21,285
Total current liabilities 15,676 13,012
Total liabilities 88,441 53,479
Total redeemable, convertible preferred stock 1,723 1,723
Total stockholders' equity (deficit) $ (61,964 ) $ (33,917 )

Frequently Asked Questions

What recent financial results did Galectin Therapeutics report?

Galectin Therapeutics reported its financial results for 2023, indicating a net loss of $44.8 million.

Who recently joined Galectin's team and why is it significant?

Khurram Jamil, M.D., joined Galectin, bringing expertise in advanced liver disease crucial for the ongoing NAVIGATE trial.

What is belapectin and its role in Galectin's trials?

Belapectin is a galectin-3 inhibitor targeted at treating patients with MASH-associated cirrhosis.

What financial support has Galectin received recently?

Galectin received a $10 million credit facility from Chairman Richard Uihlein, extending its cash runway to March 2025.

When can we expect results from the NAVIGATE trial?

Top-line interim analysis results from the NAVIGATE trial are anticipated in Q4 2024.

Last updated: Mar 29, 2024