Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update
Galectin Therapeutics, Inc. (GALT) reported financial results for 2023, highlighting progress in their MASH cirrhosis program and the NAVIGATE Phase 2b/3 trial for belapectin. The company secured additional funding, extended cash runway through March 2025, and appointed new board members. The FDA approval of resmetirom for MASH patients with liver fibrosis was noted. The upcoming interim analysis of the NAVIGATE study in Q4 2024 is eagerly anticipated.
Positive
Galectin Therapeutics made significant progress in their MASH cirrhosis program in 2023.
The NAVIGATE Phase 2b/3 trial for belapectin completed enrollment and randomization of 357 patients in 14 countries.
Belapectin, a galectin-3 targeting drug, showed encouraging safety results in the trial.
The company announced the addition of Khurram Jamil, M.D., to their team for his expertise in advanced liver disease.
The FDA approval of resmetirom for MASH patients with liver fibrosis was highlighted.
The company secured additional funding from Chairman Richard Uihlein, extending their cash runway through March 2025.
Dr. Pol Boudes emphasized the potential of belapectin to offer new treatment options for MASH-associated liver cirrhosis.
The company presented five posters at the Liver Meeting™ 2023, showcasing the safety profile and pharmacokinetics of belapectin.
Benjamin S. Carson, Sr., M.D., was appointed as a new member of the Board of Directors.
Financially, Galectin Therapeutics reported $25.7 million in cash and cash equivalents as of December 31, 2023.
Research and development expenses increased to $32.1 million in 2023, primarily due to costs related to the NAVIGATE trial.
General and administrative expenses decreased to $5.9 million in 2023, primarily due to non-cash stock-based compensation expense.
The company reported a net loss applicable to common stockholders of $44.8 million for 2023, largely due to noncash interest expense and a noncash charge related to modification of common stock purchase warrants.
The recent update from Galectin Therapeutics highlights several key aspects that are noteworthy for stakeholders. The completion of enrollment and randomization for the NAVIGATE Phase 2b/3 trial is a significant milestone, as it keeps the company on track for the top-line data readout in Q4 2024. This could potentially shift the competitive landscape in the treatment of MASH cirrhosis, particularly if belapectin proves to be effective in stopping the progression of portal hypertension.
Moreover, the financial support from the Chairman, Richard Uihlein, through a $10 million credit facility, extends the company's operational runway through March 2025. This is a strong vote of confidence, providing the company with the necessary resources to continue its research and development without the immediate need for external financing, which could dilute existing shareholders' equity.
The FDA approval of resmetirom for MASH with moderate to advanced liver fibrosis brings attention to the field and may indirectly benefit Galectin Therapeutics by increasing awareness and potentially accelerating the adoption of new therapies upon successful trial outcomes. However, it's important to monitor the cash burn rate as R&D expenses have slightly increased year-over-year. The net loss widening is also a concern, driven by noncash charges, which investors should evaluate in the context of the company's long-term value proposition.
From a drug development perspective, Galectin Therapeutics' focus on belapectin for MASH cirrhosis addresses a critical unmet medical need. Liver transplantation as the only curative treatment for advanced liver disease underscores the importance of developing therapeutic alternatives. The safety profile of belapectin, as confirmed by the independent Data and Safety Monitoring Board, is promising, considering safety is a major hurdle in drug development, especially in advanced-stage diseases.
The NAVIGATE trial's design, targeting patients with advanced liver fibrosis progressing to cirrhosis and portal hypertension, is strategic. It targets a subset of patients with more severe disease progression where therapeutic options are limited. The Fast Track Designation by the FDA is indicative of the therapy's potential to address an urgent need and may lead to expedited review, benefiting the company's timeline for potential market entry.
Understanding the pharmacokinetics of belapectin is crucial, as liver impairment can significantly alter drug metabolism. The fact that belapectin's pharmacokinetics are not affected by the degree of liver impairment could be a key differentiator in the treatment landscape, potentially simplifying dosing regimens and improving patient compliance.
Assessing Galectin Therapeutics' financial health, the $25.7 million in cash and cash equivalents, along with the additional credit facilities totaling $30 million, provide a solid buffer for the company's operations. This financial backing is essential for a biotech firm in the clinical trial phase, where cash flow is typically negative. The slight increase in R&D expenses reflects the company's investment in its NAVIGATE trial, which is expected given the trial's progression into later stages.
The decrease in general and administrative expenses, primarily due to lower non-cash stock-based compensation, suggests cost-saving measures and prudent financial management. However, the reported net loss increase, driven by noncash interest expense and a charge related to the modification of common stock purchase warrants, requires careful scrutiny. These noncash items can obscure the company's operational performance and stakeholders should focus on the underlying business and trial progress.
Investors should also consider the potential dilutive effect of the credit facilities if they are converted into equity. The company's ability to manage its debt and navigate through the capital-intensive phase of clinical trials without excessively diluting shareholder value will be critical for long-term success.
03/29/2024 - 08:00 AM
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.
NASH Cirrhosis
The NAVIGATE Phase 2b/3 trial (NCT04365868 ) evaluating the efficacy and safety of belapectin for the prevention of esophageal varices in MASH cirrhosis completed randomization of 357 patients in 14 countries on five continents. The fourth Data Safety and Monitoring Board (DSMB) meeting authorized the continuation of the trial as designed and without modifications. Upcoming milestone remains on track for top-line data readout from NAVIGATE interim analysis in Q4 2024. Presented five posters at the Liver Meeting™ 2023 of the American Association for the Study of Liver Diseases (AASLD) including the safety profile of belapectin and the fact that its pharmacokinetics properties are not affected by the degree of liver impairment. Corporate Updates
Appointed Benjamin S. Carson, Sr., M.D. as a new member of the Board of Directors, following his service as a senior advisor to the Company since 2021. Full Year 2023 Financial Highlights
As of December 31, 2023, the Company had $25.7 million of cash and cash equivalents. Additionally, the Company has $20 million remaining available under a $60 million line of credit provided by its chairman to fund operations and a newly executed $10 million line of credit also provided by our chairman. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through March 31, 2025. Research and development expenses for the year ended December 31, 2023 were $32.1 million compared with $31.7 million for the year ended December 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 year ended December 31, 2023 were $5.9 million , compared to $6.6 million for the year ended December 31, 2022. The decrease was primarily due to non-cash stock-based compensation expense. For the year ended December 31, 2023, the Company reported a net loss applicable to common stockholders of $44.8 million , or ($0.74) per share, compared to a net loss applicable to common stockholders of $38.9 million , or ($0.65) per share for the year ended December 31, 2022. The increase is largely due to an increase in noncash interest expense of $1.8 million and a noncash charge related to modification of common stock purchase warrants of $3.6 million . These results are included in the Company's Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov 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 statements.
Company Contact:
Jack Callicutt, Chief Financial Officer
Investors Relations Contacts: kgardner@lifesciadvisors.com
Chris Calabreseccalabrese@lifesciadvisors.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.
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 )
What is Galectin Therapeutics' ticker symbol?
The ticker symbol for Galectin Therapeutics is GALT.
What program did Galectin Therapeutics focus on in 2023?
Galectin Therapeutics focused on advancing their Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis program in 2023.
Who is the Chief Executive Officer and President of Galectin Therapeutics?
Joel Lewis is the Chief Executive Officer and President of Galectin Therapeutics.
What was the purpose of the NAVIGATE Phase 2b/3 trial?
The NAVIGATE Phase 2b/3 trial evaluated the efficacy and safety of belapectin for the prevention of esophageal varices in MASH cirrhosis.
What did Dr. Pol Boudes highlight regarding belapectin?
Dr. Pol Boudes emphasized the potential of belapectin to offer new treatment options for MASH-associated liver cirrhosis.
Who provided additional funding to Galectin Therapeutics?
Chairman Richard Uihlein provided additional funding of $10 million to Galectin Therapeutics.
What is the cash runway extension for Galectin Therapeutics?
The cash runway for Galectin Therapeutics was extended through March 2025.
Who was appointed as a new member of Galectin Therapeutics' Board of Directors?
Benjamin S. Carson, Sr., M.D., was appointed as a new member of Galectin Therapeutics' Board of Directors.
What were the research and development expenses for Galectin Therapeutics in 2023?
Research and development expenses for Galectin Therapeutics were $32.1 million in 2023.
What was the net loss applicable to common stockholders for Galectin Therapeutics in 2023?
The net loss applicable to common stockholders for Galectin Therapeutics was $44.8 million in 2023.
