Galectin Therapeutics Reports Fiscal 2020 Financial Results and Provides Business Update
Galectin Therapeutics Inc. (NASDAQ: GALT) reported a fiscal 2020 net loss of $23.6 million, or $0.41 per share, up from a loss of $20.2 million in 2019. The increase in losses was primarily due to higher research and development costs, particularly for the NAVIGATE clinical trial. The Company has $27.1 million in cash and expects additional funding needs of approximately $45-$50 million to advance the NAVIGATE trial through its upcoming interim analysis in late 2023. CEO Joel Lewis expressed optimism about ongoing studies and organizational improvements.
- Ongoing enrollment in the NAVIGATE trial for NASH cirrhosis, which is the only late-stage trial for this condition.
- Successful addition of key personnel to bolster the executive team and Board of Directors.
- Positive initial results from the combination therapy study of belapectin with Keytruda.
- Increased net loss from $20.2 million in 2019 to $23.6 million in 2020, indicating rising operational costs.
- Substantial rise in research and development expenses to $18.0 million, reflecting the challenges in clinical trial advancement.
- Uncertainty about securing necessary additional financing to continue operations beyond March 2022.
NORCROSS, Ga., March 31, 2021 (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, 2020. 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.
Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said, “I am very encouraged by the progress achieved in fiscal 2020, and remain extremely optimistic for 2021. Given the current challenging environment, I am proud of our success, highlighted by site activations and ongoing enrollment of our innovative NAVIGATE study. This global program continues to be the only active late-stage trial of patients with compensated NASH cirrhosis, where the medical need is greatest and with a clinically meaningful endpoint. Our concurrent hepatic impairment study will also provide important information on belapectin tolerance, safety and exposure in advanced cirrhotic patients.
Over the course of the last year at the Board’s direction we have taken aggressive steps to strengthen our organization, adding Pol Boudes as Chief Medical Officer, as well as Mr. Richard Zordani and Dr. Elissa Schwartz to our Board of Directors. These changes informed my decision to accept the role of Chief Executive Officer, and they afforded me the confidence to receive
More recently, the peer-reviewed publication of a well-recognized mouse model has shown that the combination of belapectin, a galectin-3 inhibitor, with immunotherapy reprograms the tumor microenvironment. This favors anti-tumor immunity, results in better anti-tumor activity, and most importantly, brings further rationale for our ongoing cancer trial combining belapectin with Keytruda®, a potent PD-1 inhibitor. Providence Cancer Institute is currently conducting the study and preliminary results suggest improved activity and, potentially, improved tolerance of this regimen.
I am extremely confident in our science, our team, and our progress,” concluded Lewis. The upcoming year will be dedicated to advancing our trial in NASH cirrhosis and supporting investigations of belapectin’s safety and efficacy in other indications, such as the ongoing cancer trial in conjunction with the Providence Cancer Institute. I also want to recognize the outstanding efforts of our entire team, who persevered through the challenges precipitated by COVID-19 in the interest of developing a therapy for NASH cirrhosis, a critical, unmet medical need. Let me once again thank the investigators and patients participating in our NAVIGATE trial, where a positive outcome would be very clinically relevant for patients with NASH cirrhosis.”
Richard E. Uihlein, Chairman of the Board, added, “I want to echo Joel’s sentiment and thank Pol, Jack and our entire team for their dedication throughout this past year, especially their commitment to initiating our exciting NAVIGATE trial under less than optimal circumstances due to the global pandemic. Joel has proven to be the leader we all expected, and I am pleased with the progress he has achieved since assuming the role and confident in his ability to unlock the value of our proprietary compound, belapectin. Peer-reviewed research, such as that recently published in OncoImmunology, clearly confirms our basic scientific premise regarding belapectin’s anti-inflammatory characteristics in a broad range of fibrosis as well as its ability to potentially enhance the efficacy of cancer therapies. As such, the NAVIGATE trial represents an opportunity to further demonstrate the anti-inflammatory activity of belapectin, which would open up vast new opportunities to investigate other indications and establish our compound as a foundation for a platform technology.”
NAVIGATE Trial Update
- The NAVIGATE trial uses a seamless, adaptive design to confirm dose selection and reaffirm the observed efficacy of belapectin to prevent the development of esophageal varices in the NASH-CX trial. Pre-planned adaptations will inform the larger Phase 3 trial component.
- Key clinical study milestones:
- First patient randomized August 2020
- 130+ sites, 12 countries in North America, Europe, Asia and Australia
- Phase 2b part to Interim Analysis will be ~315 patients
- Recruiting period for phase 2b portion now expected to conclude around the end of 2021 due to COVID-19 impact on recruitment
- Key inclusion criteria - NASH cirrhosis (baseline or historical liver biopsy), clinical sign of portal hypertension, no esophageal varices (esophago-gastro endoscopy)
- Interim analysis expected late 2023
Peer-reviewed publication, Scientific Presentations and Conferences
- OncoImmunology published a peer-reviewed article describing how belapectin, a potent galectin-3 inhibitor, in combination with an anti-OX40 (CD134) monoclonal antibody, reduces tumor progression compared to either agent alone. The paper, titled “Galectin-3 inhibition with belapectin combined with anti-OX40 therapy reprograms the tumor microenvironment to favor anti-tumor immunity,” describes results from a collaboration between Galectin Therapeutics and Providence Cancer Institute highlighting the mechanism of action of the combination which is explained by a reduction in myeloid-derived suppressor cell infiltration and function coupled to an increase in T-cell effector function. For many years, galectin-3 has been known to play a key role in the control of tumor-induced immunosuppression. Galectin-3 acts to maintain tumor growth, in part, by supporting the generation of suppressive macrophages and inhibiting T cell function. This creates an attractive rationale for the use of a galectin-3 inhibitor, such as belapectin, to improve anti-tumor activities of multiple cancer therapies.
Financial Results
For the year ended December 31, 2020, the Company reported a net loss applicable to common stockholders of
Research and development expense for 2020 was
As of December 31, 2020, the Company had
The Company expects that it will require more cash to fund operations after March 31, 2022, and believes it will be able to obtain additional financing as needed. The currently planned operations include costs related to our adaptively designed NAVIGATE Phase 2b/3 clinical trial. Currently, we expect to require an additional approximately
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.
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 currently planned 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, 2020, 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
(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 GR-MD-02.
Condensed Consolidated Statements of Operations
| Year Ended December 31, | ||||||
| 2020 | 2019 | |||||
| Operating expenses: | ||||||
| Research and development | $ | 17,976 | $ | 7,467 | ||
| General and administrative | 5,468 | 5,971 | ||||
| Total operating expenses | 23,444 | 13,438 | ||||
| Total operating loss | (23,444 | ) | (13,438 | ) | ||
| Other income (expense): | ||||||
| Interest income | 66 | 231 | ||||
| Interest expense | (87 | ) | (87 | ) | ||
| Total other income | (21 | ) | 144 | |||
| Net loss | $ | (23,465 | ) | $ | (13,294 | ) |
| Preferred stock dividends | (137 | ) | (263 | ) | ||
| Warrant modification | - | (6,622 | ) | |||
| Net loss applicable to common stock | $ | (23,602 | ) | $ | (20,179 | ) |
| Basic and diluted net loss per share | $ | (0.41 | ) | $ | (0.39 | ) |
| Shares used in computing basic and diluted net loss per share | 57,029 | 52,238 | ||||
Condensed Consolidated Balance Sheet Data
| December 31, 2020 | December 31, 2019 | |||
| (in thousands) | ||||
| Cash and cash equivalents | $ | 27,142 | $ | 47,480 |
| Total assets | 29,600 | 48,467 | ||
| Total current liabilities | 5,399 | 2,820 | ||
| Total liabilities | 5,407 | 2,872 | ||
| Total redeemable, convertible preferred stock | 1,723 | 1,723 | ||
| Total stockholders’ equity | $ | 29,600 | $ | 43,872 |
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