On August 16, 2021 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the quarter ended June 30, 2021 (Press release, Galectin Therapeutics, AUG 16, 2021, View Source [SID1234586621]). 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.
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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said, "Galectin continued its progress on our strategic initiatives this quarter, actively working towards achieving our goals for the Company, which include advancing our NASH cirrhosis program through global registration trials and expanding our research. We reported positive new results in a cancer immunotherapy extension trial of belapectin in combination with KEYTRUDA in a patient cohort with more advanced disease compared to earlier results, and our NASH cirrhosis trial continues to initiate new sites and increase enrollment despite the continued challenges arising from COVID-19. Organizationally, we have added and will continue to add talented and experienced professionals in key leadership roles that will strengthen the company, preparing us for significant new milestones. As my new team, including employees and external consultants, reshapes our culture internally, we continue to engage our strategic consultant, Dr. Ben Carson, in formulating new opportunities. These are exciting times, and we expect the second half of the year to bring continued success."
Richard E. Uihlein, Chairman of the Board, added, "I am excited by the idea that we have the opportunity to potentially save thousands of lives, not just in NASH cirrhosis but in cancer and other areas where galectins have been implicated. I encourage you to visit our website to study and learn more from Dr. Carson and our talented team, who have just created a series of new videos to help educate our various constituencies and provide a better understanding of why our work is so important."
Program Review
Cancer Immunotherapy
In our cancer immunotherapy program, we announced on July 9, 2021, positive top-line results in our Phase 1b clinical trial extension of belapectin in combination with KEYTRUDA in advanced metastatic melanoma and head and neck cancer. The study provided further clinical evidence that using belapectin, a potent galectin-3 inhibitor, in combination with pembrolizumab (KEYTRUDA), a PD-1 inhibitor, significantly enhances tumor response to immunotherapy in patients with advanced metastatic melanoma (MM) and head and neck squamous cell carcinoma (HNSCC). The results demonstrated that belapectin potentially improves treatment response while simultaneously reducing adverse effects often seen with KEYTRUDA alone. Most impressive, these results were obtained despite the patients in this extension cohort having a significantly higher tumor burden when enrolled as compared to the initial study – especially the melanoma patients. Furthermore, there were no toxicities deemed related, probably related, or possibly related to belapectin and the severity of toxicities in this trial were less than the anticipated toxicity with KEYTRUDA alone. Dr. Brendan Curti, M.D., the study’s principal investigator at the Earle A. Chiles Research Institute, a division of Portland Providence Cancer Institute, observed that these results highlight the potential benefit and immunological effects of this combination and were sufficiently encouraging to strengthen the rationale to conduct a larger, randomized controlled Phase 2 study.
NAVIGATE Study (NASH Cirrhosis)
Enrollment in our NAVIGATE trial in NASH cirrhosis continues, with new sites coming online in both the U.S. and Europe. A protocol amendment aimed at refining criteria for patients with portal hypertension, based on input from investigators, has been approved by institutional review boards and implemented globally resulting in an improved quality of screening and, importantly, more patients qualifying for enrollment.
Our relationship with Dr. Ben Carson as a Senior Consultant is helping increase awareness of Galectin Therapeutics, which is expected to help attract additional clinical trial sites and patients.
Our innovative NAVIGATE study web portal, NAVIGATEnash.com, has experienced a strong response. Many clinicians from our various study sites have registered for the site’s steady stream of new information and resources about NASH cirrhosis and the NAVIGATE study for both patients and physicians. NAVIGATEnash.com is also attracting significant web traffic as we build a community where NASH cirrhosis patients and the physicians can share information.
Corporate Development
The Company has been aggressively building out its management team and is in the process of making a number of key hires. Ezra R. Lowe, Ph.D. has joined as Executive Director, Clinical and Preclinical Pharmacology. Ezra Lowe brings a depth of experience in clinical pharmacology, drug metabolism, and pharmacokinetics. He has a broad base of experience working with various drug formats across a diverse array of therapeutic areas. Prior to Galectin, Ezra was Senior Director, Clinical Pharmacology in Global R&D with the Bausch Health Companies. He previously held Clinical and Nonclinical Pharmacology positions at Salix Pharmaceuticals, Bausch+Lomb, and Valeant Pharmaceuticals International, Inc. and spent time as Lead Scientist in Biotransformation and Toxicology at The Dow Chemical Company. In the course of his career, he has completed 10 different global drug approvals. The Company expects to add additional key senior resources in the remainder of 2021.
As a strategic consultant, Dr. Carson will also help amplify our story, by raising awareness with key constituencies. During a recent television appearance, in fact, he was asked about new and interesting projects he was working on, and he took the opportunity to discuss his involvement and support of Galectin. In addition, Dr. Carson was very much involved in a recent meeting of key members of the company’s leadership, where he participated in the taping of a number of videos discussing Galectin, belapectin, the management team and the road forward. His vision for the company can be seen on these videos on the company’s website: View Source .
Evolving Areas of Interest
Clinical and pre-clinical research shows the recently demonstrated mechanism of action for belapectin in cancer immunotherapy reinforces the potential for belapectin in NASH cirrhosis and other diseases driven by galectin-3. This has led to Galectin being approached by researchers from a variety of unrelated specialties that are interested in initiating collaborative research.
Dr. Carson observed, "Belapectin has broad potential applications as it pertains to galectin-3 and the whole family of galectins, which affect almost every organ system. Not just in oncology, where data has demonstrated the nefarious role that galectin-3 plays in the tumor micro-environment to stimulate tumor progression, but also in areas such as heart disease. Clearly, there are a whole host of processes that are affected, particularly those where the fibrotic and immunologic impact of galectin-3 are clinically relevant."
Mr. Lewis commented, "Having a respected physician and leader such as Dr. Carson is strategic. He is a great resource and uniquely qualified to seek out partnerships, such as collaborations that could rapidly advance additional trials in cancer immunotherapy where we already have strong Phase 1b data that encourages further study."
Financial Results
For the three months ended June 30, 2021, the Company reported a net loss applicable to common stockholders of $8.5 million, or ($0.15) per share, compared to a net loss applicable to common stockholders of $6.2 million, or ($0.11) per share for the three months ended June 30, 2020. The increase is largely due an increase in 2021 research and development expenses related to the Company’s NAVIGATE trial.
Research and development expense for the three months ended June 30, 2021, was $6.5 million compared with $4.7 million for the three months ended June 30, 2020. 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 June 30, 2021, were $1.7 million, compared to $1.4 million for the three months ended June 30, 2020.
As of June 30, 2021, the Company had $31.6 million of cash and cash equivalents. On April 16, 2021, the Company received $10 million in proceeds from an unsecured convertible promissory note from its Board Chairman, Richard E. Uihlein. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least September 30, 2022.
The Company expects that it will require more cash to fund operations after September 30, 2022, and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $30-$35 million to cover costs of the NAVIGATE trial to reach 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.
About Belapectin (GR-MD-02)
Belapectin (GR-MD-02) 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 (NAVIGATEnash.com), entitled "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" began enrolling patients in June, 2020, 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 Phase 2 development program which the company is considering.
About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis
Non-alcoholic steatohepatitis (NASH) 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 8,890 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.