On August 9, 2019 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended June 30, 2019 (Press release, Galectin Therapeutics, AUG 9, 2019, View Source [SID1234538519]). 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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Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, "Over the past several months we have made significant progress advancing our proprietary compound, belapectin (GR-MD-02) for a Phase 3 trial. After having raised approximately $44.9 million in our Rights Offering and selecting a leading global CRO with deep experience in our therapeutic area and operations in over 60 countries as our clinical research organization (CRO), we recently submitted our Phase 3 clinical trial protocols to the FDA for comment along with a draft Phase 4 synopsis and statistical analysis plan. In addition, we announced that Dr. Naga Chalasani and Dr. Stephen Harrison, key NASH opinion leaders, who dedicated considerable effort in the design of the study, have been designated as co-primary investigators in the Phase 3 NASH-RX clinical trial. Consequently, we believe all of the elements to commence this important study are solidly in place. Belapectin is the first drug to show positive results in a clinical trial in patients with compensated NASH cirrhosis without esophageal varices, and it is with great optimism that we anticipate a fourth quarter launch of this very important trial."
The NASH-RX trial is designed as an international, multicenter, randomized, placebo-controlled, double-blind, parallel-group, Phase 3 study with approximately 500 patients at up to 128 sites in 11 countries in North America, Europe, Asia, and Australia. The study is designed to evaluate the safety and efficacy of two doses of belapectin for the treatment of compensated non-alcoholic steatohepatitis (NASH) cirrhosis with clinical evidence of clinically significant portal hypertension without esophageal varices. Enrollment is expected to commence in the fourth quarter of 2019 with an estimated 12-14 months to achieve full enrollment. The treatment period for Phase 3 is two years, and topline data readout is expected around the end of 2022.
"With the continued support of the medical, patient, and investment communities we are excited to be advancing this new drug toward treating the millions of people globally with NASH cirrhosis."
Richard E. Uihlein, Chairman of the Board, added, "The success of the Rights Offering, the support of Drs. Chalasani and Harrison, execution of a start-up agreement with our CRO to accelerate time to patient enrollment, and the commitment and dedication of our employees provide Galectin with a world-class team that can ensure the upcoming clinical trials are rigorously administered. We are all looking forward to the launch of this trial in the fourth quarter and the data it will provide about the important role belapectin may play in helping those suffering from NASH cirrhosis."
Summary of Key Development Programs and Updates
Submitted our Phase 3 clinical trial protocol for using belapectin (GR-MD-02) for the treatment of compensated NASH cirrhosis in patients without esophageal varices for assessment by the FDA. Also, submitted to the FDA our complete clinical development plan, a draft Phase 4 synopsis, and statistical analysis plan among other documents in response to FDA’s questions from our February 2019 meeting.
Selected a leading global CRO with deep experience in NASH cirrhosis as our partner in the planned Phase 3 NASH-RX clinical trial and executed a start-up agreement.
Welcomed Drs. Harrison and Chalasani as Co-Principal Investigators, both of whom have been actively involved in the design of these upcoming trials and believe that this study could further the understanding of NASH and the role Galectin-3 inhibition may play in the treatment of this growing epidemic.
Raised $44.9 million in the Rights Offering and $2.5 million from a common stock warrant exercise by our chairman, Richard E. Uihlein. The Rights Offering, priced at $4.28 per share, resulted in the issuance of approximately 10.5 million shares of the Company’s common stock and stock purchase warrants for approximately 2.6 million shares at $7.00 per share which expire seven years after issuance. As a result, the Company now has approximately 56.6 million shares of common stock issued and outstanding.
Scientific Presentations and Conferences
Eliezer Zomer, Vice President, will present at the 3rd Annual Anti-Fibrotic Drug Development Summit (AFDD) on November 19, 2019, in Cambridge, Massachusetts. Dr. Zomer’s presentation titled "Therapeutic Integrin Inhibition," will discuss the next generation of Galectin-3 inhibitors, as well as the discovery of functional allosteric inhibitors as part of efforts of Galectin Sciences LLC, our majority owned subsidiary.
Financial Results
For the three months ended June 30, 2019, the Company reported a net loss applicable to common stockholders of $3.1 million, or $0.06 per share, compared to a net loss applicable to common stockholders of $4.1 million, or $0.11 per share, for the three months ended June 30, 2018. The decrease was primarily due to lower preclinical, clinical and non-cash stock-based compensation expenses in the current period compared to the prior year period.
Research and development expense for the three months ended June 30, 2019, was $1.5 million compared with $1.5 million for the three months ended June 30, 2018. There was an increase of about $0.6 million in clinical development expenses which was offset by a similar amount of decrease in non-cash stock-based compensation expense. General and administrative expense for the three months ended June 30, 2019, were $1.5 million, compared to $2.3 million for the three months ended June 30, 2018, primarily due to a decrease in non-cash stock-based compensation expenses.
As of June 30, 2019, the Company had $52.0 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date, and potential additional capital under its At the Market common stock issuance agreement. The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through December 31, 2020. The Company expects that it will require more cash to fund operations after December 31, 2020 and believes it will be able to obtain additional financing as needed. The currently planned operations include estimated costs related to a planned Phase 3 clinical trial through December 31, 2020. While the costs of the trial and general overhead during the Phase 3 trial are expected to be approximately $100 million, the costs and timing of such trial is not yet completely finalized.