Galectin Therapeutics Reports Q2 2019 Financial Results and Provides Business Update
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
“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.”
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
FDAour 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 2019meeting.
- 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.
$44.9 millionin the Rights Offering and $2.5 millionfrom a common stock warrant exercise by our chairman, Richard E. Uihlein. The Rights Offering, priced at $4.28per 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 $7.00per 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.
For the three months ended June 30, 2019, the Company reported a net loss applicable to common stockholders of
Research and development expense for the three months ended June 30, 2019, was
As of June 30, 2019, the Company had $52.0 million of cash and cash equivalents. The Company also has a
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
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 the treatment of severe atopic dermatitis, moderate-to-severe plaque psoriasis and 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 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 may not produce positive results in a timely fashion, if at all, and could prove 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
Condensed Consolidated Statements of Operations
|(in thousands, except per share data)|
|Research and development||$||1,522||$||1,476||$||2,168||$||3,774|
|General and administrative||1,498||2,283||3,219||4,163|
|Total operating expenses||3,020||3,759||5,387||7,937|
|Total operating loss||(3,020||)||(3,759||)||(5,387||)||(7,937||)|
|Other income (expense):|
|Total other income||22||(81||)||14||(161||)|
|Preferred stock dividends||(67||)||(268||)||(163||)||(553||)|
|Net loss applicable to common stock||$||(3,065||)||$||(4,108||)||$||(12,158||)||$||(8,651||)|
|Basic and diluted net loss per share||$||(0.06||)||$||(0.11||)||$||(0.26||)||$||(0.23||)|
|Shares used in computing basic and diluted net loss per share||50,301||38,227||47,653||37,755|
Condensed Consolidated Balance Sheet Data
|June 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||52,043||$||8,253|
|Total current liabilities||1,391||2,108|
|Total redeemable, convertible preferred stock||1,723||1,723|
|Total stockholders’ equity||$||49,898||$||5,175|
Source: Galectin Therapeutics Inc.