Galectin Therapeutics Reports Q1 2019 Financial Results and Provides Business Update
Subscription rights to purchase
Rights expire at
Portion of the Net Proceeds of Rights Offering to be used for Phase 3 clinical trial of belapectin, the first drug to show positive results in a clinical trial in patients with compensated NASH cirrhosis
“We are making progress with our preparations for the Phase 3 trial. A Clinical Research Organization (CRO) to run the clinical trial has been selected and engaged, and we are also in the latter stages of a process that would enlarge and strengthen our management team. Beyond our NASH trial, there have been encouraging developments in other paths forward for belapectin, as illustrated by a presentation made at the Keystone Symposia on Molecular and Cellular Biology, where Dr. Sturgill, a researcher at
“My intention is to personally subscribe $20 million dollars in this offering, which alone will be a significant portion of the total we hope to raise in this round. I hope this Rights Offering will be viewed as equitable and fair by our stockholder base, many of whom have been invested in our company for many years, and by others who invest with us in the future.”
Summary of Key Development Programs and Updates
- Filed a Registration Statement on Form S-3 with the
U.S. Securities and Exchange Commission( SEC) with regards to a planned Rights Offering of common stock and warrants to its stockholders and certain warrant holders. The offering states that the company seeks to raise $50 million to $70 million. The Registration Statement is now effective, and the Rights Offering has commenced.
- Released an open letter to stockholders written by
Richard E. Uihlein, Board Chair. In the letter, Mr. Uihlein states that he intends to personally subscribe $20 millionin the Company’s Rights Offering.
- The official nonproprietary, generic name for GR-MD-02 is now belapectin.
The United States Adopted Names (USAN) Councilis responsible for selecting simple, informative and unique nonproprietary (generic) drug names. Recently the USAN assigned the name belapectin to GR-MD-02.
Scientific Presentations and Conferences
Elizabeth Sturgillof Providence Cancer Institutepresented findings on belapectin at the 2019 Keystone Symposia on Molecular and Cellular Biology, March 25in Keystone, Colorado. In the oral presentation titled “Galectin-3 Inhibition with GR-MD-02 Synergizes with T Cell-Targeting Immunotherapy, Leading to Reduced Immune Suppression and Improved Overall Survival,” Dr. Sturgill discussed the effects belapectin had when combined with various T-cell targeting immunotherapies, including both aOX40 and Pembrolizumab (KEYTRUDA). Dr. Sturgill also gave a poster presentation titled “Galectin-3 inhibition with belapectin synergizes with agonist anti-OX40 mAb therapy leading to reduced immune suppression and improved overall survival.”
Elizabeth Sturgill’stalk described how combination therapies with belapectin have been shown to improve the survival rate of tumor-bearing mice, reducing the percentage of suppressive myeloid cells (MDSC) as well as diminishing the cells’ suppressive capabilities. Belapectin acts as an inhibitor of galectin-3, a molecule found in many tumors and associated with poor prognosis because it depresses immune response to the tumor. Under the direction of Brendan D. Curti, M.D., Member and Director, Providence Melanoma Program and Cytokine and Adoptive Immunotherapy Program, Phase 1 human trials at Providence Cancer Institute using KEYTRUDA in combination with belapectin have borne out the preclinical results, with patients in the trial showing stronger responses than expected with KEYTRUDA alone. Recent analysis confirms the preliminary findings and suggests that reduced M-MDSCs may serve as a potential biomarker for response to treatment.
Harold Shlevinpresented at the H.C. Wainwright Global Life Sciences Conference, held at the Grosvenor House in Londonon April 9.
Harold Shlevinparticipated in the Roth Capital Partners Battle of the NASH Thrones Investor Conference, held on March 28in New York City.
Dr. Shlevin concluded, “We are very excited to be embarking on a Phase 3 program using belapectin in treatment of compensated NASH cirrhotic patients. We look forward to the continued support of our stockholders in this undertaking. In particular, Mr. Uihlein has been a staunch supporter of the Company and his efforts have been instrumental in helping us advance our development programs targeted to assisting patients with NASH cirrhosis.”
For the three months ended March 31, 2019, the Company reported a net loss applicable to common stockholders of
Research and development expense for the three months ended March 31, 2019, was
As of March 31, 2019, the Company had $7.0 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, including in its Rights Offering, 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
|Three Months Ended
|(in thousands, except per share data)|
|Research and development||$ 646||$ 2,298|
|General and administrative||1,721||1,880|
|Total operating expenses||2,367||4,178|
|Total operating loss||(2,367)||(4,178)|
|Other income (expense):|
|Interest and other||(8)||(80)|
|Total other income||(8)||(80)|
|Preferred stock dividends||(96)||(285)|
|Non-cash charge related to warrant modification||(6,622)||--|
|Net loss applicable to common stock||$ (9,093)||$ (4,543)|
|Basic and diluted net loss per share||$ (0.20)||$ (0.12)|
|Shares used in computing basic and diluted net loss per share||44,975||37,284|
Condensed Consolidated Balance Sheet Data
|March 31, 2019||December 31, 2018|
|Cash and cash equivalents||$||6,972||$||8,253|
|Total current liabilities||907||2,108|
|Total redeemable, convertible preferred stock||1,723||1,723|
|Total stockholders’ equity||$||5,119||$||5,175|
Source: Galectin Therapeutics Inc.