EX-99.1 2 v423796_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

Galmed Pharmaceuticals Announces Commencement of

Patient Screening for the ARREST Study in Europe, and Reports

Third Quarter 2015 Financial Results

 

- Conference Call and Webcast Today at 8:30 a.m. EST / 5:30 a.m. PST -

 

TEL AVIV, Israel, November 9, 2015 - Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of a once-daily, oral therapy for the treatment of liver diseases, today announced the commencement of patient screening for the ARREST Study in Europe, and reported financial results for the three and nine months ended September 30, 2015.

 

Financial Summary – Third Quarter 2015 vs. Third Quarter 2014:

 

·Net loss of $2.6 million, or $0.23 per share, for the three months ended September 30, 2015, compared to a net loss of $3.2 million, or $0.29 per share, for the three months ended September 30, 2014. This period’s net loss included $0.2 million of non-cash, stock-based compensation expense versus $0.1 million of non-cash stock-based compensation expense incurred during the corresponding period in 2014.

 

·Research and development expenses of $1.9 million for the three months ended September 30, 2015, compared to $2.8 million for the three months ended September 30, 2014. The decrease in 2015 primarily resulted from lower chemistry and formulation study expenses, which were partially offset by other line-items, as our ARREST Study progresses.

 

·General and administrative expenses of $0.6 million for the three months ended September 30, 2015, compared to $0.4 million for the three months ended September 30, 2014. The increase in 2015 primarily resulted from an increase in salaries and benefits as the result of additional employees, including higher non-cash, stock-based compensation and an increase in professional services.

 

·Current assets totaled $25.7 million as of September 30, 2015, largely comprised of cash and cash equivalents, and marketable securities, compared to $32.2 million at December 31, 2014. The decrease in 2015 primarily resulted from our ongoing clinical studies and operating activities. Galmed continues to expect that its cash balance will be sufficient to maintain its current operations into 2017.

 

“At the end of the third quarter of 2015, we had received country approval in 6 out of our expected 8 countries to be included in the ARREST Study, including the United States, Germany, France, Mexico, Chile and Israel,” stated Allen Baharaff, Galmed’s President and Chief Executive Officer. Currently, 55 (fifty-five) sites out of our expected 72 (seventy-two) sites have been approved by their respective regulatory bodies and ethics committees.”

 

“Importantly, patient screening has now commenced in Europe, and remains ongoing in the United States and Latin America, as anticipated.”

 

In addition, our collaboration with OWL to develop a non-invasive, blood-based diagnostic tool continues to progress nicely. We believe that this technology could replace liver biopsy in testing the ongoing efficacy of patient treatment, which may enhance the market penetration of AramcholTM.

 

Mr. Baharaff reiterated, “The timely execution of the ARREST Study remains our main focus. We are confident that patient enrollment will continue to gain momentum.”

  

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Conference Call Details

Galmed will host a conference call and webcast today at 8:30 a.m. EST / 5:30 a.m. PST to discuss its financial results and to provide an update on current developments with respect to its clinical program for AramcholTM. Investors interested in participating in the call can dial +1-888-359-3624 from the United States or +1-719-785-1753 for international callers, and use Conference ID 1521094. A replay will be available through November 23, 2015, by dialing +1-877-870-5176 (United States) or +1-858-384-5517 (international); Passcode 1521094. A webcast will also be available at http://galmedpharma.investorroom.com.

 

 

About Galmed Pharmaceuticals Ltd.

Galmed is a clinical-stage biopharmaceutical company focused on the development of a novel, once-daily, oral therapy for the treatment of liver diseases utilizing its proprietary first-in-class family of synthetic fatty-acid/bile-acid conjugates, or FABACs. Galmed believes that its product candidate, AramcholTM, has the potential to be a disease modifying treatment for fatty liver disorders, including non-alcoholic steatohepatitis, or NASH, which is a chronic disease that Galmed believes constitutes a large unmet medical need.

 

 

Forward-Looking Statements

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Galmed’s objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Galmed intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those identified under the heading “Risk Factors” included in Galmed’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission, or the SEC, on March 31, 2015, and in other filings that Galmed has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed’s current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

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GALMED PHARMACEUTICALS LTD.

Consolidated Balance Sheets

U.S. Dollars in thousands, except share data and per share data

 

 

  

As of
September 30,
2015

  

As of
December 31,
2014

 
   Unaudited   Audited 
Assets          
Current assets          
Cash and cash equivalents  $4,463   $23,736 
Short-term deposit   -    6,000 
Marketable securities   20,862    2,250 
Other accounts receivable   346    165 
Total current assets   25,671    32,151 
           
Property and equipment, net   902    774 
           
Total assets  $26,573   $32,925 
           
Liabilities and stockholders’ equity          
           
Current liabilities          
Trade payables  $1,126   $875 
Other accounts payable   200    243 
Total current liabilities   1,326    1,118 
           
Long-term liabilities          
Related parties   187    400 
           
Stockholders’ equity          
Ordinary shares par value NIS 0.01 per share; 
Authorized 50,000,000; Issued and outstanding: 11,100,453 shares		   32    32 
Additional paid-in capital   69,246    68,116 
Accumulated other comprehensive income (loss)   (56)   4 
Accumulated deficit   (44,162)   (36,745)
Total stockholders’ equity   25,060    31,407 
           
Total liabilities and stockholders’ equity  $26,573   $32,925 

 

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GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Operations (unaudited)

U.S. Dollars in thousands, except share data and per share data

 

 

  

Three months ended
September 30,

  

Nine months ended
September 30,

 
   2015   2014   2015   2014 
Research and development expenses  $1,860   $2,791   $4,853   $5,538 
                     
General and administrative expenses   637    399    2,677    1,550 
                     
Total operating expenses   2,497    3,190    7,530    7,088 
                     
Financial expenses (income), net   103    16    (113)   36 
                     
Net loss  $2,600   $3,206   $7,417   $7,124 
                     
Basic and diluted net loss per share  $0.23   $0.29   $0.67   $0.71 
                     
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share   11,100,453    11,100,453    11,100,453    10,074,939 

  

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GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Cash Flows (Unaudited)

U.S. Dollars in thousands, except share data and per share data

 

 

   Nine months ended
September 30,		 
   2015   2014 
Cash flow from operating activities          
           
Net loss  $(7,417)  $(7,124)
Adjustments required to reconcile net loss to net cash used in operating activities          
Depreciation and amortization   32    8 
Stock-based compensation expense   1,130    470 
Amortization of investment premium, net   195    - 
Changes in operating assets and liabilities:          
Increase in other accounts receivable   (181)   (51)
Increase (decrease) in trade payables   251    (108)
Increase (decrease) in other accounts payable   (43)   154 
Increase (decrease) in related party   (213)   20 
Net cash used in operating activities   (6,246)   (6,631)
           
Cash flow from investing activities          
Purchase of property and equipment   (160)   (20)
Maturity of short term deposit   6,000      
Investment in securities, available for sale   (25,132)   - 
Maturity of securities, available for sale   6,265    - 
Net cash used in investing activities   (13,027)   (20)
           
Cash flow from financing activities          
Issuance of ordinary shares   -    2,000 
Issuance of ordinary shares upon IPO, net (*)   -    39,856 
Net cash provided by financing activities   -    41,856 
Increase (decrease) in cash and cash equivalents   (19,273)   35,205 
Cash and cash equivalents at the beginning of the year   23,736    137 
Cash and cash equivalents at the end of the period  $4,463   $35,342 
           
Supplemental disclosure of cash flow information:          
Cash received from interest  $370    - 

 

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GALMED PHARMACEUTICALS LTD.

Notes to Consolidated Statements of Operations (unaudited)

U.S. Dollars in thousands

 

 

Research and development expenses:

 

   Three months ended
September 30,		   Nine months ended
September 30,		 
   2015   2014   2015   2014 
Chemistry and formulation studies  $372   $1,186   $1,084   $2,907 
Salaries and benefits   196    126    557    336 
Stock-based compensation   88    -    216    - 
Research and preclinical studies   139    181    404    200 
Clinical studies   1,028    962    2,259    1,216 
Regulatory and other expenses   37    336    333    879 
Total R&D expenses  $1,860   $2,791   $4,853   $5,538 

 

 

 

General and administrative expenses:

 

   Three months ended
September 30,		   Nine months ended
September 30,		 
   2015   2014   2015   2014 
Stock-based compensation  $151   $110   $913   $470 
Professional fees™   153    69    611    430 
Salaries and benefits   129    99    485    339 
Rent and office-maintenance fees   59    67    230    150 
Investor relations and business development   142    48    427    136 
Other   3    6    11    25 
Total G&A expenses  $637   $399   $2,677   $1,550 

 

 

 

Investor Contact:

Josh Blacher, CFO

Galmed Pharmaceuticals Ltd.

josh@galmedpharma.com

+1-646-780-7605

 

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