EX-99.1 2 v462308_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

  

 

Galmed Pharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results

 

New Independent Research is Pointing Towards Potential Direct Effect of AramcholTM on Liver Fibrosis

 

- Conference Call and Webcast Today at 8:30 a.m. EDT / 5:30 a.m. PDT -

 

TEL AVIV, Israel, March 23, 2017 – 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 nonalcoholic steatohepatitis, or NASH, and other liver diseases, today reported financial results for the three and twelve months ended December 31, 2016, and announced new and exciting data from recently completed pre-clinical studies demonstrating AramcholTM’s potential direct effect on liver fibrosis. The data will be presented at the International Liver Congress™ 2017, to be held from April 19 to the 23rd in Amsterdam, the Netherlands.

 

The Company will host a conference call and webcast today to discuss the financial results and to provide an update on current developments with respect to its clinical programs for Aramchol™.

 

“AramcholTM’s anti-steatosis effect was previously established and translated to humans in our phase IIa study. Pre-clinical studies demonstrate AramcholTM is targeting fibrosis via two main pathways – (1) by down regulating steatosis which is the main cause of inflammation and fibrosis; and (2) by directly down regulating collagen production. The new data suggests the potential direct effect of AramcholTM in the treatment of liver fibrosis,” said Mr. Allen Baharaff, Galmed’s President and CEO.

  

“The TAA model is the best known animal model for experimental induced liver fibrosis and cirrhosis. In this model, we investigated the effect of AramcholTM on liver fibrosis. We found that AramcholTM significantly reduced the amount of fibrosis in comparison to a control group which received placebo. The results are significant and quite impressive,” said Prof. Shimon Reif, Gastroenterologist and Head of Pediatric Department at Hadassah Medical Center at the Hebrew University of Jerusalem. Prof. Reif continued, “The effect seen in the TAA model is due to direct effect on collagen production from stellate cells.”

 

“As we previously reported on January 9, 2017, we have completed the enrolment of the ARREST Study, and 248 patients have been randomized. Top line Data is expected to be available during the second quarter of 2018. We believe that our cash balance will be sufficient to maintain our current operations through the first half of 2018, and allow the completion of the ARREST study as scheduled,” said Mr. Baharaff.

  

 

 

  

Financial Summary – Full Year 2016 vs. Full Year 2015; 4Q16 vs. 4Q15:

 

·Cash and cash equivalents and marketable securities totaled approximately $15.5 million as of December 31, 2016, compared with approximately $23.0 million as of December 31, 2015. This decrease primarily resulted from approximately $12.1 million used in operating activities, mainly due to our ongoing clinical studies and operational activities, which was partially offset by net proceeds of approximately $4.5 million raised through our ATM offering.

 

·The Company recorded a net loss of approximately $17.0 million, or approximately $1.49 per share, for the twelve months ended December 31, 2016, compared with a net loss of approximately $10.6 million, or approximately $0.96 per share, for the twelve months ended December 31, 2015. During 2016, total R&D expenses increased by approximately $6.7 million, or approximately 88%, to approximately $14.3 million, and total G&A expenses decreased by approximately $168 thousand, or approximately 5%, to approximately $3.1 million. In addition, 2016’s net loss included approximately $1.6 million of non-cash, stock-based compensation expense versus approximately $970 thousand of non-cash stock-based compensation expense incurred during the corresponding period in 2015.

 

·For the quarter ended December 31, 2016, the net loss was approximately $4.8 million, or approximately $0.40 per share, which compares with approximately $3.2 million, or approximately $0.29 per share, for the same period in 2015. During the fourth quarter of 2016, total R&D expenses increased approximately $1.4 million to approximately $4.2 million, and total G&A expenses increased approximately $273 thousand to approximately $842 thousand. This quarter’s net loss included approximately $160 thousand of non-cash, stock-based compensation income versus approximately $321 thousand of non-cash stock-based compensation expense incurred during the corresponding period in 2015.

 

·The Company recognized approximately $0.5 million of revenue for the twelve months ended December 31, 2016, compared to no revenue for the same period in 2015. The revenue relates to the amortization of the up-front payments under the Company’s license agreement with Samil Pharm Co. Ltd. The remaining unamortized up-front payment of approximately $1.6 million is reflected on the balance sheet as short-term and long-term portion of deferred revenue and will be amortized through the contractual term of the agreement.

 

·Research and development expenses were approximately $14.3 million for the twelve months ended December 31, 2016, compared with approximately $7.6 million for the twelve months ended December 31, 2015. The increase primarily resulted from an increase in expenses related to the ARREST Study as the trial continues to progress. The increase is also a result of an increase in 2016 of non-cash stock-based compensation expense. For the quarter ended December 31, 2016, research and development expenses totaled approximately $4.2 million, which compares with approximately $2.8 million for the same period in 2015. The increase primarily resulted from an increase in expenses related to the ARREST Study and also as a result of an increase in non-cash stock-based compensation expense.

   

 

 

  

·The Company incurred general and administrative expenses of approximately $3.1 million for the twelve months ended December 31, 2016, compared with approximately $3.2 million for the twelve months ended December 31, 2015. The decrease primarily resulted from a decrease in investor relations expenses.

 

·For the quarter ended December 31, 2016, general and administrative expenses totaled approximately $842 thousand, which compares with approximately $569 thousand for the same period in 2015. The increase primarily resulted from an increase in stock-based compensation expense.

 

 

Conference Call & Webcast:

Thursday, March 23, 2017, 8:30 am Eastern Time / 5:30 am Pacific Time

Participant Dial-In Numbers:

Toll-Free: +1-888-663-2242

Toll/International: +1-913-312-0380

Conference ID: 3745268

Webcast: http://galmedpharma.investorroom.com/events

 

 

Replay, available until April 6, 2017

Replay Dial-In Numbers:

Toll-Free: +1-844-512-2921

Toll/International: +1-412-317-6671

Passcode: 3745268

 

 

About AramcholTM and Non-alcoholic Steatohepatitis (NASH)

AramcholTM (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. AramcholTM’s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating down regulation of the three key pathologies of NASH; steatosis, inflammation and fibrosis. The effect of AramcholTM on fibrosis is mediated by down regulation of steatosis and directly on human collagen producing cells. AramcholTM has been granted by the FDA Fast Track designation status for the treatment of NASH.

 

NASH is an emerging world crisis impacting 3% to 5% of the U.S. population and 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.

  

 

 

  

About Galmed Pharmaceuticals Ltd.:

Galmed is a clinical-stage biopharmaceutical company focused on the development of AramcholTM, a first in class, novel, once-daily, oral therapy for the treatment of NASH for variable populations, as well as other liver associated disorders. Galmed is currently conducting the ARREST Study, a multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study designed to evaluate the efficacy and safety of AramcholTM in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. Galmed also sponsors the ARRIVE Study, a proof-of-concept Phase IIa clinical trial designed to evaluate the safety and efficacy of Aramchol in up to 50 patients with HIV-associated NAFLD and lipodystrophy. The ARRIVE Study is an investigator-initiated trial, conducted at the University of California San Diego by Professor Rohit Loomba. More information about the ARREST Study and the ARRIVE Study may be found on ClinicalTrials.gov identifiers: NCT02279524 and NCT02684591, respectively.

 

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 risks and uncertainties associated with the initiation, timing, progress and results of the Company's research, preclinical studies and clinical trials as well as risks and uncertainties 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 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.

 

 

Galmed Investor & Media Contact:

Guy Nehemya, VP, Operations

Galmed Pharmaceuticals Ltd.

guy@galmedpharma.com

  

 

 

  

GALMED PHARMACEUTICALS LTD.

Consolidated Balance Sheets

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

 

 

    As of December 31, 
   

2016

   2015 
Assets           
Current assets           
Cash and cash equivalents   $3,097   $4,156 
Marketable securities    12,351    18,845 
Other accounts receivable    284    379 
Total current assets    15,732    23,380 
            
Property and equipment, net    718    883 
            
Total assets   $16,450   $24,263 
            
            

Liabilities and stockholders’ equity  

           
            
Current liabilities           
Trade payables    3,122    2,259 
Other accounts payable    363    282 
Short-term portion of deferred revenue    1,094    - 
Total current liabilities    4,579    2,541 
            
Long-term liabilities           
Related parties    267    177 
Long-term portion of deferred revenue    529    - 
Total long-term liabilities    796    177 
            
Stockholders’ equity           
Ordinary shares, par value NIS 0.01 per share; Authorized 50,000,000 shares; Issued and outstanding: 12,149,226 shares as of December 31, 2016; 11,100,453 shares as of December 31, 2015    34    32 
Additional paid-in capital    75,446    69,086 
Accumulated other comprehensive loss    (85)   (206)
Accumulated deficit    (64,320)   (47,367)
Total stockholders’ equity    11,075    21,545 
            
Total liabilities and stockholders’ equity   $16,450   $24,263 

   

 

 

  

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Operations (audited)

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

  

  

Three months ended

December 31,

  

Twelve months ended

December 31,

 
   2016   2015   2016   2015 
Revenue  $274   $-   $467   $- 
                     
Research and development expenses   4,185    2,776    14,271    7,629 
                     
General and administrative expenses   842    569    3,078    3,246 
                     
Total operating expenses   4,753    3,345    16,882    10,875 
                     
Financial expenses (income), net   73    (140)   (35)   (253)
                     
Loss before income taxes   4,826    3,205    16,847    10,622 
                     
Taxes on Income   -    -    106    - 
                     
Net loss  $4,826   $3,205   $16,953   $10,622 
                     
Basic and diluted net loss per share  $0.40   $0.29   $1.49   $0.96 
                     
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share   12,149,226    11,100,453    11,374,653    11,100,453 

  

 

 

   

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Cash Flows (audited)

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

  

   Year ended December 31, 
   2016   2015 
Cash flow from operating activities          
Net loss for the year  $(16,953)  $(10,622)
Adjustments required to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   169    50 
Amortization of discount/premium on marketable securities   44    92 
Loss from realization of marketable securities   231    50 
Stock-based compensation expense   1,628    970 
Changes in operating assets and liabilities:          
Increase in deferred revenue from collaboration agreement   1,623    – 
Decrease (increase) in other accounts receivable   95    (214)
Increase (decrease) in trade payables   863    1,384 
Increase (decrease) in other accounts payable   81    39 
Increase (decrease) in related party   90    (223)
Net cash used in operating activities   (12,129)   (8,474)
           
Cash flow from investing activities          
Purchase of property and equipment   (17)   (159)
Proceeds from sale of property and equipment   13    – 
Investment in securities, available for sale   (7,615)   (26,541)
Proceeds from sale of securities, available for sale   13,955    9,594 
Disposal of (Investment in) short-term deposit   –    6,000 
Net cash provided by (used in) investing activities   6,336    (11,106)
           
Cash flow from financing activities          
Issuance of ordinary shares   –    – 
Issuance of ordinary shares upon IPO, net (*)   –    – 
Issuance of stock offerings, net of issuance costs (**)   4,479    – 
Proceeds from exercise of options   255    – 
Net cash provided by financing activities   4,734    – 
Increase (decrease) in cash and cash equivalents   (1,059)   (19,580)
Cash and cash equivalents at the beginning of the year   4,156    23,736 
Cash and cash equivalents at the end of the year  $3,097   $4,15 
           
Cash received from interest  $382   $473 
Cash paid for taxes  $106   $- 

  

 

 

  

GALMED PHARMACEUTICALS LTD.

Notes to Consolidated Statements of Operations (audited)

U.S. Dollars in thousands

  

Research and Development Expenses:

 

  

Three months ended December 31,

  

Year ended December 31,

 
  

2016 

  

2015 

  

2016 

  

2015 

 
   (in thousands)   (in thousands) 
Chemistry and formulation studies  $267   $818   $1,802   $1,902 
Salaries and benefits   405    251    1,004    808 
Stock-based compensation   24    (105)   757    111 
Research and preclinical studies   288    233    924    637 
Clinical studies   3,103    1,412    9,263    3,671 
Regulatory and other expenses   98    167    521    500 
   $4,185   $2,776   $14,271   $7,629 

    

 

General and Administrative Expenses:

 

  

Three months ended December 31,

  

Year ended December 31,

 
  

2016

  

2015

  

2016

  

2015

 
   (in thousands)   (in thousands) 
Stock-based compensation  $297   $(55)  $871   $858 
Professional fees   144    130    683    741 
Salaries and benefits   262    262    849    747 
Traveling and conference costs   14    17    106    65 
Rent and office-maintenance fees   55    129    303    359 
Investor relations and business development
   66    78    248    457 
Other   4    8    18    19 
   $842   $569   $3,078   $3,246