Galmed Pharmaceuticals Announces the Commencement of Patient Screening in the ARREST Study in the United States and Latin America, and Reports Second Quarter 2015 Financial Results

Press Releases |

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

TEL AVIV, Israel, Aug. 13, 2015 -- Galmed Pharmaceuticals Ltd. (GLMD) ("Galmed"), a clinical-stage biopharmaceutical company focused on the development of a once-daily, oral therapy for the treatment of liver diseases, today announced that it has commenced patient screening for the ARREST Study in the United States and Latin America, as well as reported financial results for the three and six months ended June 30, 2015.

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

  • Net loss of $2.4 million, or $0.21 per share, for the three months ended June 30, 2015, compared to a net loss of $1.8 million, or $0.14 per share, for the three months ended June 30, 2014.  This period's net loss included $0.3 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 $1.6 million for the three months ended June 30, 2015, compared to $1.2 million for the three months ended June 30, 2014.  The increase in 2015 primarily resulted from an increase in research and development subcontractor expenses in connection with Aramchol's clinical development program.
  • General and administrative expenses of $1.0 million for the three months ended June 30, 2015, compared to $0.5 million for the three months ended June 30, 2014.  The increase in 2015 primarily resulted from an increase in salaries and benefits as the result of new hires, including higher non-cash, stock-based compensation and an increase in professional services.
  • Cash and cash equivalents and marketable securities totaled $27.8 million as of June 30, 2015, compared to $31.9 million at December 31, 2014.  The decrease in 2015 primarily resulted from our ongoing clinical studies and operational activities.  Galmed continues to expect that its cash balance will be sufficient to maintain its current operations into 2017.

"The ARREST Study has made significant strides in the second quarter," stated Allen Baharaff, Galmed's President and Chief Executive Officer.  "We now have received country approval in five out of our expected nine countries to be included in the ARREST Study, including the United States, Germany, France, Chile and Israel.  Currently, fifty-two (52) sites out of our expected seventy three (73) sites have been approved by their respective Ethics Committees.

Importantly, patient screening has now commenced in the United States and Latin America, and remains ongoing in Israel.  Regarding our activities in Europe, we expect our first patients to be screened in September.

We remain confident that we will have enrolled the first 120 patients in the trial by the end of 2015, which we believe should allow us to stay on track for releasing the interim results around June 2016.

Based on the trial's protocol, 240 patients will need to have completed 12 months of treatment of Aramchol, followed by a three month follow-up period in order to complete the study.  We will then need several weeks to complete the statistical analysis before we release the data.  Based on our current estimates, therefore, we now believe that top-line data will be available in the third quarter of 2017.

Finally, we would like to formally announce the appointment of Dr. Michal Ayalon who will serve as the Company's Vice President, Research and Development.  Dr. Ayalon will lead the initiation of our pipeline and next generation molecules.  We intend to share our advancements in these efforts during the balance of this year.

Prior to joining Galmed, Dr. Ayalon led the development of a Phase II, GI/Inflammatory investigational drug as Vice President Product Development at Immune Pharmaceuticals.  Dr. Ayalon previously led the development and discovery of multiple products in inflammatory and metabolic diseases at BioLineRx, Ltd. and Compugen Ltd.  Dr. Ayalon earned her PhD in Biology from Tel-Aviv University, MSc from the Department of Cell Research and Immunology at Tel Aviv University and a BSc in Life Sciences from Tel Aviv University; she gained post-doctoral training at the Weizmann Institute of Science.  We are happy to have Dr. Ayalon aboard and wish her much success in accomplishing our shared objectives.

Mr. Baharaff concluded, "timely execution of the ARREST Study remains our main goal.  With the rapid advancement of the regulatory approvals, we are confident that patient enrollment will continue to gain momentum."

Conference Call Details

Galmed will host a conference call and webcast today at 8:30 a.m. EDT / 5:30 a.m. PDT to discuss its financial results and to provide an update on current developments with respect to its clinical program for aramchol.  Investors interested in participating in the call can dial +1-888-503-8175 from the United States or +1-719-457-2085 for international callers, and use Conference ID 6082132.  A replay will be available through August 27, 2015, by dialing +1-877-870-5176 (United States) or +1-858-384-5517 (international); Passcode 6082132.  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, Aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including 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.

 

GALMED PHARMACEUTICALS LTD.

 

Consolidated Balance Sheets

 

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

 
   

As of
June 30,

2015

 

As of December
31, 2014

   

Unaudited

 

Audited

Assets

       

Current assets

       

Cash and cash equivalents

 

$             7,324

 

$           23,736

Short-term deposit

 

-

 

6,000

Marketable securities

 

20,486

 

2,250

Other accounts receivable

 

385

 

165

     Total current assets

 

28,195

 

32,151

         

Property and equipment, net

 

915

 

774

         

Total assets

 

$            29,110

 

$           32,925

         

Liabilities and stockholders' equity

       
         

Current liabilities

       

Trade payables

 

$              1,229

 

$              875

Other accounts payable

 

272

 

243

      Total current liabilities

 

1,501

 

1,118

         

Long-term liabilities

       

Related parties

 

194

 

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

 

69,006

 

68,116

Accumulated other comprehensive income (loss)

 

(61)

 

4

Accumulated deficit

 

(41,562)

 

(36,745)

     Total stockholders' equity

 

27,415

 

31,407

         

Total liabilities and stockholders' equity

 

$          29,110

 

$         32,925

           

 

 

GALMED PHARMACEUTICALS LTD.

   

Consolidated Statements of Operations (unaudited)

   

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

   
     
   

 

Six months ended

June 30,

 

 

 

Three months ended

June 30,

 
   

 

2015

 

2014

 

 

2015

 

2014

 

Research and development expenses

 

$               2,993

 

$             2,747

 

$             1,562

 

$             1,245

 

General and administrative expenses

 

2,040

 

1,151

 

967

 

518

 

Total operating expenses

 

5,033

 

3,898

 

2,529

 

1,763

 

Financial expenses (income), net

 

(216)

 

20

 

(175)

 

(6)

 

Net loss

 

$             4,817

 

$             3,918

 

$             2,354

 

$             1,757

 
                   

Basic and diluted net loss per share from
continuing operations

$               0.43

 

$              0.41

 

$               0.21

 

$                0.14

   

Weighted-average number of shares
outstanding used in computing basic and
diluted net loss per share

11,100,453

 

9,553,684

 

11,100,453

 

11,100,453

 
                 
                 

 

 

GALMED PHARMACEUTICALS LTD.

 

Consolidated Statements of Cash Flows (Unaudited)

 

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

 
   
 

 

Six months ended

June 30,

 

2015

 

2014

Cash flow from operating activities

     

Net loss

 

$    (4,817)

 

$    (3,918)

Adjustments required to reconcile net loss to net
cash used in operating activities

     

Depreciation and amortization

13

 

4

Stock-based compensation expense

890

 

361

Amortization of investment premium, net

(27)

 

-

Changes in operating assets and liabilities: 

     

Increase in other accounts receivable

(220)

 

(45)

Increase (decrease) in trade payables

354

 

(1,054)

Increase in other accounts payable

29

 

53

Increase (decrease) in related party

(206)

 

20

    Net cash used in operating activities

(3,984)

 

(4,579)

       

Cash flow from investing activities

     

Purchase of property and equipment

(154)

 

(15)

Maturity of short term deposit

6,000

   

Investment in securities, available for sale

(21,839)

 

Maturity of securities, available for sale

3,565

 

    Net cash used in investing activities

(12,428)

 

(15)

       

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

(16,412)

 

37,262

Cash and cash equivalents at the beginning of the year

 

23,736

 

137

Cash and cash equivalents at the end of the period

$        7,324

 

$       37,399

       

Supplemental disclosure of cash flow information:

     

Cash received from interest

$              245

 

 



 

 

GALMED PHARMACEUTICALS LTD.

   

Consolidated Statements of Cash Flows (Unaudited)

   

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

   
     

Research and development expense:

 

 

Six months ended

June 30,

 

Three months ended

June 30,

 

2015

 

2014

2015

 

2014

                Chemistry and formulation studies  

$               712

 

$            1,721

$               325

 

$               453

Salaries and benefits

361

 

210

203

 

210

                Stock-based compensation

128

 

-

35

 

-

                Research and preclinical studies

265

 

119

144

 

85

                Clinical studies

1,231

 

254

783

 

97

                Regulatory and other expenses

296

 

443

72

 

400

                   Total R&D expenses

$             2,993

 

$            2,747

$             1,562

 

$            1,245

     

General and administrative expenses:

 

 

Six months ended

June 30,

 

 

Three months ended

June 30,

 

2015

 

2014

2015

 

2014

                Stock-based compensation

$                762

 

$               360

$                296

 

$               151

Professional fees

458

 

361

222

 

183

                Salaries and benefits

356

 

240

188

 

34

                Rent and office-maintenance fees

171

 

83

110

 

68

               Investor relations and business
               development

 

285

 

88

 

148

 

65

                Other

8

 

19

3

 

17

                   Total G&A expenses

$             2,040

 

$            1,151

$              967

 

$                518

 

 

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Symbol Name Price Change % Volume
GLMD Galmed Pharmaceuticals Ltd. 3.51 0.13 3.85 26,649

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