Galmed Pharmaceuticals Announces Commencement of Patient Screening for the ARREST Study in Europe, and Reports Third Quarter 2015 Financial Results

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

TEL AVIV, Israel, Nov. 9, 2015 -- Galmed Pharmaceuticals Ltd. ($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 Aramchol.

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."

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 Aramchol. 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, Aramchol, 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.

 

 

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

 

 

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

 

 

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

   

-

 

 

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

 

 

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Symbol Name Price Change % Volume
GLMD Galmed Pharmaceuticals Ltd. 3.29 -0.22 -6.27 17,693

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