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 -

Nov 09, 2015, 08:00 ET from Galmed Pharmaceuticals Ltd.

TEL AVIV, Israel, Nov. 9, 2015 /PRNewswire/ -- 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 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

 

SOURCE Galmed Pharmaceuticals Ltd.



RELATED LINKS

http://www.galmedpharma.com