Galmed Pharmaceuticals Reports First Quarter 2016 Financial Results and Provides Business Update

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

May 16, 2016

TEL AVIV, Israel, May 16, 2016 /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 reported financial results for the three months ended March 31, 2016.  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™.

Financial Summary – First Quarter 2016 vs. First Quarter 2015:

  • Net loss of $4.0 million, or $0.36 per share, for the three months ended March 31, 2016, compared to a net loss of $2.5 million, or $0.22 per share, for the three months ended March 31, 2015.  This period's net loss included $0.3 million of non-cash, stock-based compensation expense, versus $0.6 million of non-cash stock-based compensation expense incurred during the corresponding period in 2015.  The increase in net loss was due primarily to increased research and development expenses.
  • Research and development expenses of $3.4 million for the three months ended March 31, 2016, compared to $1.4 million for the three months ended March 31, 2015.  The increase resulted primarily from an increase in research and development subcontractor expenses of $1.6 million in connection with significant growth in subject screening and patient recruitment, as well as initiating additional clinical testing sites for the ARREST Study.
  • General and administrative expenses of $0.7 million for the three months ended March 31, 2016, compared to $1.1 million for the three months ended March 31, 2015.  The decrease in 2016 resulted primarily from lower non-cash stock-based compensation.
  • Financial income of $0.1 million for the three months ended March 31, 2016, compared to a financial income of $0.04 million for the three months ended March 31, 2015.  The increase in 2016 financial income resulted primarily from movement in foreign currency exchange rates.
  • Cash and cash equivalents and marketable securities, or current assets, totaled $20.0 million as of March 31, 2016, compared to $23.0 million at December 31, 2015.  The decrease in the first quarter of 2016 resulted primarily 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 the second half of 2017.

"The significant increase in R&D activities and the momentum we are seeing in the ARREST Study patient recruitment pace continues to support our previously stated timelines concerning the ARREST Study," stated Allen Baharaff, Galmed's President and Chief Executive Officer.  "Specifically, as previously disclosed, we are currently on track to have 120 patients enrolled by the end of the second quarter of 2016 and 240 patients by the end of the fourth quarter of 2016."

Mr. Baharaff continued, "Worldwide, we have now screened over 575 subjects for the ARREST Study, a 37% increase since our last public disclosure on March 22, 2016, less than 2 months ago.  As of yesterday, May 15, 2016, we had randomized 107 patients (+43% since March 22, 2016) and have another 6 subjects who are eligible to be randomized.  In addition, 81 subjects are currently within the screening process, which, again, normally takes between 6-8 weeks."

Josh Blacher, Galmed's Chief Financial Officer, commented, "During the first quarter 2016, our G&A expense decreased by a total of 8% quarter-over-quarter, excluding the effect of non-cash based compensation.  Additionally, the expenses associated with R&D and G&A improved from 68% R&D / 32% G&A in the fourth quarter of 2015, to 85% R&D / 15% G&A in the first quarter of 2016.  We will continue to remain vigilant about our G&A spend."

Mr. Baharaff continued, "We recently announced an investigator initiated clinical trial agreement with the Icahn School of Medicine at Mount Sinai for a study testing the effect of a combination of Aramchol™ with Vitamin D.  Combination therapy has been widely accepted by the scientific community as the future direction of treating NASH.  Aramchol™, with its strong safety profile and promising efficacy, together with Vitamin D, which is emerging as an anti-fibrotic agent, is the first NASH combo treatment to enter a Phase IIa study.  This innovative dual therapy is a natural expansion of our pipeline in addition to the ongoing ARREST and ARRIVE studies."

Mr. Baharaff concluded, "We are encouraged by the recent preclinical data announced in March demonstrating Aramchol™'s direct anti-fibrotic effect, which, together with its clinically-demonstrated effect on steatosis, provides a strong foundation for Aramchol™ development to address the full spectrum of NAFLD and NASH through a comprehensive portfolio approach, rather than a single 'shot-on-goal."

Conference Call & Webcast:

Monday, May 16, 2016, 8:30 am EDT / 5:30 am PDT

Participant Dial-In Numbers:


Toll-Free:                 

+1-888-587-0615

Toll/International:       

+1-719-325-2323

Conference ID:           

2502914

Webcast:                   

http://galmedpharma.investorroom.com/events





Replay, available until May 30, 2016

Replay Dial-In Numbers:


Toll-Free:                      

+1-877-870-5176

Toll/International:            

+1-858-384-5517

Passcode:                      

2502914

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.  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 Aramchol™ in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic.  More information about the ARREST Study may be found on ClinicalTrials.gov identifier: NCT02279524.

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 22, 2016, 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

March 31,

2016



As of

December 31,

2015




Unaudited



Audited


Assets









Current assets









Cash and cash equivalents


$

3,084



$

4,156


Marketable securities



16,882




18,845


Other accounts receivable



256




379


Total current assets



20,222




23,380











Property and equipment, net



859




883











Total assets


$

21,081



$

24,263











Liabilities and stockholders' equity


















Current liabilities









Trade payables


$

2,951



$

2,259


Other accounts payable



73




282


Total current liabilities



3,024




2,541











Long-term liabilities









Related parties



177




177


Total long-term liabilities



177




177











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



69,359




69,086


Accumulated other comprehensive loss



(160)




(206)


Accumulated deficit



(51,351)




(47,367)


Total stockholders' equity



17,880




21,545











Total liabilities and stockholders' equity


$

21,081



$

24,263


 

 

GALMED PHARMACEUTICALS LTD. 

Consolidated Statements of Operations (Unaudited)


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








Three months ended

March 31,




2016



2015


Research and development expenses


$

3,384



$

1,431


General and administrative expenses



719




1,073


Total operating expenses



4,103




2,504


Financial income, net



(119)




(41)


Net loss


$

3,984



$

2,463











Basic and diluted net loss per share from continuing operations


$

0.36



$

0.22











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



11,100,453




11,100,453


 

 

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Cash Flows (Unaudited)


U.S. Dollars in thousands








Three months

ended March 31,




2016



2015


Cash flow from operating activities


















Net loss


$

(3,984)



$

(2,463)


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









Depreciation and amortization



32




3


Stock-based compensation expense



273




558


Amortization of discount/premium on marketable securities



(62)




(185)


Loss from realization of marketable securities



55




11


Changes in operating assets and liabilities:









Increase (decrease) in other accounts receivable



123




(223)


Increase in trade payables



692




272


Decrease in other accounts payable



(209)




(34)


Decrease in related party



-




(195)


Net cash used in operating activities



(3,080)




(2,256)


Cash flow from investing activities









Purchase of property and equipment



(8)




(2)


Investment in securities, available for sale



-




(19,445)


Realization of securities, available for sale



2,016




307


Net cash provided by (used in) investing activities



2,008




(19,140)


Decrease in cash and cash equivalents



(1,072)




(21,396)


Cash and cash equivalents at the beginning of the year



4,156




23,736


Cash and cash equivalents at the end of the period


$

3,084



$

2,340


Supplemental disclosure of cash flow information:









Cash received from interest


$

140



$

65


 

 

GALMED PHARMACEUTICALS LTD.

Notes to Consolidated Statements of Operations (unaudited)

U.S. Dollars in thousands


Research and Development Expenses:






Three months ended
March 31,


2016

2015


(in thousands)

                Chemistry and formulation studies

$             877

$             387

                Salaries and benefits

142

93

                Stock-based compensation

115

121

                Research and preclinical studies

352

448

                Clinical studies

1,745

158

                Regulatory and other expenses

153

224


$         3,384

$          1,431




General and Administrative Expenses:




Three months ended
March 31,


2016

2015


(in thousands)

                Stock-based compensation

$            159

$            466

                Professional fees

178

236

                Salaries and benefits

178

168

                Traveling and conference costs

29

24

                Rent and office-maintenance fees

85

61

                Investor relations and business
               
Development

88

113

                Other

2

5


$            719

$         1,073

 

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SOURCE Galmed Pharmaceuticals Ltd.

For further information: Investor Contact: Josh Blacher, CFO, Galmed Pharmaceuticals Ltd., josh@galmedpharma.com, +1-646-780-7605


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