TEL AVIV, Israel, May 9, 2018 /PRNewswire/ --Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Aramchol™, a once-daily, oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH, today provides updated information reaffirming the schedule of the release of the ARREST study top line results and reports financial results for the three months ended March 31, 2018. The Company will host a conference call and webcast at 08:30 a.m. ET today.
Business Update
Financial Summary - First Quarter 2018 vs. First Quarter 2017:
Conference Call & Webcast:
Wednesday, May 9th @ 8:30am Eastern Time
Within the US: |
800-239-9838 | |
Outside the US: |
323-794-2551 | |
From Israel: |
1809-212-883 | |
Conference ID: |
4575906 | |
Webcast: |
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Replays, available through May 23, 2017 | ||
Toll-Free: |
844-512-2921 | |
Toll/International: |
412-317-6671 | |
Replay PIN: |
4575906 |
About Aramchol and Non-alcoholic Steatohepatitis (NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.
NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 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 Aramchol, a first in class, novel, once-daily, oral therapy for the treatment of NASH for variable populations. 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.
GALMED PHARMACEUTICALS LTD. |
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Consolidated Balance Sheets | ||||||||
U.S. Dollars in thousands, except share data and per share data |
||||||||
As of March 31, 2018 |
As of December 31, 2017 |
|||||||
Unaudited |
Audited |
|||||||
Assets |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ |
2,631 |
$ |
13,021 |
||||
Marketable securities |
12,871 |
5,976 |
||||||
Other accounts receivable |
365 |
155 |
||||||
Total current assets |
15,867 |
19,152 |
||||||
Property and equipment, net |
433 |
491 |
||||||
Total assets |
$ |
16,300 |
$ |
19,643 |
||||
Liabilities and stockholders' equity |
||||||||
Current liabilities |
||||||||
Trade payables |
$ |
2,196 |
$ |
2,276 |
||||
Other accounts payable |
232 |
1,034 |
||||||
Short-term portion of deferred revenue |
270 |
538 |
||||||
Total current liabilities |
2,698 |
3,848 |
||||||
Stockholders' equity: |
||||||||
Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding: 14,472,414 shares as of March 31, 2018; 14,435,161 shares as of December 31, 2017 |
40 |
40 |
||||||
Additional paid-in capital |
92,723 |
92,381 |
||||||
Accumulated other comprehensive loss |
(36) |
(7) |
||||||
Accumulated deficit |
(79,125) |
(76,619) |
||||||
Total stockholders' equity |
13,602 |
15,795 |
||||||
Total liabilities and stockholders' equity |
$ |
16,300 |
$ |
19,643 |
GALMED PHARMACEUTICALS LTD. |
||||||||
Consolidated Statements of Operations (Unaudited) | ||||||||
U.S. Dollars in thousands, except share data and per share data |
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Three months ended |
||||||||
2018 |
2017 |
|||||||
Revenue |
$ |
268 |
$ |
268 |
||||
Research and development expenses |
1,944 |
2,743 |
||||||
General and administrative expenses |
883 |
789 |
||||||
Total operating expenses |
2,559 |
3,264 |
||||||
Financial income, net |
(53) |
(102) |
||||||
Net loss |
$ |
2,506 |
$ |
3,162 |
||||
Basic and diluted net loss per share from continuing operation |
$ |
0.17 |
$ |
0.26 |
||||
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share |
14,467,627 |
12,164,983 |
GALMED PHARMACEUTICALS LTD. |
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Consolidated Statements of Cash Flows (Unaudited) | ||||||||
U.S. Dollars in thousands |
||||||||
Three months ended |
||||||||
2018 |
2017 |
|||||||
Cash flow from operating activities |
||||||||
Net loss |
$ |
(2,506) |
$ |
(3,162) |
||||
Adjustments required to reconcile net loss to net cash used in operating activities |
||||||||
Depreciation and amortization |
59 |
60 |
||||||
Stock-based compensation expense |
330 |
361 |
||||||
Amortization of discount/premium on marketable securities |
9 |
(140) |
||||||
Loss from Realization of marketable securities |
3 |
78 |
||||||
Changes in operating assets and liabilities: |
||||||||
Increase in other accounts receivable |
(210) |
(52) |
||||||
Decrease in trade payables |
(80) |
(584) |
||||||
Decrease in other accounts payable |
(802) |
(167) |
||||||
Decrease in deferred revenue |
(268) |
(268) |
||||||
Net cash used in operating activities |
(3,465) |
(3,874) |
||||||
Cash flow from investing activities |
||||||||
Purchase of property and equipment |
(1) |
(7) |
||||||
Investment in available for sale securities |
(8,185) |
- |
||||||
Consideration from sale of available for sale securities |
1,249 |
2,444 |
||||||
Net cash provided in (used in) investing activities |
(6,937) |
2,437 |
||||||
Cash flow from financing activities |
||||||||
Proceeds from exercise of options |
12 |
- |
||||||
Net cash used in financing activities |
12 |
- |
||||||
Decrease in cash and cash equivalents |
(10,390) |
(1,437) |
||||||
Cash and cash equivalents at the beginning of the period |
13,021 |
3,097 |
||||||
Cash and cash equivalents at the end of the period |
$ |
2,631 |
$ |
1,660 |
||||
Supplemental disclosure of cash flow information: |
||||||||
Cash received from interest |
$ |
46 |
88 |
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. Many factors could cause Galmed's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the timing and cost of Galmed's ongoing Phase IIb ARREST Study, and planned Phase III trials for Aramchol, or whether Phase III trials will be conducted at all; completion and receiving favorable results of these Phase IIb ARREST Study and Phase III trials for Aramchol; regulatory action with respect to Aramchol by the FDA or the EMA; the commercial launch and future sales of Aramchol or any other future products or product candidates; Galmed's ability to comply with all applicable post-market regulatory requirements for Aramchol in the countries in which it seeks to market the product; Galmed's ability to achieve favorable pricing for Aramchol; Galmed's expectations regarding the commercial market for NASH in patients who are overweight or obese and have pre diabetes or type II diabetes mellitus; third-party payor reimbursement for Aramchol; Galmed's estimates regarding anticipated capital requirements and Galmed's needs for additional financing; market adoption of Aramchol by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol; the development and approval of the use of Aramchol for additional indications or in combination therapy; and Galmed's expectations regarding licensing, acquisitions and strategic operations. More detailed information about the risks and uncertainties affecting Galmed is contained under the heading "Risk Factors" included in Galmed's most recent Annual Report on Form 20-F filed with the SEC on March 13, 2018, 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.
SOURCE Galmed Pharmaceuticals Ltd.