Full Press Release Details
Pharmaceuticals Reports Second Quarter 2016 Financial Results and Provides Business Update
- Conference Call and Webcast Today at
8:30 a.m. EDT / 5:30 a.m. PDT -
TEL AVIV, Israel, August 3, 2016
- 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 and six months ended June 30, 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 AramcholTM.
Financial Summary - Second Quarter 2016 vs. Second Quarter
"Importantly, and as reflected in
the significant increase in R&D activities, and associated expenses, we believe that the momentum we are currently experiencing
in the ARREST Study continues to support our previously stated guidance regarding patient recruitment," stated Allen Baharaff,
Galmed's President and Chief Executive Officer. "As of July 31, 2016, we had randomized 132 patients and have another
27 subjects that are eligible to be randomized. In addition, 41 subjects are currently in the screening process, which normally
takes between 6-8 weeks. Based on this we continue to expect to complete the full recruitment of 240 patients by the end of the
fourth quarter, 2016."
As previously disclosed on July 28, 2016,
we executed a license agreement (the "Agreement") with SAMIL Pharm. Co., Ltd. ("Samil") for an exclusive,
royalty-bearing license for the commercialization of AramcholTM (with an option to manufacture) for the treatment of
fatty liver indications including nonalcoholic steatohepatitis, or NASH, in the Republic of Korea (the "License").
According to the Agreement, Galmed will receive an up-front fee of $2.0 million. Samil has also agreed to pay additional clinical-
and regulatory-based milestone payments, which may aggregate up to an additional $6.0 million, as well as tiered, double-digit
royalties payable on sales (under certain limitations). The funds provided by this Agreement will provide additional financing
for Galmed's development programs. Additionally, following the ARREST Study, Samil has an option to extend the License to
Vietnam, which, if exercised, would increase the clinical- and regulatory-based milestone payments.
addition, we also announced on August 1, 2016 that we had appointed Professor Ran Oren, M.D., as Chief Medical Officer ("CMO"),
effective as of August 1, 2016. Dr. Oren currently serves as Professor of Gastroenterology & Hepatology at the Faculty of Medicine,
the Hebrew University of Jerusalem, Israel, as well as the Head of the Institute of Gastroenterology
and Liver Disease at Hadassah medical center, Jerusalem, Israel ("Hadassah"). Dr. Oren will serve as CMO while maintaining
his ongoing commitments at Hebrew University and Hadassah.
Conference Call & Webcast:
Wednesday, August 3rd, 2016, 8:30
am Eastern Time / 5:30 am Pacific Time
Participant Dial-In Numbers:
| Toll-Free: | +1-888-364-3108 |
| Toll/International: | +1-719-457-2697 |
| Conference ID: | 3984671 |
| Webcast: | http://galmedpharma.investorroom.com/events |
Replay, available until August
Replay Dial-In Numbers:
| Toll-Free: | +1-877-870-5176 |
| Toll/International: | +1-858-384-5517 |
| Passcode: | 3984671 |
About Galmed Pharmaceuticals Ltd.:
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, AramcholTM, 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 AramcholTM 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 risks and uncertainties associated with the timing, progress and results of the Company's
research, preclinical studies and clinical trials as well as risks and uncertainties 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.
GALMED PHARMACEUTICALS LTD.
Consolidated Balance Sheets
U.S. Dollars in thousands, except share data and per share
| As of June 30, 2016 | As of December 31, 2015 | |||||||
| Unaudited | Audited | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 2,946 | $ | 4,156 | ||||
| Marketable securities | 13,736 | 18,845 | ||||||
| Other accounts receivable | 479 | 379 | ||||||
| Total current assets | 17,161 | 23,380 | ||||||
| Property and equipment, net | 840 | 883 | ||||||
| Total assets | $ | 18,001 | $ | 24,263 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities | ||||||||
| Trade payables | $ | 2,965 | $ | 2,259 | ||||
| Other accounts payable | 388 | 282 | ||||||
| Total current liabilities | 3,353 | 2,541 | ||||||
| Long-term liabilities | ||||||||
| Related parties | 222 | 177 | ||||||
| Total long-term liabilities | 222 | 177 | ||||||
| Stockholders' equity: | ||||||||
| Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding: 11,102,753 shares as of June 30, 2016; 11,100,453 shares as of December 31, 2015 | 32 | 32 | ||||||
| Additional paid-in capital | 70,160 | 69,086 | ||||||
| Accumulated other comprehensive loss | (104 | ) | (206 | ) | ||||
| Accumulated deficit | (55,662 | ) | (47,367 | ) | ||||
| Total stockholders' equity | 14,426 | 21,545 | ||||||
| Total liabilities and stockholders' equity | $ | 18,001 | $ | 24,263 |
GALMED PHARMACEUTICALS LTD.
Consolidated Statements
of Operations (Unaudited)
U.S. Dollars in thousands, except share data and per share
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Research and development expenses | $ | 3,360 | $ | 1,562 | $ | 6,744 | $ | 2,993 | ||||||||
| General and administrative expenses | 861 | 967 | 1,580 | 2,040 | ||||||||||||
| Total operating expenses | 4,221 | 2,529 | 8,324 | 5,033 | ||||||||||||
| Financial expenses (income), net | 89 | (175 | ) | (30 | ) | (216 | ) | |||||||||
| Loss before income taxes | 4,310 | 2,354 | 8,294 | 4,817 | ||||||||||||
| Taxes on Income | 1 | - | 1 | - | ||||||||||||
| Net loss | $ | 4,311 | $ | 2,354 | $ | 8,295 | $ | 4,817 | ||||||||
| Basic and diluted net loss per share | $ | 0.39 | $ | 0.21 | $ | 0.75 | $ | 0.43 | ||||||||
| Weighted-average number of shares outstanding used in computing basic and diluted net loss per share | 11,100,853 | 11,100,453 | 11,100,655 | 11,100,453 |
GALMED PHARMACEUTICALS LTD.
Consolidated Statements
of Cash Flows (Unaudited)
U.S. Dollars in thousands
| Six months ended June 30, | ||||||||
| 2016 | 2015 | |||||||
| Cash flow from operating activities | ||||||||
| Net loss | $ | (8,295 | ) | $ | (4,817 | ) | ||
| Adjustments required to reconcile net loss to net cash used in operating activities | ||||||||
| Depreciation and amortization | 66 | 13 | ||||||
| Stock-based compensation expense | 1,063 | 890 | ||||||
| Amortization of discount/premium on marketable securities | 35 | (27 | ) | |||||
| Loss from Realization of marketable securities | 138 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Decrease (Increase) in other accounts receivable | 43 | (220 | ) | |||||
| Increase (decrease) in trade payables | 706 | 354 | ||||||
| Increase in other accounts payable | 106 | 29 | ||||||
| Increase (decrease) in related party | 45 | (206 | ) | |||||
| Net cash used in operating activities | (6,093 | ) | (3,984 | ) | ||||
| Cash flow from investing activities | ||||||||
| Purchase of property and equipment | (23 | ) | (154 | ) | ||||
| Maturity of short term deposit | - | 6,000 | ||||||
| Investment in securities, available for sale | (1,212 | ) | (21,839 | ) | ||||
| Maturity of securities, available for sale | 6,250 | 3,565 | ||||||
| Net cash provided in (used in) investing activities | 5,015 | (12,428 | ) | |||||
| Cash flow from financing activities | ||||||||
| Issuance of ordinary shares | 11 | - | ||||||
| Deferred Issuance costs | (143 | ) | - | |||||
| Net cash used in financing activities | (132 | ) | - | |||||
| Increase (decrease) in cash and cash equivalents | 1,210 | (16,412 | ) | |||||
| Cash and cash equivalents at the beginning of the year | 4,156 | 23,736 | ||||||
| Cash and cash equivalents at the end of the period | $ | 2,946 | $ | 7,324 | ||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash received from interest | $ | 223 | 245 |
GALMED PHARMACEUTICALS LTD.
Notes to Consolidated Statements
of Operations (unaudited)
U.S. Dollars in thousands
and Development Expenses:
| Three months ended June 30, | ||||||||
| 2016 | 2015 | |||||||
| (in thousands) | ||||||||
| Chemistry and formulation studies | $ | 210 | $ | 325 | ||||
| Salaries and benefits | 240 | 203 | ||||||
| Stock-based compensation | 523 | 35 | ||||||
| Research and preclinical studies | 162 | 144 | ||||||
| Clinical studies | 2,043 | 783 | ||||||
| Regulatory and other expenses | 183 | 72 | ||||||
| $ | 3,360 | $ | 1,562 |
and Administrative Expenses:
| Three months ended June 30, | ||||||||
| 2016 | 2015 | |||||||
| (in thousands) | ||||||||
| Stock-based compensation | $ | 267 | $ | 296 | ||||
| Professional fees | 225 | 222 | ||||||
| Salaries and benefits | 212 | 188 | ||||||
| Rent and office-maintenance fees | 71 | 110 | ||||||
| Investor relations and business Development | 83 | 148 | ||||||
| Other | 3 | 3 | ||||||
| $ | 861 | $ | 967 |