Full Press Release Details
Galmed Pharmaceuticals Announces the
Commencement of Patient Screening in the
ARREST Study in the United States and Latin America, and
Reports Second Quarter 2015 Financial Results
- Conference Call and Webcast Today at
8:30 a.m. EDT / 5:30 a.m. PDT -
TEL AVIV, Israel, August 13, 2015 - Galmed Pharmaceuticals
Ltd. (Nasdaq: GLMD) ("Galmed"), a clinical-stage biopharmaceutical company focused on the development of a once-daily,
oral therapy for the treatment of liver diseases, today announced that it has commenced patient screening for the ARREST Study
in the United States and Latin America, as well as reported financial results for the three and six months ended June 30, 2015.
Financial Summary - Second Quarter 2015 vs. Second
"The ARREST Study has made significant strides in the
second quarter," stated Allen Baharaff, Galmed's President and Chief Executive Officer. "We now have received
country approval in five out of our expected nine countries to be included in the ARREST Study, including the United States, Germany,
France, Chile and Israel. Currently, fifty-two (52) sites out of our expected seventy three (73) sites have been approved by their
respective Ethics Committees.
Importantly, patient screening has now commenced in the United
States and Latin America, and remains ongoing in Israel. Regarding our activities in Europe, we expect our first patients to be
screened in September.
We remain confident that we will have enrolled the first 120
patients in the trial by the end of 2015, which we believe should allow us to stay on track for releasing the interim results around
Based on the trial's protocol, 240 patients will need
to have completed 12 months of treatment of AramcholTM, followed by a three month follow-up period in order to complete
the study. We will then need several weeks to complete the statistical analysis before we release the data. Based on our current
estimates, therefore, we now believe that top-line data will be available in the third quarter of 2017.
Finally, we would like to formally announce the appointment
of Dr. Michal Ayalon who will serve as the Company's Vice President, Research and Development. Dr. Ayalon will lead the initiation
of our pipeline and next generation molecules. We intend to share our advancements in these efforts during the balance of this
Prior to joining Galmed, Dr. Ayalon led the development of a
Phase II, GI/Inflammatory investigational drug as Vice President Product Development at Immune Pharmaceuticals. Dr. Ayalon previously
led the development and discovery of multiple products in inflammatory and metabolic diseases at BioLineRx, Ltd. and Compugen Ltd.
Dr. Ayalon earned her PhD in Biology from Tel-Aviv University, MSc from the Department of Cell Research and Immunology at Tel Aviv
University and a BSc in Life Sciences from Tel Aviv University; she gained post-doctoral training at the Weizmann Institute of
Science. We are happy to have Dr. Ayalon aboard and wish her much success in accomplishing our shared objectives.
Mr. Baharaff concluded, "timely execution of the ARREST
Study remains our main goal. With the rapid advancement of the regulatory approvals, 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. EDT / 5:30 a.m. PDT 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 +1-888-503-8175 from the United States
or +1-719-457-2085 for international callers, and use Conference ID 6082132. A replay will be available through August 27, 2015,
by dialing +1-877-870-5176 (United States) or +1-858-384-5517 (international); Passcode 6082132. A webcast will also be available
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, 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.
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.
GALMED PHARMACEUTICALS LTD.
Consolidated Balance Sheets
U.S. Dollars in thousands, except share data and per share
| As of June 30, 2015 | As of December 31, 2014 | |||||||
| Unaudited | Audited | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 7,324 | $ | 23,736 | ||||
| Short-term deposit | - | 6,000 | ||||||
| Marketable securities | 20,486 | 2,250 | ||||||
| Other accounts receivable | 385 | 165 | ||||||
| Total current assets | 28,195 | 32,151 | ||||||
| Property and equipment, net | 915 | 774 | ||||||
| Total assets | $ | 29,110 | $ | 32,925 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities | ||||||||
| Trade payables | $ | 1,229 | $ | 875 | ||||
| Other accounts payable | 272 | 243 | ||||||
| Total current liabilities | 1,501 | 1,118 | ||||||
| Long-term liabilities | ||||||||
| Related parties | 194 | 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 | 69,006 | 68,116 | ||||||
| Accumulated other comprehensive income (loss) | (61 | ) | 4 | |||||
| Accumulated deficit | (41,562 | ) | (36,745 | ) | ||||
| Total stockholders' equity | 27,415 | 31,407 | ||||||
| Total liabilities and stockholders' equity | $ | 29,110 | $ | 32,925 |
GALMED PHARMACEUTICALS LTD.
Consolidated Statements
of Operations (unaudited)
U.S. Dollars in thousands, except share data and per share
| Six months ended June 30, | Three months ended June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Research and development expenses | $ | 2,993 | $ | 2,747 | $ | 1,562 | $ | 1,245 | ||||||||
| General and administrative expenses | 2,040 | 1,151 | 967 | 518 | ||||||||||||
| Total operating expenses | 5,033 | 3,898 | 2,529 | 1,763 | ||||||||||||
| Financial expenses (income), net | (216 | ) | 20 | (175 | ) | (6 | ) | |||||||||
| Net loss | $ | 4,817 | $ | 3,918 | $ | 2,354 | $ | 1,757 | ||||||||
| Basic and diluted net loss per share from continuing operations | $ | 0.43 | $ | 0.41 | $ | 0.21 | $ | 0.14 | ||||||||
| Weighted-average number of shares outstanding used in computing basic and diluted net loss per share | 11,100,453 | 9,553,684 | 11,100,453 | 11,100,453 |
GALMED PHARMACEUTICALS LTD.
Consolidated Statements of Cash Flows (Unaudited)
U.S. Dollars in thousands, except share data and per share
| Six months ended June 30, | ||||||||
| 2015 | 2014 | |||||||
| Cash flow from operating activities | ||||||||
| Net loss | $ | (4,817 | ) | $ | (3,918 | ) | ||
| Adjustments required to reconcile net loss to net cash used in operating activities | ||||||||
| Depreciation and amortization | 13 | 4 | ||||||
| Stock-based compensation expense | 890 | 361 | ||||||
| Amortization of investment premium, net | (27 | ) | - | |||||
| Changes in operating assets and liabilities: | ||||||||
| Increase in other accounts receivable | (220 | ) | (45 | ) | ||||
| Increase (decrease) in trade payables | 354 | (1,054 | ) | |||||
| Increase in other accounts payable | 29 | 53 | ||||||
| Increase (decrease) in related party | (206 | ) | 20 | |||||
| Net cash used in operating activities | (3,984 | ) | (4,579 | ) | ||||
| Cash flow from investing activities | ||||||||
| Purchase of property and equipment | (154 | ) | (15 | ) | ||||
| Maturity of short term deposit | 6,000 | |||||||
| Investment in securities, available for sale | (21,839 | ) | - | |||||
| Maturity of securities, available for sale | 3,565 | - | ||||||
| Net cash used in investing activities | (12,428 | ) | (15 | ) | ||||
| 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 | (16,412 | ) | 37,262 | |||||
| Cash and cash equivalents at the beginning of the year | 23,736 | 137 | ||||||
| Cash and cash equivalents at the end of the period | $ | 7,324 | $ | 37,399 | ||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash received from interest | $ | 245 | - |
GALMED PHARMACEUTICALS LTD.
Notes to Consolidated Statements of Operations (unaudited)
U.S. Dollars in thousands
Research and development expense:
| Six months ended June 30, | Three months ended June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Chemistry and formulation studies | $ | 712 | $ | 1,721 | $ | 325 | $ | 453 | ||||||||
| Salaries and benefits | 361 | 210 | 203 | 210 | ||||||||||||
| Stock-based compensation | 128 | - | 35 | - | ||||||||||||
| Research and preclinical studies | 265 | 119 | 144 | 85 | ||||||||||||
| Clinical studies | 1,231 | 254 | 783 | 97 | ||||||||||||
| Regulatory and other expenses | 296 | 443 | 72 | 400 | ||||||||||||
| Total R&D expenses | $ | 2,993 | $ | 2,747 | $ | 1,562 | $ | 1,245 |
General and administrative expenses:
| Six months ended June 30, | Three months ended June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Stock-based compensation | $ | 762 | $ | 360 | $ | 296 | $ | 151 | ||||||||
| Professional fees | 458 | 361 | 222 | 183 | ||||||||||||
| Salaries and benefits | 356 | 240 | 188 | 34 | ||||||||||||
| Rent and office-maintenance fees | 171 | 83 | 110 | 68 | ||||||||||||
| Investor relations and business development | 285 | 88 | 148 | 65 | ||||||||||||
| Other | 8 | 19 | 3 | 17 | ||||||||||||
| Total G&A expenses | $ | 2,040 | $ | 1,151 | $ | 967 | $ | 518 |