Report of Foreign Issuer (6-k)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of November 2017

001-36345

(Commission File Number)

GALMED PHARMACEUTICALS LTD.

(Exact name of Registrant as specified in its charter)

16 Tiomkin St.

Tel Aviv 6578317, Israel

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover

Form 20-F or Form 40-F.

Form 20-F x Form 40-F ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(1): ____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(7): ____

This Form 6-K contains the quarterly report of Galmed Pharmaceuticals Ltd. (the “Company”), which includes the Company’s unaudited consolidated financial statements for the three and nine months ended September 30, 2017, together with related information and certain other information. The Company is not subject to the requirements to file quarterly or certain other reports under Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company does not undertake to file or cause to be filed any such reports in the future, except to the extent required by law.

On November 9, 2017, the Company issued a press release announcing the filing of its financial results for the three and nine months ended September 30, 2017 with the Securities and Exchange Commission. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

This Form 6-K and the text under the heading “Financial Summary - Third Quarter 2017 vs. Third Quarter 2016” in Exhibit 99.1 is incorporated by reference into the Company’s Registration Statement on Form S-8 filed with the Securities and Exchange Commission on August 11, 2015 (Registration No. 333-206292) and its Registration Statement on Form F-3 filed with the Securities and Exchange Commission on March 31, 2015 (Registration No. 333-203133).

FINANCIAL INFORMATION

Financial Statements

GALMED PHARMACEUTICALS LTD.

Consolidated Balance Sheets

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

	As of September 30, 2017			As of December 31, 2016
	Unaudited			Audited
Assets
Current assets
Cash and cash equivalents	$	2,614		$	3,097
Marketable securities		6,344			12,351
Other accounts receivable		171			284
Total current assets		9,129			15,732

Property and equipment, net		548			718

Total assets	$	9,677		$	16,450

Liabilities and stockholders' equity

Current liabilities
Trade payables	$	1,965		$	3,122
Other accounts payable		219			363
Short-term portion of deferred revenue		811			1,094
Total current liabilities		2,995			4,579

Long-term liabilities
Related parties		150			267
Long-term portion of deferred revenue		-			529
Total long-term liabilities		150			796

Stockholders' equity:
Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding: 12,733,512 shares as of September 30, 2017; 12,149,226 shares as of December 31, 2016		36			34
Additional paid-in capital		79,479			75,446
Accumulated other comprehensive loss		(8	)		(85	)
Accumulated deficit		(72,975	)		(64,320	)
Total stockholders' equity		6,532			11,075

Total liabilities and stockholders' equity	$	9,677		$	16,450

The accompanying notes are an integral part of the interim consolidated financial statements.

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,
	2017		2016			2017			2016
Revenue	$	273	$	193		$	811		$	193

Research and development expenses		2,331		3,342			7,421			10,086

General and administrative expenses		697		656			2,110			2,236

Total operating expenses		2,755		3,805			8,720			12,129

Financial expenses (income), net		46		(78	)		(65	)		(108	)

Loss before income taxes		2,801		3,727			8,655			12,021

Taxes on Income		-		105			-			106

Net loss	$	2,801	$	3,832		$	8,655		$	12,127

Basic and diluted net loss per share	$	0.23	$	0.34		$	0.71		$	1.09

Weighted-average number of shares outstanding used in computing basic and diluted net loss per share		12,364,249		11,150,023			12,274,536			11,101,360

The accompanying notes are an integral part of the interim consolidated financial statements.

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Comprehensive Loss (Unaudited)

U.S. Dollars in thousands

	Three months ended September 30,					Nine months ended September 30,
	2017			2016		2017			2016
Net loss	$	2,801		$	3,832	$	8,655		$	12,127

Other comprehensive loss (income):
Net unrealized loss (gain) on available for sale securities		(12	)		31		(77	)		(71	)

Comprehensive loss	$	2,789		$	3,863	$	8,578		$	12,056

The accompanying notes are an integral part of the interim consolidated financial statements.

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Changes in Stockholders’ Equity (Unaudited)

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

	Ordinary shares				Additional paid-in		Accumulated other Comprehensive			Accumulated
	Shares		Amount		capital		loss			Deficit			Total
Balance - December 31, 2016		12,149,226	$	34	$	75,446	$	(85	)	$	(64,320	)	$	11,075
Stock based compensation		-		-		1,066		-			-			1,066
Issuance of Ordinary Shares (*)		381,333		1		2,653		-			-			2,654
Options and Restricted stock units Exercise (**)		202,953		1		312		-			-			313
Unrealized gain from marketable securities		-		-		-		77			-			77
Net loss		-		-		-		-			(8,655	)		(8,655	)
Balance - September 30, 2017		12,733,512	$	36	$	79,477	$	(8	)	$	(72,975	)	$	6,530

(*) See note 3.4

(**) See note 3.5 and 3.6

The accompanying notes are an integral part of the interim consolidated financial statements.

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Cash Flows (Unaudited)

U.S. Dollars in thousands

	Nine months ended September 30,
	2017			2016
Cash flow from operating activities

Net loss	$	(8,655	)	$	(12,127	)
Adjustments required to reconcile net loss to net cash used in operating activities
Depreciation and amortization		180			118
Stock-based compensation expense		1,066			1,307
Amortization of discount/premium on marketable securities		(187	)		18
Loss from Realization of marketable securities		130			150
Changes in operating assets and liabilities:
Decrease in other accounts receivable		113			13
Decrease in trade payables		(1,157	)		(556	)
Decrease in other accounts payable		(144	)		(173	)
Increase (decrease) in related party		(117	)		45
Increase (decrease) in deferred revenue		(812	)		1,897
Net cash used in operating activities		(9,583	)		(9,305	)

Cash flow from investing activities
Purchase of property and equipment		(10	)		(26	)
Investment in securities, available for sale		(1,447	)		(2,480	)
Maturity of securities, available for sale		7,589			9,956
Net cash provided in (used in) investing activities		6,132			7,450

Cash flow from financing activities
Proceeds from issuance of stock offerings, net of issuance costs (*)		2,655			4,479
Proceeds from exercise of options (**)		313			255
Net cash used in financing activities		2,968			4,734

Increase (decrease) in cash and cash equivalents		(483	)		2,879
Cash and cash equivalents at the beginning of the year		3,097			4,156
Cash and cash equivalents at the end of the period	$	2,614		$	7,035

Supplemental disclosure of cash flow information:
Cash received from interest	$	169		$	319

(*) See note 3.4

(**) See note 3.5

The accompanying notes are an integral part of the interim consolidated financial statements.

GALMED PHARMACEUTICALS LTD.

Notes to Consolidated Financial Statements

Note 1 - Basis of presentation

Galmed Pharmaceuticals Ltd. (the “Company”) is a clinical-stage biopharmaceutical company focused on the development of a novel, once-daily, oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH, and other liver diseases.

The Company in its current legal structure was incorporated in Israel on July 31, 2013 as a privately held company, and formally commenced operations on February 2, 2014. However, the Company’s business has been operating since 2000 under a different group of companies established in 2000 (the “Group”). On February 2, 2014, upon a pre-ruling from the Israeli Tax Authorities, the Company underwent a reorganization (the “Reorganization”), pursuant to which all of the business of its predecessor, Galmed Holdings Inc., including net assets and shares in its wholly-owned subsidiary, Galmed 2000, Inc. were transferred to the Company. Contemporaneously, the Company effected a 729-for-1 stock split.

These unaudited interim consolidated financial statements have been prepared as of September 30, 2017 and for the three and nine month period then ended. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted. These unaudited interim consolidated financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Company for the year ended December 31, 2016 that are included in the Company's Annual Report on Form 20-F, filed with the Securities and Exchange Commission on March 23, 2017 (the "Annual Report"). The results of operations presented are not necessarily indicative of the results to be expected for the year ending December 31, 2017.

Note 2 - Summary of significant accounting policies

The significant accounting policies that have been applied in the preparation of the unaudited consolidated interim financial statements are identical to those that were applied in preparation of the Company’s most recent annual financial statements in connection with its Annual Report on Form 20-F.

Note 3 - Stockholders' Equity

In January 2017, the Company granted options to purchase 130,000 ordinary shares of the Company, NIS 0.01 par value per share, to certain officers and employees. The options are exercisable at $3.84 per share, have a 10 year term and vest over a period of four years. The aggregate grant date fair value of such options is approximately $376 thousand.

In April 2017, the Company granted options to purchase 30,000 ordinary shares of the Company, NIS 0.01 par value per share, to two of its consultants. The options have an exercise price ranging between $4.75 and $4.87 per share, have a 10 year term and vest over a period of between one to four years. The aggregate grant date fair value of such options is approximately $99 thousand.

In July 2017, the Company granted options to purchase 44,000 ordinary shares of the Company, NIS 0.01 par value per share, to employees and consultants. The options are exercisable at $6.57 per share, have a 10 year term and vest over a period of four years. The aggregate grant date fair value of such options is approximately $244 thousand.

In August 2017, the Company sold in a registered direct offering 332,038 ordinary shares of the Company, NIS 0.01 par value per share, at a price of $7.10. In a concurrent private placement, which closed in August and September 2017, the Company sold to two of the Company’s directors 49,295 ordinary shares, NIS 0.01 par value per share, at the same price. The aggregate gross proceeds received from the above mentioned offerings is approximately $2.7 million.

5 .

During the nine months ended September 30, 2017, certain officers, employees and former employees exercised options into 177,022 ordinary shares of the Company, NIS 0.01 par value per share, for total consideration of $313 thousand.

During the nine months ended September 30, 2017, restricted stock units held by certain officers, employees and former employees vested resulting in the issuance of 25,931 ordinary shares of the Company, NIS 0.01 par value per share.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

All references to “we,” “us,” “our,” “the Company” and “our Company”, in this Form 6-K are to Galmed Pharmaceuticals Ltd. and its subsidiaries, unless the context otherwise requires. All references to “shares” or “ordinary shares” are to our ordinary shares, NIS 0.01 nominal par value per share. All references to “Israel” are to the State of Israel. “U.S. GAAP” means the generally accepted accounting principles of the United States. Unless otherwise stated, all of our financial information presented in this Form 6-K has been prepared in accordance with U.S. GAAP. Any discrepancies in any table between totals and sums of the amounts and percentages listed are due to rounding. Unless otherwise indicated, or the context otherwise requires, references in this Form 6-K to financial and operational data for a particular year refer to the fiscal year of our company ended December 31 of that year.

Our reporting currency and financial currency is the U.S. dollar. In this Form 6-K, “NIS” means New Israeli Shekel, and “$,” “US$” and “U.S. dollars” mean United States dollars.

Cautionary Note Regarding Forward-Looking Statements

This Form 6-K contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should,” “anticipate,” “could,” “might,” “seek,” “target,” “will,” “project,” “forecast,” “continue” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements may be included in, among other things, various filings made by us with the SEC, press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the factors summarized below:

the timing and cost of our ongoing Phase IIb ARREST Study, and planned Phase III trials, for our product candidate, Aramchol ^TM (hereinafter referred to as “Aramchol”) for the treatment of patients who are overweight or obese and have pre diabetes or type II diabetes mellitus (hereinafter OD patients) with Non-Alcoholic Steato-Hepatitis, or NASH, 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 U.S. Food and Drug Administration, or FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling;

the commercial launch and future sales of Aramchol or any other future products or product candidates;

our ability to comply with all applicable post-market regulatory requirements for Aramchol in the countries in which we seek to market the product;

our ability to achieve favorable pricing for Aramchol;

our expectations regarding the commercial market for NASH in OD patients;

third-party payor reimbursement for Aramchol;

our estimates regarding anticipated capital requirements and our 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

our expectations regarding licensing, acquisitions and strategic operations.

We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the SEC on March 23, 2017 in greater detail under the heading “Risk Factors” and elsewhere in the Annual Report and this Form 6-K. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events.

All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

Overview

We are 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, as well as other liver associated disorders. We are 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 248 subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. Top line data from the ARREST Study are expected to be available during the second quarter of 2018.

We also sponsor the ARRIVE Study, a proof-of-concept Phase IIa clinical trial designed to evaluate the safety and efficacy of Aramchol in 50 patients with HIV-associated NAFLD (Non-Alcoholic Fatty Liver Disease) and lipodystrophy. The ARRIVE Study is an investigator-initiated trial, conducted at the University of California San Diego by Professor Rohit Loomba. Top line data from the ARRIVE Study are expected to be available during the first quarter of 2018. More information about the ARREST Study and the ARRIVE Study may be found on ClinicalTrials.gov identifiers: NCT02279524 and NCT02684591, respectively.

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 down regulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by down regulation of steatosis and directly on human collagen producing cells. Aramchol has been granted by the FDA Fast Track designation status for the treatment of NASH.

Financial Overview

We have funded our operations primarily through the sale of equity and debt securities (our debt securities have since been converted in whole into common equity; no debt remains on our balance sheet). At September 30, 2017, we had current assets of $9.1 million, which consists of cash and cash equivalents of $2.6 million and short-term investment securities of $6.3 million. This compares with current assets of $15.7 million at December 31, 2016, which consists of cash and cash equivalents of $3.1 million and short-term investment securities of $12.4 million. During October 2017, we raised $1.1 million in net proceeds under our “at-the-market” equity offering program (the “ATM Offering”). Although we provide no assurance, we believe that such existing funds will be sufficient to continue our business and operations as currently conducted through 2018. However, we will continue to incur operating losses, which may be substantial over the next several years, and we may need to obtain additional funds to further develop our research and development programs.

Recent Developments

During the third quarter of 2017, we announced the following developments:

In August 2017, we sold in a registered direct offering to existing investors 332,038 ordinary shares at a price of $7.10 per share. In a concurrent private placement that closed in August and September 2017, we sold to our Chairman of the Board and an additional board member 49,295 ordinary shares at the same price as the price per share in the registered direct offering. The aggregate gross proceeds received from these offerings was approximately $2.7 million.

Since the end of the third quarter of 2017 (subsequent to the balance sheet date), we had the following developments:

In October 2017, we announced the publication of a paper entitled “Role of Aramchol™ in steatohepatitis and fibrosis in mice” in Hepatology Communications, a peer-reviewed, online open access journal.

Dr. Tali Gorfine, our CMO, who was previously on medical leave, has returned to work.

As of the beginning of November, 2017, all patients have been randomized in the ARRIVE study. ARRIVE is a proof-of-concept clinical trial that is evaluating the safety and efficacy of Aramchol in 50 patients with HIV-associated lipodystrophy and NAFLD. ARRIVE is a randomized, double-blinded, placebo-controlled, proof-of-concept Phase IIa clinical trial, comparing Aramchol at 600 mg versus placebo over 12 weeks. It is an investigator-initiated study being conducted by Professor Rohit Loomba at the NAFLD Research Center, at the University of California San Diego. The primary end point is improvement in hepatic steatosis as measured by MRI. Secondary endpoints measure improvements in total body fat, metabolic profile, and liver biochemistry. Release of topline data is expected in the first quarter of 2018.

Revenues

On July 28, 2016, we entered into a license agreement, referred to herein as the Samil Agreement, with Samil Pharma. Co., Ltd. for the commercialization of Aramchol (with the option to manufacture) in the Republic of Korea. Under the terms of the Samil Agreement, we have received upfront payments of $2.1 million, and may be eligible to receive up to $6.0 million in additional payments for development and regulatory milestones for Aramchol in the licensed territories. For accounting purposes, the upfront payment has been recorded as deferred revenue. The deferred revenue is then amortized on a straight-line basis over the contractual period and milestone payments are recognized once earned.

Costs and Operating Expenses

Our current costs and operating expenses consist of two components: (i) research and development expenses; and (ii) general and administrative expenses.

Research and Development Expenses

Our research and development expenses consist primarily of outsourced development expenses, salaries and related personnel expenses and fees paid to external service providers, patent-related legal fees, costs of preclinical studies and clinical trials and drug and laboratory supplies. We charge all research and development expenses to operations as they are incurred. We expect our research and development expenses to remain our primary expenses in the near future as we continue to conduct clinical activities, as well as develop our products. Increases or decreases in research and development expenditures are attributable to the number or duration of the preclinical and clinical studies that we conduct.

We expect that a large percentage of our research and development expense in the future will be incurred in support of our current and future clinical and, to a lesser extent, preclinical development projects. Due to the inherently unpredictable nature of clinical and preclinical development processes, we are unable to estimate with any certainty the costs we will incur in the continued development of Aramchol for NASH and other indications in our pipeline for potential commercialization. Clinical development timelines, the probability of success for any given study, and development costs can differ materially from expectations. We expect to continue to conduct additional clinical trials for Aramchol, and to test Aramchol in preclinical studies for toxicology, safety and efficacy.

While we are currently focused on advancing our product development, our future research and development expenses will depend on the clinical success of Aramchol, as well as ongoing assessments of Aramchol’s commercial potential. As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for Aramchol in certain indications in order to focus our resources on more promising indications for Aramchol. Completion of clinical trials may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of Aramchol.

We expect our research and development expenses to increase in the future from current levels as we continue the advancement of our clinical product development and potentially in-license new product candidates. The lengthy process of completing clinical trials and seeking regulatory approval for Aramchol requires the expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Because of the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects.

General and Administrative Expenses

General and administrative expenses consist primarily of compensation for employees in executive and operational roles, including accounting, finance, legal and investor relations. Our other significant general and administrative expenses include non-cash stock-based compensation costs and facilities costs (including the rental expense for our offices in Tel Aviv, Israel), professional fees for outside accounting and legal services, travel costs, investors relations, insurance premiums and depreciation.

We expect our general and administrative expenses, such as accounting and legal fees, to increase as we grow and operate as a public company, and we expect an increase in our salary and benefits expense as a result of the additional management and operational personnel that we hired since our initial public offering to address the anticipated growth of our company, as well as performance-based salary increases and bonuses, if at all.

Financial Income, Net

Our financial income consists of interest income from marketable securities and short-term bank deposits. Our financial expense consists of bank fees.

Results of Operations

The table below provides our results of operations for the three and nine months ended September 30, 2017 as compared to the three and nine months ended September 30, 2016.

	Three months ended September 30,						Nine months ended September 30,
	2017			2016			2017			2016
	(unaudited)			(unaudited)			(unaudited)			(unaudited)
	(In thousands, except per share data)

Revenue		273			193			811			193
Research and development expenses		2,331			3,342			7,421			10,086
General and administrative expenses		697			656			2,110			2,236
Total operating expenses		2,755			3,805			8,720			12,129
Financial expenses (income), net		46			(78	)		(65	)		(108	)
Taxes on income		-			105			-			106
Net loss		2,801			3,832			8,655			12,127
Other comprehensive (income) loss:		(12	)		31			(77	)		(71	)
Comprehensive loss		2,789			3,863			8,578			12,056
Basic and diluted net loss per share	$	0.23		$	0.34		$	0.71		$	1.09

Revenue

Licensing revenue was approximately $273 thousand and approximately $811 thousand for the three and nine months ended September 30, 2017, respectively, compared to $193 thousand for the three and nine months ended September 30, 2016. The above mentioned revenue resulted from the amortization of the up-front payments under the license agreement with Samil Pharm.

Research and Development Expenses

Our research and development expenses amounted to approximately $2.3 million and approximately $7.4 million during the three and nine months ended September 30, 2017, respectively, representing a decrease of approximately $1.0 million, or 30%, and approximately $2.7 million, or 26%, respectively, compared to approximately $3.3 million and approximately $10.1 million for the comparable period in 2016.

The decrease during the three months ended September 30, 2017 primarily resulted from a decrease of approximately $1.0 million in subcontractor expenses in connection with the ARREST study, as compared to such expenses for the comparable period in 2016.

The decrease during the nine months ended September 30, 2017 primarily resulted from a decrease of approximately $1.4 million in subcontractor expenses in connection with the ARREST study, as well as decrease of approximately $828 thousand in drug development related expenses, as compared to such expenses for the comparable period in 2016.

General and Administrative Expenses

Our general and administrative expenses amounted to approximately $697 thousand and approximately $2.1 million during the three and nine months ended September 30, 2017, respectively, representing an increase of approximately $41 thousand, or 6%, and a decrease of $126 thousand, or 6%, respectively, compared to approximately $656 thousand and approximately $2.2 million for the comparable period in 2016.

The increase during the three months ended September 30, 2017 primarily resulted from an increase of approximately $34 thousand in professional fees, as compared to such expenses for the comparable period in 2016.

The decrease during the nine months ended September 30, 2017 primarily resulted from a decrease of approximately $97 thousand in professional fees, as well as a decrease of $67 thousand in salaries and benefits expenses, as compared to such expenses for the comparable period in 2016.

Operating Loss

As a result of the foregoing, for the three and nine months ended September 30, 2017, our operating loss was approximately $2.8 million and approximately $8.7 million, respectively, representing a decrease of $1.0 million, or 26%, and $3.4 million, or 28%, respectively, as compared to our operating loss for the comparable prior year period. These decreases for the three and nine months ended September 30, 2017 primarily resulted from a decrease in our research and development expenses as well as from our licensing revenue.

Financial (Income) Expense, Net

Our financial (income) expense amounted to approximately $46 thousand and approximately ($65) thousand during the three and nine months ended September 30, 2017, respectively, compared to ($78) thousand and ($108) thousand for the comparable period in 2016.

The decrease during the three months ended September 30, 2017 primarily resulted from an increase in currency exchange rates expenses, as compared to such expenses for the comparable period in 2016.

The decrease during the nine months ended September 30, 2017 primarily resulted from a decrease in financial income from marketable securities, as compared to such expenses for the comparable period in 2016.

Net Loss

As a result of the foregoing, for the three and nine months ended September 30, 2017, our net loss was $2.8 million and $8.7 million, respectively, representing a decrease of $1.0 million, or 26%, and $3.4 million, or 28%, respectively, as compared to our net loss for the comparable prior year period.

Liquidity and Capital Resources

To date, we have funded our operations primarily through the sale of equity and debt securities (our debt securities have since been converted in whole into common equity; no debt remains on our balance sheet) including since March 18, 2014, the sale of our ordinary shares in our initial public offering (approximately $39.9 million of net proceeds), in our ATM Offering (approximately $5.6 million of net proceeds), in an RDO and concurrent private placement (approximately $2.7 million of net proceeds), and in the upfront payment received from Samil (approximately $2.1 million). Furthermore, under the ATM Offering, we may still raise up to approximately $10.1 million through the sale of additional ordinary shares.

We have incurred substantial losses since our inception. As of September 30, 2017, we had an accumulated deficit of approximately $73.0 million and positive working capital (current assets less current liabilities) of approximately $6.1 million. We expect that operating losses will continue for the foreseeable future.

As of September 30, 2017, we had cash and cash equivalents of approximately $2.6 million and marketable securities of approximately $6.3 million invested in accordance with our investment policy, totaling approximately $9.0 million, as compared to approximately $3.1 million and approximately $12.4 million as of December 31, 2016, totaling approximately $15.5 million. The decrease is mainly attributable to our net loss of $8.7 million during the nine months ended September 30, 2017, partially offset by net proceeds of approximately $2.7 million raised through our RDO and concurrent private placement.

We had negative cash flow from operating activities of approximately $9.6 million for the nine months ended September 30, 2017, as compared to negative cash flow from operating activities of approximately $9.3 million for the nine months ended September 30, 2016. The negative cash flow from operating activities for the nine months ended September 30, 2017 is mainly attributable to our net loss of approximately $8.7 million, and as well, a decrease of approximately $2.1 million of trade payables, other accounts payables and upfront fee from license agreement; partially offset by non-cash stock based compensation expenses of approximately $1.1 million.

We had positive cash flow from investing activities of approximately $6.1 million for the nine months ended September 30, 2017, as compared to positive cash flow from investing activities of approximately $7.5 million for the nine months ended September 30, 2016. The positive cash flow from investing activities for both periods was primarily due to the net consideration of marketable securities.

We had positive cash flow from financing activities of approximately $3.0 million for the nine months ended September 30, 2017, as compared to positive cash flow from financing activities of approximately $4.7 million thousand for the nine months ended September 30, 2016. The positive cash flow from financing activities for both periods was due to the proceeds from the issuance of share offerings, net of issuance costs; as well as proceeds from exercise of options.

Although there can be no assurance, we believe that our existing cash resources will be sufficient to fund our projected cash requirements through 2018. Nevertheless, we will require significant additional financing in the future to fund our operations if and when we progress into Phase III trials of Aramchol and clinical trials for other indications, obtain regulatory approval of Aramchol and commercialize the drug. Our management may choose to raise such additional capital, which would be authorized by our board of directors, at their discretion.

Trend Information

We are a development stage company, and it is not possible for us to predict with any degree of accuracy the outcome of our research, development or commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any significant trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on our net sales or revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause financial information to not necessarily be indicative of future operating results or financial condition. However, to the extent possible, certain trends, uncertainties, demands, commitments and events are in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.

Controls and Procedures

As a “foreign private issuer”, we are only required to conduct the evaluations required by Rules 13a-15(b) and 13a-15(d) of the Exchange Act as of the end of each fiscal year and therefore have elected not to provide disclosure regarding such evaluations at this time.

EXHIBIT INDEX

Exhibit No.		Description

99.1		Press Release, dated November 9, 2017

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.