6-K

Galmed Pharmaceuticals Ltd. (GLMD)

6-K 2024-08-28 For: 2024-06-30
View Original
Added on April 06, 2026

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 August 2024

001-36345

(Commission File Number)

GALMED

PHARMACEUTICALS LTD.

(Exact name of Registrant as specified in its charter)

16Abba Hillel Road, Ramat Gan, Israel 5250608

(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 ☒ Form 40-F ☐

This Form 6-K contains the quarterly report of Galmed Pharmaceuticals Ltd. (the “Company”), which includes the Company’s unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2024, 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.

This

Form 6-K is incorporated by reference into the Company’s Registration Statement on Form S-8 (Registration No. 333-206292 and 333-227441) and the Company’s Registration Statement on Form F-3 (Registration No. 333-272722).

FINANCIAL

INFORMATION

FinancialStatements

GALMED

PHARMACEUTICALS LTD.

InterimCondensed Consolidated Balance Sheets (Unaudited)

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

As<br> of As<br> of
June<br> 30, 2024 December<br> 31, 2023
Assets
Current<br> assets
Cash<br> and cash equivalents $ 1,837 $ 2,861
Restricted<br> Cash 118 117
Short-term<br> deposit 2,046 2,253
Marketable<br> debt securities 5,940 7,528
Other<br> receivables 135 480
Total<br> current assets 10,076 13,239
Right<br> of use assets - 42
Property<br> and equipment, net - 83
Investment<br> in associate at fair value 3,265 3,265
Total<br> non-current assets 3,265 3,390
Total<br> assets $ 13,341 $ 16,629
Liabilities<br> and stockholders’ equity
Current<br> liabilities
Trade<br> payables $ 1,203 $ 1,879
Other<br> payables 351 871
Total<br> current liabilities 1,554 2,750
Stockholders’<br> equity
Ordinary shares par value NIS 0.15 per share; Authorized 20,000,000; Issued and outstanding: 6,358,747 shares as of June 30, 2024 and 5,045,324 shares as of December 31, 2023 263 209
Additional<br> paid-in capital 207,305 207,076
Accumulated<br> other comprehensive loss (435 ) (454 )
Accumulated<br> deficit (195,346 ) (192,952 )
Total<br> stockholders’ equity 11,787 13,879
Total<br> liabilities and stockholders’ equity $ 13,341 $ 16,629

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

GALMED

PHARMACEUTICALS LTD.

InterimCondensed Consolidated Statements of Operations (Unaudited)

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

2024 2023 2024 2023
Three<br> months ended June 30, Six<br> months ended June 30,
2024 2023 2024 2023
Research and development expenses 534 809 1,169 1,892
General and administrative expenses 688 1,062 1,454 1,981
Total operating expenses 1,222 1,871 2,623 3,873
Financial income, net (103 ) (278 ) (229 ) (450 )
Net loss $ 1,119 $ 1,593 $ 2,394 $ 3,423
Basic and diluted net loss per share $ 0.18 $ 0.95 $ 0.41 $ 2.04
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share 6,294,748 1,680,232 5,878,432 1,680,232

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

GALMED

PHARMACEUTICALS LTD.

InterimCondensed Consolidated Statements of Comprehensive Loss (Unaudited)

U.S.Dollars in thousands

2024 2023 2024 2023
Three<br> months ended June 30, Six<br> months ended June 30,
2024 2023 2024 2023
Net loss $ 1,119 $ 1,593 $ 2,394 $ 3,423
Other comprehensive loss:
Net unrealized loss (gain) on available for sale securities (20 ) 17 (19 ) (83 )
Comprehensive loss $ 1,099 $ 1,610 $ 2,375 $ 3,340

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

GALMED

PHARMACEUTICALS LTD.

ConsolidatedStatements of Changes in Stockholders’ Equity (Unaudited)

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

Shares Amount capital loss Deficit Total
Ordinary shares Additional<br><br> <br>paid-in Accumulated<br><br> <br>other<br><br> <br>Comprehensive Accumulated
Shares Amount capital loss Deficit Total
Balance - December 31, 2023 5,045,324 $ 209 $ 207,076 $ (454 ) $ (192,952 ) $ 13,879
Exercise of pre-funded warrants 964,330 40 (40 ) - - -
Stock-based compensation - - 153 - - 153
Unrealized loss from marketable debt securities - - - (1 ) - (1 )
Net loss - - - - (1,275 ) (1,275 )
Balance - March 31, 2024 6,009,654 $ 249 $ 207,189 $ (455 ) $ (194,227 ) $ 12,756
Exercise of pre-funded warrants 349,093 14 (14 ) - - -
Stock-based compensation - - 130 - - 130
Unrealized gain from marketable debt securities - - - 20 - 20
Net loss - - - - (1,119 ) (1,119 )
Balance - June 30, 2024 6,358,747 $ 263 $ 207,305 $ (435 ) $ (195,346 ) $ 11,787
Accumulated
--- --- --- --- --- --- --- --- --- --- --- --- --- --- --- ---
Additional other
Ordinary shares paid-in Comprehensive Accumulated
Shares Amount capital loss Deficit Total
Balance – December 31, 2022 1,692,342 $ 70 $ 200,138 $ (745 ) $ (186,040 ) $ 13,423
Stock based compensation - - 297 - - 297
Unrealized gain from marketable debt securities - - 100 - 100
Net loss (1,830 ) (1,830 )
Balance – March 31, 2023 1,692,342 $ 70 $ 200,435 $ (645 ) $ (187,870 ) $ 11,990
Balance 1,692,342 $ 70 $ 200,435 $ (645 ) $ (187,870 ) $ 11,990
Stock-based compensation - - 174 - - 174
Unrealized loss from marketable debt securities - - - (17 ) - (17 )
Net loss - - - - (1,593 ) (1,593 )
Balance – June 30, 2023 1,692,342 $ 70 $ 200,609 $ (662 ) $ (189,463 ) $ 10,554
Balance 1,692,342 $ 70 $ 200,609 $ (662 ) $ (189,463 ) $ 10,554

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

GALMED

PHARMACEUTICALS LTD.

Interim Condensed Consolidated Statements of Cash Flows (Unaudited)

U.S.Dollars in thousands

2024 2023
Six<br> months ended June 30,
2024 2023
Cash flow from operating activities
Net loss $ (2,394 ) $ (3,423 )
Adjustments required to reconcile net loss to net cash used in operating activities
Depreciation and amortization 83 17
Stock-based compensation expense 283 471
Amortization of premium on marketable debt securities - 15
Change in fair value of SAFE investment - (265 )
Interest income from short-term deposits (18 ) (16 )
Loss (gain) from realization of marketable debt securities 8 (25 )
Finance expenses 1 (2 )
Changes in operating assets and liabilities:
Decrease in other accounts receivable 345 484
Decrease in trade payables (676 ) (420 )
Increase (decrease) in other accounts payable (479 ) 102
Net cash used in operating activities (2,847 ) (3,062 )
Cash flow from investing activities
Purchase of available for sale securities (1,507 ) (3,218 )
Investment in equity of Onkai - (1,500 )
Investment in (withdrawal from) short term deposits 225 (750 )
Sale of available-for-sale securities 3,106 7,524
Net cash provided by (used in) investing activities 1,824 2,056
Decrease in cash and cash equivalents and restricted cash (1,023 ) (1,006 )
Cash and cash equivalents and restricted cash at the beginning of the period 2,978 2,130
Cash and cash equivalents and restricted cash at the end of the period $ 1,955 $ 1,124
Supplemental disclosure of cash flow information:
Cash received from interest $ 218 $ 163
Non-cash investment transaction:
Conversion of SAFE into equity of OnKai $ - $ 1,765

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

GALMED

PHARMACEUTICALS LTD.

Notesto Interim Condensed Consolidated Financial Statements

Note1 - Basis of presentation

Galmed Pharmaceuticals Ltd. (the “Company”) was incorporated in Israel on July 31, 2013 and commenced operations on February 2, 2014.

The Company holds three wholly-owned subsidiaries, Galmed International Ltd., which is incorporated in Malta, and Galmed Research and Development Ltd. (“GRD”) and Galtopa Therapeutics Ltd., both of which are incorporated in Israel. In July 2023, GRD established a new wholly-owned subsidiary incorporated under the laws of England and Wales called Galmed Therapeutics UK Limited.

The Company is a biopharmaceutical company focused on the development of Aramchol. The Company has focused almost exclusively on developing Aramchol for the treatment of liver disease and is currently developing Aramchol for Primary Sclerosing Cholangitis, or PSC, and exploring the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease. The Company is also collaborating with the Hebrew University in the development of Amilo-5MER. The Company has an operating history limited to pre-clinical and clinical drug development.

The

Company funded its research and development programs and operations to date primarily through proceeds from private placements and public offerings. The Company currently has no products approved for marketing and has not generated any revenue from product sales to date. As of June 30, 2024, the Company had cash and cash equivalents of $1.8 million, restricted cash of $0.1 million, short-term deposits of $2.0 million and marketable debt securities of $5.9 million.

The

Company has incurred operating losses in each year since inception. The Company’s loss attributable to holders of its ordinary shares for the six months ended June 30, 2024 and 2023 was approximately $2.4 million and $3.4 million, respectively. As of June 30, 2024, the Company had an accumulated deficit of $195.3 million. Substantially all of its operating losses resulted from costs incurred in connection with the Company’s development program and from general and administrative costs associated with its operations.

The Company will need to raise substantial, additional capital to fund its operations and to develop Aramchol and Amilo-5MER for, and beyond its current development stage and any future commercialization, as well as any additional indications.

Based on the Company’s current operating plan, the Company’s management currently estimates that its cash position will support its current operations as currently conducted for more than 12 months from the date of issuance of these financial statements.

These unaudited interim condensed consolidated financial statements have been prepared as of June 30, 2024 and for the three and six month periods 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 condensed 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, 2023 that are included in the Company’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission on April 4, 2024 (the “Annual Report on Form 20-F”). The results of operations presented are not necessarily indicative of the results to be expected for the year ending December 31, 2024.

Note2 - Summary of significant accounting policies

The significant accounting policies that have been applied in the preparation of the unaudited condensed 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.

Note3 – Investment in Associate at Fair Value

On

May 4, 2023, the Company entered into a definitive agreement (the “Agreement”) for a $1.5 million equity investment in OnKai, a US-based technology company developing an AI-based platform to advance healthcare for underserved populations across the United States by facilitating alignment between healthcare stakeholders.

Previously,

on November, 2022 the Company invested $1.5 million in OnKai through a Simple Agreement for Future Equity which converted at a 15% discount into series seed preferred shares upon closing of the Investment Round (as defined below).

The

Company’s investment in OnKai was part of an approximately $6.0 million investment round (the “Investment Round”) with other investors that was led by the Company of which SAFE notes of approximately $3.8 million were converted into preferred shares. On June 19, 2023, the Investment Round closed. Following the closing of the Investment Round, the Company holds 1,223,535 preferred shares which comprises approximately 24% of the outstanding share capital of OnKai on an as-converted basis as of June 30, 2024 and the Company’s Chief Executive Officer and director, Allen Baharaff serves as a board member of OnKai.

Summarizedstatement of operations (in thousands) of Onkai:

Summaryof Statement of operations

2024 2023 2024 2023
Three<br> months ended Six<br> months ended
June<br> 30, June<br> 30,
2024 2023 2024 2023
Total<br> operating loss $ 653 $ 573 $ 1,334 $ 1,171
Net<br> loss $ 645 $ 769 $ 1,312 $ 1,584

Under the terms of the Agreement, during the three-year period following the closing of the Investment Round the Company will have the right to merge with OnKai subject to the approval of the boards of directors of each of the Company and OnKai. The Company was granted certain customary pre-emptive rights as well as registration rights, first refusal rights, co-sale rights and broad based weighted average anti-dilution rights, a board seat, and certain customary protective provisions.

In connection with the Agreement, the Company’s wholly-owned subsidiary GRD entered into a services agreement with OnKai (the “Services Agreement”). The Services Agreement provides that GRD will on a non-exclusive basis (i) provide support services to OnKai relating to finance, business development, strategic planning, execution and others; and (ii) lend its experience to OnKai in building a strategy and for the development of treatments for the underserved and that OnKai shall on a non-exclusive basis (i) take part in plan preparation to serve GRD’s vision of developing drugs for the underserved population and (ii) when relevant, design a process on the clinical trial dashboard that could potentially serve GDR’s future trial.

Note4 - Stockholders’ Equity

1.<br> On May 15, 2023, the Company effected a reverse share split of the Company’s ordinary<br> shares at the ratio of 1-for-15,<br> such that each fifteen (15) ordinary shares, par value NIS 0.01<br> per<br> share, were consolidated into one (1) ordinary share, par value NIS 0.15<br> per share.<br> As a<br> result, all share and per share amounts were adjusted retroactively for all periods presented<br> in these financial statements.
2.<br> On July 18, 2023, the Company sold to investors in a public offering (i) 380,000 ordinary shares, (ii) 5,220,000 pre-funded warrants<br> to purchase 5,220,000 ordinary shares (the “Pre-Funded Warrants”), and (iii) 5,600,000 warrants to purchase 5,600,000<br> ordinary shares (the “Investor Warrants”), at a purchase price of $1.25 per share and accompanying Investor Warrant and<br> $1.249 per Pre-Funded Warrant and accompanying Investor Warrant.

The

Pre-Funded Warrants are immediately exercisable at an exercise price of $0.001 per ordinary share and will not expire until exercised in full.

The

Investor Warrants have an exercise price of $1.25 per ordinary share, are immediately exercisable, and may be exercised until July 18, 2028.

The

net proceeds to the Company were approximately $6.2 million.

As

of June 30, 2024, a total of 4,290,000 Pre-Funded Warrants were exercised into 4,286,405 ordinary shares.

Note5 – Subsequent events

1. Subsequent<br> to the balance sheet date, a total of 930,000<br> Pre-Funded<br> Warrants were exercised into 927,245<br> ordinary<br> shares. As of August 23, 2024, all outstanding Pre-Funded Warrants have been exercised.
2. Subsequent<br> to the balance sheet date, a total of 438,333 RSU’s were exercised into 438,333 ordinary<br> shares.
3. Subsequent<br> to the balance sheet date, on August 27, 2024, the Company announced that on August 29, 2024<br> it will effect a reverse share split (“August 2024 Reverse Split”)_of the Company’s<br> ordinary shares at the ratio of 1-for-12, such that each twelve (12) ordinary shares, par<br> value NIS 0.15 per share, shall be consolidated into one (1) ordinary share, par value NIS<br> 1.80 per share. Since the August 2024 Reverse Split has not been effected prior to the date<br> of issuance of these financial statements, all share and per share amounts have not been<br> adjusted for the periods presented in these financial statements.

Management’s

Discussion and Analysis of Financial Condition and Results of Operations

Allreferences to “we,” “us,” “our,” “the Company” and “our Company”, in thisForm 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 0.15 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 otherwisestated, all of our financial information presented in this Form 6-K has been prepared in accordance with U.S. GAAP. Any discrepanciesin any table between totals and sums of the amounts and percentages listed are due to rounding. Unless otherwise indicated, or the contextotherwise requires, references in this Form 6-K to financial and operational data for a particular year refer to the fiscal year of ourcompany ended December 31 of that year.

Ourreporting 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.

CautionaryNote 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:

our<br> ability to pursue, evaluate and complete any strategic alternative that yields value for<br> our shareholders;
the<br> timing and cost of our planned PSC clinical trial and our pivotal Phase 3 ARMOR trial, or<br> the ARMOR Study, if re-initiated, for our product candidates, Aramchol and Amilo-5MER, or<br> for any other pre-clinical or clinical trials;
completion<br> and receiving favorable results of our planned PSC clinical trial and the ARMOR Study (if<br> re-initiated) for Aramchol or any other pre-clinical or clinical trial;
regulatory<br> action with respect to Aramchol or any other product candidate by the U.S. Food and Drug<br> Administration, or the FDA, or the European Medicines Authority, or EMA, including but not<br> limited to acceptance of an application for marketing authorization, review and approval<br> of such application, and, if approved, the scope of the approved indication and labeling;
the<br> commercial launch and future sales of Aramchol and any future product candidates;
our<br> ability to comply with all applicable post-market regulatory requirements for Aramchol, Amilo-5MER<br> or any other product candidate in the countries in which we seek to market the product;
our<br> ability to achieve favorable pricing for Aramchol, Amilo-5MER or any other product candidate;
our<br> expectations regarding the commercial market for non-alcoholic steato-hepatitis, or NASH,<br> in patients or any other targeted indication;
--- ---
third-party<br> payor reimbursement for Aramchol, Amilo-5MER or any other product candidate;
our<br> estimates regarding anticipated capital requirements and our needs for additional financing;
market<br> adoption of Aramchol or any other product candidate by physicians and patients;
the<br> timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate;
our<br> ability to obtain and maintain adequate protection of our intellectual property;
the<br> possibility that we may face third-party claims of intellectual property infringement;
our<br> ability to manufacture our product candidates in commercial quantities, at an adequate quality<br> or at an acceptable cost;
our<br> ability to establish adequate sales, marketing and distribution channels;
intense<br> competition in our industry, with competitors having substantially greater financial, technological,<br> research and development, regulatory and clinical, manufacturing, marketing and sales, distribution<br> and personnel resources than we do;
the<br> development and approval of the use of Aramchol or any other product candidate for additional<br> indications or in combination therapy;
our<br> expectations regarding licensing, acquisitions and strategic operations;
current<br> or future unfavorable economic and market conditions and adverse developments with respect<br> to financial institutions and associated liquidity risk;
our<br> ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and
security,<br> political and economic instability in the Middle East that could harm our business, including<br> due to the the recent attacks by Hamas and other terrorist organizations from the Gaza Strip<br> and elsewhere in the region and Israel’s war against them and military hostilities<br> with Hezbollah on the northern border of Israel.

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, 2023 filed with the SEC on April 4, 2024, 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 biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver disease and have been developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibro-inflammatory and oncological indications outside of liver disease. As we continue to explore the feasibility of developing Aramchol for other indications, we do not currently have a timeline for the commencement of the PSC trial we had been planning and can give no assurances that we will commence this trial. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide.

While we previously announced that we were no longer evaluating our strategic alternatives following the initiation of our PSC clinical program and our investment and collaboration with Onkai, we have reinitiated the process of evaluating our strategic options alternatives and our structuring to best optimize our resources to enhance shareholder value and achieve our goals.

To date, we have not generated revenue from the sale of any product, excluding the licensing revenue we recorded in connection with the Samil Agreement, and we do not expect to generate any significant revenue other than the amortization of the upfront payments under the license agreement with Samil and of the subsequent royalties and/or milestones that may be earned in connection with the Samil Agreement or potential other license Agreements, unless and until we commercialize Aramchol, or license the product to additional third parties. As of June 30, 2024, we had an accumulated deficit of approximately $195.3 million.

Our financing activities are described below under “Liquidity and Capital Resources.” Obtaining approval of an NDA, MMA, or other similar application is an extensive, lengthy, expensive and uncertain process, and the FDA, EMA, MHRA and other regulatory agencies may delay, limit or deny approval of Aramchol, Amilo-5MER or any other product candidate.

FinancialOverview

To date, we have funded our operations primarily through proceeds from private placements and public offerings. As of June 30, 2024, we had current assets of $10.1 million, which includes cash and cash equivalents of $1.8 million, short term deposit of $2.0 million, marketable debt securities of $5.9 million, other receivables of $0.1 million and restricted cash of $0.1 million. This compares with current assets of $13.2 million at December 31, 2023, which includes cash and cash equivalents of $2.9 million, short term deposit of $2.2 million, marketable debt securities of $7.5 million, other receivables of $0.5 million and restricted cash of $0.1 million. Although we provide no assurance, we believe that such existing funds will be sufficient to continue our business and operations as currently conducted for more than 12 months from the date of issuance of this Form 6-K. However, we will continue to incur operating losses, which may be substantial over the next several years, and we expect that we will need to obtain additional funds to further develop our research and development programs.

Costsand Operating Expenses

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

Researchand 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 pre-clinical studies and clinical trials and drug and laboratory supplies. We account for all research and development expenses as they are incurred. We expect our research and development expense to remain our primary expense in the near future as we continue to develop Aramchol. Increases or decreases in research and development expenditures are primarily attributable to the number and/or duration of the pre-clinical and clinical studies that we conduct.

We expect that a substantial amount of our research and development expense in the future will be incurred in support of our current and anticipated pre-clinical and clinical development projects. Due to the inherently unpredictable nature of pre-clinical and clinical development studies and unpredictability of our evaluation of strategic alternatives, 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 partnering and/or commercialization. Clinical development timelines, the probability of success and development costs can differ materially from expectations. We currently expect to continue testing Aramchol in pre-clinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials for Aramchol. Nevertheless, we expect to decrease our research and development expenses as a result of the discontinuation of the Open Label Part of the ARMOR Study and our evaluation of strategic alternatives.

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.

Generaland Administrative Expenses

General and administrative expenses consist primarily of compensation for employees in executive and operational roles, including finance/accounting, legal and other operating positions in connection with our activities. 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.

General and administrative expenses also consist of costs associated with being a public company, including expenses related to services associated with maintaining compliance with The Nasdaq Capital Market and SEC requirements, directors and officers insurance, increased legal and accounting costs and investor relations costs. Our general and administrative expenses may also increase due to increases in professional and advisory fees as we evaluate our strategic alternatives.

FinancialIncome, Net

Our financial income, net consists mainly of interest income from marketable debt securities, change in fair value of convertible note and foreign currency gains. Our financial expense consists of fees associated with banking activities and losses from realization of marketable debt securities.

Resultsof Operations

The table below provides our results of operations for the three and six months ended June 30, 2024, as compared to the three and six months ended June 30, 2023.

Three months ended June 30, Six months ended June 30,
2024 2023 2024 2023
(unaudited) (unaudited) (unaudited) (unaudited)
(In thousands, except per share data)
Research and development expenses 534 809 1,169 1,892
General and administrative expenses 688 1,062 1,454 1,981
Total operating expenses 1,222 1,871 2,623 3,873
Financial income, net (103 ) (278 ) (229 ) (450 )
Net loss 1,119 1,593 2,394 3,423
Other comprehensive loss: (20 ) 17 (19 ) (83 )
Comprehensive loss 1,099 1,610 2,375 3,340
Basic and diluted net loss per share $ 0.18 $ 0.95 $ 0.41 $ 2.04

Researchand Development Expenses

Our research and development expenses amounted to approximately $0.5 million and approximately $1.2 million during the three and six months ended June 30, 2024, respectively, representing a decrease of approximately $0.3 million, or 38%, and approximately $0.7 million, or 38%, respectively, compared to approximately $0.8 million and approximately $1.9 million, respectively for the comparable period in 2023.

The decrease during the three and six months ended June 30, 2024 primarily resulted from a decrease in clinical trial expenses of approximately $0.3 million and $0.5 million, respectively.

Generaland Administrative Expenses

Our general and administrative expenses amounted to approximately $0.7 million and approximately $1.5 million during the three and six months ended June 30, 2024, respectively, representing a decrease of approximately $0.4 million, or 36%, and approximately $0.5 million, or 25%, respectively, to approximately $1.1 million and approximately $2.0 million, respectively, for the comparable period in 2023,

The decrease in general and administrative expenses for the three and six months ended June 30, 2024 resulted primarily from a decrease in salary and related expenses of $0.2 million and $0.2 million, respectively, and as well, a decrease in insurance costs of $0.1 million and $0.2 million, respectively.

OperatingLoss

As a result of the foregoing, for the three and six months ended June 30, 2024, our operating loss was approximately $1.2 million and approximately $2.6 million, respectively, representing a decrease of $0.7 million, or 37%, and a decrease of $1.3 million, or 33%, respectively, as compared to approximately $1.9 million and approximately $3.9 million, respectively, for the comparable period in 2023.

FinancialIncome, Net

Our financial income, net amounted to approximately $0.1 million and approximately $0.2 million during the three and six months ended June 30, 2024, respectively, representing a decrease of approximately $0.2 million and approximately $0.3 million, respectively, compared to financial income, net of $0.3 million and $0.5 million, respectively, for the comparable period in 2023. The decrease in financial income, net for the three and six months ended June 30, 2024 resulted primarily from exchange rate differences.

NetLoss

As a result of the foregoing, for the three and six months ended June 30, 2024, our net loss was approximately $1.1 million and approximately $2.4 million, respectively, representing a decrease of $0.5 million, or 31%, and a decrease of $1.0 million, or 29%, respectively, as compared to approximately $1.6 million and approximately $3.4 million, respectively, for the comparable period in 2023.

Liquidityand Capital Resources

To date, we have funded our operations primarily through proceeds from private placements and public offerings and we have incurred substantial losses since our inception. As of June 30, 2024, we had an accumulated deficit of approximately $195.3 million and positive working capital (current assets less current liabilities) of approximately $8.5 million. We expect that operating losses will continue for the foreseeable future.

As of June 30, 2024, we had cash and cash equivalents of approximately $1.8 million, short term deposit of $2.1 million, restricted cash of approximately $0.1 million, and marketable debt securities of approximately $5.9 million invested in accordance with our investment policy, totaling approximately $9.9 million, as compared to approximately $2.9 million, $2.2 million, $0.1 million and $7.5 million as of December 31, 2023, respectively, totaling approximately $12.7 million. The decrease is mainly attributable to the $2.8 million negative cash flow from operating activities during the six months ended June 30, 2024.

We had negative cash flow from operating activities of approximately $2.8 million for the six months ended June 30, 2024, as compared to negative cash flow from operating activities of approximately $3.1 million for the six months ended June 30, 2023. The negative cash flow from operating activities for the six months ended June 30, 2024, is mainly attributable to our net loss of approximately $2.4 million.

We had positive cash flow from investing activities of approximately $1.8 million for the six months ended June 30, 2024, as compared to a positive cash flow from investing activities of approximately $2.1 million for the six months ended June 30, 2023. The positive cash flow from investing activities for the six months ended June 30, 2024, was primarily due to net withdrawal of marketable securities of approximately $1.4 million from available for sale securities.

We had no cash flow from financing activities for the six months ended June 30, 2024.

Although we provide no assurance, we believe that our existing funds will be sufficient to continue our business and operations as currently conducted for more than 12 months from the date of issuance of this Report on Form 6-K. However, significant additional funding will be necessary to fund our ARMOR Study, our Amilo-5MER program and ongoing research and development work, to advance our product candidates through regulatory approval and into commercialization, if approved and the evaluation of our strategic alternatives. We intend to obtain additional funding through debt or equity financings, governmental grants or through entering into collaborations, strategic alliances or license agreements to increase the funds available to support our operating and capital needs. Although we have been successful in raising capital in the past, there is no assurance that we will be successful in obtaining additional financing on terms acceptable to us. If funds are not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization efforts with respect to Aramchol, Amilo-5MER and/or our other pre-clinical and clinical programs. This may raise substantial doubts about our ability to continue as a going concern.

The extent of our future capital requirements will depend on many other factors, including:

the<br> progress and costs of our pre-clinical studies, clinical trials and other research and development activities;
the<br> regulatory pathway of Aramchol, Amilo-5MER or any other product candidate;
the<br> scope, prioritization and number of our clinical trials and other collaboration research and development programs;
--- ---
the<br> amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect<br> to Aramchol or any other product candidate;
the<br> costs of the development and expansion of our operational infrastructure;
the<br> costs and timing of obtaining regulatory approval for Aramchol, Amilo-5MER or any other product candidate;
the<br> ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under<br> our potential future licensing agreements;
the<br> costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
the<br> costs and timing of securing manufacturing arrangements for clinical or commercial production;
the<br> costs of contracting with third parties to provide sales and marketing capabilities for us;
the<br> costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms;
the<br> magnitude of our general and administrative expenses;
any<br> cost that we may incur under future in- and out-licensing arrangements relating to Aramchol, Amilo-5MER or any other product candidate;
market<br> conditions;
our<br> ability to main the listing of our ordinary shares on The Nasdaq Capital Market;
our<br> ability to identify, evaluate and complete any strategic alternative that yields value for our shareholders; and
the<br> impact of any resurgence of the COVID-19 pandemic and the war between Hamas and Israel, which may exacerbate the magnitude of the<br> factors discussed above.

TrendInformation

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 loss, 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”.

Controlsand 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.

ReverseSplit

On August 27, 2024, we announced that on August 29, 2024, we will effect a reverse share split (the “August 2024 Reverse Split”) of our ordinary shares at the ratio of 1-for-12, such that each twelve (12) ordinary shares, par value NIS 0.015 per share, will be consolidated into one (1) ordinary share, par value NIS 1.80. Since the August 2024 Reverse Split has not been effected prior to the date of this Form 6-K, the information in this Form 6-K has not been adjusted for the periods presented in this Form 6-K.

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.

Galmed Pharmaceuticals Ltd.
Date:<br> August 28, 2024 By: /s/ Allen Baharaff
Allen<br> Baharaff
President<br> and Chief Executive Officer