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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 September 2026
001-36345
(Commission
File Number)
GALMED
PHARMACEUTICALS LTD.
(Exact
name of Registrant as specified in its charter)
16
Abba 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, 2026, 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 Nos. 333-206292, 333-227441,
333-284163 and 333-290399) and the Company’s Registration Statements on Form F-3 (Registration Nos. 333-272722 and 333-283241).
FINANCIAL
INFORMATION
Financial
Statements
GALMED
PHARMACEUTICALS LTD.
Unaudited
Interim Condensed Consolidated Balance Sheets
U.S.
Dollars in thousands, except share data and per share data
| | |
As of | | |
As of | |
| | |
June 30, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| Assets | |
| | | |
| | |
| | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 2,885 | | |
$ | 3,985 | |
| Restricted cash | |
| 159 | | |
| 124 | |
| Marketable debt securities | |
| 5,881 | | |
| 7,025 | |
| Short-term deposits | |
| 2,465 | | |
| 7,146 | |
| Other receivables | |
| 323 | | |
| 347 | |
| Total
current assets | |
| 11,713 | | |
| 18,627 | |
| | |
| | | |
| | |
Property and equipment, net
| |
| 48 | | |
| - | |
| Other intangible assets, net | |
| 4,642 | | |
| - | |
| Goodwill | |
| 1,764 | | |
| - | |
| Operating lease right
of use asset | |
| 116 | | |
| - | |
| Total
non-current assets | |
| 6,570 | | |
| - | |
| | |
| | | |
| | |
| Total
assets | |
| 18,283 | | |
| 18,627 | |
| | |
| | | |
| | |
| Liabilities and stockholders’
equity | |
| | | |
| | |
| | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Trade payables | |
$ | 1,897 | | |
$ | 2,003 | |
| Other payables | |
| 834 | | |
| 842 | |
| Operating lease liabilities | |
| 83 | | |
| - | |
| Total
current liabilities | |
| 2,814 | | |
| 2,845 | |
| | |
| | | |
| | |
| Non-current liabilities | |
| | | |
| | |
| Contingent Consideration | |
| 1,617 | | |
| - | |
| Deferred tax liability | |
| 1,068 | | |
| - | |
Operating lease liabilities,
net of current portion
| |
| 46 | | |
| - | |
| Total
non-current liabilities | |
| 2,731 | | |
| - | |
| | |
| | | |
| | |
| Stockholders’ equity | |
| | | |
| | |
| Ordinary shares par value NIS 14.4
per share; Authorized 112,500,000;
Issued and outstanding: 1,001,394
shares as of June 30, 2026 and 822,674
shares as of December 31, 2025 (*) | |
| 4,265 | | |
| 3,408 | |
| Additional paid-in capital | |
| 224,215 | | |
| 223,455 | |
| Accumulated other comprehensive loss | |
| (331 | ) | |
| (303 | ) |
| Accumulated deficit | |
| (215,411 | ) | |
| (210,778 | ) |
| Total
stockholders’ equity | |
| 12,738 | | |
| 15,782 | |
| | |
| | | |
| | |
| Total
liabilities and stockholders’ equity | |
| 18,283 | | |
| 18,627 | |
The
accompanying notes are an integral part of the interim condensed consolidated financial statements.
GALMED
PHARMACEUTICALS LTD.
Unaudited
Interim Condensed Consolidated Statements of Operations
U.S.
Dollars in thousands, except share data and per share data
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| | |
Three
months ended June 30, | | |
Six
months ended June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Research and development expenses | |
| 1,782 | | |
| 1,058 | | |
| 3,142 | | |
| 1,692 | |
| | |
| | | |
| | | |
| | | |
| | |
| General and administrative
expenses | |
| 993 | | |
| 1,051 | | |
| 1,677 | | |
| 1,681 | |
| | |
| | | |
| | | |
| | | |
| | |
| Total operating expenses | |
| 2,775 | | |
| 2,109 | | |
| 4,819 | | |
| 3,373 | |
| | |
| | | |
| | | |
| | | |
| | |
| Financial income, net | |
| (154 | ) | |
| (152 | ) | |
| (288 | ) | |
| (332 | ) |
| Financial expenses related to SEPA | |
| 102 | | |
| 12 | | |
| 102 | | |
| 32 | |
| Impairment of Associate | |
| - | | |
| 526 | | |
| - | | |
| 526 | |
| | |
| | | |
| | | |
| | | |
| | |
| Net
loss | |
$ | 2,723 | | |
$ | 2,495 | | |
| 4,633 | | |
$ | 3,599 | |
| | |
| | | |
| | | |
| | | |
| | |
| Basic and diluted net
loss per share (*) | |
$ | 2.86 | | |
$ | 5.06 | | |
$ | 5.21 | | |
$ | 10.04 | |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted-average number
of shares outstanding used in computing basic and diluted net loss per share (*) | |
| 952,168 | | |
| 493,524 | | |
| 888,762 | | |
| 358,325 | |
The
accompanying notes are an integral part of the interim condensed consolidated financial statements.
GALMED
PHARMACEUTICALS LTD.
Unaudited
Interim Condensed Consolidated Statements of Comprehensive Loss
U.S.
Dollars in thousands
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| | |
Three
months ended June 30, | | |
Six
months ended June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Net loss | |
$ | 2,723 | | |
$ | 2,495 | | |
$ | 4,633 | | |
$ | 3,599 | |
| | |
| | | |
| | | |
| | | |
| | |
| Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
| Net unrealized loss (gain)
on available for sale securities | |
| (52 | ) | |
| 6 | | |
| 28 | | |
| (13 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Comprehensive
loss | |
$ | 2,671 | | |
$ | 2,501 | | |
$ | 4,661 | | |
$ | 3,586 | |
The
accompanying notes are an integral part of the interim condensed consolidated financial statements.
GALMED
PHARMACEUTICALS LTD.
Unaudited
Interim Consolidated Statements of Changes in Stockholders’ Equity
U.S.
Dollars in thousands, except share data and per share data
| | |
Shares (*) | | |
Amount | | |
capital | | |
loss | | |
Deficit | | |
Total | |
| | |
| | |
| | |
| | |
Accumulated | | |
| | |
| |
| | |
Ordinary
shares | | |
Additional
paid-in | | |
other
Comprehensive | | |
Accumulated | | |
| |
| | |
Shares (*) | | |
Amount | | |
capital | | |
loss | | |
Deficit | | |
Total | |
| Balance - December 31, 2025 | |
| 822,674 | | |
| 3,408 | | |
| 223,455 | | |
| (303 | ) | |
| (210,778 | ) | |
| 15,782 | |
| Stock based compensation | |
| - | | |
| - | | |
| 156 | | |
| - | | |
| - | | |
| 156 | |
| Exercise of RSU’ | |
| 2,283 | | |
| 10 | | |
| (10 | ) | |
| - | | |
| - | | |
| - | |
| Unrealized loss from marketable debt securities | |
| - | | |
| - | | |
| - | | |
| (80 | ) | |
| - | | |
| (80 | ) |
| Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,910 | ) | |
| (1,910 | ) |
| Balance - March 31, 2026 | |
| 824,957 | | |
| 3,418 | | |
| 223,523 | | |
| (383 | ) | |
| (212,688 | ) | |
| 13,948 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Stock based compensation | |
| - | | |
| - | | |
| 156 | | |
| - | | |
| - | | |
| 156 | |
| Issuance of ordinary shares in relation to
SEPA (**) | |
| 170,135 | | |
| 817 | | |
| 488 | | |
| - | | |
| - | | |
| 1,305 | |
| Exercise of RSU’ | |
| 6,302 | | |
| 30 | | |
| (30 | ) | |
| - | | |
| - | | |
| - | |
| Unrealized gain from marketable debt securities | |
| - | | |
| - | | |
| - | | |
| 52 | | |
| - | | |
| 52 | |
| Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,723 | ) | |
| (2,723 | ) |
| Balance - June 30, 2026 | |
| 1,001,394 | | |
| 4,265 | | |
| 224,215 | | |
| (331 | ) | |
| (215,411 | ) | |
| 12,738 | |
| | |
| | |
| | |
| | |
Accumulated | | |
| | |
| |
| | |
| | |
| | |
Additional | | |
other | | |
| | |
| |
| | |
Ordinary
shares | | |
paid-in | | |
Comprehensive | | |
Accumulated | | |
| |
| | |
Shares
(*) | | |
Amount | | |
capital | | |
loss | | |
Deficit | | |
Total | |
| Balance - December 31, 2024 | |
| 208,111 | | |
| 742 | | |
| 216,470 | | |
| (416 | ) | |
| (200,469 | ) | |
| 16,327 | |
| Stock based compensation | |
| - | | |
| - | | |
| 101 | | |
| - | | |
| - | | |
| 101 | |
| Exercise of RSU’ | |
| 2,283 | | |
| 9 | | |
| (9 | ) | |
| - | | |
| - | | |
| - | |
| Issuance of ordinary shares in relation to
SEPA (**) | |
| 3,125 | | |
| 12 | | |
| 67 | | |
| - | | |
| - | | |
| 79 | |
| Issuance of SEPA commitment shares (**) | |
| 987 | | |
| 4 | | |
| 12 | | |
| - | | |
| - | | |
| 16 | |
| Issuance of ordinary shares in relation to
ATM (***) | |
| 67,750 | | |
| 262 | | |
| 1,177 | | |
| - | | |
| - | | |
| 1,439 | |
| Unrealized gain from marketable debt securities | |
| - | | |
| - | | |
| - | | |
| 19 | | |
| - | | |
| 19 | |
| Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,104 | ) | |
| (1,104 | ) |
| Balance - March 31, 2025 | |
| 282,255 | | |
| 1,029 | | |
| 217,818 | | |
| (397 | ) | |
| (201,573 | ) | |
| 16,877 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Stock based compensation | |
| - | | |
| - | | |
| 100 | | |
| - | | |
| - | | |
| 100 | |
| Issuance of SEPA commitment shares (**) | |
| 986 | | |
| 4 | | |
| 8 | | |
| - | | |
| - | | |
| 12 | |
| Issuance of ordinary shares in relation to
ATM (***) | |
| 379,641 | | |
| 1,657 | | |
| 4,378 | | |
| - | | |
| - | | |
| 6,035 | |
| Unrealized loss from marketable debt securities | |
| - | | |
| - | | |
| - | | |
| (6 | ) | |
| - | | |
| (6 | ) |
| Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,495 | ) | |
| (2,495 | ) |
| Balance - June 30, 2025 | |
| 662,882 | | |
| 2,690 | | |
| 222,304 | | |
| (403 | ) | |
| (204,068 | ) | |
| 20,523 | |
The
accompanying notes are an integral part of the interim condensed consolidated financial statements.
GALMED
PHARMACEUTICALS LTD.
Unaudited
Interim Condensed Consolidated Statements of Cash Flows
U.S.
Dollars in thousands
| | |
2026 | | |
2025 | |
| | |
Six
months ended June 30, | |
| | |
2026 | | |
2025 | |
| Cash flow from operating
activities | |
| | | |
| | |
| | |
| | | |
| | |
| Net loss | |
| (4,633 | ) | |
$ | (3,599 | ) |
| | |
| | | |
| | |
| Adjustments required to
reconcile net loss to net cash used in operating activities | |
| | | |
| | |
| Stock-based compensation expense | |
| 312 | | |
| 201 | |
| Amortization of discount (premium) on marketable
debt securities | |
| (2 | ) | |
| 16 | |
| Financial expenses related to SEPA | |
| 102 | | |
| 32 | |
| Impairment of Associate | |
| - | | |
| 526 | |
| Interest income and translation differences
from short-term deposits | |
| 81 | | |
| (70 | ) |
| Interest income from loan to associate | |
| - | | |
| (10 | ) |
| Loss (gain) from realization of marketable
debt securities | |
| 140 | | |
| (19 | ) |
| Finance expenses | |
| - | | |
| 1 | |
| Changes in operating assets
and liabilities: | |
| | | |
| | |
| Decrease in other accounts receivable | |
| 107 | | |
| 239 | |
| Increase (decrease) in trade payables | |
| (114 | ) | |
| 61 | |
| Increase (decrease) in
other accounts payable | |
| (656 | ) | |
| 187 | |
| Net
cash used in operating activities | |
| (4,663 | ) | |
| (2,435 | ) |
| | |
| | | |
| | |
| Cash flow from investing
activities | |
| | | |
| | |
| Purchase of available for sale securities | |
| (1,567 | ) | |
| (1,686 | ) |
| Withdrawal from (investment in) short term
deposits | |
| 4,600 | | |
| (3,900 | ) |
| Acquisition of business, net of cash acquired
(***) | |
| (3,183 | ) | |
| - | |
| Sale of available-for-sale
securities | |
| 2,545 | | |
| 786 | |
| Net cash provided by (used
in) investing activities | |
| 2,395 | | |
| (4,800 | ) |
| | |
| | | |
| | |
| Cash flow from financing
activities | |
| | | |
| | |
| Issuance of ordinary shares in relation to
ATM (**) | |
| - | | |
| 7,474 | |
| Issuance of ordinary shares
in relation to SEPA (*) | |
| 1,203 | | |
| 75 | |
| Net cash provided by financing activities | |
| 1,203 | | |
| 7,549 | |
| | |
| | | |
| | |
| Increase (decrease) in cash
and cash equivalents and restricted cash | |
| (1,065 | ) | |
| 314 | |
| Cash
and cash equivalents and restricted cash at the beginning of the period | |
| 4,109 | | |
| 4,773 | |
| Cash
and cash equivalents and restricted cash at the end of the period | |
$ | 3,044 | | |
$ | 5,087 | |
| | |
| | | |
| | |
| Supplemental disclosure
of cash flow information: | |
| | | |
| | |
| | |
| | | |
| | |
| Cash received from interest | |
$ | 600 | | |
$ | 376 | |
The
accompanying notes are an integral part of the interim condensed consolidated financial statements.
GALMED
PHARMACEUTICALS LTD.
Notes
to Interim Condensed Consolidated Financial Statements
Note
1 - 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 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.
On
June 8, 2026, the Company entered into a Share Purchase Agreement (the “SPA”) with Colospan Ltd. (“Colospan”),
the shareholders of Colospan that are parties thereto, who hold more than 92% of the voting power of the outstanding share capital of
Colospan, and Boaz Assaf, solely in his capacity as the representative of the shareholders of Colospan, pursuant to which, subject to
the terms and conditions of the SPA, the Company purchased all of the issued and outstanding share capital of Colospan. On June 22, 2026,
the Company entered into an amended share purchase agreement (the “Amended SPA”) with Colospan, 100% of the shareholders
of Colospan, and Boaz Assaf, solely in his capacity as the representative of the shareholders of Colospan. Consummation of the acquisition
occurred on June 22, 2026 (the “Acquisition”), which resulted in Colospan becoming a wholly-owned subsidiary of the Company.
For additional information, See Note 4.
The
Company has 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, 2026, the Company had cash and cash equivalents of $2.9 million, restricted cash of $0.2 million, short-term deposits
of $2.5 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, 2026 and 2025 was approximately $4.7 million and $3.6 million, respectively. As of June 30,
2026, the Company had an accumulated deficit of $215.4 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, 2026 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, 2025 that
are included in the Company’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission on March 31, 2026 (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, 2026.
Note
2 - Summary of significant accounting policies
Except
as described below, 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:
Business
combinations are accounted for using the acquisition method of accounting in accordance with Accounting Standards Codification (“ASC”)
805, Business Combinations (“ASC 805”). The consideration transferred in a business combination is measured at fair
value as of the acquisition date and allocated to the identifiable assets acquired and liabilities assumed based on their respective
estimated fair values as of the acquisition date. The excess of the consideration transferred over the estimated fair value of the identifiable
net assets acquired is recorded as goodwill.
The
fair values of assets acquired and liabilities assumed are determined based on assumptions that market participants would use in pricing
the assets or liabilities. Determining the fair value of certain assets acquired and liabilities assumed is judgmental in nature and
often involves the use of significant estimates and assumptions, including assumptions with respect to future cash flows, discount rates,
growth rates and asset lives.
Transaction
costs incurred to effect a business combination are expensed as incurred and are included as a component of general and administrative
expenses in the consolidated statements of operations.
Goodwill
represents the excess of the consideration transferred over the estimated fair value of the identifiable assets acquired and liabilities
assumed in a business combination. The Company evaluates goodwill for impairment annually in the fourth quarter, or more frequently if
events or changes in circumstances indicate that it is more likely than not that the fair value of a reporting unit is less than its
carrying amount.
The
Company may first perform a qualitative assessment to determine whether it is more likely than not that the fair value of a reporting
unit is less than its carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit
is less than its carrying amount, or elects to bypass the qualitative assessment, the Company performs a quantitative impairment test.
As
of June 30, 2026, no impairment charges were recorded.
The
Company’s intangible assets are finite-lived and consist primarily of acquired technology, which is amortized on a straight-line
basis over its estimated useful life of seven years. Determining the fair value of acquired intangible assets requires management’s
judgment and may involve the use of third-party valuation specialists and significant estimates and assumptions, including the timing
and amounts of future cash flows, discount rates and asset lives. The judgments made in determining the estimated fair values of acquired
intangible assets and their estimated useful lives could significantly impact the Company’s condensed consolidated financial statements
in periods following an acquisition, including through amortization expense.
The
Company evaluates its finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that their carrying
amounts may not be recoverable.
At
lease commencement, a right-of-use asset and a lease liability are recognized for all leases with an initial term in excess of 12 months
based on the initial present value of the fixed lease payments over the lease term. The lease right-of-use asset also reflects the present
value of any initial direct costs, prepaid lease payments and lease incentives. The Company’s leases do not provide a readily determinable
implicit discount rate. Therefore, management estimates the Company’s incremental borrowing rate used to discount the lease payments
based on the information available at lease commencement. The Company includes the term covered by an option to extend a lease when the
option is reasonably certain to be exercised. The Company has elected not to separate non-lease components from lease components for
all leases. Operating lease expense is recognized on a straight-line basis over the lease term and included in the condensed consolidated
statements of income.
| E. | Contingent
Consideration |
Contingent
consideration classified as a liability is initially recognized at fair value as of the acquisition date and is subsequently remeasured
at fair value at each reporting date until settled, with changes in fair value recognized in earnings.
Note
3 - Stockholders’ Equity
1.
On August 20, 2026, the Company effected a reverse share split of the Company’s ordinary shares at the ratio of 1-for-8, such that
each eight (8) ordinary shares, par value NIS 1.80 per share, were consolidated into one (1) ordinary share, par value NIS 14.40 per
share. As a result, all share and per share amounts prior to the reverse share split were adjusted retroactively for all periods presented
in these consolidated financial statements.
2.
On August 30, 2024, the Company entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, LTD., a Cayman
Islands exempt limited partnership (“YA”). Pursuant to the SEPA, the Company has the right, but not the obligation, to sell
to YA from time to time, up to $10.0 million (the “Commitment Amount”), of the Company ordinary shares, during the 36 months
following the execution of the SEPA, subject to the restrictions and satisfaction of the conditions in the SEPA. On October 21, 2024,
the Company and YA entered into an amendment to the SEPA to increase the Amount of the commitment to $20.0 million of the Company’s
ordinary shares.
The
Company evaluated the contract that includes the right to require YA to purchase shares of common stock in the future (“put right”)
considering the guidance in ASC 815-40, “Derivatives and Hedging — Contracts on an Entity’s Own Equity” and concluded
that it is an equity-linked contract that does not qualify for equity classification and therefore requires fair value accounting and
thus meets the definition of a derivative liability. Accordingly, the put right will be measured at fair value at each reporting period,
and changes in its fair value will be recognized in the consolidated statement of operations. The Put right is measured under level 2
of the Fair Value hierarchy. The Company analyzed the terms of the freestanding put right and concluded that it has an immaterial value
as of June 30, 2026 and December 31, 2025.
During
the six months ended June 30, 2026, the Company issued an aggregate of 170,135
ordinary shares to YA as Advance Shares for aggregate gross proceeds of approximately $1.3
million. Subsequent to the balance sheet date, the Company sold 40,957 ordinary shares for aggregate net proceeds of approximately
$0.3 million 0 million pursuant to the
SEPA.
3.
On November 14, 2024, the Company entered into a Capital on Demand Sales Agreement (the “2024 Sales Agreement”) with JonesTrading
Institutional Serviecs LLC (“JonesTrading”). Pursuant to the 2024 Sales Agreement, the Company may offer and sell our ordinary
shares having an aggregate offering price of up to $8.1 million, from time to time through JonesTrading. JonesTrading will receive a
commission equal to 3.0% of the gross proceeds from the sale of the ordinary shares pursuant to the 2024 Sales Agreement. As of December
31, 2025, the Company sold 460,880 of our ordinary shares for aggregate gross proceeds of approximately $8.1 million ($7.7 million net)
pursuant to the 2024 Sales Agreement. The Company did not issue any ordinary shares during the six months ended June 30, 2026.
Note
4 – Acquisition of Colospan
On
June 8, 2026, the Company entered into the SPA with Colospan, the shareholders of Colospan that are parties thereto, who hold more than
92% of the voting power of the outstanding share capital of Colospan, and Boaz Assaf, solely in his capacity as the representative of
the shareholders of Colospan, pursuant to which, subject to the terms and conditions of the SPA, the Company purchased all of the issued
and outstanding share capital of Colospan. On June 22, 2026, the Company entered into the Amended SPA with Colospan, 100% of the shareholders
of Colospan, and Boaz Assaf, solely in his capacity as the representative of the shareholders of Colospan. Consummation of the Acquisition
occurred on June 22, 2026, which resulted in Colospan becoming a wholly-owned subsidiary of the Company.
As
consideration for the sale of all of the issued and outstanding share capital of Colospan, the Company paid the Colospan shareholders
(“Selling Shareholders”) and certain SAFE investors (i) an aggregate amount of $3,300,000 in cash, which was allocated among
the Selling Shareholders and the SAFE investors (the “Cash Consideration”) and (ii) a performance-based earnout consideration
in an aggregate amount of up to $2,000,000 (the “Earnout Consideration”). The earnout payments will begin accruing on “Net
Revenue Sales”, as that term is defined in the Amended SPA, recognized from July 1, 2027, on a cumulative basis, with no payments
on the first $5 million of sales. Thereafter, payments will be calculated at 7% of incremental sales from $5 million to $12 million and
9% on sales above $12 million, with no retroactive application of higher tiers. Total earnout payments are capped at $2.0 million, but
any unpaid portion will accelerate and become immediately payable upon a qualifying sale or licensing of Colospan or its assets (subject
to customary exclusions) or if the Company completes equity financings totaling at least $17.5 million post-closing.
An
aggregate of 7.5% of the Cash Consideration issuable by the Company will be held in an escrow fund for a period of 12 months for purposes
of satisfying any post-closing indemnification claims under the Amended SPA. Pursuant to the Amended SPA, Colospan agreed to cancel,
terminate, and extinguish any outstanding stock options and warrants at closing without any right to receive any consideration.
The
acquisition of Colospan was accounted for as business combinations using the acquisition method of accounting in accordance with ASC
805, Business Combinations (“ASC 805”) , and the purchase prices were allocated to the assets acquired and liabilities assumed
based on their respective fair values as of the acquisition dates, inclusive of measurement period adjustments recorded during the period,
as presented below (in thousands). The purchase price allocations are preliminary and subject to change as we complete the valuation
of certain assets acquired and liabilities assumed.
The
aggregate fair value of the consideration transferred was approximately $4.9 million, consisting of $3.3 million in cash consideration
and approximately $1.6 million representing the acquisition-date fair value of contingent consideration. The contingent consideration
was recorded as a liability at its acquisition-date fair value and will be remeasured to fair value at each reporting date until settled,
with changes recognized in earnings.
The
acquisition-date fair value of the contingent consideration was determined using a probability-weighted valuation approach that considered
the potential payment scenarios specified in the Amended SPA. The estimated payments under the applicable scenarios were probability-weighted
based on management’s assumptions and discounted to present value using discount rates reflecting the timing and risk associated
with the respective payment scenarios. The fair value of the contingent consideration could be materially affected by changes in projected
net sales, the probabilities assigned to the applicable payment scenarios, the expected timing of the potential payments and the applicable
discount rates.
The
following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date:
Schedule of Estimated Fair Values
of Assets Acquired and Liabilities Assumed
| Consideration (USD in
thousands) | |
| |
| Cash | |
$ | 3,300 | |
| Contingent consideration | |
| 1,617 | |
| Fair value of total consideration
transferred | |
$ | 4,917 | |
| | |
| | |
| Purchase Price Allocation: | |
| | |
| Goodwill | |
$ | 1,764 | |
| Intangible assets – technology | |
| 4,642 | |
| Net tangible liabilities assumed | |
| (421 | ) |
| Deferred tax liability | |
| (1,068 | ) |
| Total consideration allocated | |
$ | 4,917 | |
The
following table presents the preliminary details of the identified intangible assets acquired (in thousands, except years):
Schedule
of Identified Intangible Assets Acquired
| | |
Fair
Value | | |
Useful
Life | |
Amortization
Classification |
| | |
(in thousands) | | |
(in years) | |
|
| Technology | |
$ | 4,642 | | |
7 | |
Research and development |
| Total Colospan intangible
assets acquired | |
$ | 4,642 | | |
| |
|
Note
5 – Subsequent events
1.
Regarding additional ordinary shares issued under the SEPA subsequent to June 30, 2025, see Note 3.3 above.
2.
On August 20, 2026, the Company effected a reverse share split of the Company’s ordinary shares at the ratio of 1-for-8, such that
each eight (8) ordinary shares, par value NIS 1.80 per share, were consolidated into one (1) ordinary share, par value NIS 14.40 per
share. As a result, all share and per share amounts were adjusted retroactively for all periods presented in these consolidated financial
statements.
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 14.40 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:
|
● |
our
ability to pursue, evaluate and complete any strategic alternative that yields value for our shareholders; |
| |
|
|
| |
● |
the
development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis,
or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; |
| |
|
|
| |
● |
our
history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty
regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to
continue as a going concern; |
| |
|
|
| |
● |
the
timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; |
| |
|
|
| |
● |
completion
and receiving favorable results of any pre-clinical or clinical trial; |
| |
|
|
| |
● |
regulatory
action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the 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 and any future product candidates; |
| |
● |
our
ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries
in which we seek to market the product; |
| |
|
|
| |
● |
our
ability to recognize the anticipated benefits of the acquisition of Colospan Ltd., or Colospan; |
| |
|
|
| |
● |
expectations
with respect to future performance and growth of Colospan |
| |
|
|
| |
● |
Galmed’s
and Colospan’s ability to execute our business plans and strategy and to receive regulatory approvals; |
| |
|
|
| |
● |
our
ability to achieve favorable pricing for Aramchol, or any other product candidate; |
| |
|
|
| |
● |
third-party
payor reimbursement for Aramchol, or any other product candidate; |
| |
|
|
| |
● |
our
estimates regarding anticipated capital requirements and our needs for additional financing; |
| |
|
|
| |
● |
market
adoption of Aramchol or any other product candidate by physicians and patients; |
| |
|
|
| |
● |
the
timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; |
| |
|
|
| |
● |
our
ability to obtain and maintain adequate protection of our intellectual property; |
| |
|
|
| |
● |
the
possibility that we may face third-party claims of intellectual property infringement; |
| |
|
|
| |
● |
our
ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; |
| |
|
|
| |
● |
our
ability to establish adequate sales, marketing and distribution channels; |
| |
|
|
| |
● |
intense
competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory
and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; |
| |
● |
our
expectations regarding licensing, acquisitions and strategic operations; |
| |
|
|
| |
● |
current
or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated
liquidity risk; |
| |
|
|
| |
● |
our
ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; |
| |
|
|
| |
● |
security,
political and economic instability in the Middle East that could harm our business, including due to the current security situation
in Israel; and |
| |
|
|
| |
● |
those
factors referred to in (i) “Item 3.D. Risk Factors,” “Item 4. Information on the Company,” and “Item
5. Operating and Financial Review and Prospects” in our Annual Report on Form 20-F for the year ended December 31, 2025 filed
with the SEC on March 31, 2026 and (ii) our Report of Foreign Private Issuer on Form 6-K filed with the SEC on June 8, 2026. |
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, 2025 filed with the SEC on March 31, 2026, in greater detail under the
heading “Risk Factors” and elsewhere in the Annual Report and this Form 6-K. In addition, additional risk factors relating
to the business of Colospan, which we acquired on June 22, 2026 are included in the section entitled “Risk Factors” in our
Report on Form 6-K filed with the SEC on June 8, 2026. 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 on Form 6-K. 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. Historically, we have focused almost exclusively on developing
Aramchol for the treatment of liver disease and were previously developing Aramchol for primary sclerosing cholangitis, or PSC, and exploring
the feasibility of developing Aramchol for other fibro-inflammatory indications outside of NASH and fibrosis.
We
are currently seeking to advance the development of Aramchol for oncological indications outside of NASH and fibrosis. In addition, as
part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting
cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development.
On
June 22, 2026, we completed the acquisition of Colospan, a medical device company focused on the development and manufacturing of innovative
solutions for colorectal surgical care. For additional information with respect to the acquisition, see “Recent Developments—Colospan
Acquisition” below. Colospan has developed the CG-100 intraluminal bypass device, a single-use, intraluminal temporary silicone
sheath designed to internally divert fecal matter away from the surgical anastomosis site in colorectal surgeries during the critical
post-operative period. For additional information with respect to Colospan’s business, see the section entitled “Colospan
Overview” in our Report on Form 6-K filed with the SEC on June 8, 2026.
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, 2026, we had an accumulated deficit of approximately $215.4 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 or any other product candidate.
Recent
Developments
Colospan
Acquisition
On
June 8, 2026, we entered into a Share Purchase Agreement, or the SPA, with Colospan, the shareholders of Colospan that are parties thereto,
who hold more than 92% of the voting power of the outstanding share capital of Colospan, and Boaz Assaf, solely in his capacity as the
representative of the shareholders of Colospan, pursuant to which, subject to the terms and conditions of the SPA, we purchased all of
the issued and outstanding share capital of Colospan. On June 22, 2026, we entered into an amended share purchase agreement, or the Amended
SPA, with Colospan, 100% of the shareholders of Colospan, and Boaz Assaf, solely in his capacity as the representative of the shareholders
of Colospan. Consummation of the acquisition occurred on June 22, 2026, or the Acquisition, which resulted in Colospan becoming a wholly-owned
subsidiary.
As
consideration for the sale of all of the issued and outstanding share capital of Colospan, we paid the Colospan shareholders, or the
Selling Shareholders, and certain SAFE investors (i) an aggregate amount of $3,300,000 in cash, which was allocated among the Selling
Shareholders and the SAFE investors, or the Cash Consideration, and (ii) a performance-based earnout consideration in an aggregate amount
of up to $2,000,000, or the Earnout Consideration. The earnout payments will begin accruing on “Net Revenue Sales”, as that
term is defined in the Amended SPA, recognized from July 1, 2027, on a cumulative basis, with no payments on the first $5 million of
sales. Thereafter, payments will be calculated at 7% of incremental sales from $5 million to $12 million and 9% on sales above $12 million,
with no retroactive application of higher tiers. Total earnout payments are capped at $2.0 million, but any unpaid portion will accelerate
and become immediately payable upon a qualifying sale or licensing of Colospan or its assets (subject to customary exclusions) or if
we complete equity financings totaling at least $17.5 million post-closing.
An
aggregate of 7.5% of the Cash Consideration issuable by us will be held in an escrow fund for a period of 12 months for purposes of satisfying
any post-closing indemnification claims under the Amended SPA. Pursuant to the Amended SPA, Colospan has agreed to cancel, terminate,
and extinguish any outstanding stock options and warrants at closing without any right to receive any consideration.
Financial
Overview
To
date, we have funded our operations primarily through proceeds from private placements and public offerings. On June 30, 2026, we had
current assets of $11.7 million, which includes cash and cash equivalents of $2.9 million, short term deposit of $2.5 million, marketable
debt securities of $5.9 million, other receivables of $0.3 million and restricted cash of $0.2 million. This compares with current assets
of $18.6 million on December 31, 2025, which includes cash and cash equivalents of $4.0 million, short term deposit of $7.1 million,
marketable debt securities of $7.0 million, other receivables of $0.3 million and restricted cash of $0.1 million. 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 Report on Form 6-K. However, significant additional funding will be necessary to fund our ongoing research and development
work and to advance our product candidates through regulatory approval and into commercialization, if approved. 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, and/or our other pre-clinical and clinical programs. This may raise substantial doubts about our ability
to continue as a going concern.
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 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 one of our primary expenses 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, we are unable to estimate with any certainty the costs we will incur in the continued development of Aramchol and other product
candidate. 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.
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 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.
Financial
Income, Net
Our
financial income, net consists mainly of interest income from marketable debt securities, expenses that we incurred in establishing the
SEPA (as defined below), which includes ordinary shares to the equity line provider, and foreign currency gains. Our financial expenses
consist of fees associated with banking activities and losses from realization of marketable debt securities.
Results
of Operations
The
table below provides our results of operations for the three and six months ended June 30, 2026, as compared to the three and six months
ended June 30, 2025.
| | |
Three
months ended June 30, | | |
Six
months ended June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| | |
(unaudited) | | |
(unaudited) | | |
(unaudited) | | |
(unaudited) | |
| | |
| | | |
| (In
thousands, except per share data) | | |
| | |
| Research and development expenses | |
| 1,782 | | |
| 1,058 | | |
| 3,142 | | |
| 1,692 | |
| General and administrative expenses | |
| 993 | | |
| 1,051 | | |
| 1,677 | | |
| 1,681 | |
| Total operating expenses | |
| 2,775 | | |
| 2,109 | | |
| 4,819 | | |
| 3,373 | |
| Financial income, net | |
| (154 | ) | |
| (152 | ) | |
| (288 | ) | |
| (332 | ) |
| Financial expenses related to SEPA | |
| 102 | | |
| 12 | | |
| 102 | | |
| 32 | |
| Impairment of Associate | |
| - | | |
| 526 | | |
| - | | |
| 526 | |
| Net loss | |
| 2,723 | | |
| 2,495 | | |
| 4,633 | | |
| 3,599 | |
| Other comprehensive loss
(gain): | |
| (52 | ) | |
| 6 | | |
| 28 | | |
| (13 | ) |
| Comprehensive loss | |
| 2,671 | | |
| 2,501 | | |
| 4,661 | | |
| 3,586 | |
| Basic and diluted net
loss per share | |
$ | 2.81 | | |
$ | 5.07 | | |
$ | 5.21 | | |
$ | 10.0 | |
Research
and Development Expenses
Our
research and development expenses amounted to approximately $1.8 million and approximately $3.1 million during the three and six months
ended June 30, 2026, respectively, representing an increase of approximately $0.7 million, or 64%, and approximately $1.4 million, or
82%, respectively, compared to approximately $1.1 million and approximately $1.7 million, respectively for the comparable period in 2025.
The
increase during the three months ended June 30, 2026 primarily resulted from an increase in chemistry and formulation studies expenses
of $0.3 million and clinical trial expenses of approximately $0.3 million, while the increase during the six months ended June 30, 2026
primarily resulted from an increase in clinical trial expenses of approximately $0.7 million and pre-clinical trial expenses of approximately
$0.3 million.
General
and Administrative Expenses
Our
general and administrative expenses amounted to approximately $1.0 million and approximately $1.7 million during the three and six months
ended June 30, 2026, respectively, representing nil increase against the general and administrative expenses for the three and six months
ended June 30, 2025.
Operating
Loss
As
a result of the foregoing, for the three and six months ended June 30, 2026 our operating loss was approximately $2.8 million and approximately
$4.8 million, respectively, representing an increase of $0.7 million, or 33%, and an increase of $1.4 million, or 41%, respectively,
as compared to approximately $2.1 million and approximately $3.4 million, respectively, for the comparable period in 2025.
Financial
income, Net
Our
financial income, net amounted to approximately $0.15 million and approximately $0.3 million during the three and six months ended June
30, 2026, respectively, representing an immaterial decrease from the financial income, net for the three and six months ended June 30,
2025.
Impairment
of Associate
Our
investment in Onkai was presented in our consolidated financial statements at its fair value. As of June 30, 2025, management, based
on its estimation, assessed the qualitative aspects of the equity investment and macroeconomic factors and determined that an impairment
should be recognized in the amount of approximately $0.5 million. On December 29, 2025, OnKai filed a certificate of dissolution with
the Secretary of State of the State of Delaware for winding up its affairs and dissolving as an entity. As of December 31, 2025, we determined
that our investment and related balances in OnKai, including a long-term loan, were not recoverable and recorded a full write-off of
such amounts.
Net
Loss
As
a result of the foregoing, for the three and six months ended June 30, 2026, our net loss was approximately $2.7 million and approximately
$4.7 million, respectively, representing an increase of $0.2 million, or 8%, and an increase of $1.1 million, or 31%, respectively, as
compared to approximately $2.5 million and approximately $3.6 million, respectively, for the comparable period in 2025.
Liquidity
and 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, 2026, we had an accumulated deficit of approximately $215.4 million and positive working capital
(current assets less current liabilities) of approximately $8.9 million. We expect that operating losses will continue for the foreseeable
future.
As
of June 30, 2026, we had cash and cash equivalents of approximately $2.9 million, short term deposits of $2.5 million, restricted cash
of approximately $0.2 million and marketable debt securities of approximately $5.9 million invested in accordance with our investment
policy, totaling approximately $11.4 million, as compared to approximately $4.0 million, $7.1 million, $0.1 million and $7.0 million
as of December 31, 2025, respectively, totaling approximately $18.3 million. The decrease is mainly attributable to our negative cash
flow from operating activities during the six months ended June 30, 2026 of $4.7 million, as well as the net cash paid for the acquisition
of Colospan of $3.2 million during the period.
We
had negative cash flow from operating activities of approximately $4.7 million for the six months ended June 30, 2026, as compared to
negative cash flow from operating activities of approximately $2.4 million for the six months ended June 30, 2025. The negative cash
flow from operating activities for the six months ended June 30, 2026, is mainly attributable to our net loss of approximately $4.7 million.
We
had positive cash flow from investing activities of approximately $2.4 million for the six months ended June 30, 2026, as compared to
a negative cash flow from investing activities of approximately $4.8 million for the six months ended June 30, 2025. The positive cash
flow from investing activities for the six months ended June 30, 2026, was primarily due to the maturity of short term deposits of $4.6
million and the net sale of available for sale securities of approximately $1.09 million; partially offset by the cash paid for the
acquisition of Colospan, net of cash acquired of $3.2 million,
We
had positive cash flow from financing activities of approximately $1.2 million for the six months ended June 30, 2026, as compared to
a positive cash flow from financing activities for the six months ended June 30, 2025. The positive cash flow from financing activities
for the six months ended June 30, 2026 was primarily due to issuance of shares in relation to the SEPA (as defined below) and 2024 Sales
Agreement (as defined below)
On
August 30, 2024, we entered into a Standby Equity Purchase Agreement, or SEPA, with YA II PN, LTD., a Cayman Islands exempt limited partnership,
or YA. Pursuant to the SEPA, we have the right, but not the obligation, to sell to YA from time to time, each such occurrence, an Advance,
up to $10.0 million, or the Initial Commitment Amount, of our ordinary shares, during the 36 months following the execution of the SEPA,
subject to the restrictions and satisfaction of the conditions in the SEPA. On October 21, 2024, we and YA entered into an amendment
to the SEPA to increase the Initial Commitment Amount to $20.0 million of our ordinary shares. At our option, the ordinary shares would
be purchased by YA from time to time at a price equal to 97% of the lowest of the three daily VWAPs (as hereinafter defined) during a
three consecutive trading day period commencing on the date that we, subject to certain limitations, deliver a notice to YA that we are
committing YA to purchase such ordinary shares, or the Advance Shares. We may also specify a certain minimum acceptable price per share
in each Advance. “VWAP” means, for any trading day, the daily volume weighted average price of our ordinary shares for such
trading day on the Nasdaq Stock Market during regular trading hours as reported by Bloomberg L.P. As consideration for YA irrevocable
commitment to purchase our ordinary shares up to the Initial Commitment Amount, we issued 3,946 ordinary shares, or the Commitment Shares,
to YA in four equal installments every 90 calendar days and also paid a $15,000 structuring fee to an affiliate of YA. During the six
months ended June 30, 2026, we issued an aggregate of 170,135 ordinary shares to YA for aggregate gross proceeds of approximately $1.3
million. Subsequent to June 30, 2026, we issued an aggregate of 40,956 ordinary shares to YA for aggregate gross proceeds of approximately
$0.3 million.
On
November 14, 2024, we entered into a Capital on Demand Sales Agreement, or the 2024 Sales Agreement, with JonesTrading Institutional
Serviecs LLC, or JonesTrading. Pursuant to the 2024 Sales Agreement, we may offer and sell our ordinary shares having an aggregate offering
price of up to $8.1 million, from time to time through JonesTrading, or the ATM Facility. JonesTrading will receive a commission equal
to 3.0% of the gross proceeds from the sale of the ordinary shares pursuant to the 2024 Sales Agreement. As of December 31, 2025, we
sold 460,880 of our ordinary shares for aggregate gross proceeds of approximately $8.1 million ($7.7 million net) pursuant to the 2024
Sales Agreement. We did not issue any ordinary shares during the six months ended June 30, 2026.
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 ongoing research and development work, to advance our product candidates through regulatory approval and into commercialization,
if approved. 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 and development
activities relating to Aramchol and our other pre-clinical and clinical programs, and/or curtail our commercialization, marketing, distribution
and other operational activities relating to Colospan. 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
outcome of an evaluation of potential strategic alternatives; |
| |
|
|
| |
● |
the
progress and costs of our pre-clinical studies, clinical trials and other research and development activities; |
| |
|
|
| |
● |
the
regulatory pathway of Aramchol any other product candidate; |
| |
|
|
| |
● |
the
scope, prioritization and number of our clinical trials and other collaboration research and development programs; |
| |
● |
the
amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect
to Aramchol or any other product candidate; |
| |
|
|
| |
● |
the
costs of the development and expansion of our operational infrastructure; |
| |
|
|
| |
● |
the
costs and timing of obtaining regulatory approval for Aramchol or any other product candidate; |
| |
|
|
| |
● |
the
successful integration of Colospan and the costs associated with its operations; |
| |
|
|
| |
● |
the
continued research, development, regulatory advancement, clinical validation and commercialization of Colospan’s product candidates
and technologies; |
| |
|
|
| |
● |
the
expansion of Colospan’s manufacturing capabilities, commercial infrastructure, strategic partnerships and market adoption efforts; |
| |
|
|
| |
● |
the
ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under
our potential future licensing agreements; |
| |
|
|
| |
● |
the
costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; |
| |
|
|
| |
● |
the
costs and timing of securing manufacturing arrangements for clinical or commercial production; |
| |
|
|
| |
● |
the
costs of contracting with third parties to provide sales and marketing capabilities for us; |
| |
|
|
| |
● |
the
costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms; |
| |
|
|
| |
● |
the
magnitude of our general and administrative expenses; |
| |
|
|
| |
● |
any
cost that we may incur under future in- and out-licensing arrangements relating to Aramchol or any other product candidate; |
| |
|
|
| |
● |
market
conditions; |
| |
|
|
| |
● |
our
ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; |
| |
|
|
| |
● |
our
ability to identify, evaluate and complete any strategic alternative that yields value for our shareholders; and |
| |
|
|
| |
● |
the
impact of the security situation in Israel, which may exacerbate the magnitude of the factors discussed above. |
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 known 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 reported financial information to not necessarily be indicative
of future operating results or financial conditions. 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.
Risk
Factors
Any
investment in our business involves a high degree of risk. Before making an investment decision, you should carefully consider the information
we include in this Report on Form 6-K, including our unaudited condensed consolidated financial statements and accompanying notes, and
the additional information in the other reports we file with the Securities and Exchange Commission. Except as set forth below and as
otherwise disclosed in our other filings made with the Securities and Exchange Commission on or prior to the date of this Form 6-K, including
our Annual Report on Form 20-F for the fiscal year ended December 31, 2025 and the additional risk factors relating to the business of
Colospan in the section entitled “Risk Factors” in our Report on Form 6-K filed with the SEC on June 8, 2026, there have
been no material changes to the risk factors previously disclosed in our most recent Annual Report on Form 20-F. These risks may result
in material harm to our business and our financial condition and results of operations. In this event, the market price of our ordinary
shares may decline and you could lose part or all of your investment.
If
we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our ordinary shares may be delisted and the price
of our ordinary shares and our ability to access the capital markets could be negatively impacted.
Nasdaq
has established certain standards for the continued listing of a security on the Nasdaq Capital Market. The standards for continued listing
include, among other things, that the minimum bid price for the listed securities not fall below $1.00 per share for a period of 30 consecutive
trading days, that we maintain a minimum of $2,500,000 in shareholders’ equity and that our Market Value of Listed Securities (“MVLS”)
not fall below $5.0 million for a period of 30 consecutive trading days, as further discussed below.
We
have in the past fallen out of compliance with certain continued listing standards, including the minimum bid price requirement, although
we have subsequently been able to regain compliance. No assurance, however, can be given that we will continue to be in compliance with
the continued listing requirements of the Nasdaq Capital Market. Failure to meet applicable Nasdaq continued listing standards could
result in a delisting of our ordinary shares. A delisting of our ordinary shares from Nasdaq could materially reduce the liquidity of
our ordinary shares and result in a corresponding material reduction in the price of our ordinary shares. In addition, delisting could
harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential
loss of confidence by investors and employees and fewer business development opportunities.
On
July 22, 2026, the SEC approved a new Nasdaq continued listing requirement applicable to companies listed on the Nasdaq Stock Market
that would require listed companies to maintain a minimum MVLS of at least $5.0 million. Under the approved rule, if a company’s
MVLS remains below $5.0 million for 30 consecutive trading days, Nasdaq will issue a Staff Delisting Determination and immediately suspend
trading in the company’s securities and commence delisting proceedings. Unlike many other Nasdaq continued listing standards, the
rule does not provide a compliance or cure period before a delisting determination is issued. Although a company may appeal a delisting
determination, the appeal generally does not stay the suspension of trading, and the company’s securities would generally trade
on an over-the-counter market during the appeals process. In addition, any exception that may be granted by a Nasdaq Hearings Panel is
limited. In particular, the Hearings Panel may grant an exception of up to 180 days only if the company demonstrates that it can satisfy
Nasdaq’s applicable initial listing requirements, which are generally more stringent than Nasdaq’s continued listing standards.
As a result, companies subject to a delisting determination under the MVLS rule may have fewer opportunities to regain compliance than
under other Nasdaq continued listing requirements.
However,
on July 29, 2026, the SEC notified Nasdaq that it had received notices of intention to petition for review of the approval order and,
pursuant to Rule 431(e) of the SEC’s Rules of Practice, the effectiveness of the approval order was automatically stayed pending
further review by the SEC. As a result, the ultimate implementation, timing and scope of the MVLS requirement remain uncertain. As of
September 1, 2026, our MVLS was approximately $4.2 million, which is below the $5.0 million threshold contemplated by the rule. Accordingly,
if the stay is lifted, the rule becomes effective and we are unable to satisfy the MVLS requirement, our securities would become subject
to suspension and delisting from Nasdaq. Any such suspension or delisting could materially reduce the liquidity and market price of our
ordinary shares, impair our ability to raise additional capital, reduce investor interest in our securities and adversely affect our
business, financial condition and prospects.
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:
September 2, 2026 |
By: |
/s/
Allen Baharaff |
| |
|
Allen
Baharaff |
| |
|
President
and Chief Executive Officer |