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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 August 2024
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, 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
Financial
Statements
GALMED
PHARMACEUTICALS LTD.
Interim
Condensed Consolidated Balance Sheets (Unaudited)
U.S.
Dollars in thousands, except share data and per share data
| |
As
of | | |
As
of | |
| |
June
30, 2024 | | |
December
31, 2023 | |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current
assets | |
| | | |
| | |
Cash
and cash equivalents | |
$ | 1,837 | | |
$ | 2,861 | |
Restricted
Cash | |
| 118 | | |
| 117 | |
Short-term
deposit | |
| 2,046 | | |
| 2,253 | |
Marketable
debt securities | |
| 5,940 | | |
| 7,528 | |
Other
receivables | |
| 135 | | |
| 480 | |
Total
current assets | |
| 10,076 | | |
| 13,239 | |
| |
| | | |
| | |
Right
of use assets | |
| - | | |
| 42 | |
Property
and equipment, net | |
| - | | |
| 83 | |
Investment
in associate at fair value | |
| 3,265 | | |
| 3,265 | |
Total
non-current assets | |
| 3,265 | | |
| 3,390 | |
| |
| | | |
| | |
Total
assets | |
$ | 13,341 | | |
$ | 16,629 | |
| |
| | | |
| | |
Liabilities
and stockholders’ equity | |
| | | |
| | |
| |
| | | |
| | |
Current
liabilities | |
| | | |
| | |
Trade
payables | |
$ | 1,203 | | |
$ | 1,879 | |
Other
payables | |
| 351 | | |
| 871 | |
Total
current liabilities | |
| 1,554 | | |
| 2,750 | |
| |
| | | |
| | |
Stockholders’
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
paid-in capital | |
| 207,305 | | |
| 207,076 | |
Accumulated
other comprehensive loss | |
| (435 | ) | |
| (454 | ) |
Accumulated
deficit | |
| (195,346 | ) | |
| (192,952 | ) |
Total
stockholders’ equity | |
| 11,787 | | |
| 13,879 | |
| |
| | | |
| | |
Total
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.
Interim
Condensed Consolidated Statements of Operations (Unaudited)
U.S.
Dollars in thousands, except share data and per share data
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended June 30, | | |
Six
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.
Interim
Condensed Consolidated Statements of Comprehensive Loss (Unaudited)
U.S.
Dollars in thousands
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended June 30, | | |
Six
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.
Consolidated
Statements 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
paid-in | | |
Accumulated
other
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
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.
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, 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.
Note
2 - 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.
Note
3 – 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.
Summarized
statement of operations (in thousands) of Onkai:
Summary
of Statement of operations
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Total
operating loss | |
$ | 653 | | |
$ | 573 | | |
$ | 1,334 | | |
$ | 1,171 | |
| |
| | | |
| | | |
| | | |
| | |
Net
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.
Note
4 - Stockholders’ Equity
| 1.
On May 15, 2023, the Company effected a reverse share split of the Company’s ordinary
shares at the ratio of 1-for-15,
such that each fifteen (15) ordinary shares, par value NIS 0.01
per
share, were consolidated into one (1) ordinary share, par value NIS 0.15
per share.
As a
result, all share and per share amounts were adjusted retroactively for all periods presented
in these financial statements. |
| |
| 2.
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
to purchase 5,220,000 ordinary shares (the “Pre-Funded Warrants”), and (iii) 5,600,000 warrants to purchase 5,600,000
ordinary shares (the “Investor Warrants”), at a purchase price of $1.25 per share and accompanying Investor Warrant and
$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.
Note
5 – Subsequent events
| 1. | Subsequent
to the balance sheet date, a total of 930,000
Pre-Funded
Warrants were exercised into 927,245
ordinary
shares. As of August 23, 2024, all outstanding Pre-Funded Warrants have been exercised. |
| | |
| 2. | Subsequent
to the balance sheet date, a total of 438,333 RSU’s were exercised into 438,333 ordinary
shares. |
| | |
| 3. | Subsequent
to the balance sheet date, on August 27, 2024, the Company announced that on August 29, 2024
it will effect a reverse share split (“August 2024 Reverse Split”)_of the Company’s
ordinary shares at the ratio of 1-for-12, such that each twelve (12) ordinary shares, par
value NIS 0.15 per share, shall be consolidated into one (1) ordinary share, par value NIS
1.80 per share. Since the August 2024 Reverse Split has not been effected prior to the date
of issuance of these financial statements, all share and per share amounts have not been
adjusted for the periods presented in these 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 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 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
timing and cost of our planned PSC clinical trial and our pivotal Phase 3 ARMOR trial, or
the ARMOR Study, if re-initiated, for our product candidates, Aramchol and Amilo-5MER, or
for any other pre-clinical or clinical trials; |
| | |
| ● | completion
and receiving favorable results of our planned PSC clinical trial and the ARMOR Study (if
re-initiated) for Aramchol or any other 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, Amilo-5MER
or any other product candidate in the countries in which we seek to market the product; |
| | |
| ● | our
ability to achieve favorable pricing for Aramchol, Amilo-5MER or any other product candidate; |
| ● | our
expectations regarding the commercial market for non-alcoholic steato-hepatitis, or NASH,
in patients or any other targeted indication; |
| | |
| ● | third-party
payor reimbursement for Aramchol, Amilo-5MER 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; |
| | |
| ● | the
development and approval of the use of Aramchol or any other product candidate for additional
indications or in combination therapy; |
| | |
| ● | 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; and |
| | |
| ● | security,
political and economic instability in the Middle East that could harm our business, including
due to the the recent attacks by Hamas and other terrorist organizations from the Gaza Strip
and elsewhere in the region and Israel’s war against them and military hostilities
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.
Financial
Overview
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.
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 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.
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. Our general and administrative expenses may also increase due to increases in professional
and advisory fees as we evaluate our strategic alternatives.
Financial
Income, 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.
Results
of 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 | |
Research
and 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.
General
and 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.
Operating
Loss
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.
Financial
Income, 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.
Net
Loss
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.
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, 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
progress and costs of our pre-clinical studies, clinical trials and other research and development activities; |
|
|
● |
the
regulatory pathway of Aramchol, Amilo-5MER or 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, Amilo-5MER or any other product candidate; |
|
|
● |
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, Amilo-5MER or any other product candidate; |
|
|
● |
market
conditions; |
|
|
● |
our
ability to main 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 any resurgence of the COVID-19 pandemic and the war between Hamas and 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 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”.
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.
Reverse
Split
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:
August 28, 2024 |
By: |
/s/
Allen Baharaff |
|
|
Allen
Baharaff |
|
|
President
and Chief Executive Officer |
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v3.24.2.u1
Interim Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
Cash and cash equivalents |
$ 1,837
|
$ 2,861
|
Restricted Cash |
118
|
117
|
Short-term deposit |
2,046
|
2,253
|
Marketable debt securities |
5,940
|
7,528
|
Other receivables |
135
|
480
|
Total current assets |
10,076
|
13,239
|
Right of use assets |
|
42
|
Property and equipment, net |
|
83
|
Investment in associate at fair value |
3,265
|
3,265
|
Total non-current assets |
3,265
|
3,390
|
Total assets |
13,341
|
16,629
|
Current liabilities |
|
|
Trade payables |
1,203
|
1,879
|
Other payables |
351
|
871
|
Total current liabilities |
1,554
|
2,750
|
Stockholders’ 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 paid-in capital |
207,305
|
207,076
|
Accumulated other comprehensive loss |
(435)
|
(454)
|
Accumulated deficit |
(195,346)
|
(192,952)
|
Total stockholders’ equity |
11,787
|
13,879
|
Total liabilities and stockholders’ equity |
$ 13,341
|
$ 16,629
|
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v3.24.2.u1
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|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
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₪ 0.15
|
₪ 0.15
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20,000,000
|
20,000,000
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6,358,747
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6,358,747
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5,045,324
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v3.24.2.u1
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3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
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, net loss per share |
$ 0.18
|
$ 0.95
|
$ 0.41
|
$ 2.04
|
Diluted, net loss per share |
$ 0.18
|
$ 0.95
|
$ 0.41
|
$ 2.04
|
Weighted-average number of shares outstanding used in computing basic net loss per share |
6,294,748
|
1,680,232
|
5,878,432
|
1,680,232
|
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6,294,748
|
1,680,232
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5,878,432
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1,680,232
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v3.24.2.u1
Interim Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
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
|
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v3.24.2.u1
Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 70
|
$ 200,138
|
$ (745)
|
$ (186,040)
|
$ 13,423
|
Balance, shares at Dec. 31, 2022 |
1,692,342
|
|
|
|
|
Stock-based compensation |
|
297
|
|
|
297
|
Unrealized loss from marketable debt securities |
|
|
100
|
|
100
|
Net loss |
|
|
|
(1,830)
|
(1,830)
|
Balance at Mar. 31, 2023 |
$ 70
|
200,435
|
(645)
|
(187,870)
|
11,990
|
Balance, shares at Mar. 31, 2023 |
1,692,342
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 70
|
200,138
|
(745)
|
(186,040)
|
13,423
|
Balance, shares at Dec. 31, 2022 |
1,692,342
|
|
|
|
|
Net loss |
|
|
|
|
(3,423)
|
Balance at Jun. 30, 2023 |
$ 70
|
200,609
|
(662)
|
(189,463)
|
10,554
|
Balance, shares at Jun. 30, 2023 |
1,692,342
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 70
|
200,435
|
(645)
|
(187,870)
|
11,990
|
Balance, shares at Mar. 31, 2023 |
1,692,342
|
|
|
|
|
Stock-based compensation |
|
174
|
|
|
174
|
Unrealized loss from marketable debt securities |
|
|
(17)
|
|
(17)
|
Net loss |
|
|
|
(1,593)
|
(1,593)
|
Balance at Jun. 30, 2023 |
$ 70
|
200,609
|
(662)
|
(189,463)
|
10,554
|
Balance, shares at Jun. 30, 2023 |
1,692,342
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 209
|
207,076
|
(454)
|
(192,952)
|
13,879
|
Balance, shares at Dec. 31, 2023 |
5,045,324
|
|
|
|
|
Exercise of pre-funded warrants |
$ 40
|
(40)
|
|
|
|
Exercise of Pre-funded warrants, shares |
964,330
|
|
|
|
|
Stock-based compensation |
|
153
|
|
|
153
|
Unrealized loss from marketable debt securities |
|
|
(1)
|
|
(1)
|
Net loss |
|
|
|
(1,275)
|
(1,275)
|
Balance at Mar. 31, 2024 |
$ 249
|
207,189
|
(455)
|
(194,227)
|
12,756
|
Balance, shares at Mar. 31, 2024 |
6,009,654
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 209
|
207,076
|
(454)
|
(192,952)
|
13,879
|
Balance, shares at Dec. 31, 2023 |
5,045,324
|
|
|
|
|
Net loss |
|
|
|
|
(2,394)
|
Balance at Jun. 30, 2024 |
$ 263
|
207,305
|
(435)
|
(195,346)
|
11,787
|
Balance, shares at Jun. 30, 2024 |
6,358,747
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 249
|
207,189
|
(455)
|
(194,227)
|
12,756
|
Balance, shares at Mar. 31, 2024 |
6,009,654
|
|
|
|
|
Exercise of pre-funded warrants |
$ 14
|
(14)
|
|
|
|
Exercise of Pre-funded warrants, shares |
349,093
|
|
|
|
|
Stock-based compensation |
|
130
|
|
|
130
|
Unrealized loss from marketable debt securities |
|
|
20
|
|
20
|
Net loss |
|
|
|
(1,119)
|
(1,119)
|
Balance at Jun. 30, 2024 |
$ 263
|
$ 207,305
|
$ (435)
|
$ (195,346)
|
$ 11,787
|
Balance, shares at Jun. 30, 2024 |
6,358,747
|
|
|
|
|
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v3.24.2.u1
Interim Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 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
|
X |
- DefinitionChange in fair value of investment.
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v3.24.2.u1
Basis of presentation
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of presentation |
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, 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.
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v3.24.2.u1
Summary of significant accounting policies
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Summary of significant accounting policies |
Note
2 - 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.
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v3.24.2.u1
Investment in Associate at Fair Value
|
6 Months Ended |
Jun. 30, 2024 |
Investments, All Other Investments [Abstract] |
|
Investment in Associate at Fair Value |
Note
3 – 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.
Summarized
statement of operations (in thousands) of Onkai:
Summary
of Statement of operations
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
months ended | | |
Six
months ended | |
| |
June
30, | | |
June
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Total
operating loss | |
$ | 653 | | |
$ | 573 | | |
$ | 1,334 | | |
$ | 1,171 | |
| |
| | | |
| | | |
| | | |
| | |
Net
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.
|
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v3.24.2.u1
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note
4 - Stockholders’ Equity
| 1.
On May 15, 2023, the Company effected a reverse share split of the Company’s ordinary
shares at the ratio of 1-for-15,
such that each fifteen (15) ordinary shares, par value NIS 0.01
per
share, were consolidated into one (1) ordinary share, par value NIS 0.15
per share.
As a
result, all share and per share amounts were adjusted retroactively for all periods presented
in these financial statements. |
| |
| 2.
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
to purchase 5,220,000 ordinary shares (the “Pre-Funded Warrants”), and (iii) 5,600,000 warrants to purchase 5,600,000
ordinary shares (the “Investor Warrants”), at a purchase price of $1.25 per share and accompanying Investor Warrant and
$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 $6.2 million.
As
of June 30, 2024, a total of 4,290,000 Pre-Funded Warrants were exercised into 4,286,405 ordinary shares.
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Subsequent events
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
Subsequent events |
Note
5 – Subsequent events
| 1. | Subsequent
to the balance sheet date, a total of 930,000
Pre-Funded
Warrants were exercised into 927,245
ordinary
shares. As of August 23, 2024, all outstanding Pre-Funded Warrants have been exercised. |
| | |
| 2. | Subsequent
to the balance sheet date, a total of 438,333 RSU’s were exercised into 438,333 ordinary
shares. |
| | |
| 3. | Subsequent
to the balance sheet date, on August 27, 2024, the Company announced that on August 29, 2024
it will effect a reverse share split (“August 2024 Reverse Split”)_of the Company’s
ordinary shares at the ratio of 1-for-12, such that each twelve (12) ordinary shares, par
value NIS 0.15 per share, shall be consolidated into one (1) ordinary share, par value NIS
1.80 per share. Since the August 2024 Reverse Split has not been effected prior to the date
of issuance of these financial statements, all share and per share amounts have not been
adjusted for the periods presented in these financial statements. |
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Basis of presentation (Details Narrative) - USD ($) $ in Thousands |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
|
|
Date of incorporation |
Jul. 31, 2013
|
|
|
Date of commenced operations |
Feb. 02, 2014
|
|
|
Cash and cash equivalents |
$ 1,837
|
|
$ 2,861
|
Restricted cash |
118
|
|
117
|
Short-term deposits |
2,046
|
|
2,253
|
Marketable securities debt |
5,940
|
|
7,528
|
Profit loss |
2,400
|
$ 3,400
|
|
Retained earnings accumulated deficit |
$ 195,346
|
|
$ 192,952
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v3.24.2.u1
Summary of Statement of operations (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Net loss |
$ (1,119)
|
$ (1,275)
|
$ (1,593)
|
$ (1,830)
|
$ (2,394)
|
$ (3,423)
|
OnKai Inc [Member] |
|
|
|
|
|
|
Total operating loss |
653
|
|
573
|
|
1,334
|
1,171
|
Net loss |
$ 645
|
|
$ 769
|
|
$ 1,312
|
$ 1,584
|
X |
- DefinitionThe portion of profit or loss for the period, net of income taxes, which is attributable to the parent.
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v3.24.2.u1
Stockholders’ Equity (Details Narrative) $ / shares in Units, $ in Millions |
|
|
6 Months Ended |
Jul. 18, 2023
USD ($)
$ / shares
shares
|
May 15, 2023
₪ / shares
|
Jun. 30, 2024
shares
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Number of ordinary shares |
380,000
|
|
|
Proceeds from issuance of ordinary shares | $ |
$ 6.2
|
|
|
Pre-Funded Warrants [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Number of warrants shares |
5,220,000
|
|
4,290,000
|
Number of warrants to purchase shares |
5,220,000
|
|
|
Purchase price | $ / shares |
$ 1.249
|
|
|
Warrants exercise price | $ / shares |
$ 0.001
|
|
|
Warrants exercised into ordinary shares |
|
|
4,286,405
|
Investor Warrants [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Number of warrants shares |
5,600,000
|
|
|
Number of warrants to purchase shares |
5,600,000
|
|
|
Purchase price | $ / shares |
$ 1.25
|
|
|
Warrants exercise price | $ / shares |
$ 1.25
|
|
|
Common Stock [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Stockholders' Equity, Reverse Stock Split |
|
1-for-15
|
|
Common Stock, No Par Value | ₪ / shares |
|
₪ 0.01
|
|
Sale of Stock, Price Per Share | ₪ / shares |
|
₪ 0.15
|
|
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- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.24.2.u1
Subsequent events (Details Narrative) - shares
|
|
|
2 Months Ended |
6 Months Ended |
|
Aug. 29, 2024 |
May 15, 2023 |
Aug. 28, 2024 |
Jun. 30, 2024 |
Jul. 18, 2023 |
Common Stock [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Reverse share split ratio |
|
1-for-15
|
|
|
|
Pre-Funded Warrants [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Class of Warrant or Right, Outstanding |
|
|
|
4,290,000
|
5,220,000
|
Number of shares exercised into ordinary shares |
|
|
|
4,286,405
|
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Reverse share split ratio |
on August 29, 2024
it will effect a reverse share split (“August 2024 Reverse Split”)_of the Company’s
ordinary shares at the ratio of 1-for-12, such that each twelve (12) ordinary shares, par
value NIS 0.15 per share, shall be consolidated into one (1) ordinary share, par value NIS
1.80 per share.
|
|
|
|
|
Subsequent Event [Member] | Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Number of shares exercised into ordinary shares |
|
|
438,333
|
|
|
Number of RSU shares |
|
|
438,333
|
|
|
Subsequent Event [Member] | Pre-Funded Warrants [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Class of Warrant or Right, Outstanding |
|
|
930,000
|
|
|
Number of shares exercised into ordinary shares |
|
|
927,245
|
|
|
X |
- DefinitionNumber of warrants or rights outstanding.
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Galmed Pharmaceuticals (NASDAQ:GLMD)
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From Dec 2024 to Jan 2025
Galmed Pharmaceuticals (NASDAQ:GLMD)
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From Jan 2024 to Jan 2025