Cover
Cover | 6 Months Ended |
Jun. 30, 2024 | |
Cover [Abstract] | |
Document Type | 6-K |
Amendment Flag | false |
Document Period End Date | Jun. 30, 2024 |
Document Fiscal Period Focus | Q2 |
Document Fiscal Year Focus | 2024 |
Current Fiscal Year End Date | --12-31 |
Entity File Number | 001-36345 |
Entity Registrant Name | GALMED PHARMACEUTICALS LTD. |
Entity Central Index Key | 0001595353 |
Entity Address, Address Line One | 16 Abba Hillel Road |
Entity Address, City or Town | Ramat Gan |
Entity Address, Country | IL |
Entity Address, Postal Zip Code | 5250608 |
Interim Condensed Consolidated
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 |
Interim Condensed Consolidate_2
Interim Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - ₪ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, par value | ₪ 0.15 | ₪ 0.15 |
Ordinary shares, authorized | 20,000,000 | 20,000,000 |
Ordinary shares, issued | 6,358,747 | 5,045,324 |
Ordinary shares, outstanding | 6,358,747 | 5,045,324 |
Interim Condensed Consolidate_3
Interim Condensed Consolidated Statements of Operations (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] | ||||
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 |
Weighted-average number of shares outstanding used in computing diluted net loss per share | 6,294,748 | 1,680,232 | 5,878,432 | 1,680,232 |
Interim Condensed Consolidate_4
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 |
Consolidated Statements of Chan
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 |
Interim Condensed Consolidate_5
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 |
Basis of presentation
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 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 0.1 2.0 5.9 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 3.4 195.3 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. |
Summary of significant accounti
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. |
Investment in Associate at Fair
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 Previously, on November, 2022 the Company invested $ 1.5 15 The Company’s investment in OnKai was part of an approximately $ 6.0 3.8 1,223,535 24 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. |
Stockholders_ Equity
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 . 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 5,220,000 5,220,000 5,600,000 5,600,000 1.25 1.249 The Pre-Funded Warrants are immediately exercisable at an exercise price of $ 0.001 The Investor Warrants have an exercise price of $ 1.25 The net proceeds to the Company were approximately $ 6.2 As of June 30, 2024, a total of 4,290,000 4,286,405 |
Subsequent events
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 438,333 438,333 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. |
Investment in Associate at Fa_2
Investment in Associate at Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments, All Other Investments [Abstract] | |
Summary of Statement of operations | 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 |
Basis of presentation (Details
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 |
Summary of Statement of operati
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 |
Investment in Associate at Fa_3
Investment in Associate at Fair Value (Details Narrative) - OnKai Inc [Member] - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended | ||
May 04, 2023 | Nov. 30, 2022 | Jun. 30, 2024 | Jun. 19, 2023 | |
Value conversion | $ 1.5 | $ 1.5 | $ 3.8 | |
Capital stock discount rate | 15% | |||
Investment | $ 6 | |||
Number of owned shares | 1,223,535 | |||
Shares owned percentage | 24% |
Stockholders_ Equity (Details N
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 |
Subsequent events (Details Narr
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 |