[Condensed Consolidated Financial Statements](index=3&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the company's financial position, performance, and cash flows for the interim period, highlighting key changes in assets, liabilities, and equity [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, Enlivex Therapeutics Ltd. reported a decrease in total assets and shareholders' equity compared to December 31, 2024, primarily driven by a reduction in current assets and an accumulated deficit Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Total Assets | $24,035 | $27,687 | | Total Current Assets | $22,647 | $25,993 | | Cash and cash equivalents | $2,053 | $3,301 | | Short-term interest-bearing deposits | $18,498 | $20,195 | | Total Liabilities | $3,408 | $4,098 | | Total Shareholders' Equity | $20,627 | $23,589 | | Accumulated Deficit | $(130,559) | $(127,107) | - Total assets decreased by approximately **$3.65 million** from December 31, 2024, to March 31, 2025, primarily due to a reduction in cash and cash equivalents and short-term interest-bearing deposits[4](index=4&type=chunk) - Total shareholders' equity decreased by approximately **$2.96 million**, with the accumulated deficit growing from **$(127,107) thousand** to **$(130,559) thousand**[4](index=4&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2025, Enlivex Therapeutics Ltd. reported a net loss of $3,452 thousand, an improvement from the $4,140 thousand net loss in the same period of 2024, driven by reduced operating expenses and increased finance income Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three months ended March 31, 2025 (in thousands) | Three months ended March 31, 2024 (in thousands) | | :----------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Revenues | $0 | $0 | | Research and development expenses | $2,550 | $2,857 | | General and administrative expenses | $954 | $1,093 | | Loss on disposal group of assets held for sale | $29 | $201 | | Operating loss | $(3,533) | $(4,151) | | Finance income, net | $81 | $11 | | Net loss | $(3,452) | $(4,140) | | Basic & diluted loss per share | $(0.15) | $(0.22) | | Weighted average number of shares outstanding | 23,758,755 | 18,727,037 | - Net loss decreased by **16.6%** from **$4,140 thousand** in Q1 2024 to **$3,452 thousand** in Q1 2025[6](index=6&type=chunk) - Operating expenses decreased by **14.9%** from **$4,151 thousand** in Q1 2024 to **$3,533 thousand** in Q1 2025, primarily due to lower R&D and G&A expenses[6](index=6&type=chunk) - Basic & diluted loss per share improved from **$(0.22)** in Q1 2024 to **$(0.15)** in Q1 2025, despite an increase in the weighted average number of shares outstanding[6](index=6&type=chunk) [Condensed Consolidated Statements of Changes in Shareholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) Shareholders' equity decreased from $23,589 thousand at December 31, 2024, to $20,627 thousand at March 31, 2025, primarily due to the net loss incurred during the period, partially offset by share issuances and share-based compensation Condensed Consolidated Statements of Changes in Shareholders' Equity (in thousands) | Metric | December 31, 2024 (in thousands) | March 31, 2025 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Total Shareholders' Equity | $23,589 | $20,627 | | Ordinary Shares (Amount) | $2,685 | $2,707 | | Additional paid in capital | $146,910 | $147,378 | | Accumulated deficit | $(127,107) | $(130,559) | | Net loss for the period | - | $(3,452) | | Issuance of shares for cash (net) | - | $197 | | Share based compensation | - | $293 | - The accumulated deficit increased by **$3,452 thousand**, reflecting the net loss for the three months ended March 31, 2025[9](index=9&type=chunk) - Shareholders' equity was positively impacted by **$197 thousand** from the issuance of shares for cash and **$293 thousand** from share-based compensation during Q1 2025[9](index=9&type=chunk) [Condensed Consolidated Cash Flow Statements](index=6&type=section&id=Condensed%20Consolidated%20Cash%20Flow%20Statements) For the three months ended March 31, 2025, the Company experienced a net decrease in cash and cash equivalents of $1,254 thousand, primarily due to cash used in operating activities, partially offset by cash provided by investing and financing activities Condensed Consolidated Cash Flow Statements (in thousands) | Metric | Three months ended March 31, 2025 (in thousands) | Three months ended March 31, 2024 (in thousands) | | :----------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Net cash used in operating activities | $(4,624) | $(4,510) | | Net cash provided by investing activities | $3,173 | $5,098 | | Net cash provided by financing activities | $197 | $524 | | (Decrease) increase in cash and cash equivalents | $(1,254) | $1,112 | | Cash and cash equivalents - end of period | $2,477 | $2,338 | - Net cash used in operating activities increased slightly to **$4,624 thousand** in Q1 2025 from **$4,510 thousand** in Q1 2024[12](index=12&type=chunk) - Net cash provided by investing activities decreased significantly from **$5,098 thousand** in Q1 2024 to **$3,173 thousand** in Q1 2025, mainly due to changes in short-term interest-bearing bank deposits[12](index=12&type=chunk) - Cash and cash equivalents at the end of the period were **$2,477 thousand**, a decrease from the beginning of the period, contrasting with an increase in the prior year period[12](index=12&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed disclosures on the company's accounting policies, financial instruments, and other significant financial information supporting the condensed consolidated financial statements [NOTE 1 – GENERAL INFORMATION](index=7&type=section&id=NOTE%201%20%E2%80%93%20GENERAL%20INFORMATION) Enlivex Therapeutics Ltd. is an Israeli clinical-stage macrophage reprogramming immunotherapy company developing Allocetra. The company is focused on R&D, has not generated revenue, and expects to incur losses, requiring additional financing to fund its operations for the long term - Enlivex Therapeutics Ltd. is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra, a universal, off-the-shelf cell therapy[14](index=14&type=chunk) - The Company has not generated any revenues or product sales since its inception and had an accumulated deficit of **$130,559 thousand** as of March 31, 2025[17](index=17&type=chunk) - Management believes current financial resources are sufficient for at least twelve months but acknowledges the need for additional debt or equity financing or partnerships for long-term development[18](index=18&type=chunk)[19](index=19&type=chunk) [General](index=7&type=section&id=General) Enlivex Therapeutics Ltd. is an Israeli company developing Allocetra, with its shares traded on Nasdaq and TASE - Enlivex Therapeutics Ltd. is an Israeli company, incorporated on January 22, 2012[13](index=13&type=chunk) - The company is developing Allocetra, a cell therapy designed to reprogram macrophages, based on discoveries by Professor Dror Mevorach[14](index=14&type=chunk)[15](index=15&type=chunk) - Ordinary Shares are traded on the Nasdaq Capital Market and the Tel Aviv Stock Exchange under the symbol 'ENLV'[15](index=15&type=chunk) [Financial Resources](index=7&type=section&id=Financial%20Resources) The company's R&D focus and accumulated deficit necessitate significant capital investment and future financing for long-term operations - The Company's primary focus is research and development, requiring significant capital investment[16](index=16&type=chunk)[17](index=17&type=chunk) - As of March 31, 2025, the Company had an accumulated deficit of **$130,559 thousand** and has not achieved profitable operations or positive cash flow from operations[17](index=17&type=chunk) - Management believes current financial resources are sufficient for at least twelve months, but additional financing will be needed for long-term development[19](index=19&type=chunk) [NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES](index=8&type=section&id=NOTE%202%20%E2%80%93%20SIGNIFICANT%20ACCOUNTING%20POLICIES) The condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim information, using management estimates for items like R&D and stock-based compensation. The functional currency is the U.S. dollar, and there have been no material changes to significant accounting policies since the 2024 Annual Report on Form 20-F - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information[20](index=20&type=chunk) - Management makes estimates and judgments, particularly for accrued research and development expenses and stock-based compensation expenses[22](index=22&type=chunk) - The functional currency of the Company is the U.S. dollar[23](index=23&type=chunk) - No material changes to significant accounting policies were disclosed since the Company's Annual Report on Form 20-F for the year ended December 31, 2024[31](index=31&type=chunk) [Basis of Presentation](index=8&type=section&id=Basis%20of%20Presentation) Interim financial statements are prepared under U.S. GAAP, with certain disclosures condensed or omitted compared to annual reports - These unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information[20](index=20&type=chunk) - Certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted[20](index=20&type=chunk) - The December 31, 2024 financial information is derived from the Company's audited financial statements[21](index=21&type=chunk) [Use of Estimates](index=8&type=section&id=Use%20of%20Estimates) Financial statement preparation involves management estimates and judgments, especially for accrued R&D and stock-based compensation expenses - Preparation of financial statements requires management to make estimates, judgments, and assumptions[22](index=22&type=chunk) - Significant estimates include those for accrued research and development expenses and stock-based compensation expenses[22](index=22&type=chunk) [Functional Currency and Translation to The Reporting Currency](index=8&type=section&id=Functional%20Currency%20and%20Translation%20to%20The%20Reporting%20Currency) The Company's functional currency is the U.S. dollar, which appreciated against the NIS during the reporting period - The functional currency of the Company is the U.S. dollar[23](index=23&type=chunk) - The U.S. dollar increased against the NIS by **1.95%** in the three months ended March 31, 2025, compared to **1.49%** in the same period of 2024[25](index=25&type=chunk) [Recently Adopted Accounting Standards](index=8&type=section&id=Recently%20Adopted%20Accounting%20Standards) ASU 2024-01 on stock compensation was adopted without significant impact on current or prospective financial statements - ASU 2024-01 (Compensation – Stock Compensation) was adopted and did not have a significant impact on financial statements, with no material impact expected prospectively[27](index=27&type=chunk) [Recently Issued Accounting Pronouncements Not Yet Adopted](index=8&type=section&id=Recently%20Issued%20Accounting%20Pronouncements%20Not%20Yet%20Adopted) The Company is evaluating the potential impact of ASU 2023-09 (Income Taxes) and ASU No. 2024-03 (Expense Disaggregation Disclosures) on future financial statements - ASU 2023-09 (Income Taxes) is effective for years beginning after December 15, 2024, and the Company is evaluating its effect on annual consolidated financial statements[26](index=26&type=chunk) - ASU No. 2024-03 (Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures) is effective for fiscal years beginning after December 15, 2026, and the Company is evaluating its impact[28](index=28&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk) [Significant Accounting Policies](index=10&type=section&id=Significant%20Accounting%20Policies) No material changes have been made to the Company's significant accounting policies since its 2024 Annual Report on Form 20-F - There have been no material changes to the significant accounting policies previously disclosed in the Company's Annual Report on Form 20-F for the year ended December 31, 2024[31](index=31&type=chunk) [NOTE 3 – CASH, CASH EQUIVALENTS AND RESTRICTED CASH](index=10&type=section&id=NOTE%203%20%E2%80%93%20CASH%2C%20CASH%20EQUIVALENTS%20AND%20RESTRICTED%20CASH) Total cash, cash equivalents, and restricted cash decreased to $2,477 thousand as of March 31, 2025, from $3,731 thousand as of December 31, 2024, primarily due to a reduction in cash held in banks and short-term EUR deposits Cash, Cash Equivalents and Restricted Cash (in thousands) | Category | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :---------------------------------------------------------------- | :----------------------------- | :----------------------------- | | Cash held in banks | $1,294 | $2,257 | | Bank deposits in EUR (original maturities of three months or less) | $759 | $1,044 | | Total cash and cash equivalents | $2,053 | $3,301 | | Restricted cash – current | $113 | $113 | | Restricted cash – noncurrent | $311 | $317 | | Total cash, cash equivalents and restricted cash | $2,477 | $3,731 | - Cash and cash equivalents decreased by **$1,248 thousand (37.8%)** from December 31, 2024, to March 31, 2025[32](index=32&type=chunk) [NOTE 4 – SHORT TERM DEPOSITS](index=10&type=section&id=NOTE%204%20%E2%80%93%20SHORT%20TERM%20DEPOSITS) Total short-term interest-bearing deposits decreased to $18,498 thousand as of March 31, 2025, from $20,195 thousand as of December 31, 2024, mainly due to a reduction in NIS deposits Short-Term Interest-Bearing Deposits (in thousands) | Category | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------------------------------ | :----------------------------- | :----------------------------- | | Bank deposits in U.S.$ (average annual interest rates) | $9,262 (5.534%) | $9,259 (5.863%) | | Bank deposits in NIS (average annual interest rates) | $9,236 (4.462%) | $10,936 (4.410%) | | Total short-term deposits | $18,498 | $20,195 | - Total short-term deposits decreased by **$1,697 thousand (8.4%)** from December 31, 2024, to March 31, 2025[33](index=33&type=chunk) - NIS bank deposits saw a notable decrease from **$10,936 thousand** to **$9,236 thousand**[33](index=33&type=chunk) [NOTE 5 – PREPAID EXPENSES AND OTHER RECEIVABLES](index=10&type=section&id=NOTE%205%20%E2%80%93%20PREPAID%20EXPENSES%20AND%20OTHER%20RECEIVABLES) Prepaid expenses and other receivables decreased to $2,090 thousand as of March 31, 2025, from $2,299 thousand as of December 31, 2024, primarily due to a reduction in receivables on account of assets sold and prepaid expenses Prepaid Expenses and Other Receivables (in thousands) | Category | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Prepaid expenses | $746 | $884 | | Tax authorities | $98 | $68 | | Receivables on account of assets sold | $1,133 | $1,234 | | Others | $113 | $113 | | Total | $2,090 | $2,299 | - Total prepaid expenses and other receivables decreased by **$209 thousand (9.1%)** from December 31, 2024, to March 31, 2025[34](index=34&type=chunk) [NOTE 6 – PROPERTY AND EQUIPMENT](index=11&type=section&id=NOTE%206%20%E2%80%93%20PROPERTY%20AND%20EQUIPMENT) Net property and equipment decreased to $568 thousand as of March 31, 2025, from $625 thousand as of December 31, 2024, primarily due to depreciation expenses Property and Equipment, Net (in thousands) | Category | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :----------------------------- | | Total cost | $3,642 | $3,627 | | Total accumulated depreciation | $3,074 | $3,002 | | Depreciated cost (net) | $568 | $625 | | Depreciation expenses (Q1) | $90 | $188 | - Depreciated cost of property and equipment decreased by **$57 thousand (9.1%)** from December 31, 2024, to March 31, 2025[35](index=35&type=chunk) - Depreciation expenses for the three months ended March 31, 2025, were **$90 thousand**, a decrease from **$188 thousand** in the same period of 2024[35](index=35&type=chunk) [NOTE 7 – OTHER ASSETS](index=11&type=section&id=NOTE%207%20%E2%80%93%20OTHER%20ASSETS) Other assets decreased to $820 thousand as of March 31, 2025, from $1,069 thousand as of December 31, 2024, mainly due to the absence of receivables on account of assets sold and long-term prepaid expenses Other Assets (in thousands) | Category | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :----------------------------- | | Restricted cash | $311 | $317 | | Receivables on account of assets sold | $0 | $206 | | Long Term Deposit | $8 | $8 | | Long-term prepaid expenses | $0 | $10 | | Right-of-Use assets, net | $501 | $528 | | Total | $820 | $1,069 | - Total other assets decreased by **$249 thousand (23.3%)** from December 31, 2024, to March 31, 2025[36](index=36&type=chunk) - Receivables on account of assets sold, which were **$206 thousand** at year-end 2024, were **$0** at March 31, 2025[36](index=36&type=chunk) [NOTE 8 – ACCRUED EXPENSES AND OTHER LIABILITIES](index=11&type=section&id=NOTE%208%20%E2%80%93%20ACCRUED%20EXPENSES%20AND%20OTHER%20LIABILITIES) Accrued expenses and other liabilities decreased to $2,611 thousand as of March 31, 2025, from $2,846 thousand as of December 31, 2024, primarily due to a reduction in general accrued expenses Accrued Expenses and Other Liabilities (in thousands) | Category | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Vacation, convalescence and bonus accruals | $1,410 | $1,407 | | Employees and payroll related | $282 | $279 | | Short term operating lease liabilities | $239 | $235 | | Accrued expenses and other | $680 | $925 | | Total | $2,611 | $2,846 | - Total accrued expenses and other liabilities decreased by **$235 thousand (8.3%)** from December 31, 2024, to March 31, 2025[37](index=37&type=chunk) - The 'Accrued expenses and other' category saw the largest decrease, from **$925 thousand** to **$680 thousand**[37](index=37&type=chunk) [NOTE 9 – LEASES](index=12&type=section&id=NOTE%209%20%E2%80%93%20LEASES) The Company's operating lease expenses decreased to $77 thousand for Q1 2025 from $112 thousand for Q1 2024. Total operating lease liabilities were $503 thousand as of March 31, 2025, with a weighted average remaining lease term of 2.6 years Lease Information (in thousands) | Metric | March 31, 2025 (in thousands) | March 31, 2024 (in thousands) | | :------------------------------------------------------------------------------------------------ | :----------------------------- | :----------------------------- | | Operating leases expenses (Q1) | $77 | $112 | | Cash used in operating activities (related to leases) (Q1) | $81 | $108 | | Right of use assets obtained in exchange for new operating lease liabilities (Q1) | $43 | $0 | | Operating lease Right-of-Use assets, net (period end) | $501 | $528 (Dec 31, 2024) | | Total operating lease liabilities (period end) | $503 | $534 (Dec 31, 2024) | | Weighted average remaining lease term in years (period end) | 2.6 | 2.85 (Dec 31, 2024) | | Weighted average annual discount rate (period end) | 8.5% | 8.5% (Dec 31, 2024) | - Operating lease expenses decreased by **$35 thousand (31.3%)** year-over-year[40](index=40&type=chunk) - Maturities of operating lease liabilities as of March 31, 2025, show a total undiscounted lease liability of **$570 thousand**, with the present value being **$503 thousand**[40](index=40&type=chunk) [NOTE 10 – COMMITMENTS AND CONTINGENT LIABILITIES](index=12&type=section&id=NOTE%2010%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENT%20LIABILITIES) The Company is obligated to pay royalties to the Israeli Innovation Authority (IIA) on products developed with IIA grants, typically 3%-5% of sales until 100% of grants plus interest are repaid. As of March 31, 2025, the gross amount of grants received was approximately $9.86 million, with no royalties paid yet - The Company is required to pay royalties of **3%-5%** of sales to the Israeli Innovation Authority (IIA) for products developed with their grants[41](index=41&type=chunk) - As of March 31, 2025, the gross amount of grants received from the IIA, including accrued interest, was approximately **$9.86 million**[42](index=42&type=chunk) - No royalties have been paid to the IIA as of March 31, 2025[42](index=42&type=chunk) [NOTE 11 – EQUITY](index=13&type=section&id=NOTE%2011%20%E2%80%93%20EQUITY) As of March 31, 2025, the Company had 7,622,359 warrants outstanding and exercisable, with a weighted average exercise price of $1.98. Warrants are classified as a component of shareholders' equity Equity and Warrants Activity | Metric | January 1, 2025 | March 31, 2025 | | :-------------------------------- | :---------------- | :---------------- | | Warrants Outstanding | 7,645,109 | 7,622,359 | | Weighted average exercise price | $2.01 | $1.98 | | Forfeited and expired | - | (22,750) | | Shares issued under ATM agreement (Q1) | - | 164,656 | | Gross consideration from ATM (Q1) | - | $203 | | Issuance costs from ATM (Q1) | - | $6 | - Warrants are classified as a component of shareholders' equity due to their characteristics as free-standing financial instruments[43](index=43&type=chunk) - The Company issued **164,656** Ordinary Shares for **$203 thousand** (net of **$6 thousand** issuance costs) under its ATM agreement during Q1 2025[46](index=46&type=chunk) [NOTE 12 – SHARE-BASED COMPENSATION](index=13&type=section&id=NOTE%2012%20%E2%80%93%20SHARE-BASED%20COMPENSATION) Total share-based compensation expense recognized for Q1 2025 was $293 thousand, a decrease from $383 thousand in Q1 2024. This includes expenses for both stock options and restricted stock units, with a significant portion allocated to general and administrative expenses Share-Based Compensation Expense (in thousands) | Metric | Three months ended March 31, 2025 (in thousands) | Three months ended March 31, 2024 (in thousands) | | :----------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Total share-based compensation expense | $293 | $383 | | R&D share-based compensation | $135 | $124 | | G&A share-based compensation | $158 | $259 | | Stock option compensation expense | $111 | $223 | | Restricted stock unit compensation expense | $182 | $160 | - Total unrecognized compensation cost for non-vested stock options was **$491 thousand** as of March 31, 2025, expected to be recognized over **1.33 years**[48](index=48&type=chunk) - Total unrecognized compensation cost for restricted stock units was **$1,075 thousand** as of March 31, 2025, expected to be recognized over **1.78 years**[50](index=50&type=chunk) [NOTE 13 – FAIR VALUE MEASUREMENT](index=17&type=section&id=NOTE%2013%20%E2%80%93%20FAIR%20VALUE%20MEASUREMENT) All financial assets measured at fair value on a recurring basis, including cash and cash equivalents, short-term deposits, and restricted cash, are classified as Level 1 as of March 31, 2025, and December 31, 2024 Financial Assets Measured at Fair Value (in thousands) | Category | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $2,053 | $3,301 | | Short term deposits | $18,498 | $20,195 | | Restricted cash | $424 | $430 | | Total financial assets | $20,975 | $23,926 | - All financial assets measured at fair value are categorized as **Level 1**, indicating they are valued using quoted prices in active markets for identical assets[51](index=51&type=chunk) - Total financial assets decreased by **$2,951 thousand** from December 31, 2024, to March 31, 2025[51](index=51&type=chunk) [NOTE 14 – EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE](index=17&type=section&id=NOTE%2014%20%E2%80%93%20EVENTS%20SUBSEQUENT%20TO%20THE%20BALANCE%20SHEET%20DATE) Subsequent to the balance sheet date, on May 2, 2025, the Company filed a new registration statement on Form F-3 to replace its previously expired registration statement - On May 2, 2025, the Company filed a registration statement on Form F-3 (File No. **333-286956**)[52](index=52&type=chunk) - This new filing replaces the Company's previously effective Registration Statement on Form F-3 (File No. **333-264561**), which expired on May 5, 2025[52](index=52&type=chunk)

Core Insights - Enlivex Therapeutics Ltd. has been selected to present at the Israeli BioMed 2025 Conference, focusing on its macrophage reprogramming therapy, Allocetra™, for treating inflammatory diseases [1][2] Company Overview - Enlivex is a clinical-stage company specializing in macrophage reprogramming immunotherapy, developing Allocetra™, a universal, off-the-shelf cell therapy aimed at resetting macrophages to their homeostatic state [4] Product Details - Allocetra™ is designed to address non-homeostatic macrophages, which are linked to various chronic and life-threatening diseases, by reprogramming them to restore immune balance [2][4] - The company is advancing a clinical pipeline that includes multiple Phase I/II trials for conditions such as osteoarthritis and psoriatic arthritis [3] Clinical Trial Results - Recent interim data from a six-month study in moderate knee osteoarthritis indicated a 47% reduction in pain, a 46% improvement in joint function, and a 40% decrease in stiffness [3]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...

Ness-Ziona, Israel, April 23, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it will present two poster abstracts at the Osteoarthritis Research Society International (OARSI) 2025 World Congress on Osteoarthritis, taking place April 24-27, 2025, in Incheon (Seoul), South Korea. "These presentations at OARSI 2025 will highlight the growing body of evidence supporting Allocetra'sTM potentia ...

Nes-Ziona, Israel, April 21, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company completed enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and treated in the Phase II stage. Oren Hershkovitz, Ph.D, CEO of Enlivex, comm ...

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [5]. Clinical Trial Progress - The company has completed patient enrollment for the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis, involving a total of 133 patients [1][3]. - The Phase I stage provided promising initial efficacy data, with significant improvements in key efficacy endpoints and no safety issues reported for the first 12 patients treated [2][3]. Future Expectations - Enlivex aims to release topline data from the Phase II trial, including full 3-month endpoints, by August 2025 [2][3]. Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million individuals globally, with projections indicating that 78 million Americans will have osteoarthritis by 2040 [4]. - The condition leads to significant healthcare burdens, with over one million hospitalizations annually in the U.S. primarily for total joint replacement, highlighting the critical need for effective treatments [4].

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, specifically developing Allocetra™ [1][6] - Allocetra™ is designed as a universal, off-the-shelf cell therapy aimed at restoring macrophage homeostasis, which is critical for immune system balance and addressing life-threatening conditions [4][6] Clinical Trial Announcement - The first patient has been dosed in a Phase I trial to evaluate the safety, tolerability, and initial efficacy of Allocetra™ for treating temporomandibular joint (TMJ) osteoarthritis [1][3] - The trial is being conducted by the Rheumatology Unit and the Department of Oral and Maxillofacial Surgery at Sheba Medical Center, which is ranked among the top 10 hospitals globally [2] Trial Details - The trial aims to recruit six patients who have not adequately responded to conventional therapies for TMJ osteoarthritis [3] - Primary safety endpoints will measure the frequency and severity of adverse events, while efficacy endpoints will assess changes in TMJ pain, joint functionality, and other disease parameters over 12 months [3] TMJ Osteoarthritis Insights - TMJ disorders affect 5% to 12% of the global population, with an annual health cost estimated at $4 billion [5][8] - TMJ osteoarthritis is the most common form of arthritis in the TMJ, leading to pain and stiffness, and currently lacks effective long-term treatments [5][8]

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [4]. Patent and Intellectual Property - The China National Intellectual Property Administration (CNIPA) has issued a notice of allowance for Enlivex's patent application number 2020800620493, which will provide intellectual property protection in China until at least 2040 for methods using Allocetra™ to treat osteoarthritis [1]. - The company anticipates that the patent will be officially issued in the first half of 2025 [1]. Clinical Trial Results - Enlivex reported positive interim data from a Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis, showing a statistically significant average pain reduction of 47.0% (P=0.0001) compared to baseline [6]. - The trial also indicated a 46% improvement in joint function and a 40% improvement in joint stiffness, with 83% of patients still considered responders after six months [6]. Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million people globally, with projections indicating that 78 million Americans will have the condition by 2040 [3]. - The disease leads to significant healthcare burdens, including over one million hospitalizations annually in the U.S. for total joint replacement, highlighting the critical need for effective treatments [3].

Core Insights - Enlivex Therapeutics Ltd. is hosting a live investor webinar on March 5, 2025, to discuss positive interim six-month data from its Phase I/II Allocetra™ trial for knee osteoarthritis [1][4] Group 1: Trial Results - The interim results from the Allocetra™ trial showed a statistically significant 47.0% average reduction in reported pain (P=0.0001) and a 46% improvement in joint function at six months post-treatment [2] - 83% of treated patients were still considered responders to treatment at six months, indicating the durability and sustained efficacy of Allocetra™ [2][3] - No serious adverse events were reported, reinforcing the favorable safety profile of Allocetra™ [2] Group 2: Company Commitment - The CEO of Enlivex expressed excitement about the promising interim results, highlighting Allocetra™'s potential to provide meaningful and sustained pain relief for patients with moderate to severe knee osteoarthritis [3] - The company remains committed to advancing this innovative therapy to unlock its full potential for millions of patients worldwide [3] Group 3: Webinar Details - The webinar will feature a detailed review of the interim results and will include a live Q&A session [4] - Interested investors can register for the free webinar through the provided link [4]

Core Insights - Enlivex Therapeutics Ltd. announced positive interim six-month efficacy data from the Phase I stage of its Allocetra™ trial for knee osteoarthritis, showing significant pain reduction and improved functionality [1][2][4] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to restore immune balance [6] Clinical Trial Details - The Phase I/II trial consists of two stages: the completed Phase I safety run-in and the ongoing Phase II double-blind, randomized, placebo-controlled trial [1][3] - The Phase I stage demonstrated a 47.0% average reduction in reported pain and significant improvements in functionality and stiffness, with 83% of patients still responding to treatment after six months [2][4] Efficacy Results - The six-month interim results showed a 51.2% reduction in WOMAC pain, a 46% improvement in WOMAC function, and a 40% improvement in WOMAC stiffness, indicating durable efficacy [2][4] - The safety profile of Allocetra™ remained consistent, with no serious adverse events reported [2][4] Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and projected to reach 78 million by 2040, highlighting the critical need for effective treatments [4][5]