Core Insights - Allocetra™ has shown statistically significant and clinically meaningful improvements in pain and function for patients with knee osteoarthritis (KOA) in a Phase IIa trial [1][3][8] - The company plans to initiate a Phase IIb trial in Q2 2026, with six-month data from the ongoing Phase IIa trial expected in November 2025 [1][13][21] Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™ as a universal cell therapy [19] - The company aims to address the unmet medical needs of the aging population suffering from primary idiopathic KOA, which currently has limited treatment options [3][12] Clinical Trial Results - The Phase IIa trial (ENX-CL-05-001) demonstrated a 72% reduction in pain and a 109% improvement in function compared to the placebo group [13] - Allocetra™ achieved substantial improvements in a population of patients aged 60 and above, representing 54% of the study population [8][12] - The treatment was well tolerated, with no serious drug-related adverse events reported [11] Market Significance - KOA affects over 32 million Americans and is projected to impact 78 million by 2040, highlighting the urgent need for effective treatments [12][18] - The prevalence of KOA increases with age, with 30% of individuals over 60 years affected, emphasizing the potential market for Allocetra™ [12][18] Future Development Plans - Enlivex is advancing Allocetra™ toward late-stage development, with key milestones including the expected regulatory approval of the Phase IIb protocol in early 2026 [13][14] - The company is also exploring potential partnerships with larger firms interested in osteoarthritis treatments [15]

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, specifically developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to their homeostatic state [5]. Patent Issuance - The company announced the issuance of an Israeli patent numbered 290470, titled "THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS," which provides intellectual property protection in Israel until at least 2040 [1]. Clinical Trial Results - Enlivex reported positive topline data from the Phase IIa clinical trial (ENX-CL-05-001) for Allocetra™ in patients with moderate-to-severe knee osteoarthritis, showing a 24% reduction in knee pain and a 26% improvement in knee function compared to placebo [2][3]. - In patients with age-related primary osteoarthritis, there was a 72% reduction in knee pain and a 109% improvement in knee function compared to placebo, indicating a substantial and statistically significant effect [3]. Osteoarthritis Context - Osteoarthritis is the most common form of arthritis, affecting over 32.5 million Americans and more than 300 million individuals globally. By 2040, it is projected that 78 million Americans will have osteoarthritis [4]. - The condition leads to over one million hospitalizations annually in the U.S., primarily for total joint replacement, highlighting the critical need for effective treatments [4].

[Condensed Consolidated Financial Statements](index=2&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Index to Condensed Consolidated Financial Statements](index=2&type=section&id=Index%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides a table of contents for the unaudited condensed consolidated financial statements, outlining the various financial reports and accompanying notes included in the filing - The index lists the Condensed Consolidated Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Changes in Shareholders' Equity, Cash Flow Statements, and Notes to the Condensed Consolidated Financial Statements[3](index=3&type=chunk) [Condensed Consolidated Balance Sheets (Unaudited)](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) The balance sheets present the company's financial position as of June 30, 2025, and December 31, 2024, showing a decrease in total assets and shareholders' equity, primarily driven by a reduction in current assets Condensed Consolidated Balance Sheets (Unaudited) | ASSETS | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $1,892 | $3,301 | | Short-term interest-bearing deposits | $17,615 | $20,195 | | Prepaid expenses and other receivables | $1,811 | $2,299 | | Assets classified as held for sale | $6 | $198 | | Total Current Assets | $21,324 | $25,993 | | Property and equipment, net | $490 | $625 | | Other assets | $784 | $1,069 | | Total Non-Current Assets | $1,274 | $1,694 | | **TOTAL ASSETS** | **$22,598** | **$27,687** | | LIABILITIES AND SHAREHOLDERS' EQUITY | | | | Accounts payable trade | $542 | $811 | | Accrued expenses and other liabilities | $2,786 | $2,846 | | Liability classified as held for sale | $- | $142 | | Total Current Liabilities | $3,328 | $3,799 | | Other long-term liabilities | $216 | $299 | | Total Non-Current Liabilities | $216 | $299 | | **TOTAL LIABILITIES** | **$3,544** | **$4,098** | | Ordinary shares | $2,708 | $2,685 | | Additional paid in capital | $147,672 | $146,910 | | Foreign currency translation adjustments | $1,101 | $1,101 | | Accumulated deficit | $(132,427) | $(127,107) | | **TOTAL SHAREHOLDERS' EQUITY** | **$19,054** | **$23,589** | | **TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY** | **$22,598** | **$27,687** | [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(Unaudited)) This statement details the company's financial performance for the three and six months ended June 30, 2025, and 2024. The company reported no revenues but showed a reduced net loss in 2025 compared to 2024, largely due to finance income Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | Metric | For the three months ended June 30, 2025 (in thousands) | For the three months ended June 30, 2024 (in thousands) | For the six months ended June 30, 2025 (in thousands) | For the six months ended June 30, 2024 (in thousands) | | :------------------------------------ | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Revenues | $0 | $0 | $0 | $0 | | Research and development expenses | $2,141 | $1,999 | $4,691 | $4,856 | | General and administrative expenses | $937 | $987 | $1,891 | $2,080 | | Loss on disposal group of assets held for sale | $- | $- | $29 | $201 | | Operating loss | $(3,078) | $(2,986) | $(6,611) | $(7,137) | | Finance income (expenses), net | $1,210 | $(110) | $1,291 | $(99) | | Net loss | $(1,868) | $(3,096) | $(5,320) | $(7,236) | | Basic & diluted loss per share | $(0.08) | $(0.16) | $(0.22) | $(0.38) | | Weighted average number of shares outstanding | 23,855,663 | 19,545,056 | 23,807,469 | 19,138,066 | [Condensed Consolidated Statements of Changes in Shareholders' Equity (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity%20(Unaudited)) This statement outlines the changes in shareholders' equity for the three and six-month periods ended June 30, 2025, and 2024, highlighting the impact of net losses, share-based compensation, and share issuances on the overall equity balance Condensed Consolidated Statements of Changes in Shareholders' Equity (Unaudited) | Item | Balance as of Dec 31, 2024 (in thousands) | Changes Q1 2025 (in thousands) | Balance as of Mar 31, 2025 (in thousands) | Changes Q2 2025 (in thousands) | Balance as of Jun 30, 2025 (in thousands) | | :-------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Ordinary Shares (Shares) | 23,650,989 | 198,946 | 23,849,935 | 8,366 | 23,858,301 | | Ordinary Shares (Amount) | $2,685 | $22 | $2,707 | $1 | $2,708 | | Additional paid in capital | $146,910 | $468 | $147,378 | $294 | $147,672 | | Foreign currency translation adjustments | $1,101 | $- | $1,101 | $- | $1,101 | | Accumulated deficit | $(127,107) | $(3,452) | $(130,559) | $(1,868) | $(132,427) | | **TOTAL SHAREHOLDERS' EQUITY** | **$23,589** | **$(2,955)** | **$20,627** | **$(1,868)** | **$19,054** | [Condensed Consolidated Cash Flow Statements (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Cash%20Flow%20Statements%20(Unaudited)) This statement provides a breakdown of cash flows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024, indicating a net decrease in cash and cash equivalents in 2025 compared to an increase in 2024 Condensed Consolidated Cash Flow Statements (Unaudited) | Cash Flow Activity | For the six months ended June 30, 2025 (in thousands) | For the six months ended June 30, 2024 (in thousands) | | :-------------------------------- | :--------------------------------------- | :--------------------------------------- | | Net loss | $(5,320) | $(7,236) | | Net cash used in operating activities | $(5,822) | $(6,307) | | Net cash provided by investing activities | $4,242 | $4,304 | | Net cash provided by financing activities | $197 | $4,943 | | (Decrease) increase in cash and cash equivalents | $(1,383) | $2,940 | | Cash and cash equivalents - beginning of period | $3,731 | $1,226 | | Cash and cash equivalents - end of period | $2,348 | $4,166 | | Cash paid for taxes | $- | $- | | Cash received for interest | $720 | $906 | [Notes to the Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations and additional information supporting the condensed consolidated financial statements, covering general company information, significant accounting policies, and specific balance sheet and income statement items [NOTE 1 - GENERAL INFORMATION](index=7&type=section&id=NOTE%201%20-%20GENERAL%20INFORMATION) This note provides an overview of Enlivex Therapeutics Ltd., its core product Allocetra, and its financial status, including accumulated deficit and future funding needs - 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 $132,427 thousand** as of June 30, 2025[17](index=17&type=chunk) - Management believes current financial resources are sufficient for at least twelve months, but additional debt or equity financing or partnerships will be needed for long-term development[19](index=19&type=chunk) [NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES](index=7&type=section&id=NOTE%202%20-%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note details the accounting principles used in preparing the financial statements, including U.S. GAAP compliance, functional currency, and evaluation of new accounting standards - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information[20](index=20&type=chunk) - The functional currency of the Company is the U.S. dollar[24](index=24&type=chunk) - The company is evaluating ASU 2023-09 (Income Taxes) and ASU No. 2024-03 (Expense Disaggregation Disclosures), with ASU 2024-01 (Stock Compensation) having no significant impact[27](index=27&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) [Significant Accounting Policies (No Material Changes)](index=11&type=section&id=Significant%20Accounting%20Policies) This note confirms that there have been no material changes to the company's significant accounting policies since the last annual report - 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[32](index=32&type=chunk) [NOTE 3 – CASH, CASH EQUIVALENTS AND RESTRICTED CASH](index=11&type=section&id=NOTE%203%20%E2%80%93%20CASH,%20CASH%20EQUIVALENTS%20AND%20RESTRICTED%20CASH) This note provides a detailed breakdown of the company's cash, cash equivalents, and restricted cash balances as of June 30, 2025, and December 31, 2024 Cash, Cash Equivalents and Restricted Cash (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------------------------------------------------------------------ | :------------ | :---------------- | | Cash held in banks | $1,892 | $2,257 | | Bank deposits in EUR with original maturities of three months or less (average annual interest rates 3.16%) | $- | $1,044 | | Total cash and cash equivalents | $1,892 | $3,301 | | Restricted cash – current – Prepaid expenses and other receivables | $113 | $113 | | Restricted cash – noncurrent – Other assets | $343 | $317 | | Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $2,348 | $3,731 | [NOTE 4 – SHORT TERM DEPOSITS](index=11&type=section&id=NOTE%204%20%E2%80%93%20SHORT%20TERM%20DEPOSITS) This note details the company's short-term interest-bearing deposits, categorized by currency and interest rates, as of June 30, 2025, and December 31, 2024 Short-Term Deposits (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------------------------------------- | :------------ | :---------------- | | Bank deposits in U.S.$ (average annual interest rates 5.202% and 5.863%) | $8,615 | $9,259 | | Bank deposits in NIS (average annual interest rates 4.537% and 4.410%) | $9,000 | $10,936 | | Total short-term deposits | $17,615 | $20,195 | [NOTE 5 – PREPAID EXPENSES AND OTHER RECEIVABLES](index=11&type=section&id=NOTE%205%20%E2%80%93%20PREPAID%20EXPENSES%20AND%20OTHER%20RECEIVABLES) This note provides a breakdown of prepaid expenses and other receivables, including amounts due from tax authorities and assets sold, as of June 30, 2025, and December 31, 2024 Prepaid Expenses and Other Receivables (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Prepaid expenses | $689 | $884 | | Tax authorities | $119 | $68 | | Receivables on account of assets sold | $890 | $1,234 | | Others | $113 | $113 | | Total | $1,811 | $2,299 | [NOTE 6 – PROPERTY AND EQUIPMENT](index=12&type=section&id=NOTE%206%20%E2%80%93%20PROPERTY%20AND%20EQUIPMENT) This note details the cost and accumulated depreciation of property and equipment, including laboratory equipment, computers, and leasehold improvements, as of June 30, 2025, and December 31, 2024 Property and Equipment, Net (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Cost: | | | | Laboratory equipment | $2,077 | $2,094 | | Computers | $502 | $462 | | Office furniture & equipment | $124 | $124 | | Leasehold improvements | $947 | $947 | | Total cost | $3,650 | $3,627 | | Accumulated depreciation: | | | | Laboratory equipment | $2,013 | $1,969 | | Computers | $370 | $328 | | Office furniture & equipment | $44 | $40 | | Leasehold improvements | $733 | $665 | | Total accumulated depreciation | $3,160 | $3,002 | | Depreciated cost | $490 | $625 | - Depreciation expenses for the six months ended June 30, 2025, were **$175 thousand**, compared to **$348 thousand** for the same period in 2024[36](index=36&type=chunk) [NOTE 7 – OTHER ASSETS](index=12&type=section&id=NOTE%207%20%E2%80%93%20OTHER%20ASSETS) This note provides a breakdown of other non-current assets, including restricted cash, long-term deposits, and right-of-use assets, as of June 30, 2025, and December 31, 2024 Other Assets (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Restricted cash | $343 | $317 | | Receivables on account of assets sold | $- | $206 | | Long Term Deposit | $8 | $8 | | Long-term prepaid expenses | $- | $10 | | Right-of-Use assets, net | $433 | $528 | | Total | $784 | $1,069 | [NOTE 8 – ACCRUED EXPENSES AND OTHER LIABILITIES](index=12&type=section&id=NOTE%208%20%E2%80%93%20ACCRUED%20EXPENSES%20AND%20OTHER%20LIABILITIES) This note details the composition of accrued expenses and other liabilities, including vacation accruals, payroll-related expenses, and short-term operating lease liabilities, as of June 30, 2025, and December 31, 2024 Accrued Expenses and Other Liabilities (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Vacation, convalescence and bonus accruals | $1,459 | $1,407 | | Employees and payroll related | $347 | $279 | | Short term operating lease liabilities | $264 | $235 | | Accrued expenses and other | $716 | $925 | | Total | $2,786 | $2,846 | [NOTE 9 – LEASES](index=13&type=section&id=NOTE%209%20%E2%80%93%20LEASES) This note provides information on the company's operating lease arrangements, including expenses, total liabilities, weighted average remaining lease term, and discount rate - Operating lease expenses for the six months ended June 30, 2025, were **$154 thousand**, down from **$207 thousand** in 2024[41](index=41&type=chunk) - Total operating lease liabilities were **$480 thousand** as of June 30, 2025, with a weighted average remaining lease term of **2.6 years** and a weighted average annual discount rate of **8.5%**[41](index=41&type=chunk) Maturities of Operating Lease Liabilities as of June 30, 2025 (in thousands) | Year | Amount | | :---------------- | :----- | | 2025 (after June 30) | $145 | | 2026 | $170 | | 2027 | $147 | | 2028 | $99 | | Total undiscounted lease liability | $561 | | Less: Imputed interest | $(81) | | Present value of lease liabilities | $480 | [NOTE 10 – COMMITMENTS AND CONTINGENT LIABILITIES](index=13&type=section&id=NOTE%2010%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENT%20LIABILITIES) This note outlines the company's commitments, including royalty obligations to the Israeli Innovation Authority (IIA) for grants received - The Company is required to pay royalties of **3% - 5%** to the Israeli Innovation Authority (IIA) on products developed with IIA grants, until **100% of the grants plus interest** are repaid[42](index=42&type=chunk) - As of June 30, 2025, the gross amount of grants received from the IIA, including accrued interest, was approximately **$9.91 million**, with no royalties paid to date[43](index=43&type=chunk) [NOTE 11 - EQUITY (Warrants)](index=14&type=section&id=NOTE%2011%20%E2%80%93%20EQUITY) This note details the company's outstanding warrants, including their classification as shareholders' equity, activity during the period, exercise prices, and expiration dates - All Company warrants are classified as a component of shareholders' equity[44](index=44&type=chunk) Warrants Outstanding as of June 30, 2025 | Item | Number of Warrants | Weighted average exercise price | | :-------------------------- | :----------------- | :------------------------------ | | Outstanding January 1, 2025 | 7,645,109 | $2.01 | | Forfeited and expired | (22,750) | $10.00 | | Outstanding and exercisable June 30, 2025 | 7,622,359 | $1.98 | Warrants Exercise Prices and Expiration Dates at June 30, 2025 | Number of Warrants | Exercise Price Per Share | Issuance date | Expiration date | | :----------------- | :----------------------- | :------------ | :-------------- | | 160,727 | $25.00 | February 12, 2021 | February 9, 2026 | | 18,774 | $25.00 | February 17, 2021 | February 9, 2026 | | 3,571,429 | $1.40 | May 29, 2024 | October 17, 2025 | | 3,571,429 | $1.40 | May 29, 2024 | November 29, 2029 (i) | | 125,000 | $1.75 | May 29, 2024 | October 17, 2025 | | 125,000 | $1.75 | May 29, 2024 | May 27, 2029 (ii) | | 25,000 | $3.25 | November 26, 2024 | February 2, 2027 | | 25,000 | $4.25 | November 26, 2024 | February 2, 2027 | | **7,622,359** | | | | [NOTE 12 – SHARE-BASED COMPENSATION](index=14&type=section&id=NOTE%2012%20%E2%80%93%20SHARE-BASED%20COMPENSATION) This note provides information on the company's share-based compensation plans, including stock options and restricted stock units, and related expenses - As of June 30, 2025, **6,900,704 Ordinary Shares** were authorized for issuance under the 2019 Equity Incentive Plan, with **2,175,667 shares available** for future grant[46](index=46&type=chunk) Stock Options Activity | Item | For the three months ended June 30, 2025 | For the three months ended June 30, 2024 | For the six months ended June 30, 2025 | For the six months ended June 30, 2024 | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Outstanding at beginning of period | 2,876,306 | 3,007,624 | 2,898,015 | 2,842,496 | | Granted | - | - | - | 250,000 | | Forfeited and expired | (5,000) | (21,921) | (26,709) | (106,793) | | Outstanding at end of period | 2,871,306 | 2,985,703 | 2,871,306 | 2,985,703 | | Exercisable at end of period | 2,393,405 | 2,228,902 | 2,393,405 | 2,228,902 | | Non-vested at end of period | 477,901 | 758,551 | 477,901 | 758,551 | - Total unrecognized estimated compensation cost related to outstanding non-vested stock options was **$384 thousand** as of June 30, 2025, expected to be recognized over a weighted average period of **1.08 years**[49](index=49&type=chunk) Restricted Stock Units Activity | Item | For the three months ended June 30, 2025 | For the three months ended June 30, 2024 | For the six months ended June 30, 2025 | For the six months ended June 30, 2024 | | :-------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | :--------------------------------------- | | Nonvested at beginning of period | 1,174,350 | 571,460 | 1,234,572 | 621,135 | | Vested | (3,425) | (3,444) | (42,656) | (44,050) | | Forfeited | (6,485) | (5,757) | (27,476) | (14,826) | | Nonvested at end of period | 1,164,440 | 562,259 | 1,164,440 | 562,259 | - Total share-based compensation expense related to restricted stock units not yet recognized was **$874 thousand** as of June 30, 2025, expected to be recognized over a weighted average period of **1.02 years**[52](index=52&type=chunk) Summary of Share-Based Compensation Expenses (in thousands) | (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :---------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research & development | $111 | $145 | $246 | $269 | | General & administrative | $184 | $243 | $342 | $502 | | Total | $295 | $388 | $588 | $771 | [NOTE 13 – FAIR VALUE MEASUREMENT](index=17&type=section&id=NOTE%2013%20%E2%80%93%20FAIR%20VALUE%20MEASUREMENT) This note details the fair value measurement of financial assets, including cash, short-term deposits, and restricted cash, categorized by fair value hierarchy levels Fair Value Measurement of Financial Assets (in thousands) | (in thousands) | Total (June 30, 2025) | Level 1 (June 30, 2025) | Level 2 (June 30, 2025) | Level 3 (June 30, 2025) | | :--------------- | :-------------------- | :---------------------- | :---------------------- | :---------------------- | | Cash and cash equivalents | $1,892 | $1,892 | $- | $- | | Short term deposits | $17,615 | $17,615 | $- | $- | | Restricted cash | $456 | $456 | $- | $- | | Total financial assets | $19,963 | $19,963 | $- | $- | | | Total (December 31, 2024) | Level 1 (December 31, 2024) | Level 2 (December 31, 2024) | Level 3 (December 31, 2024) | | Cash and cash equivalents | $3,301 | $3,301 | $- | $- | | Short term deposits | $20,195 | $20,195 | $- | $- | | Restricted cash | $430 | $430 | $- | $- | | Total financial assets | $23,926 | $23,926 | $- | $- | - All financial assets measured at fair value, including cash and cash equivalents, short-term deposits, and restricted cash, are classified as **Level 1**[53](index=53&type=chunk) [NOTE 14 – EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE](index=18&type=section&id=NOTE%2014%20%E2%80%93%20EVENTS%20SUBSEQUENT%20TO%20THE%20BALANCE%20SHEET%20DATE) This note reports significant events occurring after the balance sheet date, including share issuances and positive clinical trial data for Allocetra - During the third quarter of 2025, the Company issued and sold **315,490 Ordinary Shares** under the ATM Agreement for gross proceeds of **$446,892**[54](index=54&type=chunk) - On August 18, 2025, the Company announced positive three-month topline data from its Phase I/II trial evaluating Allocetra in patients with moderate-to-severe knee osteoarthritis[54](index=54&type=chunk) - The positive trial data showed a **24% reduction in knee pain** and **26% improvement in knee function** in the Allocetra treatment arm vs. placebo in the overall mITT population, with even more significant improvements (**72% pain reduction, 95% function improvement**) in age-related primary osteoarthritis patients[54](index=54&type=chunk) - The positive topline data fixed the expiration date of the Series A warrants issued in May 2024 to **October 17, 2025**[54](index=54&type=chunk)

Enlivex Therapeutics (ENLV) Conference Call Summary Company Overview - **Company**: Enlivex Therapeutics - **Ticker**: ENLV - **Focus**: Development of innovative therapies for inflammatory diseases, specifically targeting macrophages to treat conditions like osteoarthritis [3][15] Key Points and Arguments Phase 2a Study Results - **Study Focus**: Evaluated the efficacy and safety of Alocetra in patients with moderate to severe knee osteoarthritis [19][23] - **Market Size**: Approximately 32 million adults in the US suffer from osteoarthritis, with a current market size of $7 billion, expected to grow to $15 billion by 2030 [20][21] - **Demographics**: Prevalence of osteoarthritis increases with age, with about 40% of individuals aged 60 and above affected [22][23] - **Study Design**: Randomized, double-blind, placebo-controlled trial with 134 patients receiving either Alocetra or placebo [30][34] - **Primary Endpoint**: Safety; secondary endpoints included changes in pain and function [30][57] - **Results**: - 24% positive effect in overall pain reduction across study patients [36] - 72% effect size over placebo in primary osteoarthritis patients aged 60 and above, statistically significant [36][37] - Nearly 100% effect in function improvement across all efficacy endpoints [38] - Favorable safety profile with no serious adverse events reported [50][66] Unique Selling Proposition - **Innovative Approach**: Enlivex utilizes a novel method of reprogramming macrophages, which is distinct from other therapies in the market [15][16] - **Cost-Effectiveness**: Projected treatment cost of approximately $450, competitive with existing therapies [67][68] - **Unmet Medical Need**: Current treatments for osteoarthritis are largely ineffective, creating a significant opportunity for Alocetra [21][68] Future Plans - **Next Steps**: - Continue follow-up studies with six-month and twelve-month data expected [58][72] - Initiate Phase 2b study focusing on primary idiopathic osteoarthritis patients, targeting 75 patients per arm [55][57] - Explore partnership opportunities for further development and commercialization [60][64] Financial Position - **Cash Position**: As of March, Enlivex reported $20.6 million, with plans to utilize existing cash and explore non-dilutive funding opportunities [84] Additional Important Information - **Management Experience**: The management team has a strong background in drug development, with previous successes in the biotech industry [17][18] - **Regulatory Discussions**: Ongoing discussions with the FDA regarding the potency assay for Alocetra [80] - **Market Context**: The current landscape for osteoarthritis treatments is lacking effective solutions, positioning Alocetra as a potential leader in the market [81][84] This summary encapsulates the critical insights from the Enlivex Therapeutics conference call, highlighting the company's innovative approach, promising study results, and strategic plans for future growth.

Core Insights - Enlivex Therapeutics announced positive topline data from the Phase IIa trial of Allocetra™, showing significant improvements in knee pain and function in patients with moderate-to-severe knee osteoarthritis [1][2][3] Group 1: Clinical Trial Results - In the modified intention-to-treat population, Allocetra™ demonstrated a 24% reduction in knee pain and a 26% improvement in knee function compared to placebo [1] - For age-related primary osteoarthritis patients, Allocetra™ resulted in a 72% reduction in knee pain and a 95% improvement in knee function compared to placebo, indicating a substantial and statistically significant effect [1][2] Group 2: Safety Profile - The trial reported a favorable safety profile for Allocetra™, with no severe adverse events and only mild to moderate, transient, and treatable side effects observed in most patients [2] Group 3: Company Overview - Enlivex Therapeutics is a clinical-stage company focused on macrophage reprogramming immunotherapy, developing Allocetra™ as a universal cell therapy aimed at reprogramming macrophages to restore immune balance [8] - The company emphasizes the significant unmet medical need in the knee osteoarthritis market, which affects over 32.5 million Americans and is projected to increase to 78 million by 2040 [6]

Core Insights - Enlivex Therapeutics Ltd. will host a webinar on August 18, 2025, to present 3-month topline results from the Phase IIa stage of its ENX-CL-05-001 trial evaluating Allocetra™ in patients with moderate to severe knee osteoarthritis [1][2] 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 [5] Clinical Trial Details - The ongoing Phase IIa trial is a double-blind, randomized, placebo-controlled study assessing safety and efficacy, with endpoints measuring joint pain and function at 3, 6, and 12 months post-injection [4] - An interim analysis has been conducted to evaluate the potential benefits of expanding patient enrollment from 130 to 180, with 134 patients having completed the 3-month follow-up period [4][3] Osteoarthritis Context - Osteoarthritis affects over 32.5 million Americans and more than 300 million people globally, with symptomatic knee osteoarthritis being particularly prevalent, impacting 40% of men and 47% of women in their lifetimes [3]

Company Overview - Enlivex Therapeutics Ltd. is a clinical-stage company focused on macrophage reprogramming immunotherapy, specifically developing Allocetra™, a universal, off-the-shelf cell therapy aimed at reprogramming macrophages to their homeostatic state [4]. Clinical Trial Details - The Phase I/II trial of Allocetra™ for moderate to severe knee osteoarthritis has completed follow-up for all 134 patients, with results expected to be publicly released by August 18, 2025 [1]. - The trial consists of two stages: a Phase I safety run-in to assess safety and tolerability, followed by a double-blind, randomized, placebo-controlled Phase IIa stage [2]. - Key efficacy endpoints include evaluating joint pain and function at three, six, and twelve months post-treatment, with an interim evaluation planned to assess the potential addition of up to 50 patients to the study [2]. 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 osteoarthritis by 2040 [3]. - The condition leads to significant disability, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes, resulting in over one million hospitalizations annually in the U.S. [3]. - Currently, there are no FDA or EMA approved medications that can halt or reverse the progression of structural damage in joints affected by osteoarthritis [3].

Core Insights - Enlivex Therapeutics Ltd. will present data on its macrophage reprogramming therapy, Allocetra™, at the EULAR European Congress of Rheumatology in Barcelona from June 11-14, 2025 [1][2] - Allocetra™ aims to treat knee osteoarthritis by reprogramming macrophages to promote immune balance and reduce chronic inflammation, showing promising results in Phase I/II trials [2][4] Company Overview - Enlivex is a clinical-stage company focused on macrophage reprogramming immunotherapy, with Allocetra™ being a universal, off-the-shelf cell therapy [4] - The therapy is designed to reset non-homeostatic macrophages to a homeostatic state, which is essential for immune system rebalancing [4] Clinical Study Details - The ongoing clinical study of Allocetra™ involves patients with moderate to severe knee osteoarthritis, with all patients enrolled in the Phase II stage of the trial [2] - The company anticipates topline data from the Phase II stage to be available by August 2025 [2] Presentation Information - The poster presentation titled "Phase I/II Trial of Allocetra™ Cell Therapy for Knee Osteoarthritis: Clinical Evidence of Response to Modulation of Inflammation" will be presented by Dr. Oren Hershkovitz and Einat Galamidi at the conference [3][6]

[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]