Ness-Ziona, Israel, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it will present a late-breaking poster abstract at the American College of Rheumatology (ACR) Convergence 2025, taking place October 24–29 at McCormick Place Convention Center in Chicago, Illinois. The presentation will feature clinical data from the recently announced Phase IIa (ENX-CL-05-001) 3-month topline dat ...

Core Insights - Enlivex Therapeutics Ltd. will participate in a live investor webinar discussing advancements in the treatment of inflammatory diseases, specifically focusing on knee osteoarthritis [1][2][7] Company Overview - Enlivex is a clinical-stage company specializing in macrophage reprogramming immunotherapy, developing Allocetra™, a universal cell therapy aimed at reprogramming macrophages to restore immune balance [8] Webinar Details - The webinar is scheduled for September 30, 2025, at 10:00 AM Eastern Time, featuring key opinion leaders in musculoskeletal disease and Enlivex's Vice Chairman [1][3] - The discussion will highlight positive Phase IIa topline data from the Allocetra™ program, showing significant pain reduction and functional improvement in patients with moderate-to-severe knee osteoarthritis [2][7] Expert Panel - The panel includes notable experts such as Professor Ali Mobasheri, Professor Philip Conaghan, Dr. Roger Pomerantz, and Jason Kolbert, each bringing extensive experience in musculoskeletal health and clinical research [3][4][5][6] Clinical Significance - The Phase IIa data from the Allocetra™ program indicates a strong potential to change the treatment landscape for knee osteoarthritis, a condition currently lacking approved disease-modifying therapies [2][7]

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]