Enlivex Pivots to Crypto Treasury, Reports Non-Cash Gain Amidst Clinical Losses

TL;DR

**ENLV's 2025 'profit' is a mirage of crypto gains, not drug sales; this stock is a high-stakes bet on digital assets, not biotech innovation.**

AI Summary

Enlivex Ltd. (ENLV) reported a dual strategy for the fiscal year ended December 31, 2025, combining clinical development of Allocetra™ for inflammatory conditions with a treasury model anchored in the RAIN protocol, a decentralized prediction markets infrastructure. The company recognized net income attributable to an unrealized, non-cash gain from increases in the fair value of digital cryptocurrency assets held in its treasury, specifically the RAIN token and the RAIN Option. This gain resulted from the $212 million gross proceeds from a private placement completed on November 24, 2025, which were used to acquire these digital assets. Despite this reported net income, Enlivex has not generated any revenue from Allocetra™ or other product candidates and expects to incur additional losses from its clinical operations. The company's ability to continue as a going concern is dependent on further financial support, highlighting the significant financial risk associated with its reliance on volatile digital asset holdings. The fair value measurement of digital assets under ASU 2023-08 is expected to introduce significant volatility into reported earnings.

Why It Matters

Enlivex's bold pivot to a cryptocurrency-anchored treasury strategy, using $212 million from a private placement to acquire RAIN tokens, introduces unprecedented volatility and risk for investors. While it generated a non-cash net income for 2025, this doesn't reflect operational profitability, as the company still lacks product revenue and expects further clinical losses. This move places ENLV in a unique, high-risk category, differentiating it from traditional biotech peers and potentially attracting a new class of crypto-savvy investors, but also alienating those seeking stable pharmaceutical development. The success of this strategy hinges entirely on the highly unpredictable digital asset market, making it a speculative play in the competitive biotech landscape.

Risk Assessment

Risk Level: high — The risk level is high due to Enlivex's explicit reliance on highly volatile digital cryptocurrency assets, specifically the RAIN token, as its primary treasury reserve asset. The filing states, "The market price of digital cryptocurrency assets has historically been subject to dramatic price fluctuations and is highly volatile," and that this will create "significant volatility in our reported earnings." Furthermore, the company has not generated any revenue from its clinical operations and expects to incur additional losses, making its ability to continue as a going concern dependent on additional financial support, which could be impacted by the liquidity and value of its crypto holdings.

Analyst Insight

Investors should approach ENLV with extreme caution, recognizing it as a highly speculative investment driven by cryptocurrency market dynamics rather than traditional biotech fundamentals. Consider this a high-risk, high-reward play on the RAIN token and prediction markets, and only allocate capital that you are prepared to lose entirely. Diversify your portfolio to mitigate the inherent volatility.

Financial Highlights

debt To Equity

Not specified

revenue

$0

operating Margin

Not specified

total Assets

Not specified

total Debt

Not specified

net Income

Significant unrealized gain from digital assets

eps

Not specified

gross Margin

Not specified

cash Position

Not specified

revenue Growth

N/A

Key Numbers

• $212 million — Gross proceeds (Received from Private Placement on November 24, 2025, used to acquire digital assets.)
• 237,381,498 — Ordinary shares outstanding (As of December 31, 2025, par value NIS 0.40 per share.)
• NIS 0.40 — Par value per share (Of Enlivex's Ordinary Shares.)
• NIS 3.19 to $1.00 — Exchange rate (Reported by Bank of Israel on December 31, 2025, for U.S. dollar translations.)
• December 31, 2025 — Fiscal year end (Period covered by this Annual Report on Form 20-F.)

Key Players & Entities

• Enlivex Ltd. (company) — Registrant, formerly Enlivex Therapeutics Ltd.
• Allocetra™ (product) — Clinical-stage immunotherapy for inflammatory conditions
• RAIN protocol (company) — Decentralized prediction markets infrastructure
• RAIN token (other) — Company's primary treasury reserve asset
• Oren Hershkovitz (person) — Company Contact Person
• Nasdaq Capital Market (other) — Exchange where Ordinary Shares are registered
• Securities and Exchange Commission (regulator) — Regulatory body for filings
• Bank of Israel (regulator) — Source for exchange rate information
• United States Patent and Trademark Office (regulator) — Patent agency
• Financial Accounting Standards Board (regulator) — Issues Accounting Standards Codification

Forward-Looking Statements

• Enlivex Ltd. will continue to operate in the pharmaceutical preparations sector. (Enlivex Ltd.) — high confidence, target: 2027-03-25
• Enlivex Ltd. will file its next 20-F report around March 2027 for the fiscal year ending December 31, 2026. (Enlivex Ltd.) — high confidence, target: 2027-03-31

FAQ

Risk Factors

• Reliance on Digital Asset Holdings [high — financial]: The company's reported net income is derived from unrealized, non-cash gains on digital cryptocurrency assets (RAIN token and RAIN Option), acquired with $212 million in gross proceeds from a private placement. This reliance on volatile digital assets introduces significant earnings volatility, as fair value measurements under ASU 2023-08 are expected to impact reported results.
• Going Concern Uncertainty [high — financial]: Enlivex has not generated revenue from its core Allocetra™ development or other product candidates and anticipates further operating losses. The company's ability to continue as a going concern is contingent upon securing additional financial support, underscoring a substantial financial risk.
• Clinical Development Risks [high — operational]: The company's primary business strategy involves the clinical development of Allocetra™ for inflammatory conditions. This inherently carries significant risks, including potential clinical trial failures, regulatory hurdles, and long development timelines, with no current revenue generation from these efforts.
• Digital Asset Market Volatility [high — market]: The value of the RAIN token and RAIN Option, which form the basis of the company's treasury model and reported net income, is subject to extreme market volatility. Fluctuations in the cryptocurrency market can lead to substantial and rapid changes in the company's reported financial performance.

Industry Context

Enlivex operates in the biotechnology sector, focusing on the development of novel therapeutics for inflammatory diseases. The industry is characterized by high R&D costs, long development cycles, and significant regulatory oversight. Companies often rely on external funding and strategic partnerships to advance their pipelines. The integration of decentralized finance (DeFi) and digital assets into corporate treasury strategies, as seen with Enlivex, is a nascent and highly speculative trend within the broader industry.

Regulatory Implications

Enlivex faces standard regulatory scrutiny for its clinical development programs from bodies like the FDA. Furthermore, its novel treasury strategy involving digital assets may attract attention from financial regulators regarding disclosure, risk management, and compliance with evolving digital asset regulations.

What Investors Should Do

1. Scrutinize the sustainability of reported net income.
2. Evaluate the going concern risk.
3. Understand the volatility of digital asset holdings.

Key Dates

• 2025-11-24: Completion of Private Placement — Raised $212 million in gross proceeds, which were subsequently used to acquire digital cryptocurrency assets (RAIN token and RAIN Option).
• 2025-12-31: Fiscal Year End — Reporting period for the 20-F, reflecting the company's financial position and strategic initiatives, including its treasury model and clinical development.

Glossary

Allocetra™

Enlivex's proprietary drug candidate being developed for inflammatory conditions. (Represents the core clinical development focus of the company, from which no revenue has yet been generated.)

RAIN protocol

A decentralized prediction markets infrastructure that Enlivex is incorporating into its treasury model. (Forms the basis of the company's treasury strategy and its holdings of digital assets.)

RAIN token

A digital cryptocurrency asset held by Enlivex as part of its treasury. (Its fair value increase contributed to the reported net income, highlighting the company's reliance on digital asset performance.)

RAIN Option

A derivative instrument related to the RAIN token, also held by Enlivex. (Its fair value increase also contributed to the reported net income, adding to the volatility of the company's financial results.)

ASU 2023-08

Accounting Standards Update 2023-08, which provides guidance on accounting for digital assets. (This standard is expected to introduce significant volatility into Enlivex's reported earnings due to the fair value measurement of its digital asset holdings.)

Year-Over-Year Comparison

Information comparing key metrics to the previous year is not available in the provided text. The 20-F filing focuses on the fiscal year ended December 31, 2025, and does not contain comparative data for the prior year's financial performance or risk factors.

Key Financial Figures

• $1 — ranslated using the rate of NIS 3.19 to $1.00, the exchange rate reported by the B
• $212 million — e treasury, which we acquired using the $212 million gross proceeds received from the privat
• $1.1 billion — had retained earnings of approximately $1.1 billion. Substantially all of our operating los

Filing Documents

• ea0282960-20f_enlivex.htm (20-F) — 2077KB
• ea028296001ex2-1.htm (EX-2.1) — 40KB
• ea028296001ex4-3.htm (EX-4.3) — 58KB
• ea028296001ex8-1.htm (EX-8.1) — 3KB
• ea028296001ex12-1.htm (EX-12.1) — 11KB
• ea028296001ex12-2.htm (EX-12.2) — 11KB
• ea028296001ex13-1.htm (EX-13.1) — 4KB
• ea028296001ex13-2.htm (EX-13.2) — 4KB
• ea028296001ex15-1.htm (EX-15.1) — 2KB
• ea028296001_img1.jpg (GRAPHIC) — 8KB
• 0001213900-26-033857.txt ( ) — 9270KB
• enlv-20251231.xsd (EX-101.SCH) — 96KB
• enlv-20251231_cal.xml (EX-101.CAL) — 71KB
• enlv-20251231_def.xml (EX-101.DEF) — 372KB
• enlv-20251231_lab.xml (EX-101.LAB) — 708KB
• enlv-20251231_pre.xml (EX-101.PRE) — 387KB
• ea0282960-20f_enlivex_htm.xml (XML) — 1131KB

Item

Item 17 Item 18 If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes No TABLE OF CONTENTS INTRODUCTION ii CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS iii RISK FACTOR SUMMARY v PART ONE 1 ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS 1 ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 ITEM 3. KEY INFORMATION 1 ITEM 4. INFORMATION ON THE COMPANY 47 ITEM 4A. UNRESOLVED STAFF COMMENTS 73 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 73 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 85 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 96 ITEM 8. FINANCIAL INFORMATION 103 ITEM 9. THE OFFER AND LISTING 103 ITEM 10. ADDITIONAL INFORMATION 104 ITEM 11.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 114 ITEM 12.

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 115 PART TWO 116 ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES 116 ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS 116 ITEM 15.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 116 ITEM 16. [RESERVED] 117 ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT 117 ITEM 16B. CODE OF ETHICS 117 ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES 117 ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 117 ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS 118 ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT 118 ITEM 16G. CORPORATE GOVERNANCE 118 ITEM 16H. MINE SAFETY DISCLOSURE 120 ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 120 ITEM 16J. INSIDER TRADING POLICIES 120 ITEM 16K. CYBERSECURITY 120 PART THREE 121 ITEM 17.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 121 ITEM 18.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 121 ITEM 19. EXHIBITS 122

SIGNATURES

SIGNATURES 125 i INTRODUCTION Enlivex Ltd. (formerly known as Enlivex Therapeutics Ltd.), a company organized under the laws of the State of Israel (including its consolidated subsidiaries, " Enlivex ", " we ", " us ", " our " or the " Company "), is a quality longevity company focused on advancing therapies designed to extend health span and quality of life. Enlivex operates a dual strategy that combines clinical development in quality longevity therapeutics with a treasury model anchored in decentralized prediction markets infrastructure through the RAIN protocol. Clinical Operations: We are a clinical-stage immunotherapy company developing a novel breakthrough therapy, Allocetra TM , for the treatment of multiple inflammatory conditions, currently focused on the treatment of osteoarthritis as our primary inflammatory indication. Allocetra TM is a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state, which is critical for immune system rebalancing and the resolution of inflammatory conditions. Non-homeostatic macrophages contribute significantly to disease severity. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for debilitating and life-threatening clinical indications that are defined as "unmet medical needs," as a stand-alone therapy or in combination with other therapeutic agents. Treasury Operations: We are the first publicly listed company to have developed a treasury strategy centered on the RAIN token, which currently serves as the Company's primary treasury reserve asset. In adopting our treasury policy, we intend to provide investors with exposure to prediction markets through RAIN and to advocate for its role as digital capital. About this Annual Report on Form 20-F References in this Annual Report on Form 20-F to "U.S. dollars", "dollars", "USD", and "$" are to currency of the United States of America, and references

IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Not applicable.

OFFER STATISTICS AND EXPECTED TIMETABLE

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable.

KEY INFORMATION

ITEM 3. KEY INFORMATION 3.A. [Reserved] 3.B. Capitalization and Indebtedness Not applicable. 3.C. Reasons for the Offer and Use of Proceeds Not applicable. 3.D. Risk Factors Investing in our ordinary shares involves a high degree of risk. You should carefully consider the risks described below before investing in our ordinary shares. There are a number of risks and uncertainties that could affect our business and cause our actual results to differ from past performance or expected results. We consider the following risks and uncertainties to be those material to our business. If any of these risks actually occur, our business, financial condition and results of operations could suffer, and the trading price of our ordinary shares could decline. We urge investors to consider carefully the risk factors described below, together with the other information contained in this Annual Report on Form 20-F, in evaluating any investment in our ordinary shares. Risks Related to Our Financial Position and Capital Requirements Our historical financial statements do not reflect the potential variability in earnings that we may experience in the future relating to our RAIN governance token ("RAIN") holdings. Accordingly, it may be difficult to evaluate the Company's business and future prospects. The Company may not be able to achieve or maintain operating profitability or positive cash flows from operations in any given period. Our historical financial statements may not be indicative of our future results of operations due to the volatility associated with the digital cryptocurrency assets we hold in our corporate treasury, which we acquired using the $212 million gross proceeds received from the private placement that we completed with certain accredited investors on November 24, 2025 (the "Private Placement"). Gains and losses from changes in fair value are generally non-cash in nature, and we may report net income in periods in which we do not generate operat

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View this 20-F filing on SEC EDGAR