Enlivex Therapeutics Ltd. (ENLV) Business Model Canvas

Enlivex Therapeutics Ltd. (ENLV): Business Model Canvas [Dec-2025 Updated]

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You're looking to cut through the noise and really see how Enlivex Therapeutics Ltd. is structuring its business right now, and honestly, it's a fascinating hybrid model. We're not just talking about advancing their proprietary Allocetra™ cell therapy through crucial Phase IIb trials for knee osteoarthritis; they've also bolted on a unique treasury strategy using RAIN prediction markets tokens, which was significantly bolstered by that recent $212,000,000 PIPE financing. To be fair, this dual focus means managing both clinical risk and digital asset volatility, especially when you see the $7.53 million net loss for the nine months ended September 30, 2025, but understanding this canvas is key to assessing their path forward. Dive into the nine building blocks below to see exactly how Enlivex Therapeutics Ltd. plans to balance its biotech pipeline with its digital asset exposure.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Enlivex Therapeutics Ltd. (ENLV) has locked in as of late 2025, which are critical for both its core biotech pipeline and its novel treasury strategy. These partnerships define how the company executes its clinical roadmap and manages its capital.

The company's clinical development for Allocetra™, particularly in knee osteoarthritis (KOA), relies on external expertise for execution and validation.

  • Enlivex Therapeutics collaborates with academic medical centers and contract research organizations (CROs) across North America and Europe to advance its clinical programs.
  • The Allocetra™ Phase IIa trial for KOA is a multi-center Phase I/II clinical trial.
  • The company has received positive feedback from analysts and Key Opinion Leaders (KOLs), including reports from analyst Jason Kolbert and H.C. Wainwright analyst Raghuram Selvaraju, Ph.D..

The recent major financial event heavily involved specific external financial and strategic advisors.

Partner Type Entity/Role Transaction/Metric Value/Date
Placement Agent/Advisor BTIG (Sole placement agent and exclusive financial advisor) Private Investment in Public Equity (PIPE) Gross Proceeds $212,000,000
PIPE Transaction Detail Share Price in PIPE Premium over November 21, 2025 closing price $1.00 per share, representing a 11.5% premium
Finder Fees (Placement Agent) Cash Commission Up to 8% of gross proceeds
Finder Fees (Placement Agent) Warrants Issued Up to 8% of aggregate units issued
Treasury Strategy Partner RAIN decentralized predictions protocol Implementation of the world's first digital asset treasury strategy (DAT) via RAIN token accumulation
Treasury Token Price Movement RAIN Token Price Briefly surged from $0.0038 to $0.0076 post-announcement

The strategic shift into digital assets is anchored by the RAIN protocol, which is built on the Arbitrum network. This move positions Enlivex Therapeutics as the first U.S.-traded public company to provide investors exposure to prediction markets.

Governance and high-level strategic guidance were bolstered by a key addition to the Board of Directors.

  • Matteo Renzi, former Prime Minister of Italy, joined the Board of Directors, effective November 24, 2025.

The successful closing of the $212,000,000 transaction was announced on November 26, 2025, with the closing expected on or before November 25, 2025.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Key Activities

You're looking at the core engine of Enlivex Therapeutics Ltd., the things they absolutely must do well to move their science forward. For a clinical-stage biotech, Key Activities revolve around the lab, the clinic, and now, a very specific financial maneuver.

Advancing Allocetra™ through Phase IIb clinical trials for KOA

The primary focus here is pushing Allocetra™ for knee osteoarthritis (KOA) through the next crucial regulatory and clinical hurdles. You saw the positive signals from the earlier stage, and now the activity shifts to preparing for and executing the larger trial.

Here are the latest clinical milestones and data points:

  • Six-month readout from the ongoing Phase IIa trial completed in November 2025.
  • Expected regulatory approval of the Phase IIb protocol in Q1-Q2 2026.
  • Expected dosing of the first patient in the Phase IIb trial in Q2-Q3 2026.

The Phase IIa trial (ENX-CL-05-001) involved a total of 133 patients randomized and treated. For the primary idiopathic age-related osteoarthritis patients, representing 54% of the study population, the therapy showed a 72% reduction in pain versus placebo and a 109% improvement in function versus placebo in the 3-month data.

Research and development of the macrophage reprogramming platform

This activity covers the ongoing scientific work to support Allocetra™ and the broader platform. Since Enlivex Therapeutics is pre-revenue, these costs hit the bottom line directly. For the second quarter of 2025, the operational spend clearly shows where the effort is focused.

Expense Category (Q2 2025) Amount (USD)
Total Operating Expenses $4.14 million
Research and Development (R&D) Costs $2.86 million
Marketing, Selling, and G&A Expenses $1.09 million

The company reported a net loss of $4.14 million for Q2 2025. As of June 30, 2025, the accumulated deficit stood at approximately $132.4 million.

Regulatory filings with the FDA and other agencies

This activity is intrinsically linked to the clinical trial progression. The key activity here is securing the green light to move from Phase IIa to Phase IIb. The timeline for this critical filing is set for early 2026.

  • Expected regulatory approval of Phase IIb protocol: Q1-Q2 2026.

The efficacy data from the Phase IIa trial is specifically noted as exceeding FDA thresholds for Phase III trials in the responder population.

Managing the $212,000,000 RAIN prediction markets token treasury

This is a newly formalized, major Key Activity following a significant financing event in late 2025. Enlivex Therapeutics Ltd. closed a private investment to fund this strategy.

The transaction details are concrete:

  • Aggregate gross proceeds: Approximately $212,000,000.
  • Shares sold in the PIPE: 212,000,000 ordinary shares.
  • Price per share: $1.00.
  • Premium to November 21, 2025, close: 11.5%.
  • Closing date: November 26, 2025.

The net proceeds are intended to implement the RAIN prediction markets token treasury strategy via RAIN token accumulation, while continuing core business operations. As of November 24, 2025, the market capitalization was $241M based on 236M shares.

Manufacturing and quality control of Allocetra™ cell therapy

For a cell therapy, manufacturing is a make-or-break activity. Enlivex Therapeutics has already completed a key step to improve this area, which directly impacts future cost structures.

The development of the frozen formulation of Allocetra™ was completed ahead of schedule. This is important because the company expects its use to dramatically reduce future manufacturing costs and enable geographic expansion of clinical programs. The company has no trailing 12-month revenue as of September 30, 2025. As of June 30, 2025, cash and cash equivalents/deposits were approximately $19.5 million.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Key Resources

The Key Resources for Enlivex Therapeutics Ltd. as of late 2025 are centered on its proprietary science, a newly fortified balance sheet, and a strategic diversification into digital assets.

Proprietary Allocetra™ allogeneic cell therapy technology & Intellectual Property (IP)

The core scientific resource is the macrophage reprogramming platform, which underpins the lead candidate, Allocetra™. This technology is designed to recalibrate the innate immune system, focusing on restoring immune balance.

  • Lead product candidate: Allocetra™, an allogeneic cell therapy.
  • Target indication: Late-stage clinical development for knee osteoarthritis.
  • Platform focus: Macrophage reprogramming for life-threatening inflammatory conditions.

The protection of this platform via Intellectual Property is a critical, though non-quantified, resource, supporting the development pipeline which also explores sepsis, ARDS, and complications from stem cell transplantation.

Cash and equivalents, significantly boosted by the $212,000,000 PIPE

Liquidity was substantially enhanced by a recent capital raise, moving the financial position from one with no reported revenue and negative profitability metrics (e.g., TTM earnings ending September 30, 2025, were -$12.7M) to one with significant cash reserves.

The private investment in public equity (PIPE) closed on November 26, 2025, providing the necessary runway for ongoing operations and clinical advancement.

Financial Metric Value / Detail
Expected Gross Proceeds (PIPE) $212,000,000
Shares Sold in PIPE 212,000,000 ordinary shares
Price Per Share $1.00
Premium to Nov 21, 2025 Close 11.5%
Funding Combination $USD and USDT
Pre-PIPE Liquidity Indicator (Quick Ratio) 6.43

Specialized scientific and clinical management team expertise

The human capital includes specialized expertise in immunology, cell therapy manufacturing, and regulatory affairs, positioning Enlivex Therapeutics to scale production and pursue global approvals. The governance structure was recently augmented.

  • New Board Member: Matteo Renzi, former Prime Minister of Italy, effective November 24, 2025.
  • Operational Focus: Advancing Allocetra™ clinical programs across North America and Europe.

RAIN prediction markets tokens as a treasury reserve asset

A deliberate shift in treasury management involves allocating net proceeds to acquire RAIN tokens, making Enlivex Therapeutics the first U.S.-listed company with a treasury centered on a prediction-markets token. RAIN is built on the Arbitrum network and features a deflationary Buyback & Burn mechanism.

This strategy is supported by specific contractual elements designed to manage the entry cost and future exposure.

  • Initial Treasury Strategy: Purchase unlocked RAIN tokens from the open market and liquidity providers.
  • Effective Entry Price Support: Rain Foundation grant supporting an initial multiple (mNAV) of 0.95.
  • Long-Term Option: Option to purchase up to $918 million in RAIN tokens over 12 months at a fixed price.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Value Propositions

Enlivex Therapeutics Ltd. offers Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state, which is a novel therapeutic modality based on macrophage modulation.

The manufacturing process for Allocetra™ is described as simple, yielding a ready-to-use cell therapy that can be administered without the need to match donors.

Potential disease-modifying treatment for moderate-to-severe KOA in age 60+ patients

The Phase IIa trial data for knee osteoarthritis (KOA) in the primary age group of 60+ patients demonstrated substantial and durable clinical improvements at 6 months post-treatment.

The efficacy data from the ENX-CL-05-001 trial for age-related primary osteoarthritis patients aged 60+ showed the following compared to placebo:

Endpoint (Composite) Time Point Allocetra™ Group Change (Scale 0-100) Placebo Group Change (Scale 0-100) Improvement Over Placebo P-value
Pain and Function 3-Month -26.8 points -13.4 points 99% p=0.008
Pain and Function 6-Month -27.8 points -15.5 points 80% p=0.02

At 3 months, the treatment specifically demonstrated a 72% pain reduction versus placebo and 109% function improvement versus placebo in patients aged 60 and above.

The potential market size for KOA in the US is substantial, with over 32 million Americans affected, and this is projected to grow to 78 million by 2040.

The current US market valuation for osteoarthritis is estimated around $7 billion, with expectations for it to grow to more than $15 billion by 2030.

The company plans to initiate the follow-up pivotal Phase IIb trial in the first half of 2026.

Novel mechanism of action for life-threatening inflammatory conditions (sepsis, ARDS)

Allocetra™ is being developed as an adjunctive immunomodulating cell therapy to potentially prevent organ failure caused by sepsis.

Key statistics related to the burden of sepsis in the US and globally include:

  • At least 1.7 million adults in the United States develop sepsis each year.
  • Approximately 270,000 adults die from sepsis in the US annually.
  • Sepsis is present in 30% to 50% of hospitalizations that culminate in death.
  • Urosepsis accounts for up to an estimated 31% of all sepsis cases.
  • Urosepsis is associated with up to 1.6 million deaths worldwide annually.

In a Phase II trial for sepsis, a stand-alone analysis of Allocetra-treated subjects showed a 65% decrease in the overall mortality rate compared to expected outcomes.

For sepsis patients with urinary tract infections in that trial, data indicated a 90% decline in SOFA scores by day 28.

To extend the cash runway through the end of 2025, the company laid off 50% of its staff.

Providing investors with exposure to the prediction markets digital asset sector

Enlivex Therapeutics Ltd. is the first stock to provide investors exposure to prediction markets through a treasury strategy focused on the RAIN protocol.

The company closed a private investment round in late 2025 to fund this strategy while continuing core operations.

Financial Metric Value as of Late 2025 Date/Context
Gross Proceeds from Private Placement $212,000,000 Closed on November 26, 2025
Shares Sold in Private Placement 212,000,000 shares Priced at $1.00 per share
Stock Price (Close) $1.09 December 3, 2025
Forecasted 2025 Net Loss Per Share $0.58 Full-year forecast
Q3 2025 Earnings -$2.2M Reported on Sep 30, 2025

The net proceeds are intended to implement the world's first RAIN prediction markets token digital-asset treasury strategy via RAIN token accumulation.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Customer Relationships

You're looking at how Enlivex Therapeutics Ltd. manages its key external interactions as of late 2025. This isn't about selling widgets; it's about managing the clinical development lifecycle and capital structure.

High-touch engagement with clinical investigators and key opinion leaders

Engagement centers heavily on the progress of the Allocetra™ cell therapy in the Phase IIa trial (ENX-CL-05-001) for knee osteoarthritis (OA). The relationship is built on sharing and validating clinical outcomes with experts who influence future trial design and adoption.

  • Six-month efficacy data for the 134 patients in the Phase IIa trial was announced on November 24, 2025.
  • The data showed a durable reduction in pain and improvement in function in the age-related primary responder population (e.g., at 6-month for age 61+, Allocetra treated group improved -27.8 points vs. -15.5 points for placebo on a 0-100 scale; 80% relative improvement over placebo; p=0.02).
  • Key Opinion Leaders (KOLs), such as Prof. Conaghan, provided commentary on the growing need for effective therapies.
  • The Chief Medical Officer, Dr. Einat Galamidi, confirmed the results pave the way for the planned Phase IIb trial initiation in the first half of 2026.

Investor relations via press releases and webinars on clinical and treasury updates

Investor communication is focused on translating complex clinical milestones and significant financial maneuvers into digestible updates, often through formal events.

  • A webinar was hosted on August 18, 2025, to analyze the 3-month topline data.
  • Enlivex Therapeutics Ltd. issued press releases on November 24, 2025, detailing the 6-month clinical data, and on November 26, 2025, announcing the closing of a major private placement.
  • The company scheduled a virtual fireside chat for December 11, 2025, at 11:00 am ET to update on the RAIN token strategy and Allocetra clinical development.

Direct communication with regulatory bodies (FDA, EMA)

Communication here is about aligning development plans with expectations for future pivotal studies, given the current regulatory landscape for OA treatments.

  • To Enlivex Therapeutics Ltd.'s knowledge, neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has approved a medication demonstrated to arrest, slow, or reverse structural joint damage.
  • The company expects to receive regulatory approval for the Phase IIb protocol in Q1 2026.
  • The 3-month data showed efficacy exceeding thresholds commonly accepted by the FDA for Phase III primary endpoints, citing a 72% reduction in knee pain vs. placebo in age-related primary OA patients.

Professional relationship with financial and legal advisors for capital raises

This relationship is critical for executing major financing events necessary to fund the late-stage clinical roadmap.

Enlivex Therapeutics Ltd. closed a $212,000,000 private investment on November 26, 2025. This followed a separate funding announcement of $9,500,000 closed on November 25, 2025. The $212,000,000 raise involved selling 212 million ordinary shares at $1.00 per share or pre-funded warrants at $0.99.

The advisors involved in the primary $212,000,000 transaction were:

Role Entity Details/Counterparty
Sole Placement Agent & Exclusive Financial Advisor BTIG Legal counsels for BTIG were DLA Piper and Gornitzky & Co.
Legal Counsel for Enlivex Therapeutics Ltd. Greenberg Traurig, P.A. and FISCHER (FBC & Co.) Transaction closed on November 26, 2025

The net proceeds are intended to implement the RAIN prediction markets token treasury strategy.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Channels

You're looking at how Enlivex Therapeutics Ltd. gets its product development and capital to the right places, which is key for a clinical-stage biotech. Here's the breakdown of their primary channels as of late 2025.

Clinical trial sites (multi-center, multi-country) for product development

The development channel relies heavily on executing complex, multi-site clinical studies for Allocetra™. The Phase I/II trial for knee osteoarthritis (ENX-CL-05-001) is explicitly a multi-center, multi-country effort, which is how they gather diverse patient data for efficacy and safety validation.

For the knee osteoarthritis (KOA) program, the Phase IIa stage randomized and treated over 133 subjects, with 134 patients completing the three-month follow-up timepoint. The company is planning the next step, a Phase IIb trial, with an expected protocol approval in early 2026 and first patient dosing targeted for mid-2026. For the Sepsis indication, regulatory clearance was received in multiple countries, including Israel, Spain, and Greece, for Phase II protocol amendments back in August 2022.

Here are the key operational numbers for the primary clinical channel:

Trial Stage/Program Key Metric Value/Status as of Late 2025
Allocetra KOA (ENX-CL-05-001) Phase IIa Patients Randomized/Treated Over 133 subjects
Allocetra KOA (ENX-CL-05-001) Phase IIa Primary Endpoint Follow-up Completion 134 patients at three months
Allocetra KOA Phase IIb Initiation Expected Protocol Approval Early 2026
Allocetra KOA Phase IIb Initiation Expected First Patient Dosing Mid-2026
Allocetra Sepsis Phase II Countries with Regulatory Clearance (for amendments) Israel, Spain, and Greece

Regulatory approval pathways (NDA/BLA) for commercialization

The commercialization channel is gated by successful progression through the regulatory pathway, which for a cell therapy like Allocetra™ would typically involve a Biologics License Application (BLA) rather than a New Drug Application (NDA). As of late 2025, Enlivex Therapeutics Ltd. is focused on generating data to support future late-stage submissions, with no public announcement of an actual NDA or BLA filing date.

The immediate regulatory milestones channel involves securing protocol approval for the next trial phase:

  • Expected regulatory approval of Phase IIb protocol for KOA: Q1-Q2 2026.
  • The company is advancing toward late-stage development based on positive Phase IIa data.

NASDAQ and TASE public markets for capital raising and investor access

The financial channel for Enlivex Therapeutics Ltd. is clearly routed through its dual listing on the NASDAQ and TASE (Tel Aviv Stock Exchange). You saw significant activity in late November 2025 to fuel operations.

The company closed a massive private investment in November 2025, which is a critical channel for non-dilutive or minimally dilutive funding compared to public offerings:

  • Closing of private investment on November 26, 2025, for gross proceeds of $212,000,000.
  • This involved issuing an aggregate of 212,000,000 ordinary shares or pre-funded warrants.
  • The purchase price was $1.00 per Share or $0.99 per Pre-Funded Warrant.

This followed another capital raise just days prior:

Financing Event Date Announced/Closed Gross Proceeds Share Price
Securities Purchase Agreement November 24/25, 2025 $9,500,000 $1 per ordinary share
Private Investment Closing November 26, 2025 $212,000,000 $1.00 per share or $0.99 per pre-funded warrant

The use of proceeds from the larger placement was explicitly stated to implement the RAIN prediction markets token treasury strategy, alongside continuing core business operations.

Scientific publications and medical conferences (e.g., ACR Convergence 2025)

Dissemination of clinical data through peer-reviewed channels and major medical meetings is the essential validation channel for a clinical-stage company. Enlivex Therapeutics Ltd. actively used this channel throughout 2025.

Key conference presentations in 2025 included:

  • Presentation of a late-breaking poster abstract at the American College of Rheumatology (ACR) Convergence 2025 (October 24-29) regarding Allocetra™ for Sepsis.
  • Presentation of two poster abstracts at the Osteoarthritis Research Society International (OARSI) 2025 World Congress (April 24-27).
  • Presentation at the Israeli BioMed 2025 Conference (May 21-23).

The data presented supported the KOA indication, with positive six-month efficacy data announced on November 24, 2025, demonstrating durable pain reduction and function improvement in primary age-related patients. For instance, in age-related primary KOA patients at six months, the data showed a 80% relative improvement in a composite pain/function endpoint versus placebo (p=0.02). Finance: draft 13-week cash view by Friday.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Customer Segments

You're looking at the core groups Enlivex Therapeutics Ltd. is targeting with its Allocetra™ platform right now, late in 2025. It's a dual focus: getting the KOA therapy to patients and managing the capital structure to fund it.

Patients with moderate-to-severe knee osteoarthritis, particularly the age 60+ primary OA population

The immediate focus for the Allocetra™ intra-articular injection is patients with moderate-to-severe knee osteoarthritis (OA). Enlivex Therapeutics Ltd. has specifically identified the age-related primary OA population, noting a robust positive correlation between patient age and the magnitude of the clinical effect in their Phase IIa trial data released in November 2025. The 6-month data showed statistical significance for the composite endpoint in the age group of 60+ at 3 months and 61+ at 6 months.

The scale of this patient group is substantial, representing a significant unmet medical need, as currently, no approved medication has been shown to arrest, slow, or reverse structural joint damage.

Here are the relevant patient statistics as of late 2025:

Metric US Data Global Data Source Year
Total Adults with Osteoarthritis 51.9 million 527.8 million (15% of global adult population) 2025
Adults with Knee Osteoarthritis (KOA) 24.7 million (1 in 10 adults) N/A 2025
Annual Hospitalizations for OA (US) Over one million N/A 2025
Projected US Adults with OA 78 million by 2040 N/A 2025

Institutional and retail investors seeking biotech and digital asset exposure

Enlivex Therapeutics Ltd. actively courts investors interested in both clinical-stage biotech and novel digital asset strategies. The company recently closed a significant financing event, which is a key financial data point for this segment. The Executive Chairman is scheduled to discuss plans following the recently closed $212,000,000 private placement.

The digital asset exposure is anchored by the launch of a treasury strategy built around RAIN token accumulation. This dual-engine approach-clinical development and digital asset treasury-is a unique draw for this customer segment. On November 28, 2025, the stock price was $0.97 per share.

Institutional investment activity in the third quarter of 2025 showed mixed movement, with 11 institutional investors adding shares and 12 decreasing positions. Overall institutional ownership was reported at 1.02% of the stock.

Key institutional holders and recent activity include:

  • CITIZENS FINANCIAL GROUP INC/RI added 231,424 shares in Q3 2025.
  • CITADEL ADVISORS LLC added 68,936 shares in Q3 2025.
  • ARMISTICE CAPITAL, LLC removed 1,413,306 shares in Q3 2025.
  • MORGAN STANLEY removed 45,524 shares in Q3 2025.

Rheumatologists and orthopedic specialists who treat KOA

This segment comprises the healthcare professionals who will ultimately administer the Allocetra™ therapy. The treatment is an intra-articular injection into the target knee joint, meaning specialists familiar with joint injections are the direct users. The potential market size for the therapy they would be administering is projected to reach $13.14 billion by 2031, up from $5.9 billion in 2022.

The market size implies a large pool of specialists, though the exact number of treating rheumatologists and orthopedic specialists is not explicitly stated for late 2025. The need for treatments that reduce pain and disability is critical, as there are currently no approved medications to arrest structural damage.

Key characteristics of this segment include:

  • Administer Allocetra™ via local knee injection.
  • Treating patients with moderate-to-severe KOA (Grade two and three).
  • Seeking novel therapies due to underperformance of existing options.

Future segments: Critical care physicians treating sepsis and ARDS

Enlivex Therapeutics Ltd. is developing Allocetra™ as an adjunctive immunomodulating cell therapy platform for sepsis, administered intravenously alongside standard of care to potentially prevent organ failure.

The patient population for this indication is large, with at least 1.7 million adults in the US developing sepsis annually, resulting in approximately 270,000 deaths. The Phase II study for sepsis enrolled 120 patients.

Data points relevant to this future segment include:

Sepsis Metric Number Context
Annual US Sepsis Cases At least 1.7 million CDC data cited by Enlivex Therapeutics Ltd.
Annual US Sepsis Deaths Approximately 270,000 CDC data cited by Enlivex Therapeutics Ltd.
Phase II Sepsis Trial Enrollment 120 patients Enrolled in the Allocetra™ sepsis study.
Sepsis Hospitalization Mortality 30% to 50% of hospitalizations culminating in death Various studies cited.

Critical care physicians treating sepsis would utilize Allocetra™ via systemic administration.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Cost Structure

You're looking at the cost base for Enlivex Therapeutics Ltd. as of late 2025, which is heavily weighted toward clinical development and a very recent, significant strategic financial move. Honestly, for a clinical-stage biotech, the cost structure is almost entirely operational burn until a revenue stream kicks in.

The overall financial result for the nine months ended September 30, 2025, shows a net loss of $7.53 million. This loss compares favorably to the net loss of $9.84 million reported for the same nine-month period in 2024.

Here's a breakdown of the key cost components driving that burn:

  • High R&D expenses, primarily for clinical trial execution (Phase IIa/IIb) for AllocetraTM.
  • General and administrative (G&A) costs, including legal and public company compliance expenses.
  • Cell therapy manufacturing and supply chain costs, necessary for supporting ongoing and future clinical trials.
  • Costs associated with the acquisition and management of the RAIN token treasury, a new strategic outlay.

The most significant recent financial event impacting the cost/asset structure is the implementation of the Digital Asset Treasury (DAT) strategy.

Cost/Use of Funds Category Associated Financial Amount
Net Loss (Nine Months Ended Sep 30, 2025) $7.53 million
Gross Proceeds from PIPE for RAIN Token Treasury $212,000,000
RAIN Token Treasury Acquisition Allocation (Intended Use of Proceeds) Most of the $212 million

Drilling down into the operating expenses, while the full nine-month figures aren't immediately available, the second quarter of 2025 gives us a snapshot of the core operational spend before the treasury move. You can see the R&D focus clearly in the quarterly spend.

  • Research and Development (R&D) expenses for the three months ended June 30, 2025, were $2,141,000.
  • This R&D increase was primarily due to a $118,000 increase in payroll expenses and a $126,000 increase in expenses for clinical studies and pre-clinical studies.
  • General and Administrative (G&A) expenses for the three months ended June 30, 2025, totaled $937,000.
  • The G&A decrease for the six months ended June 30, 2025, compared to 2024, was $189,000, driven by lower lease/overhead costs ($127,000 decrease) and insurance expenses ($37,000 decrease).

The cell therapy manufacturing and supply chain costs are inherently tied to the clinical trial execution, meaning they scale directly with the advancement of AllocetraTM through Phase IIa/IIb trials.

The RAIN token treasury acquisition represents a massive, one-time strategic cost/asset allocation, with the private investment agreement for 212,000,000 ordinary shares priced at $1.00 per share, totaling approximately $212,000,000 in gross proceeds.

Finance: review the Q3 2025 cash burn rate excluding the PIPE proceeds by end of next week.

Enlivex Therapeutics Ltd. (ENLV) - Canvas Business Model: Revenue Streams

You're looking at the current state of Enlivex Therapeutics Ltd.'s revenue generation as of late 2025. Honestly, the picture is what you'd expect for a clinical-stage biotech right now: funding is the main event, not product sales.

Current and Historical Financial Performance

For the trailing 12 months ending September 30, 2025, Enlivex Therapeutics Ltd. reported $0.00 in revenue. This lack of product revenue is typical, given the company's focus on development. The net loss for the nine months ending September 2025 was $7.5 million. For the trailing 12 months ending September 30, 2025, the reported earnings were -$12.7M.

Here's a quick look at the financing that is currently fueling operations:

Financing Event Amount Share Price Premium to Prior Close Closing Date (Expected)
Private Investment in Public Equity (PIPE) Approximately $212,000,000 gross proceeds $1.00 per share 11.5% over November 21, 2025 close On or before November 25, 2025
Shares Sold in PIPE 212,000,000 ordinary shares N/A N/A Closed November 26, 2025

Equity Financing as Primary Funding Source

The most significant financial inflow, and therefore the primary source of funding right now, is the recently closed equity financing. You saw the details above: a $212,000,000 PIPE. This capital influx is intended to support core business operations while also funding a novel treasury strategy. The company's financial health, despite this cash injection, shows negative Return on Equity (-59.16%) and a negative Return on Assets (-50.78%), reflecting the developmental stage.

Potential Returns from Digital Asset Treasury Strategy

A major component of the post-PIPE strategy involves the RAIN prediction markets token. Enlivex Therapeutics Ltd. intends to use net proceeds to implement the world's first digital asset treasury strategy centered on RAIN token accumulation, making it the primary treasury reserve asset. This move is designed to provide investors with exposure to the prediction markets sector. At the time of the announcement, the RAIN token had a market capitalization of $862M. The market reacted strongly to the news; the RAIN token price surged 100%, moving from $0.0038 to $0.0076 within hours.

The expected returns from this strategy are entirely dependent on the performance of the RAIN token, which carries inherent volatility risks.

Future Potential Revenue from Allocetra™ Sales

Future revenue hinges on the successful commercialization of Allocetra™. As of late 2025, the therapy has shown positive six-month efficacy data from its Phase IIa trial in knee osteoarthritis (OA) patients, with a 72% reduction in pain versus placebo and a 109% improvement in function observed in the age-related primary OA responder group (patients aged 60 and over). This is critical because OA affects over 32 million Americans, and currently, no FDA- or EMA-approved medication can arrest or reverse structural damage.

The path to sales involves several milestones, none of which translate to immediate revenue:

  • Expected regulatory approval of Phase IIb protocol in early 2026.
  • First patient dosing in Phase IIb trial targeted for mid-2026.
  • Topline Phase IIb data anticipated by mid-2027.

Future Potential Revenue from Licensing and Collaboration

While Enlivex Therapeutics Ltd. is advancing Allocetra™ toward late-stage development, specific, quantified future revenue streams from licensing or collaboration agreements with larger pharmaceutical companies are not publicly detailed at this time. The company's immediate focus is on completing the clinical roadmap for Allocetra™ and managing the new digital asset treasury strategy.


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