Ankündigung • Sep 13

Enlivex Therapeutics Ltd. Announces Addition to the Ongoing Phase II Trial of Allocetra in Patients with Sepsis, Initiates Clinical Program in Osteoarthritis

Enlivex Therapeutics Ltd. announced a strategic reprioritization plan. The Company plans to increase its existing focus on inflammatory and autoimmune indications. The Company, since its inception, considered the inherent properties of Allocetra as a new, highly-differentiated modality for immune resolution across a wide variety of inflammatory and auto-immune indications with unmet medical needs that received strong interest from large pharma, physicians and patients. In addition to the ongoing Phase II trial of Allocetra in patients with sepsis, the Company has initiated a clinical program in osteoarthritis, a degenerative disease with low grade inflammation, and an indication with a substantial unmet medical need that potentially represents a multibillion commercial market. Within the osteoarthritis program, the Company recently dosed the first patient in a Phase I/II investigator-initiated clinical trial enrolling patients with severe knee osteoarthritis who had been scheduled for knee replacement surgeries and are offered to inject Allocetra locally into the diseased knee as a potential alternative for pain resolution and knee functionality in lieu of replacement surgery. The Company is planning, in addition to this Phase I/II trial, to initiate a randomized, controlled Phase II clinical trial in patients with moderate knee osteoarthritis in early 2024. That clinical trial is expected to enroll 120-150 patients and would be double-blinded, controlled and statistically powered to evaluate efficacy as well as safety, and potentially allow the Company to design and initiate a Phase III registrational trial upon its completion. The Company’s revised strategy is targeted at obtaining topline data readouts from two advanced-stage clinical indications by mid-2025 – (a) a randomized, controlled Phase II trial in 120 patients with sepsis with a targeted topline data readout by the end of First Quarter 2024, and (b) a randomized, controlled Phase II trial in 120-150 patients with moderate knee osteoarthritis, with a targeted topline data readout by the end of Second Quarter 2025; as well as a targeted topline data readout by the end of Third Quarter 2024 from the Phase I/II investigator-initiated clinical trial in 12 patients with severe knee osteoarthritis who had been scheduled for knee replacement surgeries. In the two ongoing oncology clinical trials, 15 patients with advanced malignancies of different origins that were heavily pre-treated with multiple lines of therapy prior to the study, were treated with repeat doses of Allocetra given intravenously or intraperitoneally. Most patients received monotherapy treatment and lower doses of Allocetra. Results demonstrated tolerability and safety, allowing the program to proceed to assess the efficacy of Allocetra in solid tumor indications in combination with other therapies and at higher doses. Pursuant to the strategic reprioritization plan, and in light of the new guidelines and regulatory initiatives set by the FDA for drug development in oncology that may result in longer clinical development cycles as foundations for regulatory approvals, the Company will cease the internal clinical development of various oncology indications and plans to seek external collaborations or out-licensing opportunities for its oncology assets. As a result of the Company’s reprioritization of its clinical indications and focus on the inflammatory and auto-immune verticals, the Company intends to reduce its workforce by approximately 50%. The workforce reductions and the savings associated with the reclassification of the oncology indications as candidates for external collaborations or out-licensing opportunities in lieu of internal development are expected to result in a substantial extension of the Company’s cash runway through the end of 2025. The revised, extended cash runway is expected to support the timeline for the topline data readouts of the two advanced-stage, randomized, controlled Phase II clinical trials in sepsis and osteoarthritis. The initiation of the clinical program in osteoarthritis followed preclinical evidence of the potential applicability of Allocetra’s mechanism of action to resolve chronic low grade inflammation of joints with osteoarthritis, as well as a substantial recovery in a case of a 70-year old patient who suffered for many years from vanishing bone disease (Gorham-Stout syndrome), which is a rare disease characterized by destruction of osseous matrix and proliferation of vascular structures, resulting in complete destruction and absorption of the patient’s shoulder joint. Despite exhaustive therapeutic attempts, the patient’s disease remained refractory to treatment and continued to deteriorate, with continuous production of synovial fluid, necessitating permanent drainage of the shoulder and, as a consequence, requiring extended hospitalization for a duration of nine months prior to compassionate treatment with Allocetra to the shoulder joint. Following five intra-articular Allocetra injections, substantial improvement was documented in multiple clinical parameters, including pain and inflammatory cytokines, and the patient was successfully discharged from the hospital. At a two-year follow-up, the improvement in the afflicted shoulder was maintained and no subsequent hospital re-admissions were required.

Seeking Alpha • Sep 30

Enlivex Therapeutics: A Very Enticing Early-Stage Biotech

Summary Enlivex Therapeutics: The early results for Allocetra for sepsis (in humans) and solid tumors (in mice) look incredible. The share offering from 2021 shows a willingness to protect existing shareholders. All in all, the risk/reward profile justifies a small bet. Enlivex Therapeutics (ENLV) is a clinical stage pharmaceutical company developing a single drug candidate called Allocetra—an off-the-shelf, scalable, and affordable cell therapy which has been designed to reprogram macrophages in order to return them to their homeostatic state. It is currently being tested for life-threatening conditions such as sepsis and solid tumors, both as a standalone monotherapy and in combination with other therapies. The approach of ENLV is to target macrophages, a type of white blood cell that performs immune system functions such as removing dead cells from the body, engulfing and eliminating intrusive and harmful microbes that have entered the body, and activating other immune system cells. Sepsis is the body’s extreme response to an infection, whereby chemicals released in the blood to fight infection can trigger extreme inflammation in other parts of the body, potentially leading to organ failure. Like patients suffering from cancer, mortality rates for sepsis patients can be high. ENLV researchers believe that the macrophages of sepsis and solid tumor patients are out of their normal homeostatic state, and rather than engaging in anti-inflammation, pro-organ restoration, and anti-tumor activities, are instead engaging in pro-inflammation, pro-organ failure, and pro-tumor activities. The goal of Allocetra is to correct this imbalance and return macrophages to their homeostatic levels, which should reduce rates of drug resistance in patients and lead to better rates of disease resolution. Allocetra is a cell therapy, which refers to the practice of placing new cells into the patient’s body. After collecting cells from healthy donors, ENLV chemically modifies these donor cells using their proprietary process. The intent is to prompt the donor cells to send out an “eat me” signal, which is accomplished by expressing the biomarker phosphatidylserine, commonly known as “PtdSer.” Once the donor cells are placed into the patient’s body, the “eat me” signal attracts the macrophages in the surrounding inflamed area, which then engulf the donor cells. The engulfed donor cells then communicate with the macrophages while inside of them, and reprogram them in order to return them to their homeostatic state. ENLV’s method of communicating with the macrophages is proprietary, and forms the basis of their differentiated mechanism of action. To date, the only results in humans that we have for Allocetra were published on September 30, 2021 in the journal Frontiers In Immunology. As you can see in Table 1 on page 4, of the ten sepsis-treated patients, all of them lived, and their sepsis and organ dysfunction were resolved. Frontiers In Immunology; 9/30/21; pg 4 It does need to be pointed out that while the control group had a mortality rate of 27% (n=10/37), the phase 1b trial was run using a matched historical control. While this does not necessarily invalidate the results, using a matched historical control group is not as ideal as running a trial with simultaneous control and treatment groups. However, the currently-recruiting phase 2 sepsis trial will be a randomized, placebo-controlled, double-blind study. If the results can be replicated in phase 2, then this should alleviate investor concerns regarding the use of a historical control group in phase 1b. Thus far, all the solid tumor data we have is from animal models. But a quick glance at the results should make the potential impact of Allocetra very clear. ENLV ran the solid tumor study in mice suffering from mesothelioma, an aggressive and deadly form of cancer that occurs in the thin layer of tissue covering the majority of internal organs. In addition to Allocetra, the study incorporated the immune checkpoint inhibitor anti-CTLA4. The five groups analyzed were: mesothelioma (no treatment), mesothelioma + anti-CTLA4, mesothelioma + Allocetra (high dose), mesothelioma + anti-CTLA4 + Allocetra (low dose), and mesothelioma + anti-CTLA4 + Allocetra (high dose). On slide 30 of the company’s September 12, 2022 investor presentation, we can see clearly the encouraging results. By day 81, all eight of the mice in the no-treatment group had succumbed to the cancer. In the anti-CTLA4 group, only two of the eight mice were still alive, which was similar to the result of the high-dose Allocetra group (two of seven still alive). In the combo group of anti-CTLA4 + Allocetra (low dose), six of the nine mice were still alive. And finally, in the combo group of anti-CTLA4 + Allocetra (high dose), not only were all nine of the mice still alive, but all nine had a miraculous 100% cure rate. Company Presentation; 9/12/22; Slide 30 Any seasoned biotech investor knows that the number of companies that have shown very promising results in animal models that did not translate into the same results in humans are too numerous to count. Thus, these incredible results should be taken with a very large grain of salt. But a 100% survival rate and a 100% cure rate in the mouse model is startling, and clearly shows the synergistic potential of Allocetra when combined with another cancer-fighting agent. At a minimum, the mouse model results are certainly deserving of further investigation. On April 29, ENLV filed their 20-F Annual Report, which shows the number of ordinary shares beneficially owned by company insiders (it needs to be emphasized that the number of ordinary shares beneficially owned includes outstanding options and warrants to purchase ordinary shares). As of March 31, 2022, company insiders owned approximately 12% of the outstanding ordinary shares (see pg. 82), with Executive Chairman Shai Novak owning almost 7% on his own. 2021 20-F Annual Report Of Mr. Novak’s 1.3M potential shares, about 133K options have an exercise price of $2.69/share, and 174K have an exercise price of $3.66/share, with both exercise prices being below the current share price of about $4.00/share (as of September 29). However, Mr. Novak’s remaining options consist of 145K with an exercise price of $6.22/share, as well as 104K with an exercise price of $12.23/share, with both of these exercise prices being well above the current price. It would have been preferable if the exercise prices of all options would have been significantly higher than the current share price, as a low exercise price does not create a very high hurdle for management to reach in order to cash out. But for new shareholders at least, this level of potential insider ownership can be seen as a positive. One thing that investors should certainly like is the offering price of last year’s capital raise. The $10M offering announced on February 9, 2021 after-hours was for 500K shares at a price of $20.00/share. This came at a 17% discount to the previous day’s close of $24.00/share. However, the stock had closed at $13.05/share on February 2, and after positive COVID data was announced on February 3, proceeded to climb up to $24.00/share over the next few days. Viewed in this light, the offering price of $20.00/share and the 17% discount do not seem so unfair to existing shareholders. Furthermore, an expanded offering was announced later that same evening on February 9, 2021. The offering was expanded due to overwhelming demand, was also done at $20.00/share, and raised an additional $46M. They announced second quarter results on August 22, and as of June 30, had cash and cash equivalents of $63M, which management expects to last through 3Q2024. This works out to a quarterly cash burn of about $7M. With Allocetra development still being at such an early stage, it’s very unlikely that they will finance future clinical expenses via debt offerings.

Zinsdeckungsgrad	n/a
Bargeld	US$5.76m
Eigenkapital	US$1.93b
Gesamtverbindlichkeiten	US$392.05m
Gesamtvermögen	US$2.33b

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/07/24 14:03
Aktienkurs zum Tagesende	2026/07/24 00:00
Gewinne	2025/12/31
Jährliche Einnahmen	2025/12/31

Paket	Daten	Zeitrahmen	Beispiel US-Quelle ^*
Finanzdaten des Unternehmens	10 Jahre	Gewinn- und Verlustrechnung Kapitalflussrechnung Bilanz	SEC-Formular 10-K SEC-Formular 10-Q
Konsensschätzungen der Analysten	+3 Jahre	Finanzielle Vorausschau Kursziele der Analysten	Analysten Research Berichte Blue Matrix
Marktpreise	30 Jahre	Aktienkurse Dividenden, Splits und Aktionen	ICE-Marktdaten SEC-Formular S-1
Eigentümerschaft	10 Jahre	Top-Aktionäre Insiderhandel	SEC-Formular 4 SEC-Formular 13D
Verwaltung	10 Jahre	Das Führungsteam Direktorium	SEC-Formular 10-K SEC-Formular DEF 14A
Wichtige Entwicklungen	10 Jahre	Ankündigungen des Unternehmens	SEC-Formular 8-K

Enlivex Balance Sheet Health

Finanzielle Gesundheit Kriterienprüfungen 6/6

Wichtige Informationen

Jüngste Berichte zur Finanzlage

Here's Why We're Watching Enlivex Therapeutics' (NASDAQ:ENLV) Cash Burn Situation

Is Enlivex Therapeutics (NASDAQ:ENLV) In A Good Position To Deliver On Growth Plans?

We're Keeping An Eye On Enlivex Therapeutics' (NASDAQ:ENLV) Cash Burn Rate

Here's Why We're Watching Enlivex Therapeutics' (NASDAQ:ENLV) Cash Burn Situation

We Think Enlivex Therapeutics (NASDAQ:ENLV) Needs To Drive Business Growth Carefully

Is Enlivex Therapeutics (NASDAQ:ENLV) In A Good Position To Deliver On Growth Plans?

Recent updates

New minor risk - Market cap size

Enlivex Receives FDA Regenerative Medicine Advanced Therapy Designation for Allocetra in Age-Related Knee Osteoarthritis

Enlivex Ltd Announces Dosing of First Patient in the United States as Part of Phase 2B Trial of Allocetra in Age-Related Primary Moderate-To-Severe Knee Osteoarthritis

Enlivex Ltd Announces Regulatory Approval for Phase 2B Trial of Allocetra in Age-Related Primary Moderate-To-Severe Knee Osteoarthritis

New major risk - Revenue and earnings growth

Enlivex Ltd. announced that it has received $19 million in funding from The Lind Partners, LLC

Enlivex Ltd Receives Ind Clearance for Phase 2B Trial of Allocetra in Age-Related Primary Moderate-To-Severe Knee Osteoarthritis

New minor risk - Share price stability

New major risk - Shareholder dilution

Enlivex Therapeutics Ltd. announced that it has received $9.5 million in funding

Enlivex Therapeutics Ltd. Announces Positive 6-Month Topline Data from the Phase I/Ii Allocetra™? Trial

Price target decreased by 26% to US$7.00

Enlivex Therapeutics Ltd. Announces the Appointment of Matteo Renzi to the Board of Directors, Effective November 24, 2025

Here's Why We're Watching Enlivex Therapeutics' (NASDAQ:ENLV) Cash Burn Situation

Enlivex Therapeutics Ltd., Annual General Meeting, Nov 10, 2025

Enlivex Therapeutics Ltd. Announces Strategic Roadmap Following Positive Phase IIa Allocetra Results

Enlivex Therapeutics Ltd. Announces Positive Topline Data from Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients with Moderate-To-Severe Knee Osteoarthritis

New minor risk - Share price stability

Enlivex Therapeutics Ltd. Reaffirms August 18, 2025 as Target Date for Announcement of Phase II Topline Data

New major risk - Financial position

Is Enlivex Therapeutics (NASDAQ:ENLV) In A Good Position To Deliver On Growth Plans?

Enlivex Therapeutics Ltd. to Present Clinical Data of Allocetra in Osteoarthritis At Eular 25 European Congress of Rheumatology

Enlivex Announces Completion of Enrollment in the Phase I/II Trial Evaluating Allocetra in Patients with Moderate to Severe Knee Osteoarthritis

Enlivex Therapeutics Ltd. Announces the Dosing of the First Patient in a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis

Enlivex Therapeutics Ltd. to Provide Additional Intellectual Property Protection in China Through At Least 2040

Enlivex Therapeutics Ltd. Announces Positive Interim Data from the Phase I/II Allocetra Trial in Patients with Moderate to Severe Knee Osteoarthritis

We're Keeping An Eye On Enlivex Therapeutics' (NASDAQ:ENLV) Cash Burn Rate

Enlivex Receives Regulatory Authorization for the Initiation of A Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis

Enlivex Therapeutics Ltd. Announces Positive Interim Efficacy Data from Allocetra Trial in Patients with Moderate to Severe Knee Osteoarthritis

Enlivex Therapeutics Ltd. Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis

Enlivex Therapeutics Ltd. Announces the Enrollment and Dosing of the First 10 Patient in the Randomized Phase II Stage of its Allocetra Trial in Patients with Moderate to Severe Knee Osteoarthritis

Enlivex Therapeutics Ltd. Receives Authorization from the Danish Medicines Agency to Initiate the Phase Ii Stage of Its Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis

Enlivex Therapeutics Ltd. Announces Positive DSMB Recommendation to Initiate the Phase I/II Trial of Allocetra in Patients with Moderate to Severe Knee Osteoarthritis

Here's Why We're Watching Enlivex Therapeutics' (NASDAQ:ENLV) Cash Burn Situation

Enlivex Therapeutics Ltd., Annual General Meeting, Oct 31, 2024

New major risk - Revenue and earnings growth

Enlivex Therapeutics Ltd. Receives Regulatory Authorization for the Initiation of A Phase I Clinical Trial to Evaluate Allocetra in Patients with Psoriatic Arthritis

Enlivex Therapeutics Ltd. Announces the Dosing of the First Patient in a Randomized, Placebo-Controlled Phase I/II Trial Evaluating AllocetraTM in up to 46 Patients with Thumb Osteoarthritis

High number of new and inexperienced directors

Enlivex Receives Regulatory Authorization for the Initiation of a Placebo-Controlled Phase I/II Trial Evaluating Allocetra in Up To 46 Patients with Thumb Osteoarthritis

New minor risk - Shareholder dilution

Enlivex Therapeutics Ltd Announces Authorization from the Danish Regulatory Agency for the Company's Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Patients with Knee Osteoarthritis

Enlivex Announces Topline Results of Its Phase II Trial Evaluating Allocetra™ in Patients with Sepsis

We Think Enlivex Therapeutics (NASDAQ:ENLV) Needs To Drive Business Growth Carefully

Enlivex Receives IMOH Regulatory Authorization for the Initiation of a Multi-Country, Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Up To 160 Patients with Moderate to Severe Knee Osteoarthritis

Enlivex Therapeutics Ltd. Announces Completion of Enrollment of its Phase II Trial Evaluating Allocetra in Patients with Sepsis

Is Enlivex Therapeutics (NASDAQ:ENLV) In A Good Position To Deliver On Growth Plans?

Price target decreased by 20% to US$12.00

Enlivex Therapeutics Ltd., Annual General Meeting, Nov 02, 2023

Enlivex Therapeutics Ltd. (NasdaqCM:ENLV) announces an Equity Buyback for $1.5 million worth of its shares.

Enlivex Therapeutics Ltd., Annual General Meeting, Oct 26, 2023

Enlivex Therapeutics Ltd. Announces Addition to the Ongoing Phase II Trial of Allocetra in Patients with Sepsis, Initiates Clinical Program in Osteoarthritis

Enlivex Therapeutics Ltd. Announces Publication of Clinical and Exploratory Data from A Phase I/II Trials Evaluating Allocetra in Patients with COVID-19 United States

Enlivex Therapeutics Ltd Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra™ In Patients With Sepsis

Here's Why We're A Bit Worried About Enlivex Therapeutics' (NASDAQ:ENLV) Cash Burn Situation

New major risk - Financial position

Will Enlivex Therapeutics (NASDAQ:ENLV) Spend Its Cash Wisely?

Enlivex Announces Issuance of Israeli Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (Crs) Resulting from Car T-Cell Therapy, Infectious Diseases or Any Non-Infectious Source of CRS

Enlivex Therapeutics Ltd. Announces Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra in Patients with Advanced Solid Tumors

Enlivex Therapeutics Ltd. Receives Authorizations from French and Belgian Regulatory Agencies to Expand Its Phase II Sepsis Clinical Trial into France and Belgium

Is Enlivex Therapeutics (NASDAQ:ENLV) In A Good Position To Deliver On Growth Plans?

Price target decreased to US$15.00

Enlivex Therapeutics: A Very Enticing Early-Stage Biotech

Enlivex to gets US patent covering use of cell therapy Allocetra

Enlivex receives notice of allowance ffrom Japan for Allocetra derived from pooled donor cells

Envilex Therapeutics reports Q2 results

We Think Enlivex Therapeutics (NASDAQ:ENLV) Can Afford To Drive Business Growth

Enlivex doses first patient in its phase 1/2 trial of peritoneal cancer combo treatment

Price target increased to US$33.00