Enlivex Therapeutics News
135 articles
growth-positive
Enlivex Therapeutics to Present Phase IIa 3-month Data of Allocetra in Patients with Moderate-to-Severe Knee Osteoarthritis at the ACR Convergence 2025
Enlivex Therapeutics Ltd, a clinical-stage company specializing in macrophage reprogramming immunotherapy, announced the presentation of positive Phase IIa clinical trial results for their product Allocetra™ at the American College of Rheumatology Convergence 2025. The trial showed significant improvements in pain reduction and function in patients with moderate-to-severe knee osteoarthritis. The data, presented by Prof. Philip Conaghan, highlights the potential of Allocetra™ as a treatment for osteoarthritis, a condition affecting a large portion of the population. The presentation is expected to enhance Enlivexs visibility and support its ongoing clinical development efforts.
Product StageFDA approved/pending approval
growth-positive
Enlivex Therapeutics and Lantern Pharma Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV
Enlivex Therapeutics Ltd. and Lantern Pharma, Inc. are featured on the RedChip Small Stocks, Big Money™ show on Bloomberg TV. Enlivexs CEO, Dr. Oren Hershkovitz, discusses positive Phase IIa results for Allocetra™ in knee osteoarthritis, highlighting its potential as a transformative therapy. The company plans further trials to validate its efficacy. Lantern Pharmas CEO, Panna Sharma, showcases their AI-driven platform, RADR®, which accelerates cancer drug discovery. Lanterns clinical-stage programs target high-need cancer indications, leveraging AI to reduce costs and timelines. Both companies are positioned as innovators in their respective fields, with Enlivex focusing on osteoarthritis and Lantern on precision oncology.
Product StagePublic Trading
growth-positive
D. Boral Capital to Host KOL Webinar With World Leading Experts Featuring Insights & Breakthroughs from Enlivex's Knee Osteoarthritis Program
Enlivex Therapeutics Ltd, a clinical-stage company specializing in macrophage reprogramming immunotherapy, is set to participate in a live investor webinar hosted by D. Boral Capital on September 30, 2025. The webinar will focus on the companys recent advancements in treating knee osteoarthritis through its Allocetra™ program. The programs Phase IIa data showed significant pain reduction and functional improvements in patients, highlighting its potential to address a large, underserved population. The event will feature key opinion leaders in musculoskeletal disease and Enlivexs Vice Chairman, discussing the promising results and future clinical development plans.
Product Stage
growth-positive
Enlivex Therapeutics and 60 Degrees Pharmaceuticals Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV
Enlivex Therapeutics Ltd. is highlighted in a press release for its positive Phase IIa topline results for Allocetra™ in treating knee osteoarthritis. The therapy showed significant improvements in pain reduction and function among patients, addressing a major unmet medical need. The company plans to release six-month data in November 2025 and initiate a Phase IIb trial in 2026. This development positions Allocetra™ as a potential transformative therapy for millions of patients. Additionally, 60 Degrees Pharmaceuticals discusses its FDA-approved antimalarial, ARAKODA®, and its strategy to repurpose it for other infectious diseases. Both companies are featured on the RedChip Small Stocks, Big Money™ show on Bloomberg TV.
Product Stage
growth-negative
Will Enlivex Therapeutics (NASDAQ:ENLV) Spend Its Cash Wisely?
Enlivex Therapeutics, a company listed on NASDAQ under the ticker ENLV, is currently facing challenges related to its cash burn. As of June 2025, the company had $20 million in cash and no debt, with an annual cash burn of $13 million, giving it a cash runway of approximately 19 months. Analysts predict that the company will reach cashflow breakeven in four years. Despite reducing its cash burn by 26% over the past year, Enlivex Therapeutics remains an early-stage business without revenue generation. The company may need to raise additional funds through issuing shares or taking on debt to sustain its operations and drive future growth.
growth-positive
Enlivex CEO Issues Letter to Shareholders Outlining Strategic Roadmap Following Positive Phase IIa Allocetra™ Results
Enlivex Therapeutics Ltd, a clinical-stage immunotherapy company, announced positive Phase IIa trial results for its product Allocetra™ in treating knee osteoarthritis (KOA). The trial demonstrated significant improvements in pain and function for patients, marking a key milestone for the company. The positive data has been well-received by industry analysts and key opinion leaders, reinforcing confidence in Allocetra™ as a potential leading therapy for KOA. The company plans to initiate a Phase IIb trial in Q2 2026, with six-month data expected in November 2025. This development is seen as a significant step forward in addressing the unmet needs of KOA patients.
Product Stage
growth-positive
Enlivex Announces Issuance of New Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis
Enlivex Therapeutics Ltd, a clinical-stage company, announced the issuance of an Israeli patent for its Allocetra™ treatment for osteoarthritis, providing intellectual property protection until at least 2040. The company reported positive results from a Phase IIa clinical trial, showing significant improvements in knee pain and function in patients treated with Allocetra™. This patent strengthens Enlivexs IP portfolio and enhances its potential to secure similar patents globally. Osteoarthritis affects millions worldwide, and there is a critical need for effective treatments. Currently, no FDA or EMA-approved medications can arrest or reverse joint damage progression.
Product StageFDA approved/pending approval
growth-positive
Enlivex advances lead cell therapy to Phase IIb in osteoarthritis
Enlivex Therapeutics is advancing its lead cell therapy asset, Allocetra, to Phase IIb trials following positive results from its Phase I/IIa study in knee osteoarthritis (KOA). The therapy showed significant improvements in knee pain, function, and stiffness in a primary osteoarthritis population. Despite not achieving statistical significance across the entire study population, the results are promising for the targeted group. Enlivex plans to seek FDA approval for the Phase IIb trial by Q2 2026, with the first patient dosing expected by Q3 2026. The osteoarthritis market, valued at $2.5 billion in 2021, presents a strong unmet need, though Allocetra will face competition from other biologic drugs in development.
Product Stage
growth-positive
Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis
Enlivex Therapeutics Ltd announced positive three-month topline data from the Phase IIa stage of their ENX-CL-05-001 clinical trial, evaluating Allocetra™ for moderate-to-severe knee osteoarthritis. The trial demonstrated significant improvements in knee pain and function, with a 72% reduction in knee pain and a 95% improvement in knee function for age-related primary osteoarthritis patients compared to placebo. The treatment showed a favorable safety profile with no severe adverse events. These results suggest Allocetra™ could become a novel, safe, and effective treatment for knee osteoarthritis, addressing a significant unmet medical need. The company hosted a webinar to discuss these findings in detail.
Product StageFDA approved/pending approval
growth-positive
Enlivex to Present 3-Month Topline Data from Phase IIa Moderate/Severe Knee Osteoarthritis Trial on August 18 Webinar
Enlivex Therapeutics Ltd, a clinical-stage immunotherapy company, is set to host a webinar on August 18, 2025, to discuss the 3-month topline results from the Phase IIa stage of its ENX-CL-05-001 trial. This trial is a double-blind, randomized, placebo-controlled study evaluating Allocetra™ in patients with moderate-to-severe knee osteoarthritis. The ongoing Phase IIa stage assesses both safety and efficacy, with endpoints measuring joint pain and function versus placebo at 3, 6, and 12 months post-injection. The trials primary timepoint for measuring key endpoints has seen 134 patients complete the 3-month follow-up period. Enlivex aims to reprogram macrophages into their homeostatic state to address life-threatening conditions.
Product Stage
growth-positive
Enlivex Reaffirms August 18, 2025 As Target Date For Announcement of Phase II Topline Data
Enlivex Therapeutics Ltd, a clinical-stage company, announced the completion of the follow-up period for all 134 patients in its Phase II trial of Allocetra™ for knee osteoarthritis. The trial aims to evaluate the safety and efficacy of Allocetra™ injections. The data is currently being analyzed, with results expected by August 18, 2025. The trial includes a Phase I safety run-in and a Phase II double-blind, placebo-controlled stage. The study focuses on joint-pain and function improvements compared to placebo. Osteoarthritis is a significant health burden, with no current FDA or EMA-approved treatments to halt its progression.
Product Stage
growth-positive
Enlivex Therapeutics and Foremost Clean Energy Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV
Enlivex Therapeutics is advancing its Allocetra™ platform, a macrophage reprogramming immunotherapy, through a Phase I/II trial for knee osteoarthritis. The company has completed enrollment for the Phase 2 stage and anticipates key data by August 2025. Foremost Clean Energy is focusing on uranium exploration in the Athabasca Basin, supported by a strategic partnership with Denison Mines, which holds a 19.13% equity stake. Foremosts exploration program is fully funded for 2025, with a focus on uranium and lithium, aligning with global clean energy trends.
Product StagePartners
growth-positive
Enlivex Therapeutics to Present Clinical Data of Allocetra in Osteoarthritis at EULAR 25 European Congress of Rheumatology
Enlivex Therapeutics Ltd, a clinical-stage company specializing in macrophage reprogramming immunotherapy, announced its participation in the European Congress of Rheumatology to present data on Allocetra™, its cell therapy for knee osteoarthritis. The therapy aims to reprogram macrophages to restore immune balance and reduce inflammation. The company has completed patient enrollment for its Phase II trial and anticipates a topline data readout by August 2025. Allocetra™ has shown promising results in Phase I/II studies, including pain reduction and improved joint function. The announcement is growth-positive, highlighting progress in clinical trials and potential market opportunities.
Product Stage
growth-positive
Enlivex Selected to Present at Israeli BioMed 2025 Conference
Enlivex Therapeutics Ltd, a clinical-stage immunotherapy company, is set to present at the Israeli BioMed 2025 Conference. The company focuses on macrophage reprogramming to treat inflammatory diseases using its Allocetra™ therapy. Allocetra™ aims to reset macrophages to a balanced state, potentially offering a novel approach to immune system rebalancing. Enlivex is advancing clinical trials for Allocetra™ in osteoarthritis and psoriatic arthritis, with promising interim results showing significant reductions in pain and improvements in joint function. The company is poised for growth as it continues to develop its clinical pipeline and explore market opportunities for its innovative therapies.
Product Stage
growth-positive
Enlivex Therapeutics to Showcase Allocetra’s Potential in Osteoarthritis at OARSI 2025 World Congress
Enlivex Therapeutics Ltd, a clinical-stage company specializing in macrophage reprogramming immunotherapy, announced its participation in the Osteoarthritis Research Society International (OARSI) 2025 World Congress. The company will present data on Allocetra™, its proprietary cell therapy designed to reprogram macrophages to restore immune balance and reduce inflammation in osteoarthritis patients. The presentations will include findings from both preclinical and clinical studies, showcasing Allocetras safety and efficacy in reducing pain and improving joint function. The event highlights the potential of Allocetra™ as a novel therapeutic approach for osteoarthritis, offering a promising treatment pathway for millions of patients worldwide.
Product Stage
growth-positive
Enlivex enrols all patients in Phase II stage of knee osteoarthritis trial
Enlivex Therapeutics, an Israel-based company, has completed the enrollment of subjects for the Phase II stage of its Phase I/II trial of Allocetra, a cell therapy targeting moderate to severe knee osteoarthritis. The trial is structured in two stages, with the initial Phase I focusing on safety and tolerability. Positive interim efficacy data from Phase I has been reported. The Phase II stage is placebo-controlled and double-blind, assessing safety and efficacy, with an independent data safety and monitoring board in place. Enlivex anticipates releasing topline data by August 2025. The company aims to transform osteoarthritis treatment with Allocetra.
Product Stage
growth-positive
Enlivex Announces Completion of Enrollment In The Phase II stage Of Its Phase I/II Trial Evaluating Allocetra In Patients With Moderate To Severe Knee Osteoarthritis
Enlivex Therapeutics Ltd, a clinical-stage company, announced the completion of patient enrollment for the Phase II stage of its Phase I/II trial of Allocetra™ for moderate to severe knee osteoarthritis. The trial aims to assess the safety and efficacy of Allocetra™, with promising initial efficacy data from Phase I. The Phase II stage is a double-blind, randomized, placebo-controlled trial involving 133 patients. The company anticipates topline data by August 2025, which could potentially transform osteoarthritis treatment. The trial includes interim statistical evaluations and safety monitoring by an independent board.
Product Stage
growth-negative
Is Enlivex Therapeutics (NASDAQ:ENLV) In A Good Position To Invest In Growth?
The article discusses the financial situation of Enlivex Therapeutics, highlighting its cash burn and cash runway. As of December 2024, the company had $23 million in cash and a cash burn rate of $13 million over the past twelve months, giving it a cash runway of approximately 22 months. Analysts predict the company will break even in about five years, suggesting the need for additional funding unless cash burn is reduced. Despite a 45% reduction in cash burn year-on-year, the company remains in an early-stage phase with no current revenue generation. The article emphasizes the potential need for Enlivex to raise more cash to sustain or accelerate growth.
growth-positive
Enlivex Announces the Dosing of the First Patient in a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis
Enlivex Therapeutics Ltd, a clinical-stage company, has initiated a Phase I trial to evaluate the safety and efficacy of Allocetra™ for treating temporomandibular joint (TMJ) osteoarthritis. This trial, conducted at Sheba Medical Center, involves dosing the first patient with Allocetra™, a macrophage reprogramming therapy. The trial aims to recruit six patients who have not responded to conventional therapies. The primary endpoint is to assess safety, while efficacy will be evaluated based on changes in TMJ pain and functionality over 12 months. Allocetra™ is designed to restore macrophage homeostasis, potentially offering a novel treatment for diseases with unmet medical needs.
Product Stage
growth-positive
Enlivex Receives Notice of Allowance for Chinese Patent Application Covering the Use of Allocetra in Patients with Osteoarthritis
Enlivex Therapeutics Ltd, a clinical-stage company, announced that the China National Intellectual Property Administration has issued a notice of allowance for a patent application related to its Allocetra™ treatment for osteoarthritis. This patent will provide intellectual property protection in China until at least 2040. The company recently reported positive interim results from its Phase I/II trial of Allocetra™ in patients with knee osteoarthritis, showing significant reductions in pain and improvements in joint function and stiffness. The patent allowance is expected to bolster Enlivexs IP portfolio globally, enhancing its market position in osteoarthritis treatment.
Product Stage
growth-positive
Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra™ Trial in Knee Osteoarthritis
Enlivex Therapeutics Ltd, a clinical-stage immunotherapy company, announced positive interim results from its Phase I/II Allocetra™ trial for treating moderate to severe knee osteoarthritis. The trial demonstrated a 47% reduction in pain and a 46% improvement in joint function six months post-treatment, with 83% of patients responding positively. No serious adverse events were reported, highlighting Allocetra™s safety and efficacy. The company is hosting a webinar on March 5, 2025, to discuss these findings further. Enlivex is committed to advancing Allocetra™ as a novel treatment for osteoarthritis, addressing unmet medical needs.
Product Stage
growth-positive
Enlivex Announces Positive Interim Data – Statistically Significant 47.0% Durable and Persistent Pain Reduction At Six Months, in Patients with Moderate to Severe Knee Osteoarthritis
Enlivex Therapeutics Ltd, a clinical-stage company, announced positive interim results from its Phase I/II Allocetra™ trial for treating moderate to severe knee osteoarthritis. The trial showed a 47% reduction in pain and significant improvements in joint function and stiffness, with 83% of patients responding positively after six months. No serious adverse events were reported, indicating a strong safety profile. The company is progressing with the Phase II stage and expects topline data by Q3 2025. These results highlight Allocetras potential as a treatment alternative, offering durable improvements in pain and function.
Product Stage
growth-negative
Enlivex Issues Urgent Statement on Fraudulent News Dissemination
Enlivex Therapeutics Ltd, a clinical-stage immunotherapy company, has refuted claims made by Tipranks.com that it suspended stock trading due to an internal investigation. The company asserts that these reports are false and misleading, emphasizing that its shares continue to trade normally on both the Tel Aviv Stock Exchange and NASDAQ. Enlivex plans to take legal action against those responsible for the misinformation. The company remains focused on its Allocetra™ program, aimed at treating osteoarthritis and other conditions by reprogramming macrophages. Enlivex encourages stakeholders to rely on official communications for accurate information.
Product Stage
growth-positive
RedChip Announces Webinar to Teach Investors How to Use RedChat, a Revolutionary AI Chatbot for Small-Cap Stock Analysis
RedChip Companies has announced a live webinar to showcase RedChat, an AI-powered stock research assistant designed for small-cap and microcap stocks. The webinar, scheduled for February 13, aims to demonstrate how RedChat can provide real-time, AI-driven insights, helping investors make informed decisions quickly. RedChat covers over 2,000 U.S.-listed small-cap and microcap stocks, including companies like ASP Isotopes and Enlivex Therapeutics. The tool is available for free and aims to revolutionize the way investors conduct stock research by offering tailored responses to specific queries, saving time and effort. The initiative is seen as a significant step in transforming small-cap stock research.
growth-positive
Enlivex Therapeutics and bioAffinity Technologies Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV
Enlivex Therapeutics and bioAffinity Technologies were featured on the RedChip Small Stocks, Big Money™ show on Bloomberg TV. Enlivex is advancing its Allocetra™ platform, a macrophage reprogramming immunotherapy, with promising Phase I/II clinical trial results for conditions like knee osteoarthritis and psoriatic arthritis. A significant milestone was achieved in 2024 with a multi-country trial for knee osteoarthritis. bioAffinitys CyPath® Lung, a noninvasive early-stage cancer diagnostic tool, secured a U.S. Federal Supply Schedule contract in October 2024, making it available to U.S. veterans and federal health service patients, which is expected to boost sales. Both companies are clients of RedChip Companies.
Product StageCustomers
growth-positive
Enlivex gains Israeli regulatory approval to commence TMJ osteoarthritis trial
Enlivex Therapeutics has received approval from the Israeli Ministry of Health to begin a Phase I trial of Allocetra for treating temporomandibular joint (TMJ) osteoarthritis. The trial will be conducted by Sheba Medical Center’s Rheumatology Unit in partnership with the Department of Oral and Maxillofacial Surgery. It aims to recruit six subjects who have not responded to existing treatments. The study will evaluate the safety, tolerability, and preliminary efficacy of Allocetra, focusing on changes in TMJ pain and joint function. Allocetra is a cell therapy designed to reset macrophages to their homeostatic state, potentially offering a new therapeutic option for osteoarthritis and other critical illnesses. The trial represents a positive development for Enlivex Therapeutics as it explores new applications for its therapy.
Partners
growth-positive
Enlivex Receives Regulatory Authorization for the Initiation of a Phase I Trial Evaluating Allocetra in Patients with TMJ Osteoarthritis
Enlivex Therapeutics Ltd, a clinical-stage immunotherapy company, announced the initiation of a Phase I trial for Allocetra™, targeting TMJ osteoarthritis. The trial, authorized by the Israeli Ministry of Health, will be conducted at Sheba Medical Center, a top-ranked global hospital. Allocetra™ aims to reprogram macrophages to their homeostatic state, potentially offering a novel treatment for TMJ osteoarthritis, a condition with limited long-term treatment options. The trial will recruit six patients who have not responded to conventional treatments, assessing safety and efficacy over 12 months. This development represents a positive step for Enlivex, as it explores new therapeutic avenues for unmet medical needs.
growth-positive
Enlivex Announces Positive Interim Efficacy Data from Allocetra Trial in Patients with Moderate to Severe Knee Osteoarthritis
Enlivex Therapeutics Ltd, a clinical-stage company based in Nes-Ziona, Israel, announced positive interim efficacy data from its Phase I/II Allocetra™ trial for treating moderate to severe knee osteoarthritis. The Phase I stage, which focused on safety and dose escalation, showed no serious adverse reactions. Interim results from the trial demonstrated significant improvements in pain reduction and functionality, with a 50% reduction in knee joint pain and a 42% improvement in knee joint function. These findings suggest Allocetra™ could offer a new treatment alternative for osteoarthritis patients. The trial is now enrolling patients for the Phase II stage, which will further evaluate the efficacy of Allocetra™ injections in a double-blind, placebo-controlled setting.
growth-positive
Join Enlivex Therapeutics' Exclusive Live Investor Webinar and Q&A Session on December 3
Enlivex Therapeutics Ltd., a clinical-stage company specializing in macrophage reprogramming immunotherapy, announced an upcoming investor webinar on December 3, 2024. The event, hosted by RedChip Companies, will feature insights from CEO Oren Hershkovitz on the companys lead product, Allocetra™, and its clinical progress. Allocetra™ is a cell therapy technology aimed at reprogramming macrophages to address conditions like osteoarthritis and sepsis. With promising Phase I/II trial results, the product targets multi-billion-dollar markets, potentially redefining treatment paradigms for inflammatory and autoimmune diseases. The webinar will include a live Q&A session, allowing participants to engage directly with the companys leadership.
growth-positive
MicroStrategy Copycats Are Buying Bitcoin as Price Nears $100,000
The article discusses how a group of small biotech companies are planning to invest up to $1 million in Bitcoin, inspired by MicroStrategys strategy. As Bitcoins price approaches $100,000, these firms are looking to capitalize on the potential gains. While these companies are not expected to become the next MicroStrategy, their actions reflect a growing trend among businesses to invest in cryptocurrencies. This move is seen as growth-positive for MicroStrategy, as it validates their investment strategy and could potentially increase the value of their Bitcoin holdings.
Investment
growth-positive
Enlivex Announces the Dosing of the First Patient in a Phase I Clinical Trial Evaluating Allocetra in Patients with Psoriatic Arthritis
Enlivex Therapeutics Ltd, a clinical-stage immunotherapy company, announced the completion of dosing and initial follow-up for the first patient in its Phase I clinical trial of Allocetra™ for psoriatic arthritis. The trial aims to evaluate the safety and therapeutic potential of Allocetra™ in patients who have not responded to conventional therapies. No safety concerns were reported after the initial dosing. The trial plans to recruit six patients, with primary endpoints focusing on safety and secondary endpoints assessing changes in pain and disease activity. The global market for psoriatic arthritis treatments is projected to grow significantly, presenting a substantial market opportunity for Enlivex. The study complements ongoing trials in osteoarthritis, aiming to address the challenges of limited efficacy and high costs in current treatments.
growth-positive
Enlivex 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., a clinical-stage immunotherapy company, announced the enrollment and dosing of the first 10 patients in the Phase II stage of its Allocetra™ trial for knee osteoarthritis. This follows a recommendation from the Data and Safety Monitoring Board and authorization from the Danish Medicines Agency. The trial aims to assess the safety and efficacy of Allocetra™ injections, with key endpoints evaluating joint pain and function. The Phase II stage is a double-blind, randomized, placebo-controlled study. Osteoarthritis is a prevalent condition with no current treatments to arrest its progression, and Enlivex hopes Allocetra™ will offer a novel treatment option.
growth-positive
Enlivex Therapeutics (ENLV) Upgraded to Strong Buy: Here's What You Should Know
Enlivex Therapeutics Ltd. has been upgraded to a Zacks Rank #1 (Strong Buy), indicating a positive outlook for the companys earnings. This upgrade is based on an upward trend in earnings estimates, which is a significant factor influencing stock prices. The Zacks rating system is highly regarded for its ability to predict near-term stock movements by tracking changes in earnings estimates. The upgrade suggests that Enlivex Therapeutics underlying business is improving, which could lead to increased stock prices as institutional investors adjust their valuation models. The Zacks Rank system has a strong track record, with top-ranked stocks historically generating substantial returns.
growth-positive
Enlivex Receives Notice of Allowance for Japanese Patent Application Covering the Use of Allocetra™ in Patients with Osteoarthritis
Enlivex Therapeutics Ltd., a clinical-stage immunotherapy company, announced that the Japanese Patent Office has issued a notice of allowance for their patent application concerning therapeutic apoptotic cells for osteoarthritis treatment. This patent, expected to be formally issued by mid-2025, will provide Enlivex with intellectual property protection in Japan until at least 2040. The patent is part of Enlivexs strategy to secure global IP protection for Allocetra™, their next-generation cell therapy aimed at addressing the unmet medical needs in osteoarthritis treatment. Osteoarthritis is a prevalent condition affecting millions worldwide, with limited treatment options available. Enlivexs CEO, Oren Hershkovitz, emphasized the companys commitment to expanding Allocetras commercial opportunities globally.
growth-positive
Enlivex 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 announced that the Danish Medicines Agency has authorized the initiation of the Phase II stage of their multi-country Phase I/II trial for moderate and severe knee osteoarthritis. This follows a recommendation by the independent Data and Safety Monitoring Board (DSMB) to proceed. The Phase II stage will be a double-blind, randomized, placebo-controlled trial to assess the efficacy of Allocetra™ injections. The trial aims to evaluate joint pain and function over three, six, and twelve months. The approval marks a significant milestone for Enlivex, indicating a positive safety profile for Allocetra™.
Customers
growth-positive
Enlivex Announces Positive DSMB Recommendation 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 announced that the independent Data and Safety Monitoring Board (DSMB) has completed an interim data review of the Phase I safety run-in stage of their ongoing Phase I/II clinical trial of Allocetra™ for treating moderate to severe knee osteoarthritis. No serious adverse reactions were reported, allowing the company to proceed to the Phase II stage. This stage will be a double-blind, randomized evaluation of the safety and efficacy of Allocetra™ compared to a placebo. The trial aims to assess joint pain and function over a period of up to 12 months. The positive safety profile is a significant milestone for Enlivex, indicating potential growth and advancement in their treatment development.
Customers
growth-positive
All You Need to Know About Enlivex Therapeutics (ENLV) Rating Upgrade to Buy
Enlivex Therapeutics Ltd. (ENLV) has been upgraded to a Zacks Rank #2 (Buy), reflecting a positive trend in earnings estimates. This upgrade is based on the Zacks rating system, which tracks EPS estimates from sell-side analysts. The upward revision in earnings estimates suggests an improvement in the companys underlying business, potentially leading to increased stock prices. The Zacks Rank system, which has a strong track record, classifies stocks into five groups based on earnings estimates. Enlivexs placement in the top 20% of Zacks-covered stocks indicates its potential for market-beating returns in the near term.
growth-positive
GreenPower and Enlivex Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV
GreenPower Motor Company Inc. and Enlivex Therapeutics Ltd. will be featured on the RedChip Small Stocks, Big Money™ show on Bloomberg TV on August 31, 2024. GreenPower, a manufacturer of all-electric, zero-emission medium and heavy-duty vehicles, has shown significant sales growth and maintains a substantial order book. Enlivex, a clinical-stage immunotherapy company, is developing Allocetra™, a cell therapy aimed at reprogramming macrophages to treat severe diseases. The show aims to provide corporate updates and highlight the growth potential of both companies.
Customers
growth-positive
Enlivex Receives Regulatory Authorization For The Initiation Of A Phase I Clinical Trial To Evaluate Allocetra In Patients With Psoriatic Arthritis
Enlivex Therapeutics Ltd. has announced that the Israeli Ministry of Health has authorized a Phase I clinical trial to evaluate the safety and tolerability of Allocetra in patients with psoriatic arthritis. The trial plans to recruit six patients who have not responded well to conventional therapies. The primary safety endpoint will measure the frequency and severity of adverse events, and secondary endpoints will include assessments of change from baseline in pain and other parameters of disease activity for up to 12 months following administration of Allocetra. The global market for psoriatic arthritis treatments, valued at approximately $10.8 billion in 2023, is estimated to grow substantially.
InvestmentExpand
growth-positive
Enlivex Therapeutics and Biotricity Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV
RedChip Companies will air interviews with Enlivex Therapeutics Ltd. and Biotricity, Inc. on the RedChip Small Stocks, Big Money™ show on Bloomberg TV. Enlivex Therapeutics is a clinical stage macrophage reprogramming immunotherapy company developing a cell therapy designed to reprogram macrophages into their homeostatic state. Biotricity offers innovative cardiac monitoring solutions, capturing an 8% market share in cardiology across 34 states and 500 centers. The company is on a clear path to profitability and expects to be EBITDA positive before the end of 2024.
CustomersPartners
growth-positive
Enlivex 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
Enlivex Therapeutics Ltd has announced the dosing of the first patient in a Phase I/II trial for Allocetra, a treatment for thumb osteoarthritis. The trial will recruit up to 46 patients and is composed of two stages: a safety run-in, open-label dose escalation phase, and a double-blind, randomized, placebo-controlled stage. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and the efficacy endpoints will include assessments of change from baseline in pain and function for up to 12 months following treatment.
CustomersExpand
growth-positive
Join Enlivex Therapeutics’ Chief Executive Officer for a Live Investor Webinar and Q&A Session on June 25
Enlivex Therapeutics Ltd has invited investors to a webinar on June 25, 2024, to discuss the companys leading product candidate, Allocetra. The companys CEO, Dr. Oren Hershkovitz, will share insights into the product and discuss the positive interim data from a Phase I/II trial in end-stage knee osteoarthritis. The trial showed a significant reduction in pain and a favorable safety profile in patients with severe knee osteoarthritis. The webinar will also cover the companys progress in various clinical programs, expected milestones, and the companys financial status following a recent registered direct offering with a single institutional investor.
Investment
growth-positive
Enlivex Announces Positive Interim Data Readout from a Phase I/II Trial Evaluating Allocetra in End-Stage Knee Osteoarthritis
Enlivex Therapeutics Ltd has reported positive interim data from a Phase I/II clinical trial of Allocetra in patients with end-stage knee osteoarthritis. The trial involved a single injection of Allocetra into the knee as a potential alternative to knee replacement surgery. The three-month data showed a significant reduction in pain and a favorable safety profile, with 89% of patients not proceeding with knee replacement surgery. The trial is ongoing, with the aim to enroll a total of 18 patients.
Customers
growth-positive
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
Enlivex Therapeutics Ltd has announced that the Israeli Ministry of Health has authorized the initiation of a Phase I/II trial to evaluate the efficacy, safety, and tolerability of Allocetra in patients with basal thumb joint osteoarthritis. The trial will be led by Dr. Amir Oron, a senior specialist in Orthopedics and Chief of Hand Surgery and Microsurgery at the Kaplan Medical Center in Rehovot, Israel. The trial will recruit up to 46 patients and is composed of two stages. The first stage is a safety run-in, open-label dose escalation phase, and the second stage is a double-blind, randomized, placebo-controlled stage.
CustomersExpand
growth-positive
Enlivex Therapeutics Closes up to $15 Million Registered Direct Offering
Enlivex Therapeutics Ltd, a clinical-stage macrophage reprogramming immunotherapy company, has announced the closing of a registered direct offering to a single healthcare-focused institutional investor. The offering includes 3,571,429 ordinary shares and clinical milestone-linked warrants, for aggregate gross proceeds of approximately $5.0 million. The potential gross proceeds from the warrants, if fully exercised on a cash basis, will be approximately $10.0 million. The company intends to use the net proceeds from the offering for working capital and general corporate purposes.
Investment
growth-positive
Enlivex secures $5 million in direct offering, eyes more funds By Investing.com
Enlivex Therapeutics Ltd. has announced a definitive agreement with an institutional investor for a registered direct offering. The deal includes the sale of over 3.5 million ordinary shares and warrants, potentially bringing in a total of $15 million. The transaction is expected to close around Wednesday, May 29, 2024, with an initial $5 million in gross proceeds. The company also issued two series of warrants, which if exercised, could yield an additional $10 million. The funds are earmarked for working capital and general corporate purposes.
Investment
growth-positive
Enlivex Therapeutics Announces up to $15 Million Registered Direct Offering
Enlivex Therapeutics Ltd has announced a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of 3,571,429 ordinary shares and clinical milestone-linked warrants. The gross proceeds from the offering are expected to be approximately $5.0 million, with potential gross proceeds from the warrants, if fully exercised, of approximately $10.0 million. The funds will be used for working capital and general corporate purposes. The offering is expected to close on May 29, 2024.
Investment
Growth-Negative
We're Keeping An Eye On Enlivex Therapeutics' (NASDAQ:ENLV) Cash Burn Rate
Enlivex Therapeutics, a company that is not currently generating revenue, is burning through its cash reserves at a concerning rate. The company had a cash runway of approximately 14 months from December 2023, meaning it could run out of cash unless it drastically reduces its cash burn. Although the company has reduced its cash burn by 26% year on year, its cash burn relative to its market cap is concerning, suggesting the company may have funding difficulties. The company may need to issue new shares or take on debt to raise more cash.
Investment
growth-positive
Enlivex CEO Issues Letter to Shareholders – Perspectives on Recent Events
Enlivex Therapeutics Ltd, a clinical-stage macrophage reprogramming immunotherapy company, has been developing its drug product candidate, Allocetra, as a modulator of a spectrum of negative immune reactions. The company has completed numerous pre-clinical studies and infused Allocetra in over 100 patients. The drug has shown potential in treating conditions like COVID-19 and vanishing bone disease. The company recently released top-line data from a Phase II trial, which evaluated Allocetra in patients with sepsis associated with various infections. The company also announced that the first two patients had been dosed in a Phase I/II trial evaluating Allocetra in patients with moderate to severe knee osteoarthritis.
InvestmentManagement Changes
growth-positive
Enlivex Announces Dosing of First Two Patients in its Randomized, Controlled Phase I/II Trial Evaluating Allocetra™ in Patients with Knee Osteoarthritis
Enlivex Therapeutics Ltd announced that the first two patients have been dosed in the companys Phase I/II trial evaluating Allocetra in up to 160 patients with moderate to severe knee osteoarthritis. The trial is composed of two stages, a safety run-in stage and a double-blind, randomized, placebo-controlled stage. The company expects to initiate the second stage following the completion of the safety run-in stage. The primary measurements will evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.
Customers
growth-positive
Enlivex 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 Therapeutics, a clinical-stage macrophage reprogramming immunotherapy company, announced that the Danish Medicines Agency authorized the expansion into Denmark of the Company’s multi-country, randomized, controlled Phase I/II trial evaluating Allocetra in up to 160 patients with moderate to severe knee osteoarthritis. The trial was previously approved by the Israeli Ministry of Health. The trial will be composed of two stages, a safety run-in and a double-blind, randomized, placebo-controlled stage. The company expects to evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months after treatment.
Expand
growth-negative
Enlivex (ENLV) Stock Plummets 51% in a Week: Here's Why
Enlivex Therapeutics, a clinical-stage pharmaceutical company, has seen a 51.2% drop in its stock after mixed results from the phase II study of its lead pipeline candidate, Allocetra. The therapy, designed to treat organ failure associated with sepsis, showed substantial reductions in sequential organ failure assessment (SOFA) scores and a reduction in overall mortality rate by 65% in patients treated with Allocetra. However, due to imbalances between the Allocetra and placebo groups, it was challenging to deduce the relative effect of Allocetra in other patient subgroups. The company is now considering a potential follow-on study focused only on high-risk UTI patients.
Management Changes
Growth-Positive
Enlivex to Host Webcast on April 12, 2024 at 8:30 a.m. Eastern Time to Discuss Topline Results from Its Phase II Trial Evaluating Allocetra™ In Patients with Sepsis
Enlivex Therapeutics Ltd, a clinical-stage macrophage reprogramming immunotherapy company, announced a conference call and webcast on April 12, 2024, to discuss the topline results from its Phase II trial of Allocetra in patients with sepsis. The trial enrolled 120 patients. The companys leadership team will discuss the results during the call, followed by a live Q&A session. Enlivex is developing Allocetra, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state.
Customers
growth-positive
Enlivex Announces Topline Results of Its Phase II Trial Evaluating Allocetra™ In Patients With Sepsis
Enlivex Therapeutics Ltd announced positive results from its Phase II study of Allocetra in patients with sepsis. The study demonstrated substantial reductions in SOFA scores and a 65% reduction in overall mortality rate. The company intends to consider a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population. The study was designed for patients to be randomized with equal degree of SOFA scores across treatment and placebo groups. The results showed a favorable safety profile for Allocetra.
Customers
Growth-Positive
Enlivex Therapeutics and Unusual Machines Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TV
RedChip Companies will air interviews with Enlivex Therapeutics Ltd. and Unusual Machines Inc. on the RedChip Small Stocks, Big Money™ show on Bloomberg TV. Enlivex Therapeutics is a biopharmaceutical company with an innovative approach to treating life-threatening and debilitating conditions through macrophage reprogramming. Its leading product, Allocetra™, is a groundbreaking cell therapy platform designed to reset the bodys immune cells to their optimal functioning state. Unusual Machines is a company focused on the drone industry, growing both organically and through strategic acquisitions. It is investing in the development or acquisition of FPV products and services that serve a broad set of industries including consumer, public safety, and drone delivery.
InvestmentExpand
growth-positive
Enlivex Receives Regulatory Authorization From Israel’s Health Ministry For The Initiation Of Phase 1/2 Trial Evaluating Allocetra In Patients With Knee Osteoarthritis
Enlivex Therapeutics Ltd., a clinical-stage macrophage reprogramming immunotherapy company, has received authorization from the Israeli Ministry of Health to initiate a new trial for Allocetra, a cell therapy for osteoarthritis patients. The phase 1/2 trial will evaluate the efficacy, safety, and tolerability of Allocetra in up to 160 moderately to severely symptomatic osteoarthritis patients. Allocetra is designed to reprogram macrophages into their homeostatic state, potentially providing a novel immunotherapeutic mechanism of action for life-threatening and debilitating clinical indications.
InvestmentExpand
growth-positive
Enlivex Completes Enrollment Of All 120 Patients In Phase 2 Trial Of Allocetra In Patients With Sepsis, Third-Leading Cause Of Mortality In US Hospitals
Enlivex Therapeutics Ltd. has completed enrollment for its phase 2 trial of Allocetra, a therapy for preventing organ failure and mortality in sepsis patients. The trial is a blinded, placebo-controlled, randomized, multi-country, multi-center study evaluating Allocetra in addition to standard of care in patients with moderate to severe sepsis associated with pneumonia, biliary, urinary tract or peritoneal infections. Data from the trial is expected to be released by the end of Q1 2024.
Investment
growth-positive
Enlivex Announces Issuance of New U.S. Patent Covering Allocetra Cells and Their Manufacturing Method
Enlivex Therapeutics Ltd., a clinical-stage macrophage reprogramming immunotherapy company, has announced that the U.S. Patent and Trademark Office has issued a new patent, number US 11,883,429, covering Allocetra, the Company’s immunotherapy product candidate. The new patent is expected to provide added intellectual property protection in the United States for the product’s composition and manufacturing method.
Customers
growth-positive
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 has announced that the Israeli Ministry of Health has authorized the initiation of a Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra in treating moderately to severely symptomatic osteoarthritis patients. The trial will be conducted in multiple countries and will involve up to 160 patients. The trial will be composed of two stages, a safety run-in and a double-blind, randomized, placebo-controlled stage. The company is increasing its focus on inflammatory diseases and specifically pushing forward the osteoarthritis development program.
CustomersExpand
growth-positive
Enlivex Announces Completion of Enrollment of Its Phase II Trial Evaluating Allocetra In Patients With Sepsis
Enlivex Therapeutics Ltd has completed the enrollment of all 120 patients for its Phase II trial of Allocetra in patients with sepsis. The trial is a placebo-controlled, randomized, dose-finding, multi-country, multi-center study, evaluating frozen-formulation Allocetra in addition to standard of care in patients with sepsis associated with various infections. The company expects to report the top-line data readout from the trial by the end of Q1 2024.
Customers
Growth-Negative
Is Enlivex Therapeutics (NASDAQ:ENLV) In A Good Position To Deliver On Growth Plans?
Enlivex Therapeutics, a biotech company, is facing concerns over its rate of cash burn. The company had $30m in cash in September 2023 and burnt through $26m in the last year, leaving it with a cash runway of approximately 14 months. Although the companys cash burn has reduced by 20%, its cash burn relative to its market cap is high, raising concerns about its financial stability. The companys cash burn of $26m is about 84% of its $31m market capitalisation, indicating a high risk of funding distress.
Investment
growth-positive
MediWound Announces Appointment of Shmulik Hess, Ph.D. as Chief Operating Officer and Chief Commercial Officer
MediWound Ltd., a biopharmaceutical company, has announced the appointment of Shmulik Hess, Ph.D. as Chief Operating Officer and Chief Commercial Officer effective from December 1, 2023. Dr. Hess will oversee all operational and commercial activities at MediWound. The company is in a crucial phase of expansion and Dr. Hesss experience in international operations and commercial activities is expected to contribute to the further evolution of MediWound. Prior to joining MediWound, Dr. Hess served as CEO at Tabby Therapeutics, Enlivex Therapeutics, and Valin Technologies.
Management ChangesExpand
Growth-Positive
Enlivex to Present at the H.C. Wainwright 25th Annual Global Investment Conference
Enlivex Therapeutics Ltd, a clinical-stage macrophage reprogramming immunotherapy company, announced that it will present a corporate update at the H.C. Wainwright 25th Annual Global Investment Conference in New York City. The company is developing Allocetra, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. The company believes that by restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications.
Investment
growth-positive
Enlivex Announces Peer-Reviewed Publication in Frontiers in Immunology of Clinical Data Details Resolution of Acute Respiratory Distress Syndrome (ARDS) from two Phase I/II Trials Evaluating Allocetra in Patients with COVID-19
Enlivex Therapeutics Ltd has announced the publication of clinical and exploratory data from a Phase Ib and a Phase IIa clinical trial in Frontiers in Immunology. The study involved 21 severe and critical COVID-19 patients treated with a single dose of Allocetra in addition to standard care. The results showed a robust safety profile, rapid resolution from ARDS, and substantial improvements in mortality. The company believes that Allocetra could potentially become a leading therapy for ARDS patients. Enlivex is currently seeking out-licensing or partnering opportunities to continue the clinical development of Allocetra for ARDS.
InvestmentExpand
Growth-Positive
Enlivex Announces Dosing of First Patient Under The Amended Protocol Of Its Phase II trial Evaluating Allocetra™ In Patients With Sepsis
Enlivex Therapeutics Ltd. has announced the dosing of the first patient under the amended protocol for the companys Phase II trial of Allocetra in patients with sepsis. The amended protocol allows for the recruitment of patients with higher levels of sepsis severity and provides for two cohorts (treatment and placebo) rather than the prior protocols four-cohort structure. The company expects the top-line data readout from the Phase II trial in Q1 2024.
CustomersExpand
growth-positive
Enlivex Announces First Quarter 2023 Financial Results and Provides a Business Update
Enlivex Therapeutics Ltd is proceeding with the enrollment of patients in Phase I/II clinical trials for Allocetra™. They are also integrating tislelizumab into the ongoing clinical trial. The company has obtained clearance from regulatory authorities in Spain and the Netherlands for their clinical trials. Enlivex Therapeutics has filed their financial results for the first quarter of 2023, reporting an increase in research and development expenses but a decrease in net loss. As of March 31, 2023, the company had $43.2 million in cash and cash equivalents. Allocetra™ is being developed as a universal cell therapy for various diseases. Enlivex Therapeutics is a clinical-stage macrophage reprogramming immunotherapy company.
CustomersPartnersInvestmentManagement Changes
growth-positive
Enlivex to Present at the 2023 Jefferies Healthcare Conference
Enlivex Therapeutics will present a corporate update at the 2023 Jefferies Healthcare Conference. The company is a clinical-stage macrophage reprogramming immunotherapy company developing Allocetra, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. The presentation will take place on June 9, 2022, at 11:30 AM Eastern Time.
Management Changes
growth-positive
Enlivex Selected for an Elevator Pitch Presentation and two additional Poster Presentations at the 2023 Annual Meeting of the International Society for Cell & Gene Therapy
Enlivex Therapeutics announced three poster presentations at the 2023 Annual Meeting of the International Society for Cell & Gene Therapy. The presentations focus on the development and regulatory acceptance of Allocetra frozen formulation, in vitro biological activity characterization, and the synergistic peritoneal ant-tumor effect of Allocetra-OTS in combination with immune checkpoint inhibitors/chemotherapy. Enlivex Therapeutics is a clinical-stage macrophage reprogramming immunotherapy company developing Allocetra as a universal off-the-shelf cell therapy. The company aims to reprogram macrophages into their homeostatic state to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications. The International Society for Cell & Gene Therapy is a global society of clinicians, regulators, researchers, technologists, and industry partners focused on translating cell and gene therapy into safe and effective therapies.
PartnersInvestment
Enlivex Announces Issuance of European Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS) Resulting from CAR T-Cell Therapy
growth-negative
We Think Enlivex Therapeutics (NASDAQ:ENLV) Needs To Drive Business Growth Carefully
Enlivex Therapeutics, a software-as-a-service business, is facing potential cash burn issues. As of December 2022, the company had a cash reserve of US$50m and no debt, with a cash burn of US$32m, giving it a cash runway of around 19 months. However, the companys cash burn increased by 67% over the last year, which could lead to a decrease in the cash runway. The companys cash burn of US$32m is about 60% of its US$54m market capitalisation, which could lead to significant dilution if the company has to issue shares to fund growth.
Investment
Enlivex Receives Notice of Allowance for U.S. Patent Application Covering the Use of Allocetra™ in Patients Receiving CAR T-Cell Therapy
growth-positive
Enlivex Appoints Andrew Singer to its Board of Directors
Enlivex Therapeutics Ltd, a clinical-stage macrophage reprogramming immunotherapy company, has announced the appointment of Andrew Singer to its Board of Directors. Singer brings over 25 years of experience in biotechnology, corporate finance, mergers and acquisitions, and business strategy. He has previously held positions at Epizyme, Credit Suisse, Wells Fargo Securities, and RBC Capital Markets. The company believes that Singers extensive experience makes him an ideal fit for Enlivex’s Board.
Management Changes
Analysts At H.C. Wainwright & Co. Set 12-Month Target Of $15 Per Share For ENLV Thanks To High Profile Collaboration Agreement, Multiple Ongoing Clinical Trials
Enlivex, Beigene Collaborate To Test A New Combination Treatment To Fight Advanced-Stage Solid Tumors
BeiGene, Ltd. (BGNE) Surges 12.5%: Is This an Indication of Further Gains?
growth-positive
Enlivex Announces Tislelizumab Clinical Collaboration, Full Year 2022 Financial Results, and Provides Business Updates
Enlivex Therapeutics Ltd has announced a clinical collaboration with BeiGene to evaluate the safety and efficacy of Allocetra, an investigational macrophage-reprogramming cell therapy, for the treatment of patients with advanced-stage solid tumors. The company also plans to file an amendment for the sepsis Phase II clinical trial in early Q2 2023. The company received positive DSMB recommendation and IMOH clearance to continue Phase I/II clinical trials of Allocetra. The companys full year 2022 financial results showed an increase in R&D expenses and general and administrative expenses, and a net loss of $31.0 million.
PartnersManagement ChangesExpand
Enlivex Announces Clinical Collaboration to Evaluate Combinations of Allocetra and PD-1 Inhibitor Tislelizumab for Patients with Solid Tumors
growth-positive
Enlivex Receives Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra combined with chemotherapy in patients with peritoneal metastases arising from solid cancers
Enlivex Therapeutics Ltd, a clinical-stage macrophage reprogramming immunotherapy company, has announced that an independent Data and Safety Monitoring Board (DSMB) has completed an interim data review for the first cohort of patients in the Company’s ongoing Phase I/II clinical trial of Allocetra™ in patients with advanced-stage peritoneal metastasis arising from solid tumors. The Israeli Ministry of Health (IMOH) also reviewed the interim data and provided regulatory clearance to continue the study and open the study’s next cohort. The safety profile supported a protocol amendment to start new patients in the second cohort with higher initial doses of Allocetra™.
InvestmentExpand
Enlivex Receives Clearance From Spanish Agency of Medicines and Medical Devices For Treatment of Patients with Advanced Solid Malignancies in the Ongoing Allocetra Phase I/II Clinical Trial
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 Announces Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra in Patients with Advanced Solid Tumors
Enlivex Receives Authorizations from French and Belgian Regulatory Agencies To Expand Its Phase II Sepsis Clinical Trial Into France and Belgium
growth-positive
Enlivex Announces Third Quarter 2022 Financial Results and Provides a Business Update
Enlivex Therapeutics Ltd has received clearance from the FDA for its frozen-formulation Allocetra for the treatment of patients with advanced solid tumors. The company has also dosed its first patient in a Phase I/II multi-center clinical trial in Israel. New preclinical data presented at the European Society for Medical Oncology Congress 2022 showed a significant survival benefit when combining cisplatin with Allocetra. The company has also obtained clearances from regulatory authorities in Israel, Spain, and Greece for amendments to the protocol of its ongoing Phase II trial evaluating Allocetra in patients with sepsis. The companys financial results for the third quarter ended September 30, 2022, were also filed with the SEC.
InvestmentExpand
growth-positive
First Patients Dosed in Phase I/II Trial of Enlivex’s Off-the-Shelf Cell Therapy Candidate, AllocetraTM
Enlivex has announced the dosing of the first patient in its Phase I/II clinical trial of Allocetra, a novel off-the-shelf cell therapy designed to break through the immune-suppressing tumor microenvironment. The trial aims to evaluate the safety, tolerability, and efficacy of Allocetra in patients with advanced solid tumors. Enlivexs lead drug candidate, Allocetra, reprograms macrophages to weaken tumor microenvironments and strengthen the immune response. The company hopes to have top-line Phase I/II data by the second half of 2023. Enlivex is focused on developing highly effective and low-cost allogeneic cell therapies for life-threatening clinical indications. The companys management team has a successful track record in the biotech industry.
Customers
growth-positive
First Patients Dosed in Phase I/II Trial of Enlivex's Off-the-Shelf Cell Therapy Candidate, AllocetraTM
Enlivex Therapeutics has announced the dosing of the first patient in its Phase I/II clinical trial of Allocetra, a novel off-the-shelf cell therapy designed to break through the immune-suppressing tumor microenvironment. The trial aims to evaluate the safety, tolerability, and efficacy of Allocetra in patients with advanced solid tumors. Enlivex is focused on developing highly differentiated cell therapies that restore macrophage homeostasis and address unmet medical needs. The companys lead drug candidate, Allocetra, has shown promising results in preclinical studies, including increased survival duration and complete remission of cancer in mice. Enlivex aims to have top-line Phase I/II data by the second half of 2023. The Phase I/II trial marks a significant milestone in the development of Allocetra as a potential treatment for solid cancers.
InvestmentExpand
growth-positive
Israeli Ministry Of Health Clears Way For Human Trials Of AllocetraTM, A Proprietary Off-the-Shelf Immunotherapy For Solid Tumors
Enlivex Therapeutics has received approval from the Israeli Ministry of Health for a Phase I/II trial of its immunotherapy drug-candidate AllocetraTM. The drug is designed to reprogram and strengthen the patients immune response against cancer. If successful, AllocetraTM could be combined with other immunotherapies and cancer treatments to improve patient outcomes. The trial will enroll up to 48 patients with advanced solid tumors and will evaluate the safety, tolerability, and efficacy of AllocetraTM alone and in combination with a checkpoint inhibitor. Enlivex is a biotech company focused on cell therapy and macrophage homeostasis. The companys management team has a successful track record in the biotech industry.
InvestmentExpand
Enlivex Receives Allocetra IND Clearance From The U.S. Food And Drug Administration For Treatment Of Patients with Advanced Solid Malignancies
Growth-Positive
Enlivex Announces Dosing of the First Patient in Phase I/II Trial Evaluating Allocetra Alone and in Combination with a PD1 Checkpoint Inhibitor in Patients with Advanced Solid Tumors - Enlivex Therapeutics (NASDAQ:ENLV)
Enlivex Therapeutics Ltd. has announced the first patient has been dosed in a Phase I/II clinical trial for its drug Allocetra. The trial is designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors. The trial builds on preclinical studies conducted in collaboration with Yale Cancer Center. The company believes that Allocetra has the potential to provide a paradigm shift in treatment of advanced solid tumors.
InvestmentExpand
growth-positive
Enlivex to Present at the 4th Macrophage-Directed Therapies Summit
Enlivex Therapeutics Ltd will participate in the 4th Macrophage-directed Therapies Summit to present their clinical programs in sepsis and solid cancers. The company is a clinical-stage immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. The summit will focus on approaches to target dont eat me signal, strategies to reprogram tumor-associated macrophages, and techniques to discover next-generation targeting methods for effective therapies. Enlivexs participation in the summit indicates growth-positive impact as they showcase their clinical programs and engage with industry experts. The article does not mention any specific partners, customers, valuation amount, acquisition amount, investment amount, layoffs, or the date of the event. Confidence level: 8/10.
PartnersManagement Changes
growth-positive
Enlivex Announces New Preclinical Data in Murine Mesothelioma Model Showing a Substantial Survival Benefit with Allocetra as Monotherapy and in Combination with Cisplatin at the ESMO Congress 2022
Enlivex Therapeutics has announced new preclinical data showing a substantial survival benefit when its immunotherapy drug, Allocetra, is combined with the chemotherapeutic agent cisplatin in a murine mesothelioma model. The data, presented at the European Society for Medical Oncology (ESMO) Congress 2022, demonstrate a statistically significant increase in survival rates when Allocetra is used in combination with cisplatin. Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. The companys ongoing Phase I/II trial is evaluating Allocetra combined with chemotherapy in patients with peritoneal metastases. The results of the preclinical studies support the trials objectives and highlight the potential of Allocetra to enhance the efficacy of complementary anti-cancer agents.
Customers
growth-positive
Enlivex Receives Notice of Allowance for U.S. Patent Application Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome in Patients Receiving CAR T Cell Therapy
Enlivex Therapeutics has announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for a patent application covering the use of Allocetra to inhibit or reduce cytokine release syndrome in patients undergoing CAR T-cell therapy. The patent is expected to be issued by the end of Q1 2023. Allocetra is a universal, off-the-shelf cell therapy being developed by Enlivex to reprogram macrophages into their homeostatic state. The therapy has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications. Enlivexs CEO, Oren Hershkovitz, stated that the patent will broaden the companys IP portfolio and is a key source of value for Enlivex.
Partners
growth-positive
Enlivex Announces Regulatory Clearance in Multiple Countries for Integration of Frozen Allocetra Formulation and Expansion of Patient Population in its Sepsis Phase II Clinical Trial
Enlivex Therapeutics has received regulatory clearance for protocol amendments to its Phase II trial evaluating Allocetra in patients with sepsis. The amendments allow for the treatment of newly recruited patients with a frozen Allocetra formulation and expand the study population to include patients with septic conditions stemming from biliary, urinary tract, or abdominal infections. The broad acceptance of these amendments is expected to shorten the timeline for potential regulatory approval and commercial launch of the frozen Allocetra formulation. The frozen formulation is expected to have a longer shelf life, improve manufacturing scalability and shipping logistics, and reduce production costs. Enlivexs sepsis program aims to address the unmet medical need for FDA-approved treatments for sepsis.
CustomersPartners
growth-positive
Enlivex Receives Israeli Ministry of Health Approval for the Initiation of a Phase I/II Trial Evaluating Allocetra™ Alone and in Combination with a PD1 Checkpoint Inhibitor in Patients with Advanced Solid Tumors
Enlivex Therapeutics has received authorization from the Israeli Ministry of Health to initiate a Phase I/II clinical trial for its immunotherapy drug, Allocetra. The trial will evaluate the safety, tolerability, and preliminary efficacy of Allocetra alone and in combination with a PD1 checkpoint inhibitor in patients with advanced solid tumors. The company aims to change the balance of macrophage populations surrounding solid tumors to overcome checkpoint inhibitor resistance. The trial will enroll up to 48 patients and will assess safety, tolerability, and various efficacy endpoints. Allocetra has the potential to reprogram pro-tumor macrophages and enhance the efficacy of checkpoint inhibitors. The limited efficacy of checkpoint inhibitors in certain solid cancers is linked to tumor mechanisms that facilitate the recruitment of pro-tumor macrophages.
CustomersPartners
growth-positive
Sheba Medical Center and Enlivex Announce Dosing of the First Patient in Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients with Peritoneal Metastases Arising from Solid Cancers
Enlivex Therapeutics has announced the initiation of a Phase I/II clinical trial for Allocetra, its immunotherapy drug, in patients with peritoneal metastases arising from solid cancer. Peritoneal cancer is a terminal disease with a poor prognosis, and current chemotherapy treatments provide only modest survival benefits. The trial aims to evaluate the safety and efficacy of Allocetra combined with standard-of-care chemotherapy. The company believes that Allocetra has strong anti-cancer potential by rebalancing macrophage populations within the tumor microenvironment. The trial will enroll approximately 12 patients across four cohorts and will assess adverse events, overall response rate, progression-free survival, and overall survival. Enlivex sees this trial as a crucial moment in its evolution and an opportunity to substantially expand its addressable patient population.
Customers
growth-positive
Enlivex Receives Israeli Ministry of Health Authorization for the Initiation of a Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients with Peritoneal Metastases Arising from Solid Cancers
Enlivex Therapeutics has received authorization from the Israeli Ministry of Health to initiate a Phase I/II clinical trial for Allocetra™ combined with chemotherapy in patients with peritoneal metastases arising from solid cancer. The trial aims to evaluate the safety and potential efficacy of Allocetra™ in this patient population. Peritoneal cancer is a terminal disease with a poor prognosis, and patients with peritoneal metastases have limited treatment options. Enlivex plans to initiate the trial in Q3 2022. Allocetra™ is a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. The company believes Allocetra™ has the potential to enhance the efficacy of existing therapies and provide an effective treatment option for patients who do not respond well to current FDA-approved therapies.
Customers
growth-positive
Enlivex Announces Issuance of Two U.S. Patents Covering Methods of Treating Sepsis with Allocetra
Enlivex Therapeutics has announced the issuance of U.S. patents providing added intellectual property protection until at least 2036 for their sepsis program. The patents cover methods of treating sepsis derived from pneumonia, urinary, or biliary tract infections. Enlivex is developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. The therapy has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications. Enlivex plans to pursue additional patents in key geographies to maximize the value of their pipeline. The announcement is growth-positive for the company.
CustomersPartners
growth-positive
אנלייבקס קיבלה אישור לפטנט בישראל
An article reports that Anlivex Therapeutics, a dual immunotherapy company, has received approval for a new patent in Israel. The patent covers Allocetra, the companys immunotherapeutic drug currently in development. The approval grants additional intellectual property protection until at least 2037. Allocetra is being developed as a universal cell therapy for reprogramming macrophages in various diseases, including solid tumors, sepsis, and COVID-19. The company aims to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications. Anlivex recently announced the initiation of a multi-center Phase IIb clinical trial for Allocetra in severe and critical COVID-19 patients with acute respiratory distress syndrome (ARDS). The trial is expected to evaluate the safety and efficacy of Allocetra compared to standard treatment.
Investment
growth-positive
Enlivex: After Review of Phase II Data, Israeli Ministry of Health Authorizes Initiation of a Multi-Center, Randomized Phase IIb Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients
Enlivex Therapeutics has received authorization from the Israeli Ministry of Health to initiate a Phase IIb clinical trial for its immunotherapy drug AllocetraTM in severe and critical COVID-19 patients. The trial will evaluate the safety and efficacy of AllocetraTM when administered in addition to standard care treatment. Previous trials have shown positive results, with a 0% mortality rate and 90.5% of patients recovering from severe/critical condition. The Phase IIb trial will have primary endpoints of ventilation-free survival and recovery, and will also assess secondary endpoints such as long-COVID-19 symptoms. Enlivex is a clinical-stage immunotherapy company developing AllocetraTM as a universal, off-the-shelf cell therapy for various life-threatening conditions.
CustomersExpand
growth-negative
אנלייבקס: ההפסד הנקי לרבעון הסתכם בכ - 3.1 מיליון דולר, בהשוואה להפסד נקי של כ - 3 מיליון דולר ברבעון המקביל
Anlivex Therapeutics reported financial results for the second quarter of 2021, with a net loss of approximately $3.1 million. The company had cash and marketable securities of $90.6 million as of the end of June. Anlivex expects its cash and marketable securities to fund operational expenses and capital requirements until 2023. The CEO of the company, Dr. Oren Hershkovitz, expressed satisfaction with the companys recent progress and highlighted the clinical advancements and potential of Allocetra in improving cancer treatments and COVID-19 therapies. The company is planning to expand clinical trials for Allocetra in Europe. The article does not mention any specific partners, customers, or acquisition or investment amounts. The event described in the article occurred on August 9, 2021.
Investment
growth-positive
Enlivex to Present at the Improvate Life-Saving Technologies International Conference 2021
Enlivex Therapeutics announced that its CEO will participate in a virtual conference to discuss the companys AllocetraTM macrophage reprogramming cell therapy platform and development plans. The conference, called Improvate Life-Saving Technologies International Conference 2021, aims to connect leaders, decision makers, companies, and investors with technology and innovation companies. Enlivex is a clinical-stage immunotherapy company developing AllocetraTM, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. The companys participation in the conference suggests a positive impact on its growth and potential partnerships.
Partners
growth-positive
Enlivex Announces Issuance of New U.S. Patent Covering Methods of Treating Gout, Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis and GvHD Using Allocetra Immunotherapy
Enlivex Therapeutics has been issued a new patent for its immunotherapy product candidate, AllocetraTM. The patent provides intellectual property protection for methods of treating autoimmune and inflammatory diseases. While Enlivex is currently focusing on life-threatening diseases such as sepsis, COVID-19, and solid tumors, pre-clinical data show the potential applicability of AllocetraTM in providing immune rebalancing for patients with autoimmune or inflammatory diseases with no effective treatment options. AllocetraTM is being developed as a universal, off-the-shelf cell therapy to reprogram macrophages into their homeostatic state. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications. Enlivex is a clinical-stage macrophage reprogramming immunotherapy company.
Customers
growth-positive
ביקושים ערים: אנלייבקס גייסה 46 מיליון דולר בהנפקה לציבור
Anlivex, a company developing drugs for COVID-19, sepsis, and cancer, has announced a $46 million public fundraising. The company raised $10 million initially and increased it to $46 million due to high demand. The fundraising was managed by H.C. Wainwright. The stock price of the company has decreased by 17.5% in Tel Aviv, translating to $21.4 per share. The market value of the company is now approximately $1 billion. The fundraising will allow Anlivex to continue its clinical trials for COVID-19 and sepsis.
Investment
growth-positive
Enlivex Announces $10 Million Bought Deal Offering of Ordinary Shares
Enlivex Therapeutics has entered into an underwriting agreement with H.C. Wainwright & Co., LLC for the purchase of 500,000 ordinary shares at a price of $20.00 per share. The closing of the offering is expected to occur on or about February 12, 2021. The gross proceeds to Enlivex are expected to be $10 million, which will be used for clinical, regulatory, manufacturing, research and development activities, potential acquisitions and in-licensing, and other general corporate purposes.
Investment
growth-positive
Enlivex reports strong Phase II Covid treatment results
Enlivex Therapeutics has reported positive results from its Phase II trial of Alloctera, a drug for severely or critically ill Covid-19 patients. The trial involved 16 patients, 14 of whom were released from hospital after treatment with Alloctera. The company will submit these results to regulatory authorities in the US, Europe, and other countries to determine what additional trials will be required. Enlivexs share price rose 6.97% on Nasdaq following the announcement.
InvestmentCustomers
growth-positive
Enlivex Reports Positive Top-Line Results from Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients and Provides a Program Update
Enlivex Therapeutics Ltd. has reported positive results from a Phase II clinical trial of Allocetra in severe and critical COVID-19 patients. The trial was completed early due to the positive results and the company plans to submit a summary of the data for review by regulatory bodies. The trial saw 0% mortality on day 28 and 87.5% of patients recovered and were discharged from the hospital by day 28. The company believes that Allocetra could potentially fill the void that currently exists for the treatment of severe and critical COVID-19 patients.
Investment
growth-positive
Enlivex Announces Pre-Print Publication of Full Results from Phase Ib Severe Sepsis Trial on medRxiv
Enlivex Therapeutics has announced positive safety and efficacy data from a Phase Ib clinical trial evaluating AllocetraTM in patients with severe sepsis. The trial showed significant positive responses in organ failure, duration of ICU stay, and mortality rates. None of the AllocetraTM-treated patients died during the 28-day study period, compared to a 27% mortality rate in the control group. The patients treated with AllocetraTM also had rapid and complete recovery from septic conditions and organ dysfunction. The ICU length-of-stay for AllocetraTM-treated patients was significantly shorter than the control group. AllocetraTM was shown to be safe and tolerable with no serious adverse events. The results suggest that AllocetraTM has the potential to be effective in treating sepsis and other clinical indications associated with cytokine storms.
CustomersPartners
growth-positive
Enlivex Announces Issuance of New Chinese Patent Covering Allocetra Immunotherapy
Enlivex Therapeutics has been issued a new patent by the China National Intellectual Property Administration (CNIPA) for its immunotherapy product candidate, AllocetraTM. The patent provides added intellectual property protection in China and covers methods, uses, and pharmaceutical compositions. AllocetraTM is designed to target life-threatening clinical indications such as organ dysfunction, acute multiple organ failure associated with Sepsis and COVID-19, and solid tumors. Enlivex Therapeutics is a clinical-stage immunotherapy company focused on developing an allogeneic drug pipeline for immune system rebalancing. This announcement is expected to have a positive impact on the companys growth.
PartnersCustomers
growth-positive
Enlivex Reports Positive Interim Results From Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients
Enlivex Therapeutics has reported positive interim results of a Phase II clinical trial for AllocetraTM in severe and critical COVID-19 patients. The trial showed that all patients treated with AllocetraTM had complete recovery from their respective severe/critical condition and were discharged from the hospital. The treatment was well tolerated with no serious adverse events. The results indicate the potential efficacy of AllocetraTM in treating severe and critical COVID-19 patients and other conditions involving cytokine storms and organ dysfunctions. Enlivex believes that AllocetraTM could address the treatment gap for severe or critical COVID-19 patients, even with the anticipated regulatory approval of COVID-19 vaccines.
Customers
growth-positive
Enlivex Reports Positive Two-Year Clinical Outcome For A Hospitalized Patient with Erosive Osteoarthritis Treated with Allocetra
Enlivex Therapeutics reported a positive two-year clinical outcome following the first Allocetra treatment of a hospitalized patient with erosive osteoarthritis. The patient experienced significant improvement and was released from the hospital after treatment. Allocetra is currently being evaluated in clinical studies for other diseases related to hyper-expression of cytokines. Enlivex recently reported positive results from a Phase Ib clinical trial of Allocetra in COVID-19 patients. The therapy was well-tolerated and all patients recovered from their respective conditions.
Customers
growth-positive
Enlivex Appoints Former ArQule, Inc. Executive Dr. Brian Schwartz to the Company's Board of Directors
Enlivex Therapeutics announced that Dr. Brian Schwartz, former Chief Medical Officer of ArQule, has joined their Board of Directors. Dr. Schwartz brings significant experience in drug development and believes in the potential of Enlivexs immunotherapy approach. The company is focused on developing an allogeneic drug pipeline for immune system rebalancing to treat life-threatening immune and inflammatory conditions. Enlivex is currently working on clinical development for sepsis and COVID-19, as well as preclinical development for solid cancers. The appointment of Dr. Schwartz is expected to contribute to the sustained near- and long-term growth of the company.
Management Changes
growth-positive
Enlivex Receives Notice of Allowance for U.S. Patent Application Covering Methods of Treating Gout, Inflammatory Bowel Disease, Crohn's Disease, and Ulcerative Colitis with Allocetra Immunotherapy
Enlivex Therapeutics has announced that the U.S. Patent and Trademark Office has issued a notice of allowance for a new patent application covering methods of using Allocetra™, the companys immunotherapy product candidate. The new patent will provide added intellectual property protection for methods of treating autoimmune and inflammatory diseases. The company expects the patent to be issued in the United States in the coming months. Enlivex is focusing its clinical development efforts on life-threatening diseases with high mortality rates and no effective treatments, but pre-clinical data have shown the potential applicability of Allocetra™ in providing immune rebalancing for patients with autoimmune or inflammatory diseases with unmet needs, such as Crohns Disease.
Customers
growth-positive
Enlivex: Israeli Ministry of Health Authorizes Initiation of Phase IIb Clinical Trial Evaluating Safety and Efficacy of Allocetra in Sepsis Patients
Enlivex Therapeutics has received authorization from the Israeli Ministry of Health to initiate a Phase IIb clinical trial for its immunotherapy drug, Allocetra™, in sepsis patients. The trial will evaluate the safety, tolerability, and efficacy of Allocetra™ in combination with standard of care treatment. The company previously conducted a Phase Ib trial in sepsis patients, which showed positive results with no deaths among the Allocetra™-treated patients. Allocetra™ is also being developed for the treatment of severe and critical COVID-19 patients. Enlivex is a clinical-stage immunotherapy company focused on immune system rebalancing.
Customers
growth-positive
Enlivex Reports Dosing of First Two Patients in Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients
Enlivex Therapeutics has reported that the first two patients have been dosed in a Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients. The trial aims to recruit up to twenty-four patients and assess the safety, tolerability, cytokine profile, and efficacy of AllocetraTM in combination with standard care treatment. This Phase II study follows positive results from a Phase Ib trial where all five COVID-19 patients completely recovered after receiving AllocetraTM. Enlivex Therapeutics is a clinical-stage immunotherapy company developing an allogeneic drug pipeline for immune system rebalancing.
Customers
growth-positive
Enlivex: After Expedited Review, Israeli Ministry of Health Authorizes Initiation of Phase II Clinical Trial Evaluating Allocetra in COVID-19 Severe and Critical Patients
Enlivex Therapeutics has received authorization from the Israeli Ministry of Health to initiate a Phase II clinical trial for AllocetraTM in severe and critical COVID-19 patients. The trial will evaluate the safety, tolerability, cytokine profile, and efficacy of AllocetraTM in combination with standard of care treatment. Enlivex recently reported positive results from a Phase Ib clinical trial of AllocetraTM in severe and critical COVID-19 patients. The Phase II trial is expected to recruit up to 24 patients. Enlivex expressed gratitude to the Israeli Ministry of Health for the expedited review and authorization of the trial.
CustomersInvestment
growth-positive
Enlivex soars on Covid-19 success - raising questions
Enlivex Therapeutics Ltd. reported positive results from an initial trial of its product, Allocetra, at Hadassah Hospital. Five severely ill COVID-19 patients treated with Allocetra recovered within 5-8 days and tested negative for the virus upon release. The announcement led to a 21% increase in Enlivexs share price on Nasdaq and a 120% increase on the Tel Aviv stock exchange. The companys share price on Nasdaq is currently up 87% at $11.11, resulting in a market cap of $150 million. Enlivex plans to continue analyzing the trial and will publish further details after the official monitoring period ends. The company is considering seeking emergency use authorization for Allocetra based on the trial results. The product is designed to control the immune systems activity in severe cases of infectious disease.
Customers
growth-positive
Enlivex Announces Allowance of New Chinese Patent Covering Allocetra Immunotherapy
Enlivex Therapeutics has announced that the China National Intellectual Property Administration (CNIPA) has issued a notice of allowance for a new patent application covering their immunotherapy product candidate, ALLOCETRA. The new patent will provide added intellectual property protection, including methods, uses, and pharmaceutical compositions. Enlivex expects the patent to be issued in China in the fourth quarter of 2020. ALLOCETRA is designed to provide a novel immunotherapy mechanism of action for life-threatening clinical indications, including organ dysfunction and acute multiple organ failure associated with Sepsis and COVID-19, as well as treating solid tumors by modulating the tumors microenvironment.
Investment
growth-positive
Enlivex Announces Allowance of New U.S. Patent Covering Allocetra Immunotherapy
Enlivex Therapeutics announced that the U.S. Patent and Trademark Office issued a notice of allowance for a new patent application covering ALLOCETRA, the companys immunotherapy product candidate. The new patent will provide added intellectual property protection and is expected to be issued in the United States during the fourth quarter of 2020. ALLOCETRA is designed to target life-threatening clinical indications, including organ dysfunction and acute multiple organ failure associated with Sepsis and COVID-19, as well as treating solid tumors by modulating their microenvironment.
Investment
growth-positive
Enlivex Selected by the Israel Innovation Authority to Receive $1.5 Million Grant to Fund COVID-19 and Sepsis Clinical Trials
Enlivex Therapeutics has been selected by the Israel Innovation Authority to receive a non-dilutive grant of approximately $1.5 million for its planned COVID-19 and sepsis clinical programs. This brings the total amount of grants received from the IIA to approximately $4.31 million. Enlivex plans to initiate a Phase IIb/III trial of AllocetraTM for the treatment of organ dysfunction associated with sepsis, as well as a clinical trial of AllocetraTM in COVID-19 patients. Enlivex is a clinical-stage immunotherapy company focused on immune system rebalancing for the treatment of immune and inflammatory conditions. The companys Phase Ib clinical trial in severe sepsis patients yielded positive results.
Investment
growth-negative
Enlivex plummets after raising cash at discount
Enlivex Therapeutics raised $8 million at a discount on the market price of its shares, causing its share price to fall by 6.3% in New York. The companys market cap is now $90 million, a 40% decrease from the opening price in Tel Aviv.
Investment
growth-positive
Israel's Enlivex reports drug could help COVID-19 patients
Enlivex Therapeutics is increasing production of Allocetra, a drug for treating patients with multisystem failure related to sepsis. The company has begun a program to increase production in preparation for potential requests for treatment of hospitalized COVID-19 patients. Enlivex reports positive interim results in a trial of Allocetra. Enlivex is listed on the Nasdaq Capital Market and Tel Aviv Stock Exchange with a market cap of $96 million. The company became a public company last year through a merger into Bioblast. Enlivexs share price jumped 23% in Tel Aviv and 26.55% in New York following the announcement.
Customers
growth-positive
https://www.jpost.com/HEALTH-SCIENCE/Israeli-company-ready-to-assist-coronavirus-victims-with-novel-drug-617777
Enlivex, an Israeli immunotherapy company, is ready to assist health authorities in combating complications caused by the novel coronavirus. Their Allocetra cell-based therapy, which rebalances the immune system, could potentially help severe cases of COVID-19 where the immune system overreacts and leads to organ dysfunction. Enlivexs therapy cannot vaccinate against or kill the coronavirus, but it aims to return overreactive immune systems to equilibrium. The company is reaching out to global authorities to offer their solution on an experimental basis. Enlivexs therapy has shown positive results in clinical trials for sepsis patients with multiple dysfunctional organs. The company plans to release a full dataset of 10 patients within the next 30 days. They also suggest stockpiling the therapy for potential future outbreaks.
Customers
growth-negative
CEO of Nasdaq-Listed Cell Immunotherapy Company Enlivex Steps Down
Enlivex Therapeutics Ltd. announced that its CEO, Schmuel Hess, will step down in December due to personal reasons. The company plans to appoint Dror Mevorach, the founder and chief scientific officer, as interim CEO until a new CEO is selected. Enlivex, founded in 2005, develops cell-based treatments for life-threatening immune and inflammatory conditions, including graft versus host disease. The announcement of the CEOs resignation has a negative impact on the companys growth.
Management Changes
growth-positive
Immunotherapy Company Enlivex Announces Dual Listing on the Tel-Aviv Stock Exchange
Enlivex Therapeutics Ltd, a clinical-stage immunotherapy company, has been approved for dual listing on the Tel Aviv Stock Exchange (TASE) starting on July 22, 2019. The companys ordinary shares will continue to trade on NASDAQ. Enlivex is developing ALLOCETRA™, a novel immunotherapy for life-threatening diseases. The company has successfully completed a phase IIa clinical trial and recently reported positive safety results from a Phase Ia clinical study. A phase II/III clinical trial is expected to begin in the first half of 2020. The dual listing is expected to expand Enlivexs shareholder base and provide a convenient way for Israeli institutional investors to invest in the company.
Public Trading
growth-positive
IMMUNOTHERAPY COMPANY ENLIVEX THERAPEUTICS SELECTED TO RECEIVE AN ADDITIONAL $1 MILLION GRANT BY THE ISRAEL INNOVATION AUTHORITY FOR ITS SEPSIS CLINICAL PROGRAM
Enlivex Therapeutics has been selected by the Israel Innovation Authority to receive a non-dilutive grant of approximately $1.0 million for its clinical program on the prevention of cytokine storms and organ dysfunction associated with sepsis. The company is eligible for additional grants in 2020 and 2021. Enlivex is currently planning Phase II trials for its ALLOCETRATM drug candidate for sepsis prevention and complications post bone-marrow transplantations. The company aims to develop immunotherapy treatments for life-threatening medical conditions and solid tumors. Enlivex has received a total of approximately $4.2 million in grants from the Israel Innovation Authority.
Investment
growth-positive
IMMUNOTHERAPY COMPANY ENLIVEX THERAPEUTICS COMPLETES PREVIOUSLY ANNOUNCED FINANCING PRICED AT $12.25 PER SHARE, RAISING A TOTAL OF APPROXIMATELY $8.4 MILLION
Enlivex Therapeutics has announced the final closing of a private placement financing, raising approximately $8.4 million. The funds will be used to initiate several late-stage immunotherapy clinical trials and reach multiple clinical milestones. These trials include studying prevention of complications post bone-marrow transplantations, prevention of cytokine storms associated with sepsis, and a unique program for the treatment of solid cancers. Enlivex is a clinical-stage immunotherapy company developing a drug pipeline for immune system rebalancing. The private placement consisted of the issuance of 682,631 ordinary shares. The shares have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States without registration or an applicable exemption.
Investment
growth-positive
ENLIVEX THERAPEUTICS TO PRESENT AT THE 2019 H.C. WAINWRIGHT GLOBAL LIFE SCIENCES CONFERENCE
Enlivex Therapeutics Ltd. will make a corporate presentation at the H.C. Wainwright Global Life Sciences 2019 conference. The company is a clinical-stage immunotherapy company focused on developing a drug pipeline for immune system rebalancing. The presentation will discuss Enlivexs product, ALOCETRATM, which targets life-threatening clinical indications and unmet medical needs. The company aims to provide prevention or treatment for complications associated with bone marrow transplantations, organ dysfunction and acute multiple organ failure associated with sepsis, and enable an effective treatment of solid tumors via immune checkpoint rebalancing. The presentation will take place on April 8, 2019, in London, UK.
Expand
growth-positive
Cell Immunotherapy Company Enlivex Merges With Nasdaq-Listed Bioblast, Raises $5.3 Million
Enlivex Therapeutics Ltd. has raised $5.36 million in a private offering and completed a merger with Bioblast Pharma Ltd. The merged entity is now listed on Nasdaq under the ticker ENLV. Enlivex develops cell-based treatments for immune and inflammatory conditions.
InvestmentAcquisitionPublic Trading
growth-positive
Enlivex raises $5.3m on Nasdaq, merges with Bioblast
Enlivex Therapeutics, an Israeli drug development company, has completed its merger with Bioblast Pharma. As part of the merger, Enlivex raised $5.3 million, bringing its total fundraising to $10.6 million. The merger has resulted in a company value of $120 million. Enlivex is developing a treatment for graft versus host disease and is preparing for a Phase II/III trial. The companys product also has potential applications in the treatment of sepsis and other diseases related to immune system activity. The merger has been hailed by Hadasit Bio-Holdings, which will hold 18% of the merged company. Enlivexs CEO is Dr. Shmuel Hess.
AcquisitionInvestment
growth-positive
Immunotherapy Company Enlivex Therapeutics Announces Nasdaq Listing Under Symbol "ENLV" and Closing of Private Placement of Ordinary Shares Priced at $12.25 Per Share
Enlivex Therapeutics Ltd has announced its Nasdaq listing and the closing of a private placement of ordinary shares priced at $12.25 per share. The financing was led by institutional investors KIP Global Pharma Private Equity Fund and HBL - Hadasit Bio Holdings. The company expects the cash balance to allow initiation of several late-stage immunotherapy clinical trials and potentially reach multiple clinical milestones. Enlivex is developing a novel immunotherapy candidate that targets life-threatening, unmet medical needs. The company believes that these indications represent multi-billion dollar revenue opportunities.
InvestmentPublic Trading
growth-negative
https://www.globenewswire.com/news-release/2019/03/06/1748659/0/en/Bioblast-Announces-Effectiveness-of-Eight-to-One-Reverse-Split.html
Bioblast Pharma Ltd. has announced the effectiveness of an eight to one reverse split of its share capital. The reverse split was approved by the companys shareholders in December 2018. Bioblast has also entered into a definitive merger agreement to acquire Enlivex Therapeutics Ltd., with Enlivex surviving the merger as a wholly owned subsidiary of Bioblast. The merger is subject to the condition that Bioblast effect a reverse stock split of its ordinary shares. Bioblast shareholders will receive one contingent value right (CVR) per ordinary share, entitling them to a pro rata share of consideration from Bioblasts Trehalose program. Bioblast has sold its Trehalose program to Seelos Therapeutics, Inc. Trading of Bioblasts ordinary shares on the Nasdaq Capital Market will continue on a split-adjusted basis.
AcquisitionPublic Trading
growth-positive
Bioblast Pharma Ltd. Announces Entry Into Merger Agreement to Acquire Enlivex Therapeutics Ltd. to Advance Clinical Stage Immunotherapeutic Drug Pipeline for the Treatment of Life-Threatening Diseases Sepsis, GvHD and Solid Tumors
Bioblast Pharma Ltd. has announced plans to acquire Enlivex Therapeutics Ltd., a private, venture-funded clinical stage immunotherapy company. The combined company will be renamed Enlivex Therapeutics Ltd., and its trading ticker will change accordingly. The last financing round of Enlivex was done at a $100 million pre-money valuation. The ownership split of the combined company is anticipated to be approximately 96% Enlivex shareholders and 4% Bioblast shareholders. The merger is expected to close during the first quarter of 2019.
AcquisitionInvestment
growth-positive
Korean fund to invest in Enlivex Therapeutics at $100m value
Enlivex Therapeutics has signed a memorandum of understanding for a $10 million investment led by South Korean investment fund KIP. The investment is for the development of a treatment for Graft-versus-Host disease resulting from bone-marrow transplants. Under the terms of the agreement, the investment will take place if an additional $6 million is raised. Enlivexs product has not yet undergone Phase III clinical trials but has the potential to reduce the immune systems activity. The company plans to continue developing the product for other diseases related to unwanted immune system activity.
InvestmentExpand
growth-positive
Israeli immunotherapy co Enlivex Therapeutics raising $10m
Enlivex Therapeutics, a portfolio company of Hadasit Bio Holdings, has raised $10 million in a funding round at a valuation of $50 million. The round was led by Korea Investment Partners and Hadasit Bio. The funding will enable Enlivex Therapeutics to begin a Phase III trial for the treatment of graft-versus-host disease (GvHD). The company also plans to develop its product for additional diseases related to immune system activity. Enlivex Therapeutics has expressed its intention to list on Nasdaq in the future, depending on market conditions. The companys share price rose on the Tel Aviv Stock Exchange, and Hadasit Bio currently has a market cap of NIS 36.5 million.
InvestmentExpand
growth-positive
Enlivex Therapeutics Announces Closing of USD 8 Million Series B Round Led by KOREA INVESTMENT PARTNERS (KIP) and HADASIT BIO HOLDINGINGS LTD. (HBL)
Enlivex Therapeutics has closed an $8 million equity financing round, with a valuation of approximately $50 million pre-closing. Korea Investment Partners (KIP) invested $6 million, and Hadasit Bio Holdingings Ltd. (HBL) co-invested $2 million. The financing will fund Phase III clinical trials of Enlivexs lead compound, Allocetra™, for the prevention of Graft Vs Host Disease (GVHD) post bone-marrow transplantation. KIP has appointed two new members to Enlivexs Board of Directors. Enlivex will also continue pre-clinical and clinical development for other immunotherapy indications.
Investment
growth-positive
Cell treatment co Enlivex Therapeutics raises $7m
Enlivex Therapeutics Ltd., a portfolio company of Hadasit Bio Holdings Ltd., has raised $7 million in a convertible loan from a group of investors led by Shai Novik, the CEO of Opko Biologics. The company is developing cell immunotherapy treatments for Graft versus Host Disease (GvHD), a lethal side effect of bone marrow transplants for the treatment of blood cancer. The proceeds from the financing will be used to initiate next stage trials.
Investment
