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What's Next For Cell Therapy In Oncology? Enlivex (NASDAQ: ENLV) Says It Has The Answers

Enlivex Therapeutics, Ltd.

Since Robert Hooke discovered cells in 1665 and Theodor Schwann proposed the classical cell theory in 1839, the cell therapy industry has grown by leaps and bounds. Today, there are several potential applications of cell therapies. They can be used in treating infectious and autoimmune diseases, fighting cancers, improving a weakened immune system, helping patients with neurological disorders, rebuilding damaged cartilage in joints and repairing spinal cord injuries, among other applications. Because of the wide applications of this technology, the global cell therapy market is growing. Governments around the world are increasingly investing in the biopharmaceutical industry's development, and the cell therapy industry is being propelled forward by an increase in the number of clinical trials for cell-based treatments. Already, leading industry participants like Fate Therapeutics (NASDAQ: FATE), Enlivex Therapeutics Ltd. (NASDAQ: ENLV), bluebird bio Inc. (NASDAQ: BLUE) and NKarta Therapeutics Inc. (NASDAQ: NKTX) are introducing ground-breaking cell treatments into the global market. What's Next For Cell Therapy In Oncology? In particular, Enlivex Therapeutics says it is already looking into the future of cell therapy in oncology. Currently, cellular therapies are designed to improve the immune system's ability to fight cancer. Manufacturing them involves collecting a specific set of cells — T-cell transfer therapy — from the blood, modifying them to produce a more vigorous attack on a patient's cancer cells and then reinjecting them into the patient. Apart from T-cell therapy, another area of research in cell therapy is CAR-T cell therapy. In this treatment, T-cells are taken from a patient's blood. Then, the gene for a unique man-made receptor binds to a specific protein on the patient's cancer cells — known as a chimeric antigen receptor (CAR) — and is added to the T-cells. This alteration turns the T-cells into CAR-T cells that attack the patient's cancer cells. In what could be a new approach, Israel-based Enlivex reports developing Allocetra™, an off-the-shelf therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These nonhomeostatic macrophages contribute significantly to the severity of such diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide an immunotherapeutic mechanism of action for life-threatening clinical indications – defined as unmet medical needs – as a stand-alone therapy or in combination with therapeutic agents. Equilibriums That Solve Complex Diseases Enlivex Executive Chairman Shai Novik, speaking at Cantor Fitzgerald's Cell and Genetic Medicines Conference, highlighted the company's initial focus on sepsis indication, which has a high unmet need. He said that the first solid tumor clinical trial was initiated a few months ago. Since being founded in October 2005, the company reports its mission has been to establish new equilibriums that solve complex diseases. According to Enlivex, Allocetra™ cell-based therapy breaks old paradigms, effectively treating numerous acute conditions through a radically different clinical approach. Novik said in an interview with The Jerusalem Post that a team of scientists, doctors, investors and entrepreneurs are working together to develop what they believe could "tackle some of the most problematic diseases, save more patients and ultimately change the world." Preclinical And Clinical Trials Of Allocetra™ As a clinical-stage company focused on macrophage reprogramming, Enlivex says it intends to develop and commercialize a drug pipeline for macrophage reprogramming in solid cancers, sepsis and other indications. The company reports that preclinical and clinical trials of Allocetra™ have been promising. The trials have started to show that restoring macrophage homeostasis could help people recover faster and with fewer complications when used on its own or in combination with other therapeutic agents. As part of a new generation of companies representing the future of cell therapy – off-the-shelf, highly scalable and low COGS “beyond CAR-T” cell therapies – Enlivex is focused on a highly differentiated novel immunotherapeutic mechanism – macrophage homeostasis. Macrophage homeostasis is severely disrupted by certain diseases states, and such imbalance is critical to the progression of the diseases. Allocetra has the potential to introduce highly-effective, low-cost allogeneic cell therapies for life-threatening clinical indications that are defined as "unmet medical needs", including sepsis – one of the leading causes of mortality, and oncology, through restoration of macrophage homeostasis. Enlivex is led by a seasoned management team who founded PROLOR Biotech and led it to a successful $560 financial exit and a partnership with Pfizer. PROLOR’s lead product, now named NGenla® by Pfizer, recently received marketing approval in Australia, Canada, Japan and the EU. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Shachar Shlosberger shachar@enlivexpharm.com Company Website https://enlivex.com

December 06, 2022 08:00 AM Eastern Standard Time

Context Therapeutics announces bispecific antibody clinical candidate to treat CLDN6+ cancers

Context Therapeutics

Contact Details Proactive Investors USA Proactive Investors USA +1 347-449-0879 na-editorial@proactiveinvestors.com

December 06, 2022 03:40 AM Pacific Standard Time

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UNOS CEO Calls for Expanded Improvements in the Organ Donation and Transplant Field

United Network for Organ Sharing

On Monday, Interim CEO of United Network for Organ Sharing (UNOS), Maureen McBride, Ph.D., addressed the Organ Procurement and Transplantation Network (OPTN) Board of Directors and called for the donation and transplant community to address public concerns by expanding ongoing efforts to improve the U.S. organ donation and transplant system. “Our national donation and transplant system saves thousands of people’s lives every year. But as long as there are patients on the waiting list, there is more we need to do,” said Dr. McBride. “Our critics agree – they have been vocal. Our supporters, too, have offered constructive feedback. … Here is where we all agree: We can do better. We must do better. We will do better.” Dr. McBride outlined several areas for improvement, including organ utilization and transportation, equity in access to the waitlist, oversight and coordination with the government, technology and patient engagement. “It’s clear that each year, too many donated kidneys never find a recipient, and that number is growing,” said Dr. McBride. “This is unacceptable.” Acknowledging previous board work to improve organ utilization – including implementing recommendations from the National Kidney Foundation’s Consensus Conference to Decrease Kidney Discards – Dr. McBride stated that the OPTN must seek additional opportunities to address the issue. Suggested actions included examining methods to increase usage of older and more complex donor organs as well as prioritizing discussions and potential solutions for safe and efficient organ transportation. “Practical, logistical, and regulatory obstacles to the safe and efficient delivery of donor organs should be identified, remedied, and monitored,” said Dr. McBride. Dr. McBride went on to address issues of inequitable patient access to the organ transplant waitlist. While the OPTN has the data and resources to maintain equitable services for waitlisted patients, there remains a challenge in helping pre-waitlisted patients, whose needs and data currently fall outside of the OPTN’s purview. “I am committed to seeking HRSA’s continued support for access to the data,” said Dr. McBride. “In my view, it is time for us to take bigger, bolder steps to increase equity across the entire donation and transplant landscape, not just one part.” Dr. McBride also acknowledged system improvement efforts by lawmakers and members of Congress, including the U.S. Senate Committee on Finance, expressing her belief that oversight should include all members of the donation and transplant system. “In August, the Senate Finance Committee stated that ‘Everybody wants this system to work with as few errors as possible.’ We completely agree,” said Dr. McBride. “My vision for the OPTN is one in which we work alongside, closely and collaboratively, with members of Congress, HHS, HRSA, CMS and others in the federal government to do the hard work of driving change and instituting substantive reforms.” Noting OPTN technology as another focus of congressional attention, Dr. McBride spoke of the need to match public expectations and continuously evolve IT and other technologies that the system relies upon. “We stand ready to alleviate those concerns, serve as a resource and engage in one-on-one conversations to provide assurances – to HHS and Congress, patients, and the general public – that our systems remain secure and effective.” Lastly, Dr. McBride addressed the importance of patient engagement, referencing feedback from patient representatives that their input might have limited impact on board decisions and that non-volunteer patients require more comprehensive information to help them or their loved ones. “We will commit to ensure you have the support you need to make a meaningful contribution and that you feel you are heard and valued,” said Dr. McBride. “For patients not yet involved in the OPTN policy process, I’ve heard that they want an easy-to-access source of information – content and resources that will help them on their transplant journey … Work already is underway to offer more educational resources to meet those needs.” Stressing that each topic of concern aligns with ongoing initiatives to better serve the donation and transplant community, Dr. McBride urged the OPTN Board of Directors to join her in seeking these improvements. “I am calling on everyone in this room … to work with me to make these changes,” said Dr. McBride. “All of us have worked very hard to drive significant progress to date and we all are committed to doing even more. This is our profound responsibility – one we can never take lightly.” Dr. McBride was appointed Interim Executive Director of the OPTN in October. She has been with UNOS since 1995, most recently serving as the organization’s Chief Operating Officer until she accepted the role of Interim CEO. A copy of Dr. McBride’s remarks can be found here. About UNOS United Network for Organ Sharing (UNOS) is a non-profit, charitable organization that serves as the Organ Procurement and Transplantation Network (OPTN) under contract with the federal government. The OPTN helps create and define organ allocation and distribution policies that make the best use of donated organs. This process involves continuously evaluating new advances and discoveries so policies can be adapted to best serve patients waiting for transplants. All transplant programs and organ procurement organizations throughout the country are OPTN members and are obligated to follow the policies the OPTN creates for allocating organs. Contact Details Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

December 05, 2022 01:03 PM Eastern Standard Time

Oxford Cannabinoid Technologies appoints new CEO

Oxford Cannabinoid Technologies Holdings PLC

Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

December 05, 2022 09:38 AM Eastern Standard Time

Video

The Company With A Big Smile This Black Friday

Bruush Oral Care Inc.

Read The Latest Report About Brüush. Brüush Oral Care Inc. (NASDAQ: BRSH) is back - after a strong Thanksgiving weekend, the leading electric toothbrush company announced record revenue, with over $500,000 of revenues for the month of November, representing year-over-year growth of over 50%. The long, post-Thanksgiving weekend stretching from Black Friday to Cyber Monday is a frenetic time for shops and shoppers alike. Spending totaled $188 billion in 2020, and with things back to normal this year, consumer activity is returning to pre-pandemic levels. In response to modern consumer needs, much Black Friday sales activity has moved online - with a record-breaking $9.12 billion spent online this year - and Brüush is riding this digital market wave. The Vancouver-based toothbrush company, boasting a cutting-edge product and strong online presence, saw one of its strongest weekends of sales in company history this Thanksgiving. Brüush sells top-of-the-line electric toothbrushes and is looking to become a leader in an oral care market worth $33.7 billion. The company, which already has a big smile over its partnership with comedian Kevin Hart, is delighted with this significant weekend of sales and record numbers of Brüush subscriptions and individual purchases. Brüushing Ahead This Black Friday Brüush can be proud of a strong weekend with record revenue from sales that provide significant growth for the company. The company believes that it is poised to become a leading provider of oral hygiene products going forward. As well as its strong individual kit sales, the company saw a boom in its subscription service, with 35,000 subscribers versus 28,000 before its IPO in August. The company’s individual toothbrush kits come with an electric brush and 3 replaceable heads, while its highly affordable subscription service provides 3 replacement heads every 6 months for only $21.60. Brüush’s mid-range pricing - with kits starting at only $80 - makes its brushes an attractive option compared with competitors. These include electric brushes from Oral B, owned by Procter and Gamble (NYSE: PG) and Koninklijke Philips ’ (NYSE: PHG) product, Sonicare. Along with its affordable price tag, Brüush offers a premium product that it claims gives the best teeth cleaning in the market. The Brüush brushes at 42,000 strokes per minute - compared with the average electric brush that brushes just 30,000 times - and removes over 20% more plaque than a manual brush. Its batteries last an industry-leading 4 weeks on a single charge, and the brushes have a 2-year warranty, though the company is confident it won’t be needed. The mid-range prices that provide top-quality oral hygiene results - along with savvy digital marketing - make Brüush popular among millennials, with 18-45-year-olds forming the largest segment of the company's customer base. Building on its resounding Thanksgiving successes, Brüush reports it will be launching a range of oral hygiene products in 2023 to complement its toothbrushes, including a line of toothpaste, floss, mouthwash, and more. Want to read more about Brüush? Visit its website. About Bruush Oral Care Inc. Bruush Oral Care Inc. is on a mission to inspire confidence through brighter smiles and better oral health. Founded in 2018, Brüush is an oral care company that is disrupting the space by reducing the barriers between consumers and access to premium oral care products. The Company is an e-commerce business with a product portfolio that currently consists of a sonic-powered electric toothbrush kit and brush head refills. Brüush has developed a product to make upgrading to an electric brush appealing with three core priorities in mind: (i) a high-quality electric toothbrush at a more affordable price than a comparable electric toothbrush from the competition; (ii) a sleek, countertop-friendly design; and (iii) a convenient brush head refill subscription program that eliminates the frustrating experience of purchasing replacement brush heads at the grocery/drug store. The Company is rooted in building a brand that creates relevant experiences and content, with the goal of becoming the go-to oral care brand for millennials and Generation Z.For more information on Bruush Oral Care Inc visit https://bruush.com. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details TraDigital IR - Colette Eymontt colette@tradigitalir.com Company Website http://www.tradigitalir.com

December 02, 2022 11:15 AM Eastern Standard Time

BriaCell’s Lead Candidate Bria-IMT™ Shows Promising Results For Advanced Breast Cancer Patients

BriaCell Therapeutics Corp.

The world of biotech is having what some are calling a golden age. Many companies are presenting new and innovative drugs to the FDA for approval and later the public for consumption. Smart Beta EFTs like SPDR S&P Biotech (NYSEARCA: XBI) (“XBI”) and iShares Biotechnology (NASDAQ: IBB) (“IBB”) are bringing a lot of awareness and attention to the field for investors to get excited about. BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”) presented positive initial efficacy data in its 2021-2022 cohort of 12 advanced breast cancer patients for its clinical study of Bria-IMT™ immunotherapy treatment during the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting. Breast cancer is still one of the deadliest cancers globally. Each year in the U.S. there are about 264,000 new diagnoses and about 42,000 women and 500 men die each year from breast cancer. The average risk that a woman will develop breast cancer sometime in her lifetime is around 13%. For certain populations that risk is higher; breast cancer is the number one cause of cancer death for Hispanic women. BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. BriaCell’s lead candidate Bria-IMT is marketed as an off-the-shelf personalized cellular approach to immunotherapy for the treatment of advanced solid tumors. The targeted patients are advanced breast cancer patients or terminal breast cancer patients. The Bria-IMT™ study showed disease control, tumor shrinkage, and potential survival benefits among 12 patients in Phase I/IIa when in combination with Incyte’s retifanlimab. 70% of patients showed either disease control or progression-free survival benefits compared with their previous therapy attempts. Prior to the BriaCell study, the 12 patients had each failed at least 2 previous attempts at therapy regimens like chemotherapy or “targeted” therapy. The Bria-IMT clinical success is arguably even more impressive with this in mind. “We are very pleased to report that our combination therapy with Incyte’s retifanlimab produced clear evidence of tumor shrinkage and showed potential survival benefit in heavily pre-treated advanced breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We interpret these results to offer a potential opportunity for treatment in otherwise terminal patients. It’s very important to emphasize that these responses and clinical benefit occurred in women with advanced-stage breast cancer who have exhausted other treatment options.” What Else Does BriaCell Have In The Pipeline? BriaCell also reports it is currently developing next-generation off-the-shelf personalized immunotherapies targeting patients with advanced breast cancer and advanced prostate cancer. Bria-OTS+™, for advanced breast cancer, and Bria-PROS™, for advanced prostate cancer, are designed to activate naïve T cells and produce a strong immune response in patients. The company is impressed with the current data showing the ability of Bria-OTS+™ and Bria-PROS™ to boost the immune system response and produce strong anti-tumor responses in patients with advanced cancers. BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details CORE IR investors@briacell.com Company Website https://briacell.com/

December 02, 2022 10:00 AM Eastern Standard Time

First Patients Dosed in Phase I/II Trial of Enlivex’s Off-the-Shelf Cell Therapy Candidate, AllocetraTM

Enlivex Therapeutics, Ltd.

On November 13, Enlivex (NASDAQ: ENLV) announced that the first patient has been dosed in its Phase I/II clinical trial of Allocetra. The novel off-the-shelf cell therapy is designed to help break through the immune-suppressing tumor microenvironment – a key roadblock rendering potent immunotherapies less effective against solid cancers – to render those tough-to-treat cancers more responsive to these treatments. After a growing body of preclinical data demonstrated Allocetra’s potential to prolong survival duration and increase survival probability in mice, the Phase I/II studies are an important next step in evaluating their efficacy in humans. Immunotherapies Tap the Body’s Own Cancer-Fighting Capabilities – But Solid Cancers Remain Resistant As the field of immunotherapy makes strides, solid tumors continue to elude these novel treatments largely due to their complex and ever-adapting “tumor microenvironments.” These microenvironments leverage a range of immune-suppressing mechanisms that counteract the potent effects immunotherapies have had on skin and blood cancers. Chimeric Antigen Receptor (CAR)-T therapies, for example, have demonstrated a success rate as high as 90% for refractory B lymphocytic leukemia but as low as 17% for solid cancers. Novartis AG ’s (NYSE: NVS) Kymriah, the first CAR-T therapy to receive approval from the Food and Drug Administration, has since shown a durable remission and long-term survival rate, with as many as 55% of treated patients still alive more than five years later compared to the standard disease prognosis of 10% to 25%. The reason for this difference is largely due to the range of mechanisms tumors use to resist or evade the immune system including disguising themselves as healthy cells, releasing immune suppressing signals, and blocking immune cells from getting into the core of the tumor. The more the tumor grows, the stronger these immunosuppressive mechanisms get – making it harder for the immune system to detect it. This makes tumors some of the least responsive cells to immunotherapies of all kinds as that microenvironment counteracts the effects of the treatment. Even in cases where tumors do initially respond to the drug, they adapt to resist it and the once-helpful immunotherapy is rendered ineffective. Allocetra TM Uses Cell Reprogramming to Simultaneously Weaken Tumor Microenvironments and Strengthen the Immune Response Enlivex’s lead drug candidate, Allocetra TM, was developed as an off-the-shelf cell therapy that reprograms macrophages, the immune cells responsible for killing infected or harmful cells in the body. In cancer patients, macrophages often become reprogrammed out of their homeostatic state of relatively stable equilibrium so that they not only stop recognizing tumors as harmful but become weaponized by cancer to fend off other immune cells trying to attack the tumor. This reprogramming is a key mechanism of the resistance that cancer develops against immunotherapies. So the goal with Allocetra is to introduce healthy donor cells that have been modified with an “eat me” signal on their surface to trigger the non-homeostatic macrophages to engulf them. Once eaten, the donor cells are able to bring those macrophages back to a homeostatic state. Early preclinical results show that this process, on a stand-alone basis, is enough to increase survival duration and overall survival in mice with solid cancers similarly to current FDA-approved immune checkpoint inhibitors (anti-PD1 like Merck & Co Inc. ’s (NYSE: MRK) Keytruda, BMS’s Opdivo and Yervoy). But even more impressive was the synergistic effect of administering Allocetra in combination with these immune checkpoint inhibitors, which led to up to 100% complete remission of the cancer in the mice. The Start of Human Trials Marks a Key Milestone in Allocetra’s Development The next step for this new cell therapy is to test whether these promising preclinical results will translate to human studies. This month, Enlivex initiated a Phase I/II trial to do just that. After receiving approval from the Israeli Ministry of Health in October, Enlivex began dosing the first patients in the trial in November. The trial will enroll up to 48 patients with advanced solid tumors to evaluate the safety and tolerability of Allocetra as well as its preliminary efficacy, as measured by overall response rate and survival. Patients will be divided into two groups – stage one and stage two – with stage one patients receiving escalating doses of Allocetra as a standalone treatment while stage two patients will receive three injections of Allocetra combined with an anti-PD1 checkpoint inhibitor. As Enlivex enrolls more patients into the trial in 2023, it hopes to have top-line Phase I/II data by the second half of the year. As part of a new generation of companies representing the future of cell therapy – off-the-shelf, highly scalable and low COGS “beyond CAR-T” cell therapies – Enlivex is focused on a highly differentiated novel immunotherapeutic mechanism – macrophage homeostasis. Macrophage homeostasis is severely disrupted by certain diseases states, and such imbalance is critical to the progression of the diseases. Allocetra has the potential to introduce highly-effective, low-cost allogeneic cell therapies for life-threatening clinical indications that are defined as "unmet medical needs", including sepsis – one of the leading causes of mortality, and oncology, through restoration of macrophage homeostasis. Enlivex is led by a seasoned management team who founded PROLOR Biotech and led it to a successful $560 financial exit and a partnership with Pfizer. PROLOR’s lead product, now named NGenla® by Pfizer, recently received marketing approval in Australia, Canada, Japan and the EU. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA TM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA TM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. Contact Details Shachar Shlosberger shachar@enlivexpharm.com Company Website https://enlivex.com

December 02, 2022 08:00 AM Eastern Standard Time

Israeli Ministry Of Health Clears Way For Human Trials Of AllocetraTM, A Proprietary Off-the-Shelf Immunotherapy For Solid Tumors

Enlivex Therapeutics, Ltd.

The Israeli Ministry of Health (MOH) approved a Phase I/II trial of Enlivex Therapeutics Ltd. ’s (NASDAQ: ENLV) proprietary immunotherapy drug-candidate Allocetra TM. Allocetra TM is a cell therapy that uses healthy donor cells to reprogram and strengthen the patient’s immune response against cancer. If approved, the drug candidate would be a universal, off-the-shelf immunotherapy that could be combined with other leading immunotherapies and cancer treatments to improve a patient’s odds of beating this hard-to-treat disease. Here’s how the Israel-based biotech’s macrophage reprogramming drug works and what the latest clinical trial measures. Allocetra TM Reprograms Macrophages To Weaken Cancer Cells The first responders of the body’s immune systems, macrophages, patrol the bloodstream looking for signs of infection. Once spotted, they engulf the pathogen, rip it apart and alert other immune cells like T cells that it’s time to take action. When cancer cells grow in the body, the disease evades detection by tricking macrophages into believing the cancerous cell is a normal, healthy cell. Then, it can turn that macrophage into a pro-tumor ally that will suppress any immune response trying to kill the cancer. With Allocetra, healthy donor cells are sent in to reprogram the patient’s own macrophages so they not only stop helping the tumor but also start working with the immune system to fight those cancer cells again. To do that, Enlivex developed a proprietary process to program those donor macrophages to send out an “eat me” signal once injected. That signal tells the patient’s macrophages to eat the donor cells. Once engulfed, they set to work restoring it to its homeostatic state. Restoring Macrophage Homeostasis Could Help Overcome Checkpoint Inhibitor Resistance While reprogramming macrophages may already help boost the body’s cancer-fighting ability on its own, one of the most exciting potentials of this novel treatment is its ability to combat the resistance that cancers often develop against other immunotherapies. Because cancer can trick macrophages into defending tumors instead of attacking them, other immunotherapies, including checkpoint inhibitors like Merck & Co. Inc. ’s (NYSE: MRK) Keytruda or Bristol-Myers Squibb Co. ’s (NYSE: BMY) YERVOY, struggle to bypass the cancer’s new defenders. This challenge has resulted in response rates as low as 13% to these novel treatments. That figure is disappointing because, in theory, checkpoint inhibitors are extremely promising. Checkpoints like PD-1 and CTLA-4, the ones blocked by Keytruda and YERVOY, respectively, are “off switches” that help the immune system recognize and avoid attacking the body’s own cells. Just as cancer can trick macrophages into coming to its defense, it can use those checkpoints to trick the immune system into believing the cancer cell is a normal cell. By blocking those checkpoints, the cancer is no longer able to escape detection in this way. However, even when those checkpoints are blocked and the immune system kicks into action to fight the cancer cells it can now recognize, dysregulated macrophages form a kind of protective layer on top of a tumor that prevents the immune system from effectively attacking it. It’s that last layer of defense that researchers think may play a role in the low response rate of checkpoint inhibitors. Enlivex hopes that Allocetra TM ’s potential to reprogram those macrophages will help remove that protective barrier so that when the checkpoint inhibitor gets rid of the cancer’s “off switch,” the patient’s immune system won’t have any obstacles in its way to attacking that tumor. The Phase I/II Clinical Trial Will Study Allocetra TM Alone and in Combination with a Checkpoint Inhibitor The recent MOH approval paves the way for Enlivex to enroll up to 48 patients with advanced solid tumors in a multicenter, open-label trial that will include two stages. In stage one, patients will receive escalating doses of Allocetra TM by itself. The intravenous injections will be administered once a week for three weeks. In stage two, patients will receive three injections of Allocetra TM in combination with an anti-PD1 checkpoint inhibitor. In preclinical studies, this combination resulted in 50% survival probability for mice with ovarian cancer, compared to 15% or less for anti-PD1 checkpoint inhibitors on their own. While the primary objective of the study is to evaluate the safety and tolerability of Allocetra TM alone and in combination, researchers will also be measuring efficacy, including overall response rate, survival and progression-free survival. Enlivex says the new trial is slated to begin in the third quarter of this year. As part of a new generation of companies representing the future of cell therapy – off-the-shelf, highly scalable and low COGS “beyond CAR-T” cell therapies – Enlivex is focused on a highly differentiated novel immunotherapeutic mechanism – macrophage homeostasis. Macrophage homeostasis is severely disrupted by certain diseases states, and such imbalance is critical to the progression of the diseases. Allocetra has the potential to introduce highly-effective, low-cost allogeneic cell therapies for life-threatening clinical indications that are defined as "unmet medical needs", including sepsis – one of the leading causes of mortality, and oncology, through restoration of macrophage homeostasis. Enlivex is led by a seasoned management team who founded PROLOR Biotech and led it to a successful $560 financial exit and a partnership with Pfizer. PROLOR’s lead product, now named NGenla® by Pfizer, recently received marketing approval in Australia, Canada, Japan and the EU. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA TM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA TM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. Contact Details Shachar Shlosberger shachar@enlivexpharm.com Company Website https://enlivex.com

December 01, 2022 02:00 PM Eastern Standard Time

ALR Technologies Announces Co-branded Distribution Partnership with Covetrus for GluCurve Pet CGM, the First Continuous Glucose Monitoring System for Diabetic Pets

ALR Technologies SG Ltd

SINGAPORE- Media OutReach - 1 December 2022 - ALR Technologies SG Ltd (“ALRT”) (OTCQB: ALRTF), the diabetes management company, today announced it has entered into a co-branded distribution agreement (the “Agreement”) with Covetrus, Inc. (“Covetrus”), a global leader in animal-health technology and services, for ALRT’s GluCurve Pet CGM, a continuous glucose monitoring (“CGM”) system for diabetic cats and dogs. The GluCurve Pet CGM is the first and only continuous glucose monitoring system designed for diabetic cats and dogs and sold directly to veterinarians. “After meeting with many of the largest animal-health companies, Covetrus stood out as the clear choice as our partner to launch the GluCurve Pet CGM,” said Sidney Chan, chairman and CEO of ALRT. “Covetrus is uniquely suited for the sale and distribution of the GluCurve Pet CGM because of their industry leading service organization and differential go-to-market strategy that will help drive GluCurve to become the new standard of care for millions of diabetic animals around the world.” According to studies 1,2, 1 in 300 dogs and 1 in 175 cats have diabetes and until now, treating them could be a challenge for pet parents and veterinarians. The GluCurve records blood sugar levels every 3 minutes for up to 14 days, readings are displayed for the pet owner in the GluCurve app for iOS and Android and uploaded to a veterinary patient management web portal. In the web portal, the data are analyzed and organized into time saving graphs and tables, along with additional features such as glucose curve comparisons and overlays, insulin dose calculators, best practice guidelines, and more. “We welcome the opportunity to bring innovative technologies and devices, such as the GluCurve Pet CGM, to market to help animal health professionals battle a progressive but often manageable disease such as diabetes, in new and innovative ways,” said Cesar França, president, Global Proprietary Brands at Covetrus. “Veterinarians and their patients are our first priority and bringing products and technology to our customers that improve access, reduce burden and enhance care are the cornerstones of our mission.” Under the terms of the Agreement, Covetrus will have the exclusive rights to sell ALRT’s GluCurve Pet CGM as a co-branded product to veterinary clinics throughout the U.S., Brazil, United Kingdom, the European Union, and various other countries globally. Sales in the U.S. are expected to commence by the end of 2022. The quantity of available units will ramp up monthly to support a full U.S. launch followed by a global launch as inventories permit. 1 O'Neill, D G et al. “Epidemiology of Diabetes Mellitus among 193,435 Cats Attending Primary-Care Veterinary Practices in England.” Journal of veterinary internal medicine vol. 30,4 (2016): 964-72. doi:10.1111/jvim.14365 2 Yoon, Samuel et al. “Epidemiological study of dogs with diabetes mellitus attending primary care veterinary clinics in Australia.” The Veterinary record vol. 187,3 (2020): e22. doi:10.1136/vr.105467 About ALR Technologies SG Ltd. ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. In addition, the animal health division of ALRT has developed the GluCurve Pet CGM; a solution to assist veterinarians better determine the efficacy of insulin treatments and to help to identify the appropriate dose and frequency of administration for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans. More information about ALRT can be found at www.alrt.com and https://sg.alrt.com. About Covetrus Covetrus is a global animal-health technology and services company dedicated to empowering veterinary practice partners to drive improved health and financial outcomes. We are bringing together products, services, and technology into a single platform that connects our customers to the solutions and insights they need to work best. Our passion for the well-being of animals and those who care for them drives us to advance the world of veterinary medicine. Covetrus is headquartered in Portland, Maine with more than 5,700 employees serving over 100,000 veterinary customers around the globe. For more information about Covetrus, please visit https://covetrus.com/. ALR Technologies SG Ltd Forward-Looking Statement This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties, including statements about our plan, objectives, expectations and intentions. Such statements are subject to numerous risks and uncertainties. Factors that could adversely affect our business and prospects are set forth in our public filings with the Securities and Exchange Commission. Our forward-looking statements are based on current beliefs and expectations of our management team and, except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise. Investors are cautioned not to place undue reliance on these forward-looking statements. Contact Details ALR Technologies SG Ltd. Media Relations media@alrt.com ALR Technologies SG Ltd. Jacqueline Wu Jacqueline.wu@alrt.com

December 01, 2022 08:28 AM Eastern Standard Time

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