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Does This Brain Drink Help You Leave Work Earlier?

TruBrain

Interested in investing in TruBrain's campaign? Click here to get started! In our more remote, information-driven economy, efficiency and value creation are prized over the 1990s office model of 9 to 5 coffee-driven meetings and water cooler gossip. As a remote worker who writes for a living, I need long periods of deep work, when I can be both efficient and creative. TruBrain has helped me crack the code. TruBrain recognizes that most people today - regardless of their work - want to have healthy boundaries between their career and personal life so that they can put time into meaningful activities that matter most to them. The company is looking to help these people by providing drinks and edible products that nourish the brain and increase efficiency. Already over 90% of employees want a job that’s part or full-time remote - saying it allows better work/life balance - but achieving a productive flow state poses a real challenge for many people. The internet - with its continuous notifications and diversions - is the greatest source of distraction for most people. This kills efficiency, as brain science tells us that it can take as much as 23 minutes to return to a proper flow state after we’ve been distracted. Chugging a cup of coffee, blocking youtube, and locking yourself out of Twitter might be strategies that help some people deal with shallow work, but cutting-edge efficiency requires sustained focused concentration. That’s where TruBrain products come in - its ketone and nootropics products fuel the brain for its best thinking, giving it the nutrition it needs for concentration and focus. Finding the Brain Food That Works for You TruBrain primarily produces brain foods, though it has a variety of products. Tackling workplace stress - which over 90% experience at work - TruBrain has developed wearable tech that uses vibrotherapy in an effort to destress America’s workforce. Meanwhile, its custom drinks include various nootropics - as part of a $3.3 billion industry. Nootropics are natural or synthetic cognitive enhancers that increase concentration, creativity, memory, and brain growth. Caffeine is a basic nootropic, which works by blocking the drowsiness receptors in the brain - however, TruBrain’s drinks harness a host of healthy ingredients to power the brain for clearness and creativity. Its tasty drinks are based on various formulas combine to make a fully customized product line. TruBrain provides its personalized drinks package because it knows that each individual brain is influenced by a combination of unique genetic and external factors. The package currently offers a variety of 7 nootropics drinks designed to maximize mental performance. The range of the drinks means that you can tailor consumption based on your unique brain to perform at your best, regardless of the situation. TruBrain is a grassroots company with over 2000 individual investors. Profitable since 2019 as a company, TruBrain looks to advance in the direct-to-consumer market, with comparables in the space like successful companies Hims (NYSE: HIMS), RXBar, and EAS. With over $18 million in lifetime sales, it is currently raising funds through a new round of investing – will TruBrain become another great direct-to-consumer winner? Want to find out how to invest in TruBrain? Click here. To learn more about TruBrain, visit its website. TruBrain is a profitable brand in high-performance cognitive nutrition with over $18 million in lifetime sales. We deliver patent-pending brain food designed by neuroscientists to enhance your memory, focus, sleep, and more. Our personalized formulas will empower you to be the best version of your unique self. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Benzinga may receive monetary compensation from the issuer, or its agency, for publicizing the offering of the issuer’s securities. This content is for informational purposes only and is not intended to be investing advice. This is a paid ad. Please see 17b disclosure linked in the campaign page for more information. TruBrain's Reg A+ offering is made available through StartEngine Primary, LLC, member FINRA /SIPC.This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. For more information about this offering, please view TruBrain's offering circular and risks associated with this offering. Contact Details TruBrain Investor Relations invest@trubrainstock.com Company Website https://www.trubrain.com/

December 06, 2022 08:00 AM Eastern Standard Time

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

Video

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

Patient Safety Authority warns about the hidden risk of wheelchairs

Patient Safety Authority

A finger amputation while opening a wheelchair prompted the Patient Safety Authority (PSA) to issue a Safety Alert about wheelchair-related finger injuries. The alert warns the public and healthcare facilities to be vigilant when unfolding or sitting in the device. Hundreds of wheelchair-related injuries have been reported nationwide into the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) reporting system. Improperly opening a folded wheelchair can cause finger injuries, including amputation, bone fractures, nail loss, cuts, crushing, and pinching. Some reported injuries occurred when users placed their hand on the seat to open the chair. Others happened when the user tried to sit in the chair to unfold it. Wheelchairs are one of the most common assistive devices used in healthcare facilities, as well as malls, airports, arenas, courthouses, houses of worship, and other public buildings. They are often opened by volunteers, untrained staff, the users themselves, or their family members. Anyone who operates a wheelchair should read and understand the manufacturer's instructions before use. Wheelchairs are deceptively simple “The big challenge is that wheelchairs seem so simple to use. Yet, there are so many different types of chairs that there isn’t a one-size-fits-all way to open them properly,” notes PSA Patient Safely Liaison Molly Quesenberry, whose research led to the Safety Alert. "You really need the manufacturer’s instructions.” “Despite being an RN, I was never personally trained on how to unfold a wheelchair properly. I never realized the danger of losing a finger by improperly unfolding a wheelchair.” She recommends that facilities consider replacing folding wheelchairs with rigid frame ones or using an anti-fold device to keep them open, if available. PSA has also created a warning tag to urge the public to ask for assistance with a folded wheelchair and disseminated it to all Pennsylvania healthcare facilities. https://patientsafetyj.com/index.php/patientsaf/article/view/wheelchair-risks/wheelchair-tags Four additional wheelchair safety tips Check that the brakes are locked before sitting down in a wheelchair Use proper hand hygiene before and after use to decrease your risk of infection and illness Use extreme caution when considering buying used equipment Ensure seats are fully engaged before allowing someone to sit in the wheelchair “Wheelchairs are readily available from second-party vendors, such as Facebook Marketplace and EBay, but the safest choice is to purchase from a medical equipment company,” advises Quesenberry. “Get proof that it has been inspected and maintained and that the original manufacturer instructions are included.” Pennsylvania is the only state that requires healthcare facilities to report harmful events, as well as those that do not result in patient harm (i.e., near misses) but may be a harbinger of a potentially serious problem. The reports are collected in the Pennsylvania Patient Safety Reporting System (PA-PSRS), the largest repository of its kind in the United States. The PSA analyzes those events, facilitates widescale performance improvement projects, and shares the information globally. The PSA is an independent state agency that collects and analyzes patient safety data to improve safety outcomes and help prevent patient harm. http://patientsafety.pa.gov/ About PSA Established under the Medical Care Availability and Reduction of Error (MCARE) Act of 2002, the PSA, an independent state agency, collects and analyzes patient safety data to improve safety outcomes and help prevent patient harm. http://patientsafety.pa.gov/ Contact Details Bev Volpe +1 609-230-4696 bev@madisongall.com Company Website http://patientsafety.pa.gov/

December 02, 2022 09:45 AM Eastern Standard Time

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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

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