News Hub | News Direct

Healthcare

Addiction Biotech Cannabis Genetics Healthcare Medical Devices Pharmaceutical Science Veterinary
Article thumbnail News Release

Detecting Early Signs of Heart Disease

YourUpdateTV

One in five people worldwide have inherited high lipoprotein(a) and most don’t know it. Because high Lp(a) isn’t screened for, often the first sign of this condition can be a heart attack or stroke. There are more than 60 million people in the United States at high risk for a heart attack or stroke because they were born with high lipoprotein(a). Recently, Katherine Wilemon, founder and CEO of the Family Heart Foundation, teamed up with preventive cardiologist Dr. Seth Baum, chief scientific officer of Flourish Research, on a nationwide satellite media tour to raise awareness and encourage people to get screened. A video accompanying this announcement is available at: https://youtu.be/NGQBZxqF-GI Lp(a) is a cholesterol-like substance that is unrelated to the food you eat or how you live. People inherit Lp(a) levels from their parents and high levels of Lp(a) significantly increase your likelihood of having a heart attack or stroke. High Lp(a) is a "triple threat" as it can clog your arteries like LDL cholesterol but it also promotes inflammation and increases the risk of your blood clotting. If you have heart disease or have had a stroke, or someone in your family has experienced cardiovascular disease, it is important to get screened for high Lp(a). In addition, if your LDL cholesterol is very high — over 190 mg/dL —you should also have your Lp(a) tested. Research from the Family Heart Foundation revealed that fewer than 1% of Americans had ever had their lipoprotein(a) tested – and it’s a simple blood test. “The truth is with 20% of the population affected, and heart disease continuing to be the single biggest threat to one’s ability to live a long healthy life, everyone should be screened,” said Dr. Baum. The Family Heart Foundation declared March 24 Lp(a) Awareness Day to raise awareness worldwide. In its second year, this day draws attention to high Lp(a) as an under-recognized cause of premature heart disease and stroke. “March 24 is a perfect time for everyone to think about their family history, be screened for high Lp(a) and maybe change the future for millions of Americans,” said Wilemon. For more information, visit FamilyHeart.org. The Family Heart Foundation’s Care Navigation team can answer questions and connect you to a healthcare provider near you. About Katherine Wilemon On the month she turned 39 years old, Katherine Wilemon’s world was rocked by a heart attack caused by a complete artery blockage. It was the importance of family that drove Katherine to investigate the deeper physiological issues that contributed to her cardiac event. She learned that she had familial hypercholesterolemia (FH), and, years later, that she also had elevated levels of lipoprotein(a). The more Katherine advocated for herself, the more she encountered an inadequate understanding of genetic conditions such as FH. Always an entrepreneur, she founded the Family Heart Foundation in 2011 to increase early diagnosis and treatment. Over the years the Foundation has helped create a national research registry for FH, established diagnostic codes and consensus statements for care, and provided a community for those living with inherited cholesterol disorders. Now, the organization has expanded to drive awareness and scientific understanding of Lp(a) so that others with high levels can better protect themselves and their families. About Seth Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC Dr. Seth J. Baum is Chief Scientific Officer at Flourish Research, and clinical affiliate professor of Cardiology at FAU Medical School. He actively consults in Clinical Lipidology and Cardiovascular Disease Prevention and continues to offer lipoprotein apheresis for patients in southeast and central Florida. Dr. Baum has practiced Preventive Cardiology and Clinical Lipidology since 2000. He is a fellow of the American College of Cardiology, the American Heart Association, the American College of Preventive Medicine, the National Lipid Association, and the American Society for Preventive Cardiology. Dr. Baum is a past President of the American Society for Preventive Cardiology (ASPC). He currently serves on both the ASPC and Family Heart Foundation Advisory Boards. He has published over 100 peer reviewed papers and abstracts as well as two books. In 2013, he was awarded Cleveland Heart Lab’s “Heart Award” for lifelong dedication to Preventive Medicine. In 2019, Dr. Baum received Mended Hearts’ biennial Dwight Emary Harken Award. Dr. Baum is the Founder of Excel Medical Clinical Trials, LLC, a consortium of clinicians dedicated to the safe and professional conduct of high-level scientific trials. He has served as Principal Investigator in over 100 clinical trials covering a broad range of disease states. Dr. Baum is the Chief Scientific Officer of Flourish Research, a leading national clinical research company. Dr. Baum is a graduate of Columbia College and Columbia College of Physicians and Surgeons, and completed training in Internal Medicine, Cardiology, Interventional Cardiology, and Electrophysiology. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

March 22, 2023 09:19 AM Eastern Daylight Time

Video
Article thumbnail News Release

What Is Autologous Cell-Based Therapy, The Treatment Revolutionizing Regenerative Medicine That Could Be Set To Explode Over The Next Few Years?

BioRestorative Therapies, Inc.

By Julian Richard, Benzinga Successful Autologous Cell-Based Therapies The global CAR-T cell therapy market is growing continuously due to novel clinical and commercial developments in this therapy. As a result, the Global CAR-T cell therapy market is expected to be worth USD 4.36 billion by 2028 from 2.31 billion in 2023, growing with a healthy CAGR of 13.5% during the forecast period. Companies like Pfizer (NYSE: PFE) Johnson & Johnson (NYSE: JNJ, Bristol-Meyers Squibb (NYSE: BMY) as well as Gilead Sciences (NASDAQ: GILD) all are focusing on this innovative CAR-T cell therapy. Autologous cell based therapies are personalized therapies using your own cells to target a disease or disorder. Personalized therapies targeting cancer such CAR-T cell therapies have generated impressive clinical results with complete remission rates in B-acute lymphoblastic leukemia in over >80% of patients. One of the reasons this therapy has been successful is because it is autologous. In 2017, the U.S. FDA approved the first two CAR-T cell therapies: Novartis’ Kymriah ® for treatment of acute lymphoblastic leukemia (ALL) and Gilead subsidiary Kite Pharma’s Yescarta ® for certain types of large B-cell lymphomas, a type of non-Hodgkin lymphoma. These autologous therapies are patient-specific where the therapeutic CAR-T cells are created from a patient’s own cells. The Value of Autologous Stem-Cell Therapies Autologous stem-cell therapy is a novel medical technology that is revolutionizing the way the medical community approaches the treatment of metabolic, autoimmune and degenerative diseases. Additionally, this technique has been used successfully to develop skin grafts for wound care, treat burns and bedsores and speed up recovery after surgery. The method involves extracting stem cells from a patient’s body and culturing them in laboratory conditions before reintroducing them into the patient. Stem cells are a unique type of cell that can develop into any other cell in the body. These “supercharged” cells can be used for tissue regeneration and repair, making stem cells a potent tool in modern personalized medicine. Stratified medicine simply cannot compete with this customization, precision, and safety profile. The main benefit of using autologous cells is that these cells come from your own body and therefore do not trigger any immunological rejection reactions. They also minimize the risk of infection from non-patient sources. This allows autologous cell therapy to be used safely over a longer term, ensuring that the patient can access consistent and reliable treatment without risk of rejection or complications due to incompatibility. In 2021, the autologous cell therapy market was valued at $4.3 billion and was projected to skyrocket to $29.1 billion by 2031—marking a compounded annual growth rate (CAGR) of 21% from 2022-2031. Although the market is still nascent, it is expected to eventually create a new healthcare sector with revenue similar to that of the pharmaceutical, biotechnological, and medical devices industries. An Autologous Stem Cell-Based Approach to treat Disc Pain BioRestorative Therapies Inc (NASDAQ: BRTX) focuses on innovative “home-grown” autologous stem-cell therapies to address unmet needs in patients with common yet serious diseases. It was founded by medical doctors, scientists and world-renowned stem-cell researchers committed to developing novel stem-cell therapies. The lead candidate in BioRestorative’s musculoskeletal stem-cell platform is BRTX-100, administered as a minimally-invasive single intradiscal injection. BRTX-100 is currently being evaluated in an FDA gold standard phase 2 double-blind, controlled, randomized study in those with chronic lumbar disc disease (cLDD). Chronic lumbar disc disease affects over 500 million individuals globally and is currently only treatable with opioids and surgery. Despite being the most commonly prescribed drug for cLLD, no clinical data supports the use of opioids in cLLD, which only serves to increase the opioid crisis in the USA. Surgery for cLLD carries many disadvantages and limitations. The cost of surgery can be high. While surgical intervention may reduce pain in some cases, it often fails to restore previous levels of function or mobility. Revision or reoperation rates for surgical intervention in the spine can be upwards of 20-30% of the cases performed. Furthermore, a more extended recovery period is associated with an increased risk of mechanical instability of the spine and potentially increased failure rates compared to non-surgical treatments. It would appear a bright future awaits BioRestorative Therapies and the autologous cell therapy market in general as patients increasingly look at personalized alternatives to surgery and conventional medicine. BRTX-100 is an innovative and minimally-invasive technology set to revolutionize lower back pain treatment. Visit https://www.biorestorative.com for more information on the company and its product candidates. This article was originally published on Benzinga here. BioRestorative Therapies was founded by scientists and researchers committed to developing stem cell therapies to address unmet needs in patients with highly prevalent conditions.Our advances in stem cell biology and delivery protocols harbor great promise in conditioning our bodies’ own regenerative potential to treat major diseases more effectively than current interventions.Today, BioRestorative is actively developing programs that aim to dramatically increase quality of care for both (i) chronic back pain caused by disc degeneration, as well as (ii) metabolic disorders including obesity and diabetes. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Investor Relations ir@biorestorative.com Company Website https://www.biorestorative.com/

March 22, 2023 09:15 AM Eastern Daylight Time

Article thumbnail News Release

Coya Therapeutics’ COYA 302 Treating ALS Proves Effective In Proof-Of-Concept Academic Clinical Study

Coya Therapeutics Inc.

By David Willey, Benzinga Coya Therapeutics, Inc. (NASDAQ: COYA) recently reported 48-week clinical data for its proof-of-concept open-label study in 4 ALS patients indicating that treatment with COYA 302 appeared to significantly ameliorate disease progression (stopping progression in all patients at 24 weeks with minimal decline at 48 weeks.) This was in a patient cohort who was declining prior to entry into the study. Four ALS patients with a mean decline of -1.1 points/month in the Revised ALS Functional Rating Scale (ALSFRS-R) score prior to study initiation, were treated for 48 consecutive weeks with COYA 302 and were evaluated for safety and tolerability, Treg suppressive function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale. Following the administration of COYA 302 for 48 weeks, patients were evaluated over an 8-week washout period. During the 48-week treatment period, COYA 302 appeared to be well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths or other serious adverse events were reported. Preliminary efficacy of COYA 302 was measured by the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment with COYA 302 were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), indicating significant amelioration in the progression of the disease over the 48-week treatment period. Treg suppressive function, expressed as percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period. Treg suppressive function at 24 weeks (79.9±9.6) and 48 weeks (89.5±4.1) were significantly higher compared to baseline (62.1±8.1) (p<0.01), suggesting enhanced and durable Treg suppressive function over the course of treatment. In contrast, Treg suppressive function (mean ±SD) was significantly decreased at the end of the 8-week washout period compared to end-of-treatment at week 48 (70.3±8.1 vs. 89.5±4.1, p <0.05). The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggest a decrease of these biomarker levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing. This article was originally published on Benzinga here. About Coya Therapeutics, Inc.Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice Contact Details David S. Snyder David@coyatherapeutics.com Company Website https://coyatherapeutics.com/

March 22, 2023 09:15 AM Eastern Daylight Time

Article thumbnail News Release

RenovoRx’s Principal Investigator of Phase III Clinical Trial Discusses Positive Interim Results on Patients with Locally Advanced Pancreatic Cancer on OncologyTube

TalkMarkets

In the interview, Dr. Michael Pishvaian discussed the trial's potential impact on the oncology community as well as how pancreatic cancer patients are treated. Dr. Pishvaian’s interview with OncologyTube is featured here. Recently RenovoRx ( RNXT ) announced interim data in the Phase 3 open-label TIGeR-PaC clinical trial investigating the company's first product candidate, RenovoGem, as a potential treatment option in locally advanced pancreatic cancer (LAPC). The interim analysis suggests a 6-month potential improvement in median overall survival with RenovoGem. The study compares treatment with RenovoTAMP versus standard-of-care systemic intravenous administration of gemcitabine and nab-paclitaxel, which has a seven-week survival benefit and a $1 billion addressable market. About Locally Advanced Pancreatic Cancer (LAPC) According to American Cancer Society’s Cancer Facts & Figures 2023, pancreatic cancer has a 5-year combined overall survival rate of 12% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond pancreas, however, has advanced to the point where it cannot be surgically removed. LAPC is typically associated with patients in stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system. About RenovoGem RenovoGem™ is the first drug-device combination product candidate that utilizes the RenovoTAMP ® therapy platform via pressure-mediated delivery technology to deliver gemcitabine, an FDA-approved chemotherapy, locally across the arterial wall to bathe tumor tissue in the chemotherapy. RenovoGem is currently being evaluated in the Phase III TIGeR-PaC clinical trial study in Locally Advanced Pancreatic Cancer (LAPC) patients. The Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA) in a clinical trial, which is anticipated to begin in the first half of 2023. About RenovoRx, Inc. RenovoRx is a clinical-stage biopharmaceutical company with a vision to disrupt the current paradigm of cancer treatment. Our mission is to lead a revolution in oncology therapy by delivering its innovative and targeted intra-arterial (IA) delivery of chemotherapy directly to solid tumors. The proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP ® ) therapy platform aims to avoid the harsh side effects typical of the current standard of care, or systemic delivery methods, thus improving patient well-being and, potentially extension of life, so more time may be enjoyed with loved ones. RenovoTAMP utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and clinical use, with the goal of improving their safety, tolerance, and widening their therapeutic window by providing more targeted delivery at the location of the tumor tissue. RenovoRx’s lead product candidate, RenovoGem TM, is a combination of gemcitabine and its patented delivery system, RenovoCath ®, and is regulated by the FDA as a novel oncology drug product to treat unresectable locally advanced pancreatic cancer (LAPC). RenovoGem is currently being studied in the Phase III TIGeR-PaC clinical trial for the treatment of LAPC. RenovoRx’s patent portfolio for its therapy platform and product candidates includes eight issued U.S. patents, one issued European patent, and several additional patents pending in the US, EU and Asia. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer (cholangiocarcinoma). Originally published on TalkMarkets Related Articles: RenovoRX's Latest Innovative Technology Creates New Hope For Chemotherapy Patients RenovoRx Phase III Open Label TIGeR-PaC Interim Analysis Shows Promising Data That Support Continued Clinical Investigation Of RenovoGemTM As A Treatment Option For Locally Advanced Pancreatic Cancer More By TalkMarkets Newswire: BriaCell Announces Positive End of Phase II Meeting with the FDA for Bria-IMT(TM) Combination in Advanced Metastatic Breast Cancer SurgePays Passes 150,000 Mobile Broadband Subscribers SurgePays Announces the Acquisition of Torch Wireless Contact Details TalkMarkets +1 732-325-3037 ir@talkmarkets.com

March 22, 2023 09:00 AM Eastern Daylight Time

Image
Article thumbnail News Release

Global Wellness Company Fine Hygienic Holding Launches eon Longevity, an All-Natural Herbal Longevity Supplement

Fine Hygienic Holding

Fine Hygienic Holding (FHH), one of the world’s leading wellness groups, today announced the launch of eon ™, a powdered, herbal beverage supplement that supports overall health and longevity. Comprising an all-natural, proprietary herbal blend, eon Longevity +Plus (eon’s signature product) underwent one of the largest clinical studies in the supplement space. The results verified that eon supports the health of the cardiovascular, respiratory, and gastrointestinal systems; regulates normal metabolic balance; and helps reduce inflammation — all of which result in a healthier and stronger body. One of the most impactful findings is eon’s ability to reduce inflammation, which is a breakthrough since inflammation is at the core of most, if not all, diseases in the human body. “With these outstanding clinical results, it can be argued that eon could be the healthiest beverage a person can consume and should be part of everyone’s personal wellness program to improve quality of life and even life expectancy,” said Medical Wellness Association (MWA) President Dr. Christopher Breuleux, who underwrote the clinical study. “We are a company devoted to improving people’s health and lives by providing reliable, tested, high-quality products,” said eon Founder and FHH President of Wellness Elia G. Nuqul. “We are extremely happy to finally make this amazing product available after more than 3.5 years of hard work. The biggest reward in all this is knowing we have something that can really improve people’s health and lives, and unlock their longevity at an affordable price.” eon is the first FHH product to be fully procured, manufactured, packaged and launched in the U.S. The beverage supplement has also been professionally certified by the MWA. FHH CEO James Michael Lafferty said, “eon reduces total body inflammation, resulting in significant health benefits. You will not find a modern drug using these powerful ingredients to battle inflammation, which is often linked to conditions such as cancer, heart disease, diabetes, asthma, and Alzheimer's disease.” Inspired by Tea from the Mediterranean The inspiration behind eon’s innovation came from a viral video viewed by Lafferty and Nuqul. It featured a centenarian man youthfully navigating his village, climbing trees, and attributing his long and healthy life to his herbal tea. Captivated by this video, Nuqul embarked on an international sojourn to locate the elder gentleman and learn directly about the drink that kept him so spry. After studying, modifying, and enhancing the tea with the MWA, eon is the result. “eon is a beautiful marriage of nature and science. The ingredients of this beverage supplement have been tested independently and proven to have significant health benefits, most notably in the battle of inflammation and the systemic problems it causes,” added Lafferty. “Here was this centenarian living a healthy and full life attributed to drinking this drink, so we asked ourselves: What if the root to longevity is in the Mediterranean — and what if this benefit was available to everyone for the same price as a cup of coffee?” Clinical Study Results The clinical study, underwritten by the Medical Wellness Association, was one of the largest ever in the wellness supplement industry. Each participant consumed the beverage daily, all under medical supervision. The clinical trials scientifically proved, with statistical significance, that the consumption of eon Longevity +Plus yielded a range of health benefits, including: Reduces and controls inflammation and pain, a breakthrough since inflammation is at the core of most, if not all, diseases in the human body Supports cardiovascular and respiratory health Powerful source of antioxidants Regulates normal metabolic syndrome and improves gastrointestinal (gut) health Improves kidney and liver function (*amongst a subset of the clinical study) Reduces pre-diabetes risk factors Reduces stress Improves mood, vitality and sleep eon Now Available In addition to the clinically proven eon Longevity +Plus (which includes the highly bioavailable curcumin), customers also have access to eon Longevity, which is the all-natural herbal proprietary blend inspired by the centenarian man (without the curcumin). For best results, consume either blend at least once daily mixed with warm or cold water on an empty stomach. It may also be added to other beverages such as coffee or tea. The beverage supplement is only available as individual stick packs online at www.eon-longevity.com. About eonThe eon Longevity Blends™ are all-natural, herbal beverage supplements inspired by a generations-old formula and created by nature. Through one of the largest clinical studies conducted in the supplement space, eon Longevity +Plus (eon’s signature product) has been scientifically proven to provide significant health benefits when consumed at least once a day, especially through the reduction of inflammation. eon is part of Fine Hygienic Holding, one of the world’s leading wellness groups. More at www.eon-longevity.com. About Fine Hygienic HoldingFine Hygienic Holding (FHH), one of the world’s leading wellness groups and MENA’s leading manufacturer of hygienic products, serves consumers in more than 80 countries around the world. Originally established as a paper manufacturer, FHH has transformed into a wellness company dedicated to enhancing global health and wellbeing. Committed to becoming “the shining star of the Arab FMCG business world,” the Group focuses on wellness, sustainability, pioneering CSR programs, and state-of-the-art production processes. Fine Hygienic Holding offers a diverse array of award-winning products, including sterilized facial tissues, napkins, kitchen towels, toilet paper, baby diapers, adult briefs, jumbo rolls. It also offers away-from-home products to accommodate all types of private and public institutions in addition to its advanced range of personal protective equipment and long-lasting germ protection solutions. FHH also brings Nai natural iced teas and innovative nutritional supplements, such as eon and Motiva, to the market. Contact Details Rana Kawalit | │ Corporate Communication & PR Director +971 54 531 5575 Rkawalit@finehh.com Company Website https://www.finehh.com/

March 21, 2023 05:20 PM Eastern Daylight Time

Article thumbnail News Release

Evogene Offers Stock Investors An Excellent Risk/Reward Ratio

TalkMarkets EVGN

We think the company’s main CPB computational engine has the potential to be an extraordinary value creation engine as it can create: A near endless stream of potentially valuable new compounds. Developing these in subsidiaries with the ability to tap their own sources of funding (milestone payments, participations, license and royalty sales, etc.). They already have five subsidiaries and one division. Commercial success, three of their subsidiaries already have products on the market, albeit in the very early innings. IPOs, putting a market value on the subsidiary and a large pile of additional cash. Rinse-repeat. The company has no debt and has enough cash to last into next year with multiple additional sources of funding likely materializing at the subsidiary level well before that. The market cap ($27M) is a fraction of the potential with many of its subsidiaries likely exceeding that on an individual basis. There is risk, but it’s well spread among five subsidiaries and one division, investors only need one of these to succeed to de-risk their investment at these levels. Introduction Evogene ( EVGN ) has a proprietary CPB (Computational Predictive Biology) platform in order to greatly improve the chances of successful product discovery and speed up product development in life science industries through the use of big data and AI. Unlike competitors like Schödinger ( SDGR ), Evogene mainly develops new compounds for its own development (through five subsidiaries and one division), rather than third parties even if it does have quite a number of partnerships and some income from IP. Some of the products have already reached the commercial stage. Other competitors include Ginkgo Networks ( DNA ), Exscientia ( EXAI ), and Relay Therapeutics ( RLAY ) Successful product candidates are given their own subsidiary for further development and commercialization and they can also attract partners which help with capital needs and put a valuation on the subsidiary. At present, the company has five subsidiaries: Biomica: Microbiome based therapeutics Lavie Bio: Ag biologicals Ag Plenus: Ag chemicals Canonic: Medical cannabis Casterra: Castor oil production The CPB platform The mission of the CPB platform is ( 20-F ): to revolutionize the product discovery and development approach in life science industries by decoding the biological world using computational biology The CPB platform uses big data and machine learning and is greatly helped by the twin data and computational processing revolutions (20-F): This platform is the outcome of over a decade long multidisciplinary effort to integrate scientific concepts with big data and advanced computational analytics in order to develop predictions of potential product candidates that later undergo experimental validation and optimization toward commercialization. We believe that the uniqueness of our computational prediction approach stems from our ability to successfully address multiple product attributes at the beginning of the discovery process, and during the optimization phase. The CPB platform has three engines, each tailored for a specific domain ( see graphic ): MicroBoost AI for the identification and development of new microbial candidates. ChemPass AI for the identification and development of new small molecules. GeneRator AI for the identification and development of genetic elements. The addressable market is very large. But management indicated that in order to preserve cash, they will focus on the development of existing products in their existing subsidiaries, rather than discovering new compounds, which is reasonable as the subsidiaries already have plenty of useful compounds to bring to market (in fact, some of them have already been introduced to the market). Before we describe the company’s different subsidiaries, we have to draw attention to the fact that Evogene’s Ag-Seed division is still part of Evogene’s business. The division has cooperation deals with the likes of Monsanto, now Bayer ( BAYRY ) and several others like Corteva ( CTVA ), Tropical Melhoramento & Genética S/A, and TMG for the development of bio seeds. These agreements are confidential, so we don’t really know the progress here. There were more recent deals with Plastomics in 2021 for the joint development of novel insect control traits for soybeans, and Bayer revived its interest in December 2022 with a $3.5M payment for the license to genes discovered to address specific seed traits, for use in corn, soy, cotton, and canola. The biotech seeds market is huge and is expected to reach $78 billion by 2030. SUBSIDIARIES: Biomica Biomica, 67% owned by Evogene (after it raised $20M from partners at a $50M valuation), develops solutions for the human microbiome, focusing on innovative microbiome-based therapeutics for the treatment of immune-mediated and infectious diseases, in particular, Immuno-Oncology, GI-related disorders, and Antimicrobial resistance. The realization that the microbiome (the bacteria in the gut) plays a crucial part in human health and the immune system has grown very fast in the last years. It won’t be a surprise that this field offers a large and very fast-growing market ( see graphic ), as can be seen from Bionica’s IR presentation. There are all sorts of potentially very interesting opportunities, as is illustrated from Science Magazine: Early results from two groups described at the annual meeting of the American Association for Cancer Research (AACR) here this week suggest some patients who initially did not benefit from immunotherapy drugs saw their tumors stop growing or even shrink after receiving a stool sample from patients for whom the drugs worked. However, researchers caution, the results are preliminary. But it isn’t clear which microbes are responsible for this remarkable effect, providing ample space for discovery and the company already developed BMC128 which is pretty promising. As in other fields, the computational method of finding key microbes using big data and machine learning can deliver much faster results than the traditional biological method. Central in the company’s discovery and development process is its proprietary PRISM (Predictive, High Resolution, Integrative Selection of Microbes) platform. There is a considerable degree of the personalization involved ( see graphic ). The company also has the ability to identify which genetic microbe functions are producing which aspect of product development, such as stability, efficacy, shelf life, etc. ( see graphic ). BCM128 showed similar promise when used with a checkpoint inhibitor against melanoma ( see graphic ). Within the confines of this article, we can’t cover all the details, but these can be found in the IR presentation and a detailed article By Steven Goldman. Building on these very impressive successes, BMC128 already started a phase 1 trial (in combination with Bristol Myers' PD-1 checkpoint inhibitor) with the first patient given a dose in July last year ( see graphic ). The trial has already progressed to the third patient (from a total of 12) and the first results (when the first few patients have concluded their treatment programs) are expected in the spring of this year with the trial finishing before the end of the year. It’s early days but these preclinical results were highly impressive, potentially opening up BMC128 for a host of solid tumor treatments producing significant improvement (in combination with checkpoint inhibitors). They have also been given the green light from Israeli regulators for another clinical trial for BMC128 in combination with Opdivo for treating patients with Non-Small Cell Lung Cancer "NSCLC", Melanoma or Renal Cell Carcinoma and they have a supply agreement with Bristol Meyer in place. But it’s early days, we don’t even have the results of stage I clinical trial yet, but on the other hand, we should also not forget that their pipeline has several other candidates: BMC333 for IBD (inflammatory bowel disease), with early indications of success and for solid tumors (in combination with immune checkpoint inhibitors). Once again, Steven Goldman provides more details. BMC426 for IBS (Irritable Bowel Syndrome). BMC202 to address C. difficile infections. A small molecule in the advanced discovery stage that is a candidate to address MSRA infections. Nor should we overlook their data and computational engines that can continue to provide the company with a stream of new promising candidates. The company did raise $20M in financing last December, $10M of which from Chinese private equity firm Shanghai Healthcare Capital, giving it a 20% stake in the company so the deal puts a $50M valuation on the company, almost double the entire market cap of Evogene. Lavie Bio Lavie Bio, 72% owned by Evogene, develops two types of products, bio stimulants and bio pesticides. The company has a substantial pipeline with one product, Thrivus (formally called result), already in the commercial stage and two others close to it (Source: Lavie IR presentation). Thrivus (LAV211) has already been selling in the crop season in parts of South Dakota last year, with the help of a distribution deal with United Agronomy, and is expected to expand sales to other areas in the US and Canada in the 2023 crop season. Thrivus has been field tested for four years and can bring significant advantages to farmers ( company PR ): the development of result™ included positive four-year field trials in multiple locations and commercial validation through broad-acre fields under standard farmer practices in target locations. The results achieved in the field trials have demonstrated that result™ has the potential to contribute an additional 3-4 bushels per acre and showed increased yield improvement compared with industry benchmarks. Based on current wheat prices for farmers, this could provide growers an average of $30-40 in additional revenue per farmed acre. Lavie also has two strategic partners, Corteva and ICL ( see graphic ). Including the shares of Taxon Bioscience, the investment of Corteva in Lavie was $27.5M for a roughly 28% stake in Lavie. The $10M investment from ICL was a SAFE (simple agreement for future equity) investment with a fixed value for the next round and not likely below the Corteva value in 2019 when there wasn’t a commercial product yet. The fact that Evogene still owns 72% of Lavie should have investors rejoicing as it indicates that Lavie’s value alone is considerably above Evogene’s market cap (which is under $30M). Investors should be aware of the potential. The Spring Wheat market covers 10M acres throughout the US and constitutes a $12M market opportunity for the company. Adding Canada would make this 25M acre. There are other expansion opportunities: Further territories will be addressed during the 2024 spring wheat season in a few other states and a part of Canada, this could ultimately spread to all of the US and Canada Further international use Label expansion, for instance addressing the winter wheat market which is 5-10x the size of the spring wheat market. Further label expansion like addressing additional small grains, such as durum, barley, and oats, adding over 20M acres in North America; international expansion and/or using Thrivus on oil seed crops, such as canola and soybean. And it’s not just Thrivius, there are plenty more candidates in the pipeline ( see graphic ). LAV311/LAV312, a biofungicide targeting fruit rots and powdery mildews based on novel bacteria naturally present in nature, could very well be their second product as it is close to commercialization. The company has supplied the registration package to the EPA in October 2022. This process normally takes some 18 months. Management hopes to soft launch for the 2024 growing season, this is a $2B market and the indications so far are very promising ( company PR ): Over the past three years, LAV.311 has consistently demonstrated control of fruit rots and powdery mildew in grapes, strawberries, cucurbits, and fruiting vegetables, in over 30 trials conducted in the U.S., Europe and Israel. Indeed, here is management on the Q4CC: The initial product market type for LAV311 is over $200 million in the treatment of risk and there is a potential room to expand the target market to over $800 million, once it includes targeting additional fruits and vegetables. In the coming year, we plan to expand the potential addressable market for LAV311 by broadening its applications to additional crop while optimizing the product and manufacturing costs. LAV321/LAV322 is another candidate targeting the Downey Mildew market, a $350M market (grapes chemical usage) with further potential $150M upside although a commercial launch won't be before 2025. Apart from one commercial launch and several promising products in its pipeline, investors should further appreciate that Lavie has not only achieved two well-capitalized partners, it also reached the commercial stage with Thrivus, lessening the financing need of Evogene. So this could quickly add up a few years down the road. Therefore, we think Lavie alone could be worth hundreds of millions of dollars in a few years, making a mockery of Evogene’s present market cap. Ag Plenus This subsidiary plans to introduce something that hasn’t happened for three decades, new MoA (Mode-of-Action) non-toxic weed killers. This is a very large market with an urgent need for innovation. Simply mentioning RoundUp and the trouble it has gotten into, there is an urgent need for non-toxic weed killers and protective insecticides. Apart from toxicity, the market also suffers from increasing weed resistance to many herbicides, there is a real problem here, and a large market opportunity for products that can solve these. The company has a considerable pipeline of substances but they’re got significant work to do before they can reach commercialization, as seen from the AgPlenus IR presentation. The table excludes product development programs undertaken with collaborators (which are subject to confidentiality restrictions). Their main candidate APTH1 has broad applicability ( see graphic ). Broad applicability for a non-toxic weed killer, that would open up a huge market opportunity, in fact, they’re developing both herbicides and insecticides ( see graphic ). And here too, the company is collaborating with Corteva: Develop new MoA herbicides to target resistant weeds Started in March 2020 AgPlenus will discover and optimize herbicide candidates Corteva will conduct testing and product development License to Corteva Corteva has exclusive license to products of collaboration AgPlenus receives research fees, milestones and royalties upon commercialization From the Q4CC: Corteva received license to this product subject to AgPlenus being paid, research fees, milestone and royalty upon commercialization. The AgPlenus-Corteva collaboration has been ongoing since March 2020. With a $90B market (by 2026) to go after, big commercial crops like corn and other cereals already show tolerance to the company’s APTH1, and other crops could follow by developing a resistance trait for them (something that the company has already shown for tobacco). Management argues that a novel mode of action herbicide such as APTH1 could generate peak sales of $750M to $1.5B, again making a mockery of the company’s market cap. But once again, we’re a long way off from there, and it’s likely they will partner well before that happens, or do an IPO. Canonic Canonic uses plant genomics data and computational genomics, which is Evogene’s GeneRator AI tech engine to enhance properties in medical cannabis, as seen from the company IR presentation ( see graphic ). The company already has one commercial product and another one under development, as seen from the Evogene IR presentation ( see graphic ). The company launched a second generation products with even higher THC levels and unique terpene profiles with a market introduction in Israel that was very well received. The company also struck a licensing deal with GroVida, a Portuguese cannabis cultivation company, for the commercialization of two of their new cannabis lines in Europe. The company announced in February that these six products are now launched in Israel: Synergy Sativa (THC 24%) Combo Indica (THC 24%) Mosaic Indica (THC 23%) Mash Kush Indica (THC 24.4%) Blend Kush Indica (THC 23.8%) Two Stars Sativa (THC 24.2%) Looking ahead, we will continue the development of our third-generation products, particularly with selecting new and unique terpenes. Furthermore, we intend to sell our products to broader markets starting with Europe Not everybody might be familiar with Terpenes ( Q3CC ): plant compounds known to provide relief for many mental symptoms, including pain relief, anti-inflammation, anti-anxiety, anti-depression and more. They also influence the aroma and the scent of the cannabis inflorescence. The market for medical Cannabis products has become quite competitive so management is reducing cost and is considering various longer-term options for the company. Casterra Recently interest has been greatly revived in this subsidiary due to renewed interest in castor oil as a biofuel and the phasing out of some alternatives like palm oil, resulting in a major deal for the company with a large European energy company (see below). Using Evogene’s GeneRator engine, Casterra is developing compounds to assist the cultivation of castor grains and the castor oil value chain with end-to-end solutions, as seen in the following graphic from the Casterra website. Casterra is an offshoot of Evogene’s Ag-Seed’s division which has a wider remit, targeting key commercial crops such as corn, soy, wheat, rice and cotton in order to improve plant traits. Casterra is concentrating on castor grains, utilizing biotechnology approaches in order to improve traits. The company has a number of solutions, including three castor varieties and even some proprietary machinery, like a fast-moving harvesting header with reduced field losses and a high-capacity dehulling machine. Castor beans have significant advantages for the biofuel market (Q4CC): Castor beans represent the highest energy return to growth as they have high oil content, approximately 50% can go on marginal lands, meaning that they pose no competition on land which can support other edible crops and support environmentally-friendly cultivation practices. This is a $1.2B global market, and given the high oil and energy content and environmentally friendly cultivation practice, biofuel is a significant opportunity, with tailwinds from regulation in Europe (requiring transportation fuels to contain 14% biofuels by 2030 and banning products linked to deforestation, like Palm oil to fulfill this role). The company’s varieties have considerable advantages over existing ones (95% come from India), from Steven Goldman quoting Evogene’s CEO Ronen: Ronen explained that traditional castor oil plants (grown from Indian sourced seeds) are typically tall, grown plantation style and have low grain yields: 500 kg/Hectare or Ha (approximately 2.2 acres) in non-irrigated soils and 700 kg/Ha in irrigated soils with less than 50% oil content, generating 250 kg to 350 kg of castor oil per Hectare. In contrast, Casterra's proprietary castor oil seeds result in castor oil plants which are smaller, with a denser architecture, shorter growth cycle and much higher yield of 2,000 kg to 3,000 (or higher) per hectare per cycle, generating 1,000 to 1,500 kg of castor oil, with the potential to increase the number of castor bean crop plant/harvest cycles each year from two to three. In fact, Ronen indicated that in remarkably optimized conditions, he has seen reports of Casterra's castor bean seeds producing 5,000 kg of castor beans per hectare yields generating approximately 2,500 kg of oil per hectare (per growing cycle). The current market price for unrefined castor oil is approximately $1,800 US FOB per metric ton. Indeed, in January 2023, the company announced an agreement with a major European energy company (one of the seven sisters) for the biofuel market. The PR sounds a little dry but management is very encouraged by this as it can potentially open up tens of millions of dollars in orders in a couple of years. This deal alone has put the company on the map and investors should take notice. In November 2022 the company signed a long-term exclusive production and distribution agreement with Titan Castor Farms in Zambia where Titan will pay royalties on the sale of its castor oil products starting in 2023. The market opportunity is substantial with roughly $500 per hectare per year in yield and likely to be at least a few million hectares by 2030, we’re looking at several hundred million dollars assuming Casterra can capture a significant part of that market. To compare, CoverCress is a company with a similar concept to Casterra, doesn’t produce revenues yet, and was sold to Bayer for what management believes to be roughly $200M. There is lots of interest in the sector. Finances The company still doesn’t generate much in terms of revenue ( see chart ). But with several subsidiaries (Canonic, Lavie) now having commerical products on the market, that is likely to change. The cash bleed is down to under $30M per year ( see chart ). The company has $35M in cash, which is certainly enough to take them into 2024 as they expect a cash burn of $27M-$29M this year. And this assumes no additional financing on the subsidiary level, given what happened last year this strikes us as unlikely. For starters, there is the $10M from SHC, the Chinese private equity fund investment in Biomica, which could very well arrive in the coming weeks after clearing with Chinese regulators. Speaking of financial injections, the Biomica and Lavie financings have been done at levels that value each subsidiary well above the whole present market cap of Evogene (less than $30M), that should tell investors something of the possibilities here. The share count did go up significantly in H2/20, but since then has been quite steady as the company still has cash until the end of 2024 and several subsidiaries tapped their own financial sources (Lavie with $10M from ICI, an earlier $10M from Corteva, Biomica raised $20M, the Ag-Seeds division raised $3.5M from Bayer in a license payment etc.) or are even already selling commercial products (like Canonic and Lavie, and Casterra could be close). See grahic. The company has no debt and one might be surprised to know that the market capitalization (at $0.67 per share) is just $27.6M, the shares trade below cash. An IPO of one of its subsidiaries (as things stand now that would most likely be Lavie Bio) could put a market value on the subsidiary and provide tens of millions of additional cash for parent Evogene. Conclusion We see a lot to like here: The company has an impressive core capability with their three-engine computational CPB platform, which already has generated numerous potentially very valuable compounds and can keep doing this. A number of these compounds have been given their own subsidiary (and one division) for further development, partnerships and tapping their own financial sources, greatly stretching the financial reach of the company. Three of these divisions (Lavie Bio, Canonic and Casterra) already have commercial products, although these are in the very early innings. We think each of these subsidiaries (and the Ag-Seed division) could be worth a multiple of the company’s market cap (just $31M at the point of writing) in a couple of years, if not sooner. The company has no debt and $38M in cash which would last them until the end of 2024. But the capacity for raising additional sources of funds are numerous, through participations, licenses and royalties, commercial success, or, as is the goal of management, one or more IPOs. Financing rounds at Biomica and Lavie have valued each subsidiary well above the entire market cap of parent Evogene, we think this is likely to hold for all their subsidiaries. A single IPO of one of its subsidiaries (at this stage the most likely candidates are Lavie Bio or Casterra, as they have launched commercial products already and the interest in Casterra has recently spiked) would put a market value on it and likely provide substantial additional funds, extending the cash another couple of years. This IPO process could extend when developments in other subsidiaries (or the Ag-Seed division) is sufficiently interesting to consider this route. So the company’s main CPB engine could create a stream of potentially valuable new compounds, subsidiaries, IPOs and even commercial success, it has the potential to be an extraordinary value creation engine. We think at these levels the shares offer a potentially huge upside at quite acceptable risk levels, given that they have so many shots on goal that the chance of missing all seems quite acceptable to us. Originally published on TalkMarkets More By This Author: RenovoRX's Latest Innovative Technology Creates New Hope for Chemotherapy Patients 7 Reasons Why SurgePays Is Going To Surge Protalix BioTherapeutics Well Placed to Advance in 2023 Disclosure: This article is part of a new “UnderCovered” series of exclusive articles featuring companies with limited coverage. Authors are compensated by TalkMarkets for their time, and otherwise represent their own assessments and opinions. Authors are not compensated by the subject companies in any way. This article is also part of our IR Insights Initiative in which articles about participating companies can receive greater visibility. To learn more click here.​Author Disclosure: No position in EVGN at the time of writing. Contact Details TalkMarkets ir@talkmarkets.com

March 21, 2023 01:45 PM Eastern Daylight Time

Article thumbnail News Release

Predictive Oncology partners with Cancer Research Horizons to leverage AI for new cancer drugs

Predictive Oncology Inc.

Predictive Oncology chief business officer Pamela Bush and Dom Pollard, business development manager at Cancer Research Horizons, join Proactive's Natalie Stoberman to discuss their new partnership for new cancer drug development. The collaboration will utilize Predictive Oncology’s PEDAL technology to evaluate Cancer Research Horizons’ pre-clinical drug inhibitors of Glutaminase in order to determine which cancer types and patient populations are most likely to respond to treatment with these compounds. PEDAL is an artificial intelligence (AI) and machine learning platform which makes high-confidence drug response predictions enabling a more informed selection of drug-tumor type combinations for clinical development. Contact Details Proactive USA +1 347-449-0879 na-editorial@proactiveinvestors.com

March 21, 2023 01:38 PM Eastern Daylight Time

Video
Article thumbnail News Release

Online Capital Formation is a cost-effective and reliable alternative to fund businesses

KoreconX

With the latest happenings in the online banking world, venture capital funding is uncertain for the short term. Yet challenging times are when capital for innovation and development is needed most, leading companies at all stages to evaluate a different alternative for capital: the private market. Venture capital refers to investments made by venture capital firms, typically in early-stage startups or companies with high growth potential. Private capital, on the other hand, can come from a variety of sources, such as high-net-worth individuals, family offices, or private equity firms. These investments are made in countless industries and stages of development. Another difference that may lead entrepreneurs to opt for private capital is that, in most cases, venture capital firms take an active role in the management, while private capital investors do not - which allows entrepreneurs to retain control. Oscar A Jofre, Co-founder and CEO of KoreConX, explains. “Using digital platforms to raise funds from investors through JOBS Act regulations, companies have access to the exemptions from SEC registration such as RegA+, RegCF, RegD, and RegS, reaching a larger pool of investors beyond traditional VCs and private equity firms. These investments can be accessed by anyone, regardless of their net worth or accreditation status, and at any time, 24 hours a day, 365 days a year”. The SEC reports that $4.5T was raised in the private capital markets in 2022, of which the new JOBS Act regulations (RegCF, RegA+, RegD) accounted for $150.9B. Online capital formation platforms allow greater transparency, giving investors more information about an offering before they commit to investing in a particular business. This allows investors to make more informed decisions and reduces the risks associated with investing. Online platforms also typically charge lower fees than traditional VCs and private equity firms, making it a more cost-effective way to raise funds. Taken together, these advantages make online capital formation through RegA+, RegCF, RegS, or RegD attractive, viable alternatives to traditional venture capital for companies looking to access a wider pool of investors quickly and efficiently and with greater transparency. About KoreConX Founded in 2016, KoreConX is the first secure, All-In-One platform that manages private companies' capital market activity and stakeholder communications. With an innovative approach and to ensure compliance with securities regulations and corporate law, KoreConX offers a single environment to connect companies to the capital markets and now secondary markets. Additionally, investors, broker-dealers, law firms, accountants, and investor acquisition firms, all leverage our eco-system solution. Founded in 2016, KoreConX provides the first secure online infrastructure for private companies to conveniently and compliantly manage every aspect of their capital market activities, from issuing securities to shareholder relations. Investors, broker-dealers, law firms, accountants, and investor acquisition firms all leverage our ecosystem solution. KoreConX also maintains a large online library of educational content to help companies navigate their capital-raising journey. Contact Details Rafael Goncalves +1 888-885-0881 rafael@koreconx.com Company Website https://www.koreconx.com

March 21, 2023 12:59 PM Eastern Daylight Time

Image
Article thumbnail News Release

Doceree takes the lead on transparency in programmatic Point-of-Care messaging by championing adoption of IAB standard

Doceree

Doceree today launched an industry-first initiative championing an existing standard that aims to authenticate messaging from point-of-care publishers within healthcare. The initiative mitigates any possible risks arising from ambiguity of the ecosystem, something not previously done within point-of-care media and media aggregators. Programmatic technology provides incredible convenience to showcase messages from life sciences brands to healthcare professionals (HCPs) on point-of-care platforms. However, the lack of transparency in the space has marred the progress of the entire ecosystem. In 2017, Interactive Advertising Bureau (IAB) introduced the ads.txt standard to bolster transparency by authenticating publisher platforms. The adoption of the standard is happening at a slow pace, especially so in the pharmaceutical industry, a sector which is still new to adopting digital tools and technologies to engage HCPs programmatically, compared to those in the consumer marketing space. As a leader in the point-of-care messaging category, Doceree is championing the adoption of the ads.txt standard in the healthcare industry. As part of its latest effort, the company has also released a white paper entitled “ Bolstering Transparency in Programmatic Pharma Messaging” that delves into the crucial role of ads.txt and how its adoption ensures transparency in programmatic media. “It is equally as important to effectively address the downsides of new technologies and empower companies to confidently use programmatic tools for their business growth and success. Being a leader in this ecosystem, it is our responsibility to do everything that bolsters transparency. This is what we are attempting to achieve with our adoption of IAB’s standard ads.txt practice,” said Harshit Jain MD, Founder and Global CEO, Doceree. “With Programmatic display ad spending estimated at nearly $150 billion this year, outpacing topline digital ad spending (according to emarketer US market forecast), it’s imperative that marketers know “who” and “where” are the authorized marketplaces. In healthcare marketing, we walk a very fine line to ensure that the right information is getting to the right patient, caregiver and HCP. This additional level of checks/balances is needed for brand safety and transparency. ” said Karima Sharif, Strategy Lead + Head of Inclusive Investments, Publicis Health Media. The Doceree White Paper can be downloaded here. About Doceree Doceree is a global platform building unprecedented solutions for healthcare professional (HCP) programmatic messaging with proprietary data tools. It facilitates messaging between life sciences brands and HCPs through an extensive global network of digital endemic and point-of-care platforms to programmatically deliver personalized communications to HCPs and transparent marketing campaign metrics at scale. To learn more, visit doceree.com. Contact Details Kyle Murray +91 70420 89805 kyle@kitehillpr.com Company Website https://doceree.com/us/

March 21, 2023 11:42 AM Eastern Daylight Time

1 ... 144145146147148 ... 306