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Citius Pharmaceuticals (NASDAQ: CTXR) Advances Oncology Asset, Paving Way For Spin Out Of Advanced T-cell Lymphoma Treatment

Benzinga

By Meg Flippin, Benzinga Chemotherapy and radiation are proven ways to treat cancer, but for the patients, they usually mean untold suffering. Finding effective alternatives, especially for people with rare cancers, can seem impossible. For rare cancers, there often isn’t a lot of information to help develop treatments, enough animal or cell models to test, or tumor samples to research. As a result, rare cancers account for 25 % of all cancer deaths in the U.S. Immunotherapy To Kill Cancer Cells One alternative treatment that seems to be getting attention is immunotherapy. It’s a treatment that uses the patient’s immune system to seek and kill cancer cells. Immunotherapy treatments are designed to boost a patient’s immune system so the body can work harder to destroy cancer cells. It is proving effective with companies including Citius Pharmaceuticals Inc. (NASDAQ: CTXR) advancing oncology treatments through an innovative immuno-oncology approach. Citius’ lead asset aims to leverage the body's own defense mechanisms to destroy malignant tumors. The therapy targets the interleukin-2 receptors found on malignant T-cells regulatory T-cells (Tregs), opening the potential for new therapeutic approaches to the treatment of cutaneous T-cell lymphoma (CTCL). This innovation could be transformative for individuals with rare cancers like CTCL, potentially enhancing their quality of life significantly. Additionally, Citius highlights compelling market opportunities that the company says are poised for growth. Broadly, the global cancer therapy market is forecast to grow at a CAGR of 9.12% from now until 2027, while the immuno-oncology market is projected to grow at a CAGR of 22.94%, hitting $396.07 billion by 2034. LYMPHIR Poised to Make Inroads The company’s lead immunotherapy, LYMPHIR, is under review by the U.S. Food and Drug Administration (FDA) for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma. In Japan, the formulation is approved and marketed for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Just last month, the U.S. FDA accepted the resubmission of a Biologics License Application (BLA) for LYMPHIR for the treatment of patients with relapsed or refractory CTCL after at least one prior systemic therapy. According to the company, the FDA has assigned a PDUFA goal date of August 13, 2024, the company said. "We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative,” said Leonard Mazur, Chairman and CEO of Citius. “We are grateful for the FDA's vital support for rare disease drug development as we work to expand treatment options for patients with cutaneous T-cell lymphoma. We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL,” continued Mazur. Citius believes the market for LYMPHIR for CTCL will exceed $400 million and is particularly attractive because it is underserved by existing treatments. The Proof Is In The Results LYMPHIR is a recombinant engineered fusion protein that combines interleukin-2 and diphtheria toxin. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. Notably, malignant T-cells and immunosuppressive regulatory T-cells share a common marker, the IL-2 receptor. Consequently, LYMPHIR targets both malignant T-cells and transiently eliminates Tregs, supporting the potential to unleash potent immune responses by the patient’s immune system against their tumors. In recent preclinical studies, denileukin diftitox has demonstrated the ability to deplete murine Tregs in-vivo and human Tregs ex vivo. In addition, the combination of denileukin diftitox with anti-PD1 showed improved tumor response and very significant improvement in survival in the combination groups relative to either therapy alone in a syngeneic mouse solid tumor model. Based on this data, two investigator-initiated trials are underway to evaluate the potential safety and efficacy of LYMPHIR in combination with Pembrolizumab (anti-PD1) in patients with recurrent or metastatic solid tumors and LYMPHIR given prior to lymphodepletion (LD) chemotherapy and CAR-T therapies for the treatment of relapsed/refractory B-cell lymphomas. The results of these preclinical trials will determine if the company will develop these treatments further. The Path To Commercialization In addition to inroads on the regularity front, the company is making strides to commercialize LYMPHIR. A spinout to form Citius Oncology is in the works. The company announced plans to form a standalone public oncology company a few months ago. In a recent press release, Citius mentioned the transaction will improve the company’s access to the public equity markets and help facilitate the commercialization of LYMPHIR. "We believe this transaction will allow us to unlock the value of LYMPHIR, and solidly position Citius Pharma to advance our diversified pipeline,” said Mazur at the time. “This transaction will enable Citius Oncology, with access to the broader capital markets, to better support the successful commercialization of LYMPHIR, if approved, and explore additional potential targeted oncology therapies. Our majority ownership position and shared services agreement ensures that the Citius Pharma management team will remain fully engaged with the development and commercialization efforts at Citius Oncology.” Featured photo by the National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

April 18, 2024 08:45 AM Eastern Daylight Time

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Hydrogen Utopia CEO discusses advances in cannabis operation and future hydrogen projects

Hydrogen Utopia International PLC

Hydrogen Utopia International PLC (LSE:HUI, OTCQB:HUIPF) CEO Aleksandra Binkowska joined Proactive's Stephen Gunnion to discuss progress at the company’s cannabis operation in Macedonia, highlighting two successful harvests and ongoing developments. Binkowska noted the company has a 49% option in Ohrid Organics, highlighting its impressive facilities and high-tech enhancements, including an advanced drying system that significantly improves product quality. Binkowska emphasized the importance of the location’s natural benefits and technological enhancements for achieving high-quality outputs. Currently, Hydrogen Utopia is awaiting laboratory results to officially confirm the product quality, which is necessary for obtaining the requisite governmental paperwork for product sales. She mentioned preparations for EU GMP certification audits, which will facilitate entry into the European market at higher certification levels, potentially allowing for a higher product price point. Furthermore, Binkowska outlined the financial success of Ohrid Organics, projecting earnings that would fund Hydrogen Utopia’s first waste plastics hydrogen facility. The profits from Ohrid could potentially finance this without additional capital raising, underscoring the strategic advantage of the investment. She also highlighted the supportive role of the Macedonian government in facilitating the company's initiatives in both the cannabis and hydrogen sectors. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

April 18, 2024 08:40 AM Eastern Daylight Time

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CURE ALZHEIMER’S FUND REACHES $200 MILLION IN RESEARCH GRANTS

Alzheimer’s Disease Research Foundation

April 18, 2024 — Cure Alzheimer’s Fund, a nonprofit dedicated to funding the most promising research to prevent, slow or reverse Alzheimer’s disease, announced today that it has reached an important milestone—awarding more than $200 million in research grants to leading scientists throughout the world investigating the disease. Since its establishment in 2004, Cure Alzheimer’s Fund (CureAlz) has supported more than 840 innovative grants led by more than 300 scientists resulting in 1,182 published peer-reviewed papers in prominent scientific journals. Many of these projects have yielded significant breakthroughs, resulting in findings contributing to new and critical avenues for development of novel treatments. “CureAlz was founded with one mission: to fund research that will accelerate prevention, treatment and a cure for this disease,” said Henry McCance, Chair of Cure Alzheimer’s Fund. “Since the beginning, our approach has attracted others to join us in this fight, all who have been vital to what we have achieved. It has been an honor to deploy more than $200 million dollars in funding that is enabling and accelerating extraordinary research pursued by brilliant and determined scientists around the world.” Funded projects have included: · The Alzheimer’s Genome Project, the first large-scale, family-based study of the human genome specific to Alzheimer’s disease. · Projects that explore how the body’s complex immune responses may contribute to Alzheimer’s disease. · A consortium of experts to expand our understanding of the role the APOE gene may have in Alzheimer’s disease. “For 19 years, our Founders and Board of Directors have been steadfast in their commitment to our mission to end the terrible burden of Alzheimer’s. The field’s top scientists contribute their expertise and guidance to CureAlz, meaning science and data are always our lodestars to a cure,” said Meg Smith, CEO of Cure Alzheimer’s Fund. “Our leadership’s vision, drive and generosity are matched by that of our dedicated donor and researcher communities. We celebrate this milestone as the shared achievement it is, and at the same time rededicate ourselves to accelerating an end to Alzheimer’s.” Cure Alzheimer’s Fund is a non-profit dedicated to funding the most promising research to prevent, slow, or reverse Alzheimer’s disease. Since its founding in 2004, Cure Alzheimer’s Fund has provided more than 840 grants to more than 300 of the world’s leading researchers and contributed more than $200 million to research. Its funded initiatives have been responsible for many key breakthroughs in understanding the causes and pathology of Alzheimer’s disease. Cure Alzheimer’s Fund has received a 4-star rating for more than 12 consecutive years from Charity Navigator. Our Board of Directors, Trustees, and a core group of other donors direct their donations to our overhead expenses so that 100% of general donations go to our research program. For more information, visit CureAlz.org. To learn about the impact of Alzheimer’s on women and women working towards a cure, WomenandAlzheimers.org. Contact Details Barbara Chambers +1 978-417-9890 BChambers@CureAlz.org Company Website https://curealz.org

April 18, 2024 08:00 AM Eastern Daylight Time

MJ ATTACHÉ LAUNCHES BUSINESS WITH DEBUT OF FIRST-OF-ITS-KIND LUXURY CACHE-AND-CARRY BAG FOR CANNABIS CONNOISSEURS, IN TIME FOR APRIL 20, CANNABIS CELEBRATION DAY

MJ Attaché

MJ Attaché, a designer and developer of luxury Italian-made leather bags and accessories for the cannabis connoisseur, announced today the official launch of the business. The commencement of MJ Attaché is marked by the introduction of the first-of-its-kind, premium, 100% Italian leather bag, The Anthony, carefully curated for cannabis cache and carry. The Anthony’s debut comes just in time for April 20 th, a day when cannabis is celebrated. MJ Attaché’s bags are market-disrupting; they boast patent-pending modular elements -- not found in any other bag -- that encourage a personalized cannabis experience specific to each one’s individual consumption needs. Catering to both male and female cannabis users, The Anthony’s novel magnetic, re-attachable accessories are fully customizable. Elements inside the bag can be easily added or deleted, depending on what each user prefers for their cannabis self-care ritual. Cleverly crafted by hand in Florence, Italy of the finest Italian leather, The Anthony’s features distinguish it from any other cannabis carry-all bag currently available in the market. Available in five colors, The Anthony bag includes a secure lock closure, removable smooth leather rolling tray, modular elements for customization, such as a pipe case, lighter sleeve, jar sleeve a smell-proof glass jar and a removable, adjustable crossbody strap. The combination of the leather and smell-proof jar aids in disguising odors and keep contents discreet. The MJ Attaché brand challenges outdated, inaccurate stereotypes of cannabis consumers by offering mainstream users a way to elevate their cache-and-carry preferences and experiences. Cannabis has come a long way from its prior perceptions, and MJ Attaché recognizes its broader adoption by users spanning the spectrum. Like many entrepreneurs, ideas are often spurred by personal experience. MJ Attaché is no exception. Founder Christy Fuicelli created the brand and designed its premium bag when she was personally searching for a sophisticated, safe and discreet carry-all solution for her cannabis and accessories. She came up emptyhanded when shopping for options of the same high-quality, sophistication and style to which she was accustomed. Fuicelli believed this void in the marketplace stemmed from stigmas associated with overall cannabis use and she set out to change the market landscape with the design, development and introduction of The Anthony. “I went on a crusade to create a stylish, luxury, handcrafted bag many would be proud to carry. With its impeccable style, quality Italian leather components and customizable modular system, The Anthony bag transcends the outdated “stoner” stereotypes cannabis users are often perceived as and creates the ultimate luxury cannabis experience. I travelled on this journey witnessing nearly a dozen iterations of The Anthony until I was pleased because I could not find a functional, sophisticated, stylish and well-made cannabis transport option, which sparked my interest in developing one myself,” entrepreneur Fuicelli said. “Additionally, I was determined to challenge preconceived notions relating to cannabis use stereotypes. Many people use cannabis medicinally as well as to reduce stress and anxiety and promote relaxation. For me, my cannabis use not only helped alleviate certain medical conditions but also can be directly attributed to the deep creativity it ignited in me, sparking my idea for The Anthony and other bags and accessories in the MJ Attaché product line. I am hoping adoption of The Anthony and other MJ Attaché offerings will simplify the lives of cannabis users around the world. The Anthony truly marks an entry into a market where no other bag like it exists,” Fuicelli concluded. The Anthony, with a price point of $2,150.00, can be purchased here. Looking ahead, MJ Attaché is currently developing other cannabis bag styles and accessories, which are slated for introduction into the marketplace in the latter part of 2024. About MJ Attaché Denver-based MJ Attaché is a designer and developer of high-quality, handmade Italian leather bags and accessories for the cannabis connoisseur. The luxury brand, with its moniker MJ (short for Mary Jane an alias for marijuana), was founded by entrepreneur Christy Fuicelli, a stylish cannabis user. She realized a void in the marketplace to cache and carry her cannabis in a discreet manor reflective of the luxury she enjoyed in other personal products she owned and believed this stemmed from stigmas associated with cannabis use. Determined to bridge this gap, MJ Attaché was born. Fuicelli set out to create a premium bag that would appeal to both male and female cannabis users. She spent years designing and creating beautifully crafted bags that embody elevated style, sophistication, high quality and fine craftmanship. By bringing ease and style to the cannabis industry with her bags, MJ Attaché brings the first accessory of its kind, The Anthony bag, to the marketplace. For more information, visit www.mjattache.com and connect with the Company and its products on Facebook and Instagram. Contact Details PAIRELATIONS, LLC for MJ Attaché Susan J. Turkell +1 303-766-4343 sturkell@pairelations.com

April 17, 2024 10:00 AM Eastern Daylight Time

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Theriva Biologics Hits Several Milestones In 2023, Positioning Itself For Growth As The Firm Targets Difficult-To-Treat Cancers

Benzinga

By Meg Flippin, Benzinga Theriva™ Biologics (AMEX: TOVX), the clinical-stage immuno-oncology company developing therapies for difficult-to-treat cancers, hit several milestones during 2023, potentially positioning it for a strong year ahead. That could be good news for patients with pancreatic, retinoblastoma, head and neck, brain or ovarian cancers. If Theriva is right, its oncolytic viruses can overcome the protective barrier surrounding solid tumors and selectively kill tumor cells. Its developmental therapies are designed to enable systemic delivery – which means they can target the tumor and distant metastases and have the potential to enhance current standard-of-care therapies, the company says. Theriva’s oncolytic viruses can be administered intravenously or as a direct injection into the tumor or tumor compartment. Trials Underway Announcing its financial results for the full year 2023, Theriva reported ending the year in a good position with VCN-01, its lead therapy candidate. VCN-01 is currently in a phase 2b trial for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) and in investigator-sponsored studies in a number of indications. As of late March, dosing was underway and enrollment continues to progress for VIRAGE, the randomized, controlled, multicenter open-label phase 2b trial of VCN-01 in combination with standard-of-care chemotherapy as a first-line therapy in newly diagnosed metastatic PDAC patients. The trial is targeting enrollment of 92 evaluable patients and the company reports it's on track to complete enrollment in the first half of this year. Patients are being enrolled in six sites in the U.S. and nine in Spain and will continue without any changes to the protocol after an evaluation by the Independent Data Monitoring Committee (IDMC) found no safety concerns. Intravenous VCN-01 has been well tolerated and demonstrated a safety profile consistent with prior clinical trials, Theriva reports. Importantly, it said no additional toxicities were observed in patients receiving a second dose of VCN-01. That means repeated systemic dosing of VCN-01 is feasible from a safety perspective, paving the way for Theriva to focus on whether the repeated dose VCN-01 regimen may lead to improved clinical outcomes for patients. “We believe VCN-01’s differentiated mechanism of action has the potential to address the urgent need for new treatment options for patients with PDAC by degrading the tumor matrix and increasing tumor access by VCN-01 and co-administered cancer therapies,” said Theriva CEO Steven Shallcross during a conference call to discuss full year 2023 earnings. To date, more than 100 patients have been dosed with VCN-01 in clinical trials in patients with a broad range of cancers, including PDAC, retinoblastoma, colorectal cancer and head and neck squamous cell carcinoma (HNSCC). Additional investigator-sponsored studies have been initiated in patients with brain cancers and ovarian cancers. Beyond Pancreatic Cancer Treating pancreatic cancer with VCN-01 isn’t the only area Theriva focused on during the year. The company is also engaged in a phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma. That trial is making progress, with the company completing patient treatment. The trial is designed to evaluate escalating doses of VCN-01 administered by two intravitreal injections separated by 14 days. The investigator-sponsored phase 1 trial will complete patient follow-up in the first half of 2024, and the results will help inform the planned phase 2 trial design, Theriva says. Additionally, the University of Pennsylvania continues to enroll and treat patients in their phase 1 investigator-sponsored trial administering VCN-01 with huCART-meso cells to patients with ovarian or pancreatic cancers. VCN-01 is designed to increase tumor immunogenicity and improve access by additional therapies such as huCART-meso cells. Dosing is also underway for the ongoing phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). Theriva said SYN-004 appears to be well tolerated. Collaborating And Expanding Partnerships Not one to rest, Theriva was also busy during the year expanding collaborations and identifying new areas that may benefit from VCN-01. Late last year it signed an exclusive option to license intellectual property from Sant Joan de Déu-Barcelona Children’s Hospital (SJD) to explore the therapeutic potential of VCN-01 in combination with topoisomerase I inhibitors. This strengthens a long-term research collaboration with SJD and builds on an ongoing trial evaluating VCN-01 in pediatric cancers. The company is also pursuing licensing discussions for its SYN-020 intestinal alkaline phosphatase asset. SYN-020 is a recombinant bovine intestinal alkaline phosphatase (IAP) formulated for oral delivery to the small intestine and designed to diminish fat absorption and intestinal inflammation, tighten the gut barrier to mitigate “leaky gut” and promote a healthy microbiome. It has the potential to become a multi-indication therapeutic capable of addressing disorders stemming from gastrointestinal (GI) inflammation. Theriva is doing all this and keeping costs down. For the year ended December 31, 2023, general and administrative expenses decreased 28% to $7.1 million from $9.9 million in the year-earlier period. Meanwhile, the company increased spending on research and development by 22%, with an eye on the future based on an observed uptick in demand for its compounds. “In 2023, we continue to make steady progress to drive forward our oncology-focused portfolio designed to address unmet needs for difficult-to-treat cancers,” said Shallcross on the earnings call. “Our primary efforts and resources are focused on pursuing multiple therapeutic opportunities for our lead clinical candidate VCN-01. We'll continue to look for ways to drive additional value for our shareholders and for the long-term success of what we're trying to do, namely delivering promising treatments for very, very difficult-to-treat cancers.” Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

April 17, 2024 08:30 AM Eastern Daylight Time

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Japan’s Premier Clinical CRO A2 Healthcare, an ITOCHU Subsidiary, Launches US Expansion

A2 Healthcare

A2 Healthcare, ITOCHU Corporation’s (ITOCY) leading subsidiary in healthcare headquartered in Tokyo, Japan, announced its US expansion. Leveraging regulatory strategy and clinical development expertise in Japan and Taiwan on a global scale, A2 Healthcare aims to transform the Japanese drug market, the third largest in the world. The company will support new drug development in Japan by expanding its partnerships with biotech and pharmaceutical companies based in the United States, the world leader in biopharmaceutical R&D. The United States accounts for around a third of the global market, according to the Pharmaceutical Research and Manufacturers Association (PhRMA). A2 Healthcare President and CEO Hitoshi Kamiya is confident that the Boston branch will help US companies navigate the Japanese market. “Pharmaceutical companies shy away from the Japanese market due to Japan’s strict pharmaceutical regulations, complex clinical trial-related procedures, and drug pricing system that differs from Europe and the United States. Hence, fewer new drugs enter the Japanese market, creating ‘drug loss.’ In 2020, 72 percent of drugs approved in Europe and the United States were not approved in Japan,” said Kamiya. “Unfortunately, this rate is on the rise. More than half of the domestically unapproved drugs in Japan are developed by biotech companies overseas. With the launch of the US office in Boston, A2 Healthcare is optimally positioned to change this narrative. We are offering a new mechanism to eliminate drug loss by encouraging companies to develop drugs in Japan at ease.” As a top CRO in Japan, A2 Healthcare has successfully supported new drug development, including a large number of sponsor-initiated clinical trials and investigator-initiated studies in various fields and diseases. A2 Healthcare’s advanced use of IT in its innovative clinical trials and high patient enrollment results in Japan were recognized with the “Best CRO/CDMO” prize from the Citeline Pharma Intelligence Awards Japan in October 2023. The Boston metropolitan area is an ideal networking environment as part of the world's largest biotech cluster with more than 1,000 biotech companies working on new drug development pipelines. A2 Healthcare will also offer its Pipeline Accelerator Program, a financing program for these companies. Hiroki Matsushima, head of A2 Healthcare’s Global Business Expansion in charge of the US Boston Office, stated, “Boston is the perfect location for launching global CRO services for new drug development in Japan, especially in supporting the development of drugs highly sought after by Japanese patients.” He added, “Japan is a country with a population of over 120 million people and an average lifespan of 84 years. In clinical trials, patient compliance is very high, while the drop-out rate is low. Sustained by a large patient pool for most target indications, Japan remains one of the most attractive and cost-effective places to implement global drug development plans. Additionally, Japan's low inflation over the past decades has helped keep costs down, unlike in most other countries.” A trusted partner for the global life science, medical and pharmaceutical industries, A2 Healthcare offers the most efficient regulatory pathway in Japan for new drug development and regulatory submissions to gain approval. Combining extensive clinical experience and 84 million patient data from 97,000 Japanese sites in the company’s own database, A2 Healthcare has recently achieved a 96 percent enrollment compliance rate within the agreed schedule, setting an impressive standard in the CRO industry. For more information about A2 Healthcare’s services and to request business meetings, contact the Boston Office at matsushima-h@a2healthcare.com or +1(857) 265-0605. ### About A2 Healthcare Corporation A2 Healthcare Corporation, an ITOCHU company, is a premier clinical contract research organization (CRO) founded in 2003 to enhance the quality of lives. Specializing in global clinical trial and research services, we support the development of new drug treatments across wide-ranging therapeutic areas and modalities. A2 Healthcare operates in the United States, Japan and Taiwan, leading the industry by providing best-in-class quality and deliverables through its clinical operations. For more information, visit www.a2healthcare.com/en. Media Contact: A2 Healthcare US Boston Office Hiroki MATSUSHIMA matsushima-h@a2healthcare.com +1(857) 265-0605 A2 Healthcare Japan PR: marke@a2healthcare.com Investor Relations: watanabe-se@a2healthcare.com Contact Details A2 Healthcare US Boston Office Hiroki MATSUSHIMA +1 857-265-0605 matsushima-h@a2healthcare.com

April 17, 2024 08:04 AM Eastern Daylight Time

Clarified Precision Medicine Raises $1.2 Million in Seed Funding and Appoints Health Tech Leader Rajni Natesan, MD, MBA as CEO

Clarified Precision Medicine

Clarified Precision Medicine, the only company that provides oncologists with prioritized therapy options via a combination of algorithmic testing and physician oversight, announced that it closed on its seed round of $1.2 million led by Avestria Ventures, with participation from Joyance Partners, both early-stage funds focused on improving health. The company also named Rajni Natesan, MD, MBA as its Chief Executive Officer. Dr. Natesan is an experienced executive and medical doctor with an extensive background scaling startups at the intersection of healthcare and technology, with a focus on artificial intelligence and machine learning. “Clarified Precision Medicine is offering the right technology at the right time,” Dr. Natesan said. “I’m excited to guide Clarified through this period of commercialization and growth as we follow through on our mission to provide any patient, anywhere, with cutting-edge, guidelines-based access to precision medicine.” Founded in 2021 by Dr. Lincoln Nadauld, MD, PhD, Lisa Alderson, MBA, Howard McLeod, PharmD, and Jody Simon, PharmD, Clarified Precision Medicine uses an algorithm to analyze NGS lab results and then works with oncologists to interpret genomic test results to recommend the best targeted treatment. I n the United States, there are 18 million patients with a history of cancer and 1.9 million new cancer diagnoses each year. Patients who receive precision therapies have survival rates that are three times greater than those who do not. However, 75 percent of doctors say they need help interpreting genomic tests—which leads to more effective utilization of these powerful 21-century tools. Clarified’s combination of advanced technology and physician oversight provides oncologists at community cancer centers with the precision treatment knowledge and expertise usually reserved for leading research institutions. “Dr. Natesan is the perfect leader to help us scale Clarified Precision Medicine to ensure that oncology practices across the country have access to expert guidance to deliver improved outcomes,” said Clarified Precision Medicine Co-founder Lisa Alderson. “She has the right combination of business acumen and clinical expertise to drive adoption and engage with key stakeholders to make world-class precision medicine expertise accessible to every cancer patient and every oncology practice. We’re excited to support Dr. Natesan as she leads us into the next chapter of growth.” With deep C-suite expertise in finance, strategy, operations and clinical functions across medical devices and health tech, Dr. Natesan has led companies across all phases of their product and organizational life cycles, from conceptual design to FDA trials, commercialization, IP and M&A preparation. Dr. Natesan began her career as one of the first physicians on Wall Street, leading health care mergers, acquisitions and financing deals for pharma, biotech and med device clients as an investment banker in Lehman Brothers’ health care group and as a health care strategy consultant in a boutique practice. Most recently, Dr. Natesan served as Chief Strategy and Medical Officer at Braid Health, a venture-backed, disruptive digital health infrastructure company. Clarified Precision Medicine is already supporting numerous U.S. oncology practices and testing labs and offers flexible payment options, including direct insurance billing in some cases. More information on Clarified Precision Medicine solutions is available from the Clarified Precision Medicine Business Development team. About Clarified Precision Medicine Clarified Precision Medicine is the first scalable molecular tumor board with a combination of ML-based platform plus medical group, offering expert clinical somatic and pharmacogenomics consultations through its ClarifiedSelect™ and OncoGuardian™ solutions. Clarified accelerates the delivery of guidelines-based genomic insights to patients and providers by bringing together nationally recognized experts in medical oncology, oncology pharmacy, data integration, and molecular pathology who have over 100 years of collective experience in the application of precision oncology. For more information, visit: www.clarifiedprecisionmedicine.com Contact Details For Clarified Precision Medicine info@clarifiedmedicine.com Company Website https://clarifiedprecisionmedicine.com/

April 16, 2024 10:09 AM Eastern Daylight Time

PathAI Partners with Google Cloud to Transform Drug Discovery and Precision Medicine Through AI-Powered Pathology

PathAI

PathAI, a global leader in AI-powered pathology, today announced a strategic partnership with Google Cloud at Bio-IT World Conference & Expo to help biopharma companies and anatomic pathology (AP) labs accelerate the adoption of AI and digital pathology. PathAI’s AISight 1 Intelligent Image Management System (IMS) is an AI-native IMS that seamlessly blends PathAI and third-party algorithms into a single laboratory workflow and image analysis platform, providing researchers and pathologists direct access to powerful biomarker quantification tools that have the potential to increase lab operational efficiency and aid in disease staging and scoring. PathAI will leverage Google Cloud’s infrastructure to bring AISight to more biopharma companies and AP labs worldwide, enabling faster deployments of novel AI models for a variety of clinical and research needs. "Bio-IT World is where pioneers convene to address the industry's most significant challenges, including how to leverage massive scale data from biological and clinical studies to accelerate the discovery and development of transformative new therapies for patients. PathAI partners across the drug development paradigm, firstly with biopharma by enabling the development of new insights and diagnostics and supporting global clinical trials through PathAI’s AISight Clinical Trials platform, trial-ready algorithms, and Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliant laboratory; and also with AP labs ensuring scaled access to algorithms through AISight," said Dr. Andy Beck, CEO and co-founder of PathAI. "Our partnership with Google Cloud helps us transform our capabilities to accelerate adoption of these powerful tools and ultimately reshape how disease is understood and treated.” The partnership will involve the integration of PathAI’s AISight solution with Google Cloud's infrastructure and AI capabilities, providing: Accelerated adoption of precision medicine solutions: Google Cloud's infrastructure enables rapid scaling of AISight's digital pathology IMS and algorithmic capabilities globally, aiding digital pathology laboratory operations and researchers in processing petabytes worth of data for large-scale biomarker discovery and clinical studies, ultimately bringing advancements to patients more quickly. Customized solutions and tailored AI models: The latest Google Cloud AI tools within the AISight platform provide the ability to quickly develop customized solutions and deploy novel AI models tailored to specific research needs. "We understand the urgent need within the biopharmaceutical industry for secure, scalable solutions in AI-driven drug discovery, laboratory operations, and biomarker quantification,” said Ryan Terry, managing director, Healthcare and Life Sciences, Google Cloud. "We're incredibly excited to partner with PathAI to create a new wave of solutions that leverage precision medicine to help solve the industry’s most significant challenges." 1 AISight is For Research Use Only. Not for use in diagnostic procedures. About PathAI PathAI is dedicated to improving patient outcomes through its groundbreaking AI-powered pathology platform. Our solutions provide invaluable insights for biopharmaceutical companies, researchers, and laboratories, ultimately enabling precision pathology and the vision of more effective treatments. Learn more at www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

April 16, 2024 09:00 AM Eastern Daylight Time

Unicorn Hailo Closes $120 Million Funding Round, Debuts Powerful Hailo-10 AI Accelerator Bringing GenAI To Edge Devices

OurCrowd

By Matthew Kalman Hailo, the pioneering chipmaker of edge artificial intelligence (AI) processors, announced the successful extension of its series C fundraising round with an additional investment of $120 million, bringing its valuation to more than $1 billion, Bloomberg reported. The successful close is “the latest sign of investor enthusiasm for startups that can help address a global chip shortage and fuel the development of generative AI,” Bloomberg reported. The company also announced the introduction of its innovative Hailo-10 high-performance generative AI (GenAI) accelerators that usher in an era where users can own and run GenAI applications locally – including on many edge devices – without registering to cloud-based GenAI services. “Hailo’s chips execute AI tasks with lower memory usage and power consumption than a typical processor, making them a strong candidate for compact, offline and battery-powered devices such as cars, smart cameras and robotics,” said TechCrunch. While the funding round has officially closed, investors can still participate in this raise for a limited period via an exclusive allocation available through OurCrowd, the online investment platform. “OurCrowd first invested in Hailo when it was valued at about $30 million. Now it’s a unicorn,” said Jon Medved, OurCrowd’s Founder and CEO. “We are excited and delighted to be able to offer investors the opportunity to participate in the development of impressive startups like this.” The current round brings Hailo’s total funding to more than $340 million. “The closing of our new funding round enables us to leverage all the exciting opportunities in our pipeline, while setting the stage for our long-term future growth,” said Orr Danon Hailo’s CEO and Co-Founder. “Together with the introduction of our Hailo-10 GenAI accelerator, it strategically positions us to bring classic and generative AI to edge devices in ways that will significantly expand the reach and impact of this remarkable new technology.” “We designed Hailo-10 to seamlessly integrate GenAI capabilities into users’ daily lives, freeing users from cloud network constraints. This empowers them to utilize chatbots, copilots, and other emerging content generation tools with unparalleled flexibility and immediacy, enhancing productivity and enriching lives,” Danon said. GenAI At The Edge The new Hailo-10 GenAI accelerator enables a whole spectrum of applications that maintain Hailo’s leadership in both performance-to-cost ratio and performance-to-power consumption ratio. Hailo-10 leverages the same comprehensive software suite used across the Hailo-8 AI accelerators and the Hailo-15 AI vision processors, enabling seamless integration of AI capabilities across multiple edge devices and platforms. Enabling GenAI at the edge ensures continuous access to GenAI services, regardless of network connectivity; obviates network latency concerns, which can otherwise impact GenAI performance; promotes privacy by keeping personal information anonymized and enhances sustainability by reducing reliance on the substantial processing power of cloud data centers. By unlocking the power of GenAI on edge devices, such as personal computers, smart vehicles and commercial robots, Hailo-10 allows users to completely own their GenAI experiences, making them an integral part of their daily routine. Hailo accomplishes this immersive GenAI experience through a Hailo-10 architecture that supports maximum GenAI performance with minimum required power. “As GenAI on the edge becomes immersive, the focus turns to handling large LLMs in the smallest possible power envelope — essentially less than five watts,” Danon said. Since its founding in Israel in 2017, Hailo has become a leading global supplier of intelligent AI chips that serves more than 300 customers around the world. The company has offices in the United States, Europe, Japan, South Korea, China and Taiwan. “Whether users employ GenAI to automate real-time translation or summarization services, generate software code, or images and videos from text prompts, Hailo-10 lets them do it directly on their PCs or other edge systems, without straining the CPU or draining the battery,” Danon said. Top Class Performance Hailo’s specialized AI processors enable data center-class performance on edge devices. Hailo’s processors are the product of a rethinking of traditional computer architecture, enabling smart devices to perform sophisticated deep learning tasks such as object detection and segmentation in real-time, with minimal power consumption, size and cost. The processors are designed to fit into a multitude of smart machines and devices, impacting a variety of sectors including compute, automotive, security, industry 4.0, and retail. Early applications of Hailo-10 GenAI accelerators will be targeting PCs and automotive infotainment systems, empowering current and future CPUs that cannot by themselves power the chatbots, copilots, personal assistants and speech-operated operating systems that have become standard today. Hailo will begin shipping samples of the Hailo-10 GenAI accelerator in Q2 of 2024. Among popular GenAI platforms, Hailo-10 can run Llama2-7B with up to 10 tokens per second (TPS) at under 5W of power. In processing Stable Diffusion 2.1, a popular model that produces images from text prompts, Hailo-10 is rated at under 5 seconds per image in the same ultra-low power envelope. Hailo-10 is capable of up to 40 TOPS (tera operations per second), a new performance standard for edge AI accelerators. Hailo-10 is faster and more energy efficient than integrated neural processing unit (NPU) solutions and delivers at least 2X more performance at half the power of Intel’s Core Ultra NPU, according to recently published benchmarks. Hailo will be present at the Embedded World exhibition in Nuremberg, April 9-11, Booth 126, Hall 1, and at the ISC West exhibition in Las Vegas, April 10-12, Booth #31065. For more information about investing in Hailo via the OurCrowd platform, click HERE. Featured photo courtesy of OurCrowd. OurCrowd was started in 2013, driven by the idea that the business of building startups grows bigger and better when the global ‘crowd’ gains access to VC-level investment opportunities.Today, OurCrowd is a global venture and alternative investing platform that empowers institutions and individuals to invest and engage in emerging companies. OurCrowd vets and selects companies, invests its capital, and provides its global network with unparalleled access to co-invest and contribute connections, talent and deal flow. OurCrowd builds value for its portfolio companies throughout their lifecycles, providing mentorship, recruiting industry advisors, navigating follow-on rounds and creating growth opportunities through its network of multinational partnerships. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Lisa Graston lisa.graston@ourcrowd.com Company Website http://www.ourcrowd.com

April 16, 2024 08:45 AM Eastern Daylight Time

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