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Capturing Consumer Spending on Health Care with XLV

Select Sector SPDR

With consumer spending on health care continuing to increase, the Health Care Select Sector SPDR Fund ( XLV ) provides an opportunity for investors to leverage this trend. XLV tracks health care stocks within the S&P 500 Index, offering broad exposure to core companies in the U.S. healthcare sector. The fund's top holdings* are comprised of market leaders across several sub-sectors of healthcare including companies such as Eli LIlly & Co (11.34%), Unitedhealth Group (8.36%), Johnson & Johnson (6.96%), Merck & Co (6.11%), AbbVie Inc. (5.87%), Thermo Fisher Scientific (4.10%), Abbott Laboratories (3.61%), Danaher Corp (3.00%), Pfizer (2.86%), and Amgen (2.78%). Growth Drivers in the Healthcare Sector As the health care sector continues to grow, these companies are well-positioned to benefit from increased consumer spending. The growth history in this sector has been driven by several factors, including a rise in chronic diseases, an aging population, and advancing medical technology. Total spending on health care rose from 16% of GDP in 2007 to an estimated 18% in 2023. Simultaneously, the total GDP has risen nearly 70% in that time, from 14.47 trillion in 2007 to 25.5 trillion in 2022. Investing in XLV offers a diversified way to capture steady consumer spending on health care. By investing in the health care market in a broad way, the ups and downs of a particular big name in the sector are mitigated by the exposure to other healthcare companies. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. *Holdings, Weightings & Assets as of 3/31/24 subject to change DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007449 EXP 5/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

April 22, 2024 05:00 AM Eastern Daylight Time

Elsevier Appoints Dr Kieran West MBE as Executive Vice President of Strategy

Elsevier

Elsevier, a global leader in scientific information and analytics, announced today the appointment of Dr Kieran West MBE as Executive Vice President of Strategy, effective immediately. As an established senior executive with a track record of driving transformation and growth, Kieran joins Elsevier with extensive experience in healthcare, retail, consumer goods, and pharmaceuticals across international markets. Most recently, he served as Strategy Director at Bupa Global and UK, a leading healthcare provider and insurer, where he was instrumental in shaping the company's strategic direction. Prior to his time at Bupa, he served as an Associate Partner at McKinsey, where he advised both domestic and global companies on achieving commercial success. He previously taught mathematics at King’s College School, UK. His academic achievements include a PhD in History from the University of Cambridge, an MA in War Studies from King’s College London, and a PGCE degree in Mathematics. Kieran is also a world champion rower and Olympic gold-medallist, having won in the Men’s Eights in the 2000 Sydney Olympics. Kumsal Bayazit, CEO of Elsevier, said: “I am thrilled to welcome Kieran to Elsevier and look forward to the contribution that he will make with his strong strategic and operational experience, and his understanding of the healthcare, life sciences and academic communities. He is also passionate about developing individuals and delivering as a team, which is very much aligned with our values as an organization.” Kieran joins Elsevier’s Executive Leadership Team and will work across all areas of the company to develop and drive global strategic plans, including business development initiatives. He will be based in London. About Elsevier As a global leader in scientific information and analytics, Elsevier helps researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. We do this by facilitating insights and critical decision-making with innovative solutions based on trusted, evidence-based content and advanced AI-enabled digital technologies. We have supported the work of our research and healthcare communities for more than 140 years. Our 9,500 employees around the world, including 2,500 technologists, are dedicated to supporting researchers, librarians, academic leaders, funders, governments, R&D-intensive companies, doctors, nurses, future healthcare professionals and educators in their critical work. Our 2,900 scientific journals and iconic reference books include the foremost titles in their fields, including Cell Press, The Lancet and Gray’s Anatomy. Together with the Elsevier Foundation, we work in partnership with the communities we serve to advance inclusion and diversity in science, research and healthcare in developing countries and around the world. Elsevier is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. For more information on our work, digital solutions and content, visit www.elsevier.com. Contact Details Dan DiPietro-James +1 323-252-0645 Dan.james@elsevier.com

April 22, 2024 04:00 AM Eastern Daylight Time

UNOS unveils new artwork honoring organ donors and recipients

United Network for Organ Sharing

Today, the United Network for Organ Sharing (UNOS) installed a mural by acclaimed artist Hamilton Glass to recognize the far-reaching impact of organ donation and to pay tribute to organ donors. The artwork is a Glass original, designed specifically for UNOS, and lives above the main entrance of UNOS’ headquarters in Richmond, Va. The mural portrays the interconnectedness of the organ donation and transplant community, with hands symbolizing the gesture of giving and receiving the gift of life. The blue ripples illustrate the ripple effect of donation on families and communities. “The artwork serves as a poignant reminder that every donation is a gift that touches us all, creating a network of support that UNOS tirelessly collaborates with daily to save lives,” said Glass. UNOS invited Richmond-based architect and artist Glass and his wife and business partner Taekia to design and create a piece of art that visually connects to and builds on the meaning of the National Donor Memorial. The memorial honors organ, eye and tissue donors and is open 24/7 to allow visitors to reflect on the journey of donation and transplant. “The lifesaving and lifechanging impact an organ donor has on both a recipient and their loved ones is incredibly profound, which is why we wanted to work with Hamilton Glass to create a piece of art that honors the selfless gifts organ donors provide,” said Maureen McBride, Ph.D., CEO of UNOS. “We want people to visit this mural and take in and learn how significant and impactful organ donation is.” Glass uses art to engage the public through big, bold designs and messages of hope, and has more than 300 murals on display throughout Richmond. The mural is approximately 16 feet tall and 40 feet wide and is comprised of 18 PVC panels. It is located on the exterior of UNOS’ building on North 4th Street in Richmond, Va. About UNOS United Network for Organ Sharing (UNOS) is the mission-driven non-profit serving as the nation’s transplant system under contract with the federal government. We lead the network of transplant hospitals, organ procurement organizations, and thousands of volunteers who are dedicated to honoring the gifts of life entrusted to us and to making lifesaving transplants possible for patients in need. Working together, we leverage data and advances in science and technology to continuously strengthen the system, increase the number of organs recovered and the number of transplants performed, and ensure patients across the nation have equitable access to transplant. Contact Details United Network for Organ Sharing Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

April 19, 2024 03:54 PM Eastern Daylight Time

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BioHarvest Sciences secures new state of the art 80,0000 square foot manufacturing facility

BioHarvest Sciences Inc

BioHarvest Sciences CEO Ilan Sobel joined Steve Darling from Proactive to to unveil two significant agreements that mark a transformative milestone for the company: an equipment purchase agreement for 12 state-of-the-art GMP clean rooms and a long-term lease agreement for a new 80,000 square foot facility in Yavne, Israel. Sobel elaborated on the exciting developments, highlighting that the new facility represents a major expansion for BioHarvest Sciences. Equipped with industry-leading clean rooms, as well as fully built-out laboratory space and offices, the facility is poised to support the company's ambitious growth plans. Notably, it also provides the necessary infrastructure to accommodate the anticipated expansion of the Contract Development and Manufacturing Organization (CDMO) Business Unit. The strategic significance of this transaction lies in its immediate access to cutting-edge clean rooms and laboratories, essential for meeting the evolving needs of both the Products Business Unit and CDMO customers. Furthermore, the facility boasts ample additional space, enabling the construction of a new 50-ton manufacturing facility slated for operation in the second half of 2025. This facility will incorporate upgraded equipment and technologies, representing the second generation of the Botanical Synthesis manufacturing process. These enhancements are designed to optimize production yields and efficiencies, further solidifying BioHarvest Sciences' position as a leader in botanical synthesis technology. Sobel emphasized that the relocation of Research & Development and corporate administrative offices to the new BioHarvest Campus is imminent, expected to be completed within the next 6-9 months. This consolidation of operations underscores BioHarvest Sciences' commitment to streamlining its operations and fostering collaboration across its various business units. As BioHarvest Sciences embarks on this exciting new chapter of growth and expansion, Sobel expressed confidence in the company's ability to capitalize on the vast opportunities that lie ahead. With its state-of-the-art facilities and cutting-edge technologies, BioHarvest Sciences is poised to drive innovation and deliver value to its customers and stakeholders alike. Stay tuned for further updates as the company continues to forge ahead on its journey of growth and success. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 18, 2024 09:43 AM Eastern Daylight Time

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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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