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AGC Biologics to Manufacture First-ever FDA Approved Gene Therapy for Early-onset Metachromatic Leukodystrophy, Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel)

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Milan site to begin commercial manufacturing for the lentiviral vector and genetically modified cell drug product (DP) of Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy for the treatment of pre-symptomatic late infantile, pre-symptomatic early juvenile and early symptomatic early juvenile metachromatic leukodystrophy (MLD). Lenmeldy received approval by the FDA on Monday, March 18. “It is wonderful to see Orchard Therapeutics reach this goal. This accomplishment is a strong proof point of our commitment at AGC Biologics to collaborating directly with developers to meet rigorous regulatory standards and achieve the best possible results for our partners,” says Patricio Massera, CEO of AGC Biologics. Lenmeldy is the first therapy to receive U.S. FDA approval for MLD. With this announcement, AGC Biologics Milan becomes the only global CDMO site to receive the regulatory agency’s clearance to produce this treatment for patients in the U.S. commercially. The FDA approval is the culmination of a partnership that started in 2018 with Orchard Therapeutics, which also includes guiding the product through commercial approval by the European Commission (EC) in 2021. AGC Biologics’ Milan site is uniquely connected to this product’s full lifecycle, as the facility and its scientific teams partnered with each company that owned this treatment’s IP over the last 20 years to help advance it from research and development stages to this DP commercial milestone. “We congratulate Orchard for reaching this important stage. Our team has had the privilege of supplying every clinical milestone for Lenmeldy and are glad to see it reach FDA approval,” said Luca Alberici, General Manager of AGC Biologics Milan. “I am proud of the work of the Milan team. This demonstrates our unique ability to collaborate on technical processes to deliver groundbreaking treatments to patients worldwide. This approval makes our site one of the rare few in the viral vector and genetically modified cells field that has commercial manufacturing authorization from two of the world’s leading regulatory authorities." "AGC Biologics has played a pivotal role as a strategic partner throughout the clinical development and commercial scale-up of atidarsagene autotemcel, which helped facilitate regulatory approvals in Europe and the U.S.," said Nicoletta Loggia, Ph.D., chief technical officer of Orchard Therapeutics. "Utilizing our best-in-class commercial HSC gene therapy manufacturing platform, we have consistently met the demands for drug product production since the European launch in early 2021. This has enabled us to provide treatment to patients from three continents, including Europe on a commercial basis, the Middle East through treatment abroad programs, and the U.S., under compassionate use. With the recent U.S. approval, we are excited to further expand access to this vital therapy for eligible children with early-onset MLD. The AGC Biologics Milan location has 30 years of experience in the cell and gene field and expertise with complex advanced cell therapy projects. The core team has guided three cell therapy products from development to commercial stages and has manufactured hundreds of batches of cell therapies for clinical and commercial usage. The site serves as the AGC Biologics’ Global Cell and Gene Center of Excellence for AGC Biologics. The team has a track record for helping developers meet regulatory guidelines and achieve quality performance metrics, and experience with navigating the unique complexities of technology transfers and scaling up and scaling out manufacturing within the cell and gene space. To learn more about AGC Biologics’ global cell therapy services, visit: www.agcbio.com/capabilities/cell-therapy, go to www.agcbio.com/capabilities/viral-vector and learn more about the CDMO’s viral vector offerings. Lenmeldy™ (atidarsagene autotemcel) is a trademark of Orchard Therapeutics. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs ten different facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

March 18, 2024 11:30 PM Pacific Daylight Time

AGBOOST SCALES AI-ENABLED GENETIC DATA ANALYSIS SOFTWARE FOR CATTLE PRODUCERS

AgBoost

After years of product development and field testing, AgBoost announced the global commercial expansion of its cloud-based data analysis platform that helps cattle producers interpret genomic data for selective breeding, health, market value and nutrition management. Despite a 65% increase in U.S. beef herd productivity over five decades, according to United Stated Department of Agriculture (USDA), rising demand for sustainably produced meat and shrinking profit margins underscore the importance of genetic data for herd efficiency. "Too often, cattle producers invest in DNA technology without unlocking its full potential," said Sean Akadiri, founder and CEO of AgBoost, at the 2024 Animal AgTech Innovation Summit and World Agri-Tech Innovation Summit. "Our platform revolutionizes decision-making, empowering ranchers with faster, more precise choices. By putting genetics at their fingertips, we're reducing the average $2,000 loss per calf during breeding and development, giving ranchers a decisive advantage over the competition.” Traditionally, breeding decisions rely on visual appraisals and multi-generation written records of estimated genetic merit. AgBoost's software combines genomic and production data, including live birth weight and diverse phenotypic information, for individual animals. Users can track animals individually or group them, such as in replacement heifer groups. By selecting specific traits, producers gain a comprehensive view to inform feeding, animal health, and marketing decisions effectively. “Genomic testing data can feel like deciphering hieroglyphics to most producers. But AgBoost transforms complexity into simplicity, presenting data in a visual wheel that sparks meaningful conversations. Now, we can swiftly identify the top bulls with complementary traits for desired calves,” said Nick Jorgensen, CEO and CFO of Jorgensen Land and Cattle, who not only licenses the platform for its large seed stock operation but also invested in the company. Seedstock cattle producers depend on analytics for marketing in bull and production sales. AgBoost visually showcases genetic value and identifies DNA-linked traits, like production, maternal, and carcass traits, aiding in sorting and selecting specific characteristics. The tool also allows for scenario planning, including establishing keep/cull lines to distinguish the top and bottom of the gene pool. Poised for Rapid Expansion into New Geographies and Livestock Introduced to U.S. cattle producers in 2018, AgBoost now holds millions of genomic data records for individual cows. With recent patent approvals, the company aims to expand into top-producing markets like Brazil, Canada, China, and the United Kingdom. The global beef market, valued at $526.50 billion in 2023, is projected to grow at a 4.2 percent CAGR by 2030. Currently, AgBoost supports all sizes of seedstock and commercial cow/calf producers, regardless of breed association, with an interactive pedigree and sire link, with a breeding suggestion calculator coming in late 2024. As pioneers in the market, the company intends to broaden individual producer subscriptions, enterprise licensing agreements, and tailor the platform for additional livestock and related industries to meet current demand. For more information, visit www.Ag-Boost.com. About AgBoost Established in 2013 by engineers and cattle producers as a subsidiary of the animal agtech leader, Agric-Bioformatics, Inc., AgBoost pioneers affordable, user-friendly genetic management tools for livestock producers worldwide. Our comprehensive software streamlines the entire process—from ordering tests to interpreting data for actionable insights and creating effective marketing tools. At AgBoost, our mission is clear: to prioritize producers by empowering them to own and comprehend their data, unlocking maximum growth potential for the future. To learn more or request a demo, visit www.Ag-Boost.com. Contact Details AgTech PR for AgBoost Jennifer Goldston jennifer@agtechpr.com

March 18, 2024 12:17 PM Central Daylight Time

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Abingdon Health CEO discusses strong interim results, robust pipeline and growth strategy

Abingdon Health PLC

Abingdon Health PLC (AIM:ABDX) CEO and co-founder Chris Yates discusses the company's interim results and business operations in an interview with Proactive's Stephen Gunnion. Abingdon Health is a lateral flow, contract development, and manufacturing organisation (CDMO), supporting customers from product ideation to commercial success. It offers services including development, scale-up manufacturing, regulatory and analytical laboratory provision, and packaging. Yates said a 117% revenue increase to £2.4 million during the interim period was primarily driven by its CDMO division. This growth was attributed to increases in development, operational revenues, and the emergence of regulatory area revenues. Despite an inflationary environment, Abingdon Health managed to maintain stable operating costs, resulting in improved gross margins to over 50%. The company has a robust opportunity pipeline with 29 ongoing projects, emphasizing its fully integrated solution's appeal to customers. Yates also highlighted a good start to the second half of the year, with revenues expected to grow significantly while controlling costs to enhance operating profit performance. Contact Details Proactive UK Proactive UK +44 20 7989 0813 UKEditorial@proactiveinvestors.com

March 18, 2024 07:10 AM Eastern Daylight Time

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Faron Pharmaceuticals reports promising phase 1 results from BEXMAB study

Faron Pharmaceuticals Oy

Faron Pharmaceuticals Limited (AIM:FARN) chief executive Dr Markku Jalkanen joins Proactive's Stephen Gunnion with additional positive data from the Phase 1 study of the ongoing bexmarilimab (BEXMAB) trial that has moved into Phase 2 for higher-risk (HR) myelodysplastic syndrome (MDS) patients failed on previous hypomethylating agent (HMA). Dr Jalkanen said the study demonstrated promising results in reducing cancer cells and extending life expectancy in patients. He highlighted the durability and effectiveness of the treatment, particularly in patients with a severe form of myeloid leukemia called MDS, where current treatment options are limited. Dr Jalkanen said the Phase 1 results showed a high overall response rate and an extended overall survival rate among patients, which could lead to a new treatment option for an underserved patient population. He emphasized the importance of continuing the study and engaging with regulators to bring the treatment to market as swiftly as possible. He also noted the potential for increased interest from other pharmaceutical companies based on the positive data released. Faron Pharmaceuticals has moved to the Phase 2 part of the study, focusing on finalising dosing and drug levels as per FDA guidance. The goal is to establish a clear pathway to market approval. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

March 18, 2024 07:02 AM Eastern Daylight Time

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Candel Therapeutics (NASDAQ: CADL) Lead Product Candidate CAN-3110 Demonstrates Promise To Treat Deadly Brain Tumors

Candel Therapeutics

By Jeremy Golden, Benzinga Among brain tumors, high-grade gliomas are the most frequently diagnosed and fatal. Most of the patients with high-grade glioma will have glioblastoma, a more aggressive form of the cancer. The global burden of high-grade gliomas, which have a median overall survival of less than 15 months, cannot be understated, especially given the lack of available treatments to date. The unmet need is even greater in patients with recurrent high-grade glioma, where the expected median overall survival is less than 6 to 9 months. A leader in the development of therapies to treat this field of rare tumors, clinical-stage biopharmaceutical company Candel Therapeutics, Inc. (NASDAQ: CADL), is developing CAN-3110 – a first-in-class drug candidate – to help patients combat these deadly tumors. Candel Therapeutics leverages the ability of viral gene constructs to activate cancer-killing mechanisms, exposing multiple tumor antigens and inhibiting the immunosuppressive tumor microenvironment. The company reports that this tactic has been shown to produce an individualized immune response specific to the patient and their cancer. The company’s viral immunotherapy approach utilizes intratumoral administration of genetically engineered viruses to selectively induce tumor cell death. This elicits an innate and adaptive systemic immune response against the injected tumor and uninjected distant metastases. Best of all, local delivery enables Candel to achieve these results while aiming to minimize systemic toxicity. The lead product candidate in Candel Therapeutics’ HSV platform, CAN-3110, is a replication-competent herpes simplex virus-1 (HSV-1) engineered to enhance the selective killing of cancer cells while sparing healthy neighboring cells. Designed with dual activity for oncolysis and immune activation in a single therapeutic, CAN-3110’s activity is designed to be conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase 1b investigator-sponsored clinical trial in patients with recurrent high-grade glioma. The results from this ongoing clinical trial were recently published in Nature. Investigators discovered that the drug candidate was well tolerated with no dose-limiting toxicity reported, and CAN-3110 was associated with improved survival. Pre-existing anti-HSV-1 immunity increased infiltrating immune cells in the tumor microenvironment and expansion of the T cell repertoire after treatment were all associated with improved survival. “Single-timepoint intralesional injection of rHGG with CAN-3110 enriches the tumor microenvironment with tumor infiltrating lymphocytes, inducing defined changes in peripheral and tumor T cell repertoires and tumor transcriptomic signatures,” investigators wrote in the report. “These changes are particularly evident in patients who are seropositive for HSV1 and are associated with improved survival in this otherwise therapy-refractory cancer. These findings therefore provide human immunological and biological evidence supporting the ability of CAN-3110 to convert the immunosuppressive one immunosuppressive tumor microenvironment characteristic of many solid cancers into a one that is more favorable to immunologic rejection of the tumor.” In the CAN-3110 clinical trial, Candel Therapeutics reports that a near-doubling of the expected median overall survival was observed after a single CAN-3110 injection, compared to historical reports of less than 6 to 9 months in this therapy-resistant condition. The company’s scientists and academic collaborators are currently evaluating the effects of multiple CAN-3110 injections in recurrent high-grade glioma, supported by the Break Through Cancer Foundation. Fresh off receiving FDA Fast Track Designation for the treatment of recurrent high-grade glioma, Candel Therapeutics plans to announce a data readout for the multiple injection cohort in CAN-3110’s phase 1 trial in 2H 2024. They expect initial results in the second half of 2024. How Does CAN-3110 Work? The off-the-shelf drug candidate is engineered for selective replication by placing ICP34.5 – the gene controlling HSV replication – under the control of the Nestin promoter. Nestin is highly expressed in high-grade glioma cells but absent in healthy adult brain cells, which could explain why dose-limiting toxicity was not observed in a study of a single injection of CAN-3110 into the brain tumor in patients with recurrent high-grade glioma. Nestin expression has also been detected in aggressive tumors other than high-grade glioma, broadening the potential reach of CAN-3110 into other indications outside the brain – creating a future pipeline-in-a-product. For more information on Candel Therapeutics, visit candeltx.com. Featured photo by National Cancer Institute on Unsplash. Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. This article includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Aljanae Reynolds +1 617-916-5445 areynolds@wheelhouselsa.com Company Website https://www.candeltx.com/

March 15, 2024 08:15 AM Eastern Daylight Time

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How Theriva Biologics Is Using An Adenovirus To Develop A Novel Treatment For Pancreatic Cancer, As Well As Other Cancers With An Unmet Need

Benzinga

By Faith Ashmore, Benzinga Pancreatic cancer has, unfortunately, been in the news lately due to the rising rates of early-onset cancer, especially in young people. The gastrointestinal cancer, which has a 12% five-year survival rate, is expected to become the second-highest cause of cancer-associated deaths in 2030 in the U.S. In 2024, it is projected that 64,440 Americans will be diagnosed with pancreatic cancer. The global market size for pancreatic cancer was valued at $2.22 billion in 2022, and it is expected to be worth around $7.91 billion by 2032. Despite the multi-billion dollar market size, the industry is expected to grow at 13.6% through 2032, and pancreatic cancer still needs more therapeutic options – especially for advanced cases or when existing treatments don’t yield the desired results. Theriva Biologics (AMEX: TOVX) is a biotech company that is looking to use adenoviruses to help treat pancreatic cancer. Adenoviruses are a class of viruses with an established safety profile. They are highly prevalent in the environment, making them ideal candidates for therapeutic use in the cancer field. Theriva Biologics' lead product candidate, VCN-01, is a uniquely modified human adenovirus designed for systemic delivery to treat different types of cancer. Theriva Biologics reports that phase 1 clinical trials of VCN-01 have shown promising results for the treatment of several additional indications apart from pancreatic cancer, such as retinoblastoma, head and neck squamous cell carcinoma (HNSCC) and colorectal cancer (CRC) in combination with chemotherapy and immunotherapies. Currently, the company is conducting a phase 2b clinical trial of VCN-01 in combination with standard-of-care chemotherapy for first-line metastatic pancreatic cancer. It is on track to complete enrollment into the VIRAGE Study by the first half of 2024. In the first quarter of 2024, a Drug Monitoring Committee (DMC) conducted a thorough safety review of VCN-01, and found that the VCN-01 safety profile permitted the VIRAGE study to continue without modification. By the second half of 2024, Theriva Biologics aims to perform an interim analysis of the data obtained from the VIRAGE Study. Pancreatic cancer presents several unique challenges that contribute to its high mortality rate and the difficulty in managing the disease. One major challenge is the aggressive nature of pancreatic cancer, which often spreads to other organs before being diagnosed. Approximately 50% of patients are diagnosed when the cancer has already metastasized, resulting in advanced-stage disease. Pancreatic cancer is also known for causing nonspecific symptoms, making it challenging to detect in its early stages. VCN-01 has a systemic delivery approach, which means it can target both the main tumor and distant metastases, which makes it a promising therapeutic option for advanced and difficult-to-treat cancers like pancreatic cancer. If the company can successfully harness the benefits of adenoviruses, it will present suffering patients around the globe with a novel solution to extend their lives. Featured photo by Olga Kononenko 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

March 14, 2024 08:20 AM Eastern Daylight Time

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Arecor Therapeutics announces collaboration on oral GLP-1 drug for diabetes and obesity treatment

Arecor Therapeutics PLC

Arecor Therapeutics PLC (AIM:AREC) CEO Sarah Howell joined Proactive's Stephen Gunnion with details of a collaboration with TRX Biosciences to develop an oral GLP-1 product for treating type 2 diabetes and obesity. GLP-1s are therapeutic peptides known for improving blood sugar levels and promoting weight loss. The market for GLP-1 products is expected to reach $100 billion by 2030. Currently, GLP-1 treatment options are predominantly injectable, which limits patient compliance and adoption. Arecor aims to develop an oral GLP-1 with enhanced bioavailability, making it a once-daily pill. This development could significantly increase access to effective treatments for these conditions. Howell told Proactive that Arecor is well-positioned for this development due to its successful track record with its Arestat technology platform, which enhances the profiles of existing therapeutics. The collaboration aims to overcome challenges faced by the only available oral GLP-1, such as low bioavailability and the need for dosing on an empty stomach, by leveraging Arecor's technology in conjunction with TRX Biosciences' Lipper core technology. She said the collaboration complements Arecor's existing diabetes portfolio, which includes two leading insulin products and Gluco, a product for severe hypoglycemia in diabetes patients. The focus is on reducing the daily burden of disease management and improving patient outcomes. TRX Biosciences was chosen for their complementary technology and expertise in oral peptide delivery. The initial development phase will last up to 18 months, aiming to demonstrate the feasibility of a stable, orally delivered GLP-1 with improved bioavailability. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

March 14, 2024 08:13 AM Eastern Daylight Time

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The Cultivated B Introduces n!Biomachines: Fit-For-Purpose Bioreactors Designed to Easily and Affordably Scale Cellular Agriculture

The Cultivated B

The Cultivated B (TCB) today announced the name change of its Canadian subsidiary, now embracing a broader mission. Formerly called The Cultivated B Canada and located in Burlington, Ontario, n!Biomachines (pronounced “n factorial biomachines”) is dedicated to fulfilling the commercial scalability and viability potential of industrial cellular agriculture technologies across a number of product categories. Unlike over-engineered bioreactors that were designed predominantly for pharmaceutical use, n!Biomachines delivers affordable, easy-to-operate systems for the food, dietary supplement and cosmetics industries, offering sustainable solutions that consume remarkably low amounts of electricity, in some cases as low as 150 watts. The company’s AUXO V fit-for-purpose bioreactors are engineered to focus on single applications, such as animal cells or yeast. This streamlines complex processes and eliminates the operational clutter that multifunctionality typically brings to bioprocessing. The AUXO V’s revolutionary design benefits large-scale manufacturing by improving process efficiency and drastically reducing the level of expertise needed to operate a bioreactor. “The mathematical term, 'n!', or n factorial, acknowledges the core of our mission: scalability and multiplication, with respect to our bioreactor capacity as well as bioprocessing opportunities for our customers,” said Dr. Hamid Noori, CEO of n!Biomachines and The Cultivated B. “'Biomachines' refers to the revolutionary redesign of bioreactors to be useful across all industry sectors that want to step away from overengineered, overly complex equipment. The name n!Biomachines signifies our ambition to expand the applications of bioprocessing through affordable, sustainable and purpose-driven bioreactor design.” Unparalleled usability, increased automation and optimized operational and equipment costs define this new generation of bioreactors for benchtop-, pilot- and industrial-scale bioprocessing without compromising production quality, safety or efficiency. With an emphasis on rapid delivery and cost-effective design, n!Biomachines unlocks bioprocessing for new industries while accelerating growth and innovation for established sectors. “It became clear to us that cellular agriculture industry is at an inflection point where benchtop processes are quite well-proven, but scalability and commercial viability have yet to be sufficiently addressed,” continued Dr. Noori. “Our new bioreactor designs enable efficient processes and the faster delivery times needed to accelerate and integrate cellular agriculture as an additional pillar of our food production system. n!Biomachines is the answer to removing the bioreactor bottlenecks that currently prevent this emerging industry from scaling.” About n!Biomachines n!Biomachines, a subsidiary of The Cultivated B, specializes in developing and manufacturing fit-for-purpose bioreactors for the next generation of bioprocessing. It targets benchtop, pilot- and industrial-scale bioprocessing, ensuring high-quality, safe and efficient operations. Unlike traditional bioreactors that were designed primarily for the pharmaceutical industry, n!Biomachines provides affordable, user-friendly systems for various bioprocesses and organisms, improving commercial viability and scalability for the food, supplement and cosmetics industries. By overcoming industry growth barriers, n!Biomachines aims to revolutionize manufacturing and facilitate the adoption of cellular agriculture technologies sustainably and efficiently. For more information, visit https://www.n-factorial.com/ and follow the company on LinkedIn. About The Cultivated B (TCB) The Cultivated B is a multinational company dedicated to the development and application of breakthrough technologies in cellular agriculture, precision fermentation and bioreactor engineering to enable scalable commercialization of the cellular-agriculture industry. TCB serves startups, corporations and academic research institutions within the food, pharma, cosmetics and personal care industries with its outstanding capabilities. The companyâs fundamental commitment to minimizing the natural resources used paves the way towards a sustainable future, locally, regionally and globally. TCBâs research and development team is based in Germany. PreFer Industries and n!Biomachines, based in Canada, are subsidiaries of TCB. For more information, visit https://www.thecultivatedb.com and follow the company on LinkedIn. Contact Details Jenna Beaucage +1 508-340-6851 tcb@rainerco.com Company Website https://www.thecultivatedb.com

March 13, 2024 06:03 AM Eastern Daylight Time

UNOS welcomes new seven-member board of directors

United Network for Organ Sharing

On Friday, March 8, 2024, the United Network for Organ Sharing (UNOS) announced the seven members of its new board of directors, who begin their terms on March 30, 2024. For the first time in nearly 40 years, UNOS’ board of directors will be independent from the Organ Procurement and Transplantation Network’s (OPTN) board of directors. The new UNOS board takes effect the day after UNOS’ current OPTN contract with the federal government ends. The creation of a new, independent UNOS board eliminates any conflict of interest in the governance of the OPTN. Currently, the same 42 people oversee both UNOS and the OPTN. The board separation represents a significant change in governance structure, and it has received wide-ranging support – from HRSA, from members, and even from critics of the current OPTN system - as it benefits the entire transplant community. Board separation also is in line with HRSA’s own Modernization Initiative. While HRSA is working to finalize plans for the OPTN board when the current contract expires, UNOS has followed through on its commitment to remove the conflict of interest that has been in place for decades by announcing its new board of directors. Now, after working on board separation plans with HRSA for years, UNOS remains confident that HRSA will act by March 30 to finalize this critical change that is best for the entire transplant community. “Having independent and distinct boards will appropriately allow each organization to benefit from board members who have a singular focus on the mission of the organization they support without conflicts of interest that may cause unnecessary challenges,” said Maureen McBride, Ph.D., CEO of UNOS. “I look forward to working with our new UNOS board, as well as the OPTN board, to not only continue our lifesaving work within the U.S. donation and transplant system, but to also expand our reach as a company to help improve the health and lives of more people around the globe.” UNOS’ new board members were selected for their diverse range of expertise and experience in business strategy, health care, information technology and information security, and the organ donation and transplant system. The members are: Sue Dunn, former CEO of Donor Alliance Bapu Jena, M.D., Ph.D., professor of health care policy at Harvard Medical School, internist at Massachusetts General Hospital Maryl Johnson, M.D., professor at the University of Wisconsin School of Medicine Irene Kim, M.D., director of the Comprehensive Transplant Center at Cedars-Sinai Jake Kouns, founder of RVAsec James Pittman, assistant vice president of transplant and dialysis services for HCA Healthcare Marie Quintero-Johnson, retired vice president of corporate development for Coca-Cola and kidney recipient Establishing a UNOS board that is distinct from the OPTN board is aligned with HRSA’s Modernization Initiative, calls from Congress to separate the boards, and UNOS’ Action Agenda. UNOS worked with HRSA as UNOS took action to establish its new governance structure separate from the OPTN: June 22, 2021 – UNOS met with HRSA to present on the establishment of a separate OPTN board. January 10, 2023 – UNOS sent a letter to HRSA Administrator Carole Johnson expressing a shared desire to create two distinct boards of directors. The letter noted that UNOS sent the contracting officer a request for a “modification to the current OPTN contract. The proposed modification would assign UNOS a task to develop a plan to separate the OPTN Board of Directors from UNOS’ Board of Directors.” UNOS asked the administrator to approve the contract modification noting that “the end of the current contract, September 29, 2023, would be an ideal time to complete the separation of the boards.” March 22, 2023 – HRSA announced its OPTN Modernization Initiative, which noted that as part of the effort, HRSA will work to ensure the OPTN board of directors “has greater independence.” May 2023 – HRSA issued a contract modification directing UNOS to submit an OPTN Board Independence Plan that complies with the National Organ Transplant Act and the OPTN Final Rule and included required activities, with timelines and milestones, to incorporate the OPTN as an independent legal entity governed by the OPTN board of directors. July 14, 2023 – UNOS submitted its OPTN Board Independence Plan. July 20, 2023 – The Senate held a hearing focused on the Securing the U.S. Organ Procurement and Transplantation Network Act, which according to the bill’s sponsor will for the first-time mandate an independent Board of Directors to oversee OPTN separate from the contract holder. July 27, 2023 – HRSA issued a statement on the OPTN reform law: "The Health Resources and Services Administration shares Congress’ goal of making the Organ Procurement and Transplantation Network (OPTN) work better for the more than 100,000 people on the waiting list for organs. Individuals on the wait list, organ donors, and their families deserve an OPTN governed by an independent, representative board…” September 28, 2023 – HRSA executed a unilateral extension of UNOS’ contract through March 29, 2024. October 30, 2023 – UNOS and HRSA met at UNOS’ request regarding board separation effective March 30, 2024, the day after UNOS’ contract ends. HRSA indicated it cannot dictate the corporate governance structure of a private entity. November 29, 2023 – UNOS and HRSA had a follow-up meeting at UNOS’ request regarding board separation. December 5, 2023 – UNOS board voted to establish a new governance structure distinct from the OPTN Board, a decision made in the best interest of patients and the nation’s organ donation and transplant system. The board made the effective date of this action March 30, 2024, to align with the end of UNOS’ 6-month contract extension. December 13, 2023 – UNOS and HRSA had a follow-up meeting at UNOS’ request regarding board separation. December 2023 – HRSA reiterated its commitment to an independent OPTN board: “For nearly 40 years, the Board of Directors for the Organ Procurement and Transplantation Network (OPTN) has been comprised of the same individuals who serve as the Board of Directors for the private entity that has held the OPTN contract. No formal requirements existed to protect against conflicts of interest resulting from this shared role.” February 22, 2024 – UNOS membership ratified the UNOS board decision to establish a new UNOS governance structure. March 29, 2024 – UNOS’ current contract with HRSA ends. Although the federal government’s timeline for implementing its OPTN Modernization Initiative has shifted, UNOS, under new leadership, has remained committed to being a good partner to the administration, Congress and stakeholders to change the current governance structure that requires UNOS board members to serve as OPTN board members. Effective March 30, 2024, OPTN board members will not have a fiduciary duty to UNOS as a non-profit organization. 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

March 12, 2024 02:46 PM Eastern Daylight Time