Northwest Biotherapeutics Announces the Completion of Financing on a Favorable Terms for Approximately $8 Million

Northwest Biotherapeutics | August 12, 2020

Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the Company has completed a financing on favorable terms for approximately $8 million.  The Company anticipates that this financing will help maintain the Company's momentum, and will provide some prudent protection in the midst of the current global economic uncertainties.  The financing also further broadens the lock-up of warrants that the Company has been building. An additional approximately 75.5 million existing warrants, outstanding prior to this financing and held by investors in this financing, have been suspended until December 15, 2020 as part of this financing.  These warrant suspensions were compensated on a similar basis as the warrant suspensions previously reported.  In addition, all new warrants in this financing are suspended until December 15, 2020. As the Company approaches the read-out of its Phase III trial of DCVax®-L for Glioblastoma brain cancer, the Company is working with a growing team of technical experts and regulatory advisers on various readiness preparations, including manufacturing related preparations.  This financing will help the Company maintain its momentum in these very important activities.

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Recognized as one of the most successful public health screening programs to date, neonatal screening has traditionally been designed to identify newborn babies with conditions that are treatable, but not clinically evident in the newborn period.


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MEDICAL

Dover To Acquire Manufacturer Of Flow-Measurement Devices For Biopharma And Semiconductor Production Applications

Dover | May 11, 2022

Dover (NYSE: DOV) announced today that it has entered into a definitive agreement to acquire Malema Engineering Corporation ("Malema"), a designer and manufacturer of high-precision, mission-critical flow-measurement and control instruments serving customers in the biopharmaceutical, semiconductor, and industrial sectors. Malema will become part of the PSG business unit within Dover's Pumps & Process Solutions segment. Malema's products will expand Dover's biopharma single-use production offering, which already includes Quattroflow pumps, CPC connectors, and em-tec flowmeters. Based in Boca Raton, FL, and with facilities in San Jose, CA, Singapore, South Korea, and India, Malema expects to generate approximately $40-45 million in revenue during the full year 2022 and has a robust growth outlook. Over the past four decades, Malema has cultivated a loyal base of blue-chip customers, OEMs, and end-users with substantial aftermarket and recurring revenue streams. Malema's first-of-its-kind single-use flow sensor using Coriolis technology offers superior flow-measurement performance and accuracy versus alternative technologies, reducing the potential for measurement error and eliminating the need for calibration in time-sensitive and contamination-intolerant environments. We see a tremendous long-term growth opportunity in the bioprocessing industry driven by a strong and growing pipeline of effective novel biologic drugs, biosimilars, protein therapies, non-COVID mRNA vaccines, as well as budding cell & gene therapies. Additionally, the growing adoption of more efficient single-use production processes supports a robust outlook for our offerings of single-use components to end-customers. We believe that pairing Malema's technology with our existing portfolio of single-use pumps for biopharma processing will greatly enhance the accuracy and value proposition of our solutions to our customers. PSG's President, Karl Buscher. We are methodically building out our biopharma platform through proactive capacity additions, new product development, and opportunistic acquisitions of highly-attractive niche component technologies, Malema represents a strategic and highly-complementary flow-control and sensing technology and further strengthens our sensor portfolio with new proprietary technology. In addition to attractive biopharma applications, we expect strong growth in the semiconductor space on the capacity expansion and re-shoring tailwinds." Richard J. Tobin, President and Chief Executive Officer of Dover. The purchase price is comprised of $225 million in cash at closing, subject to customary purchase price adjustments, and up to $50 million in contingent consideration dependent on the achievement of certain financial objectives over a two-year period. The transaction is expected to close in the second quarter and is subject to the satisfaction of customary closing conditions, including applicable regulatory approvals. About Dover: Dover is a diversified global manufacturer and solutions provider with annual revenue of approximately $8 billion. We deliver innovative equipment and components, consumable supplies, aftermarket parts, software and digital solutions, and support services through five operating segments: Engineered Products, Clean Energy & Fueling, Imaging & Identification, Pumps & Process Solutions, and Climate & Sustainability Technologies. Dover combines global scale with operational agility to lead the markets we serve. Recognized for our entrepreneurial approach for over 65 years, our team of over 25,000 employees takes an ownership mindset, collaborating with customers to redefine what's possible. Headquartered in Downers Grove, Illinois, Dover trades on the New York Stock Exchange under "DOV." About PSG: PSG is a global pump solution expert and leading manufacturer of pumps, systems, and related flow-control technology for the safe and efficient transfer of critical and valuable fluids and materials. Headquartered in Oakbrook Terrace, IL, PSG is comprised of several world-class brands, including Abaque®, All-Flo®, Almatec®, Blackmer®, Ebsray®, em-tec®, Griswold®, Hydro Systems™, Mouvex®, Neptune™, Quantex™, Quattroflow®, and Wilden®. PSG products are manufactured in three continents – North America, Europe, and Asia – in state-of-the-art facilities that practice lean manufacturing and are ISO-certified. PSG is part of the Pumps & Process Solutions segment of Dover Corporation.

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INDUSTRIAL IMPACT

ThinkCyte's Shares Applications of Ghost Cytometry with Industrial and Academic Thought Leaders

ThinkCyte Inc. | July 12, 2022

ThinkCyte Inc., a biotechnology company pioneering novel cell analysis and sorting instruments, announced that applications of its Ghost Cytometry technology were presented at several leading industry meetings. In May, the company was selected to present applications of the platform to experts in drug discovery at the prestigious Keystone Symposia. The company was also selected to deliver a podium presentation at the 2022 International Association for the Advancement of Cytometry's annual meeting, sharing applications in clinical medicine and cellular therapy with a talk entitled 'Machine vision-based label-free cell analysis and sorting for clinical diagnosis and cell therapy.' The company and its Ghost Cytometry platform were also selected as one of three finalists for the Technology Showcase at CYTO, which highlights innovative and disruptive cytometric technologies. "We are incredibly pleased to be able to share our most recent work using Ghost Cytometry with the broader scientific community. It's an exciting time to be in the field of drug and cellular therapy with innovative approaches being developed to extract novel information from cells. We look forward to showcasing more of our internal work and collaborations with existing partners in the months ahead." ThinkCyte's CEO Waichiro Katsuda Ghost Cytometry is a novel flow-cytometry based platform for cell analysis and sorting. Using a combination of proprietary optical designs and artificial intelligence, Ghost Cytometry provides researchers with an entirely new data lens for capturing complex single-cell phenotypes into a "cellular fingerprint" and enables the isolation of live target cells, untouched by external labels, for downstream research and development applications. About ThinkCyte Inc. ThinkCyte, founded in 2016 with offices in Tokyo, Japan and San Carlos, California is a biotechnology company that develops innovative instruments based on integrated, multidisciplinary technologies to enable life science research, diagnostics, and therapeutic development. The company pioneered Ghost Cytometry, a proprietary AI-based, label-free cell sorting technology and works with major global biopharmaceutical companies and leading academic research institutes to further drive pioneering research.

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INDUSTRIAL IMPACT

Providence Therapeutics Signs Licensing Agreement with SickKids for Immunotargeting Technology

Providence Therapeutics | July 13, 2022

Providence Therapeutics, Canada's premier mRNA medicines company, is pleased to announce that it has entered into an exclusive licensing agreement with The Hospital for Sick Children of Toronto, ON, for an immunotargeting technology platform. This platform provides an innovative approach to generating adjuvant-free vaccines and works by targeting Antigen Presenting Cells of the immune system via the MHC Class II molecules on their surface. This can result in an enhanced immune response to antigens which are coupled to the targeting monoclonal antibody (mAb). The technology builds on the earlier pioneering work done by Dr. Brian Barber, Professor Emeritus of Immunology at the University of Toronto, and has been extensively refined in the laboratory of Dr. Jean-Philippe Julien, Senior Scientist in the Molecular Medicine program at SickKids. The versatile technology platform can generate both monovalent and multivalent therapeutics, in a varied field of applications, including vaccines. With additional features, such as incorporating T-cell epitopes with the aim of generating a broader and longer immune response, the technology can engage both the humoral and cellular components of the immune system. Providence Therapeutics, an emerging specialty Biopharma, has successfully developed a robust, scalable, and effective mRNA medicine platform as exemplified by the clinical success of PTX-COVID19-B. The company is currently applying this platform to a variety of other infectious diseases and to an emerging oncology pipeline. The immunotargeting technology will enable the development team at Providence to explore the development of a new generation of unique mRNA medicines and vaccines by combining both platforms synergistically, potentially offering a multivalent dimension which will be new and unique in the field. "We are very excited to be working with a prestigious institution like SickKids. The immunotargeting technology is an excellent addition to our existing world class mRNA platform and will be important in enhancing the depth and scope of our portfolio of development programs." Brad Sorenson, CEO of Providence Therapeutics "We are excited to identify and potentially develop further novel applications for our immunotargeting technology, which provides an alternative to the use of adjuvants in vaccines," says Dr. Jean-Philippe Julien, the co-inventor of the technology. "This opportunity, emerging from Drs. Julien and Barber's research, is an example of how SickKids Industry Partnerships & Commercialization is working to support promising research and provide access to the robust research and clinical innovation ecosystem at SickKids," says Ihor Boszko, Executive Director, SickKids Industry Partnerships & Commercialization. The financial terms of the License are not being disclosed, but does include a provision for development of the technology through future sponsored research at SickKids. The company is committed to commercializing the technology and has an option for licensing of additional related technologies from the PI's laboratory in the future. About Providence Therapeutics Providence is a leading Canadian clinical stage biotechnology company pioneering mRNA therapeutics and vaccines with operations in Calgary, AB and Toronto, ON. In response to a worldwide need for a COVID-19 vaccine, Providence expanded its focus beyond oncology therapies and devoted its energy and resources to develop a world-class mRNA vaccine for COVID-19, PTX-COVID19-B, which is currently in the planning stages for a Phase 3 booster study to begin before the end of the year. Providence is focused on serving the needs of Canada, and other countries that may be underserved by large pharmaceutical programs.

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MEDTECH

AMPEL BioSolutions' Precision Medicine Breakthrough Predicts Drug Options with RNA Analytics & Machine Learning

AMPEL BioSolutions | July 07, 2022

AMPEL BioSolutions announces a breakthrough in precision and personalized medicine that could modernize the way doctors treat patients across a wide variety of diseases including autoimmunity, infectious disease and cancer. Revealed at the Precision Medicine World Conference in Silicon Valley California, the first-in-class platform technology utilizes RNA analytics and machine learning to characterize an individual's gene expression and provide clinical decision support to physicians for treatment options for their patients. The technology, only a concept for the last few years, is being utilized to launch a portfolio of 10+ clinical tests over the next five years to provide decision support for diseases that affect more than 50 million Americans. AMPEL's innovative machine learning approach, which is now ready to be developed as a clinical decision support biomarker test, could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely. AMPEL's approach is sufficiently sensitive to detect early signs of disease and group patients by the severity of their condition. The application of AMPEL's technology is already assisting 15+ pharmaceutical companies in drug development and clinical trials. Patients with autoimmune and inflammatory diseases often suffer from unpredictable disease activity that impacts daily activities like work and family life. Since unpredictable symptoms often result in trips to the Emergency Room, the ability to predict worsening disease and systemic involvement with routine testing has important health care and health economics implications. AMPEL expects to bring it's first two products to market in the next few years, LuGENE® blood test for Lupus and DermaGENE® skin biopsy test for Psoriasis, Atopic Dermatitis, Scleroderma and Lupus. In addition, AMPEL's CovGENE® blood test that predicts how severe a disease course a COVID patient may experience and may be applicable to "long COVID" is ready for licensing/co-development with a company already offering COVID diagnostic testing. Paired with AMPEL's pipeline of tools to analyze very large and complex clinical datasets ("Big Data"), AMPEL's Genomic Platform technology with machine learning is a significant step towards implementing routine testing to monitor disease activity and provide decision support for treatment based on a patient's gene expression. This will transform the way doctors treat patients by using the information gathered by the lab test and analyzed by machine learning to diagnose, characterize the precise molecular abnormalities and treat diseases before damage begins, saving patients from pain and inconvenience of diseases that otherwise drastically affect their lives. Pharmaceutical companies test drugs in clinical trials and face the challenge of enrolling patients that have the best potential to respond to the treatment being tested. Enrolling the "wrong" patients can result in trial failure, often leading to cancellation of a drug's development towards FDA approval that may have benefit in a sub-group of the overall patient population. AMPEL's technology helps pharmaceutical companies proactively identify the patients most likely to respond to specific treatments, thereby helping improve outcomes in clinical trials and quality of life for patients in need. AMPEL's Pharma work was highlighted by Dr. Peter Lipsky at the Precision Medicine World Conference in a panel discussing the use of machine learning in clinical trial patient selection and outcome prediction and by Dr. Amrie Grammer at a Google-Reuters webinar focused on machine learning approaches to select the right patient for the right trial at the right time. "It is very gratifying to see a concept develop into a reality that can help patients. When we began some years ago we thought that analyzing gene expression data could subset patients effectively and allow the molecular profile of each patient to be used to help identify the best treatment for each individual. By applying novel machine learning approaches, we are now ready to launch our first application that we believe should be a major step toward providing patients with autoimmune diseases true precision medicine." Dr. Peter Lipsky, AMPEL Co-Founder, CEO and Chief Medical Officer Dr. Amrie Grammer, AMPEL Co-Founder, President and CSO: ""Our team has developed a genomic platform technology with machine learning that supports clinical precision medicine tests that predict drug options based on gene expression. AMPEL is changing the paradigm of treatment in autoimmune and inflammatory diseases. We are proud to be doing this work in Virginia and will continue to recruit talent and grow our business here." Many chronic diseases have unexpected flares that dramatically affect patient quality of life. Further, treatments for chronic disease have been developed based on a patient population as a group, so some individuals will respond differently or not at all to available treatments. For the past nine years, the scientists and clinicians at AMPEL have been working on ways to address this problem, by designing concepts to personalize treatments for an individual patient as opposed to a patient population. Peer reviewed publications confirm the practicality of AMPEL's concept, which are now in the commercialization phase. AMPEL's initial focus was lupus but the test can be used for many autoimmune or inflammatory diseases. AMPEL's blood and tissue biopsy tests are prognostic and staging biomarkers that will provide decision support for their physician with the most appropriate drugs for the patient at that moment in time. About AMPEL BioSolutions LLC AMPEL BioSolutions is a precision medicine company commercializing a development pipeline of CLIA-certified gene expression tests for blood or tissue samples that provide clinical decision support by determining disease status, identifying molecular pathway and predicting drug options. AMPEL's technology is a cloud-based platform that hosts proprietary RNA analytic tools and machine learning algorithms covered by 25+ filed/pending patents and 80+ peer-reviewed publications in high impact journals. Disease Areas for AMPEL's precision medicine test portfolio include Systemic Lupus Erythematosus, Psoriasis, Scleroderma, Atopic Dermatitis, Lupus Nephritis, Fibromyalgia, Cardiovascular, Sjogren's Syndrome, ASD, Wellness, Lung Cancer and SARS-Cov2. AMPEL's technology covers over 95% of all known genes and AMPEL's exclusive curated database of >15,000 individual gene expression profiles with rich clinical information fuels machine learning predictions based on evidence. AMPEL BioSolutions was elected to the Coalition for 21st Century Precision Medicine in early 2022.

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Recognized as one of the most successful public health screening programs to date, neonatal screening has traditionally been designed to identify newborn babies with conditions that are treatable, but not clinically evident in the newborn period.

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