founder and CEO of Buyins.net, Thomas Ronk As the founder and CEO of Buyins.net, Thomas Ronk has created a proprietary database and trading strategy based on short sale timing and sales data that was not accessible to anyone prior to January 2005. As a registered representative of Transamerica Financial Resources, a division of Transamerica, Mr. Ronk managed more than $150-million in equity accounts from 1993 until 1998. He has 27 years of trading experience and is the principal of Century Pacific Investments, a registered investment advisor in California. Prior to the investment business, Mr. Ronk studied Electrical Engineering and Computer Science at the University of California in San Diego. In this interview with BioTuesdays, Mr. Ronk discusses manipulative short selling and how his company helps clients to analyze and develop a plan to deal with it. Let’s begin with a brief history of your company. Back in 1996, I first recognized a naked short sale in a small health care company and then witnessed a buyin. At the time, stock exchanges only tabulated total short interest in a stock and the SEC did not allow the purchase of trade identifier data. So when you see a trade cross the tape, you don’t know if the trade is a buy, buy to cover, sell or short sale. We began lobbying in 1996 to obtain trade identifier data and in January 2005, that data became available. What we’ve done is build a large scale-computing network that purchases trade identifier data from each stock on the 14 stock exchanges in the U.S. each trading day. We have also developed a lot of different ways we use that data. Can you explain the term, buyin? A buyin occurs when a regulator or broker dealer forces an account to buy back stock that was previously sold short. The most obvious time you’d see an account buying stock to cover a short position is when the stock price is rising and the short position is losing money. But if an account has violated securities laws by putting on a short position, and if a regulatory or broker dealer discovers this violation, they can force the account to buyin. What does your company do? We have created a reporting tool that keeps track of all trading in every stock in the U.S. on a daily basis. Effectively, we have consolidated the tape. That helps our clients understand what’s going on in the trading of their shares. according to ronk, buyins.net has created a reporting tool that keeps track of all trading in every stock in the U.S. on a daily basis What’s been the impact of electronic trading? We have seen much greater short selling by institutions since the late 1990s as electronic trading has grown. Institutions are shorting stocks and claiming exemptions to short positions that we suggest are unfairly claimed. Market makers are effectively holding positions over night and they are only supposed to trade intra day. And they are doing this without borrowing the shares and without covering. How do you help companies combat manipulative short selling? Access to trade identifier data to obtain the total number of shares shorted every day in a particular stock can allow companies to understand why their stock is going up or down. In addition, they can take corrective action by working with regulators and communicating with investors. Sometimes 50% to 60% of a stock’s daily turnover can be short selling, which makes it impossible for market makers to cover on the same trading day. What technologies do you use to address short selling? We operate a full-scale computing platform and our technology is at the epicenter of everything we do. Initially, we use our platform to consolidate trading data each day, which is a huge feat in itself. We’ve also found a way to dynamically generate research for clients so that management can understand what is going on and can share our research with their current and prospective investors. The ultimate objective is to create a source of information for our clients about what is going on with the trading in their shares and how they can deal with it. What sort of success have you had and what do you charge? Over the past 12 years, we have provided data to more than 2,000 companies and at any one time, we may have 10-to-50 clients. The first shock wave companies feel is greater than normal volume in their stock along with a greater than normal decline in their trading price. We start surveillance for clients and monitor the research from our system. We conduct conference calls with management and executives responsible for investor relations to discuss and analyze what is behind unusual trading behavior, whether it is short selling, real selling or short covering. Bottom line is we help companies quantify the problem and develop a plan to deal with it. The typical cost for our service is $1,500 a month. Do you offer any other products or services? We are developing another set of technologies that we plan to use to expand into Asia and then into Europe. It will include our current data on short selling plus 10 other categories that institutions and Wall Street use to make investment decisions; things like trading strategies, earnings, seasonality and insider trading. We are creating a global analytic view about how a specific stock is valued and traded so clients will understand the forces at work in their stock. via BioTuesdays Features - BioTuesdays http://ift.tt/2riVC4t
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Vaughn Embro-Pantalony, CEO Following a meeting with the FDA last month, Microbix Biosystems (TSX:MBX) is entertaining expressions of interest from potential partners to license or acquire its anti-clotting urokinase drug, which has been rebranded as Kinlytic, and also provide funding for its re-launch in the U.S. market. “We believe the outcome of our consultation indicates the planned path to approval of our lead indication is worthwhile, information that will help us conclude a development agreement and re-launch Kinlytic," Vaughn Embro-Pantalony, CEO of Microbix, says in an interview with BioTuesdays. “We plan to retain a significant interest in the economics of Kinlytic following an agreement with an investor to enable a re-launch program,” he adds. He says the company received clarification from the FDA on several issues related to the fact that the previous product, Abbott Labs’ Abbokinase, has been off the market for several years. Urokinase was originally launched by Abbott and was the leading anti-thrombolytic drug in the market, generating peak annual sales of more than $300-million, before Abbott discontinued sales due to manufacturing issues. The drug has been administered to more than four million patients. After Abbott split into two publicly traded companies, it sold the NDA regulatory file and all of its urokinase assets to another party, from which Microbix later acquired them, making Microbix the only worldwide source of low-molecular-weight urokinase. According to Mr. Embro-Pantalony, the global use of thrombolytic drugs that dissolve blood clots has been increasing annually and now exceeds $1-billion in the U.S. alone Microbix has manufactured urokinase at commercial scale and performed numerous biochemical and functional analyses on the product that demonstrate its ability to undertake its reintroduction into the marketplace, he adds. According to Mr. Embro-Pantalony, the global use of thrombolytic drugs that dissolve blood clots has been increasing annually and now exceeds $1-billion in the U.S. alone. Currently, only one thrombolytic drug, tissue plasminogen activator, or tPA, is available for dissolving blood clots in hospitals and clinics in the U.S. market. “We believe there is significant need for another therapeutic option, both to provide an alternative choice for care providers and patients, and to mitigate the risk of supply disruptions,” he contends. The company’s three-year program includes transferring the production process to a contract manufacturing organization, which should shorten the timeline to return urokinase to the market; producing new batches of urokinase according to the original NDA drug file, which Microbix owns; and complete comparability analysis and pivotal testing. “We are finalizing the budget to re-launch Kinlytic within the next three years,” Mr. Embro-Pantalony says, adding that the company has already assembled many of the assets needed to return urokinase to the North American market. “Following the positive outcome of our meeting with the FDA, our focus now shifts to attracting a development partner,” Mr. Embro-Pantalony says. via BioTuesdays Features - BioTuesdays http://ift.tt/2rLE6DS Dana Matzen, VP of business and corporate development With a burgeoning pipeline of pharmaceutical oral films, IntelGenx’s (OTCQX:IGXT; TSXV:IGX) business development strategy is focused on partnering its product pipeline along with actively meeting with potential partners to explore manufacturing opportunities, and continuing to build its product pipeline jointly with R&D. “We are a global leader in oral thin films and our mission is to use our technology to develop products that can be taken without water and can improve the safety and performance of existing drugs,” Dana Matzen, VP of business and corporate development, says in an interview with BioTuesdays. “We develop rapidly disintegrating oral films products that provide tangible benefits for patients, such as improved efficacy due to better bioavailability, quicker onset of action and reduced side effects,” she adds. “We then engage with partners to finalize development and bring the product to market.” As many as 40% of American adults have experienced difficulty swallowing traditional tablets and capsules, she points out, making the company’s VersaFilm and AdVersa products an ideal solution, especially for pediatric and geriatric patients. IntelGenx also focuses on the repurposing of existing drugs for new indications and developing opportunities for life cycle extensions of brand products leveraging its VersaFilm technology platform for oral thin films. The company also has products based on the AdVersa technology for controlled-release tablets for oral absorption over an extended period of time that are available for licensing outside the U.S. Dr. Matzen says the company also offers partners a full service of growth opportunities, including R&D formulation and feasibility studies; patent protected intellectual property for the VersaFilm technology, regulatory and quality dossiers in the U.S. and Europe to ensure GMP compliance and a smooth transition to regulatory approval and commercial manufacturing; and state-of-the-art, high capacity manufacturing. according to matzen, intelgenx's mission is to use their technology to develop products that can be taken without water and can improve the safety and performance of EXISTING durgs Addressing an unmet medical need, with strong safety and efficacy data, is critically important for payers to consider reimbursement, she adds. Prior to founding IntelGenx in 2003, Horst Zerbe, chairman, president and CEO, was a co-developer of Listerine thin filmstrips as a novel breath freshener. Today, some of IntelGenx’s partners are U.S.-based Par Pharmaceutical, Endo Pharmaceuticals of Ireland and the U.S., RedHill Biopharma of Israel and Chemo Group of Spain, which has an exclusive worldwide license to commercialize two generic tablets and a U.S. license for two other generic oral films. “This is not an easy and fast approach, but we are a lean organization that lets us develop strong relationships with our partners,” Dr. Matzen contends. “This is how we differentiate ourselves from bigger companies.” IntelGenx’s most advanced VersaFilm product is Rizaport for migraines, which is partnered with RedHill Biopharma and received European marketing approval in November 2015. RedHill is funding the development program and the companies, which anticipate FDA approval within the next 12 months, share net revenues. Distribution deals have been signed for several European and Asian countries. Rizaport, which contains rizatriptan, is bioequivalent to Merck’s Maxalt-MLT and negotiations with U.S. commercialization partners are ongoing, Dr. Matzen points out. “Rizaport can be attractive for migraine patients because it does not need to be taken with water and has the potential to avoid gastrointestinal side effects,” she adds. IntelGenx’s most advanced VersaFilm product is Rizaport for migraines, which is partnered with RedHill Biopharma and received European marketing approval in November 2015 The FDA is expected to conduct a pre-approval inspection in the second half this year of IntelGenx’s 17,000-square-foot manufacturing plant in Montreal. A GMP certificate is part of the FDA approval process for new products. IntelGenx has three other oral films available for partnering: Tadalafil, for erectile dysfunction (ED); Loxapine, for agitation in schizophrenia and bipolar 1 disorder; and Montelukast, for brain degenerative diseases, such as early-stage dementia. IntelGenx previously confirmed the bioequivalence of Tadalafil to Eli Lilly’s Cialis, which had sales of $1.5-billion in 2016 but faces generic competition in 2020. IntelGenx has an exclusive license for oral films from Lilly for its dosing patent, which would allow Tadalafil to enter the ED market in the U.S. free from patent litigation from Lilly. Dr. Matzen explains that Tadalafil, which offers a discrete dosing alternative, could enter the market in 2018, with up to three years of market exclusivity before Cialis is hit with generic competition. In addition, IntelGenx is currently optimizing the oral film formulation of Loxapine, which has been shown to offer greater absorption, faster onset of action and no pulmonary complications, compared with a tablet and an inhalation device that must be taken under supervision of a physician. “We believe our oral film will have a significant benefit for patients,” she adds. Dr. Matzen says IntelGenx also is looking for a commercial partner to share the development risk of its Montelukast oral film, which has generated strong early-stage data and is based on an active pharmaceutical ingredient approved for a completely different indication. “Our data indicates that Montelukast oral film crosses the blood-brain-barrier and reaches its target while the existing tablet, on which it is based, does not,” she contends, adding that the company is now preparing the protocol for a proof-of-concept study. Intelgenx's product pipeline via BioTuesdays Features - BioTuesdays http://ift.tt/2qMrFKC Avivagen Inc. (TSX-V: VIV) , a company with a commercially-ready, patent-protected product intended to replace the antibiotics added to livestock feeds as growth promoters, intends to effect a 10 to 1 consolidation of its common shares. The date on which the Consolidation will take effect will be announced once the TSX Venture Exchange approval has been received. The Consolidation was approved by the Corporation's shareholders at the annual general and special meeting of shareholders held on April 11, 2017. "We heard from a number of institutional investors and potential purchasers of our OxC-betaTM for Livestock product that we had the right operating company profile, but didn't fit the appropriate capital markets profile in order for them to do business with us. As we consider international expansion and U.S. capital markets strategies, we considered a consolidation factor of 10 to 20 old shares for each new share. Based on our view of our growth potential, we have unanimously selected the 10:1 ratio. We will provide another press release the day before the share consolidation will take effect." - Kym Anthony, Chairman and Interim CEO of Avivagen Inc. Last month, Avivagen announced positive results from a proof-of-concept study that could extend Avivagen’s OxC-beta™ technology into human health applications. The proof-of-concept study evaluated Avivagen’s OxC-beta™ technology as a preventative therapeutic against C. difficile infection (CDI). As strains of C. difficile change, antibiotics are becoming less effective or even completely ineffective in clearing CDI. The proof-of-concept study evaluated three doses of the OxC-beta™ technology for the ability to improve survival rate, increase median time until death, and improve clinical indicators of health using a standard mouse model of human C. difficile infection. The results of the study demonstrate that the highest dose of the OxC-beta™ technology tested increased survivability and clinical scores in mice compared to the un-supplemented mouse control group. Treatment with the OxC-beta™ technology increased median time until death to greater than seven days in the mouse group treated with OxC-beta compared to only three days in the un-supplemented mouse control group. About OxC-beta™ Livestock There is growing pressure on food producers to maintain high production and low costs, while continuing to bring us great tasting, high quality food. Historically, the use of antibiotics at low doses to help optimize the growth of food animals has helped to achieve this aim. Avivagen has developed a proprietary, naturally-derived product, OxC-beta™, which has been clinically proven to help animals grow healthier, faster, with comparable feed rations, reducing the single-largest cost in rearing food animals. co-founder and chief technical officer, Dr. Yijun Huang As a co-founder and chief technical officer of closely held EyeKor, which helps clients navigate the ever-changing landscape of ophthalmic clinical trials, Dr. Yijun Huang, a bioengineering executive, cut his teeth developing software and hardware solutions for ophthalmic imaging applications, both in academic and industrial situations. They include VP of engineering at Topcon Medical Systems, a major Japanese manufacturer of ophthalmic devices. He was also a member of Fundus Photograph Reading Center at the University of Wisconsin-Madison, which acts as a central imaging lab collecting and interpreting images from various ophthalmic clinical trials. In this interview with BioTuesdays, Dr. Huang discusses EyeKor’s Excelsior software platform for imaging data management, its market penetration and a recent collaboration with Clearside Biomedical (NASDAQ:CLSD). Let’s begin with a brief history of EyeKor. My two partners and I founded EyeKor in 2012 to be a software-as-a-service company that provides imaging management services for CROs and reading centers, specializing in ophthalmic clinical studies. We were driven to develop methodologies related to ophthalmic imaging and analysis to increase efficiency, gain additional insights, shorten development time, and reduce costs for ophthalmic clinical trials. Our goal is to provide clinical trial sponsors with image and data management services, ranging from clinical trial imaging experts, reading centers with expertise across a broad range of ocular testing, consultants in clinical trial design, experts in ophthalmic data reading and interpretation, as well as site-training, certification and monitoring. Our imaging expertise covers a full spectrum of ocular testing methods, including but not limited to, fundus photography and angiography, optical coherence tomography, fundus autofluorescence imaging, corneal endothelial cell analysis, dark adaptation, and electrophysiological testing. Excelsior is a first-of-its kind application with cloud-based architecture designed to enhance efficiency and accuracy in the collection and interpretation of data from ophthalmic clinical trials What are the advantages of Excelsior? Excelsior is a first-of-its kind application with cloud-based architecture designed to enhance efficiency and accuracy in the collection and interpretation of data from ophthalmic clinical trials. It is designed to allow principal investigators, clinical trial sponsors, and data flow managers to access the real-time progression of their data through each workflow stage and track the actual time spent against a target time from a web browser. Excelsior is the only software that has received FDA 510(k) clearance for use as a data management system for ophthalmic clinical trials. The software platform also is compliant with the Health Insurance Portability and Accountability Act, which sets the standard for electronic security of sensitive patient data, and can provide a full audit trail for data management and analysis. Can you explain how you interact with reading centers? Reading centers act as central imaging laboratories in the collection, interpretation and analysis of ophthalmic images in clinical studies. While they excel in a research perspective, a common concern is image management that is required to meet strict regulatory guidelines for clinical trials. This can lead to difficulties managing diverse ophthalmic modality types, standardizing imaging outputs, harmonizing computing infrastructure and tracking workflow and study progress. EyeKor solves these issues, enabling reading centers to provide diverse grading services in many ophthalmology disorders, while EyeKor focuses on workflow tracking, performance metrics, data display and reviewer access, as well as providing training and certification for sponsors and imaging professionals and imaging technologies. How successful have you been in terms of market penetration? Reading centers act as central imaging laboratories in the collection, interpretation and analysis of ophthalmic images in clinical studies As of April 2017, nearly 5,800 users, including trial sponsors, staff, clinical site coordinators and technicians, had used the Excelsior platform in 50 clinical trials in 39 countries. Excelsior has participated in four Phase 1 studies; eight Phase 1/2s; 17 Phase 2s; and 21 Phase 3 studies. In total, we have been engaged with nearly 9,000 subjects enrolled in these studies at 865 global clinical sites, of which about half were in the U.S. We also have managed more than six million ophthalmic images. Can Excelsior bridge the gap between preclinical and clinical trials? Our Preclinical platform brings the advanced management capabilities of its flagship clinical trial system to the preclinical phase of development where image analysis plays a key role in advancing treatments to the next stage of development. By providing a centralized hub for all preclinical activities, our Preclinical platform allows trial managers to funnel a variety of imaging data into a single system, eliminating the risks of human error while saving time in the process. In addition, our platform allows the study sponsor to have high-resolution, quantitative, in vivo, and real-time assessment of the examined animal retinas during the entire course of a preclinical study. Clearside Biomedical and EyeKor recently entered a strategic collaboration. What are you doing for Clearside? The creation of a strategic collaboration between Clearside and EyeKor enables both partners to invest in the relationship to mutual benefit. Clearside is developing advanced clinical and preclinical drug candidates using a unique delivery approach to the back-of-the-eye through the suprachoroidal space for patients suffering from sight threatening diseases like uveitis, retinal vein occlusion, diabetic macular edema and wet age-related macular degeneration. Excelsior will enable Clearside and its contract research organizations to manage the ocular images and other data collected during its clinical and non-clinical trials, enhancing the efficiency and accuracy of data collection and interpretation. It will also allow scientists, principal investigators, data managers and reading center graders to access and track data in real time. We see this as a great collaboration because we admire Clearside’s culture, scientists and commitment to data quality, and through Excelsior, we can facilitate the management of images from all of their studies for cost containment and efficiency, both preclinical and clinical, all the way through NDA filing and beyond. via BioTuesdays Features - BioTuesdays http://ift.tt/2puFusL VIA BIOTUESDAYS.COM >> As CEO of 3D Signatures (OTCQB: TDSGF; TSX-V: DXD; FSE: 3D0) since last September, Jason Flowerday is putting the diagnostic company on people’s radar. Unlike most diagnostic companies, 3DS’ proprietary imaging software, known as TeloView, goes beyond identifying whether a patient suffers from a specific condition. By analyzing a patient’s chromosomal arrangement, or signature, TeloView can help doctors tailor personalized treatment and manage each individual patient. With two decades of executive life sciences management and start-up experience, including successive roles at Bayer and J&J, Mr. Flowerday’s mission at 3DS is to transform a highly promising platform technology into a commercial reality with U.S. partners, focusing on those tests that can deliver early value and broaden the company’s development program. In this interview with BioTuesdays, Mr. Flowerday discusses recent advances in 3DS’ lead diagnostic programs and their application to drug development.
Let’s begin with a brief history of 3DS. The company was co-founded in 2014 by Dr. Sabine Mai, our principal inventor. She began her research over 20 years ago and discovered that the 3-dimensional arrangements of telomeres, which are located at the tips of each chromosome, represent a new class of biomarkers. Her research explored 13 different cancers and Alzheimer’s disease and concluded that by analyzing telomeres and their organization, we have the potential to determine how a disease will progress and if a patient will respond to specific treatment. This information enables clinicians to measure the appropriateness and effectiveness of different treatment options for each individual patient. Can you give us a description of your technology? Using fluorescent markers and high-resolution microscopes, the location of each telomere within the cell nucleus can be visualized and digitally analyzed. And using 3DS’ TeloView software platform, the 3-dimensional organization of telomeres within a given cell becomes highly predictive of the disease status of a particular patient. So what all this means is that we have the ability to identify the structural organization of a patient’s chromosomes, which is a measure of genomic instability. And by mapping telomere signatures and measuring the level of genomic instability, we can potentially predict the aggressiveness of a disease and drug responsiveness. The technology is well developed and supported by 22 clinical studies on over 2,000 patients in 13 different cancers and Alzheimer’s disease. MINNEAPOLIS, MINNESOTA – (Marketwired) – May 1, 2017 – DiaMedica Therapeutics Inc. (TSX-V: DMA) (OTCQB: DMCAF), today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 9,616,015, entitiled “Formulation of Human Tissue Kallikrein-1 for Parenteral Delivery and Related Methods” for DM199. The patent protects the methods of parenterally administrating DM199 to patients in need where absorption into the circulation via methods such as intravenous (“IV”) or subcutaneous administration improves systemic pharmacokinetics (“PK”), bioavailability, safety, and/or convenience related to IV or other forms of administration. The patent has an expiration date of 2035, which does not include any potential patent term extension. “We are very excited to have received additional patent protection covering parenteral delivery, including subcutaneous and IV administration and related methods. We believe these methods of delivery could more completely address the needs of patients by offering better options for acute and chronic therapy.” - Rick Pauls, President and CEO. In a recent clinical trial, a dose of DM199 administered via IV infusion mimicked the anticipated drug profile of IV-administered urinary KLK1 (Kailikang®). This study also identified a dose of DM199 via subcutaneous injection having a superior PK profile that maintains KLK1 levels throughout day. The Company believes this profile could improve the efficacy of DM199. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica's shares are listed on the TSX Venture Exchange under the trading symbol "DMA" and on the OTCQB under the trading symbol "DMCAF". For more information, please vist www.diamedica.com. |
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