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Shiva 490-0874COOTRIO Pharmaceuticals, Inc., USAReiner Laus, MD, Co-Founder + CEO, Inventor of the first cancer vaccine, Provenge Shiva Bhowmik, PhD, Co-Founder + COO, Inventor of the first site-specific Prostate Cancer ADC Alan Wahl, PhD, Chief Scientist, Inventor of the first ADC drug, ADCETRISBiologicsDeveloping dual action cancer drugs to selectively eliminate immunosuppression whilst stopping tumor growth.Value: Generating immunogenic tumors by eliminating immunosuppressor cells and cancer cells. Immunogenic tumors are essential for the high efficacy of IO drugs. Current cancer drugs are unable to generate immunogenic tumors. Innovation: Our approach is the ONLY WAY for Tumor Specific Elimination of Immunosuppression.Cancer $1B+Merck BMS Seagen AstraZeneca Merck KgANational phasePre-clinicalIND candidate in 2 years IND in 3 years Complete phase 1 in 4 yearsPrivate investors$26MDeveloping dual action cancer drugs to stop both tumor growth and immunosuppression. Current cancer drugs do not selectively stop immunosuppression in the tumor whilst stopping tumor growth. TRIO is solving this by developing dual action antibody drugs TRIObody and TRIObody Drug Conjugates (TDC). TRIObodies and TDCs are designed to eliminate cancer cells to stop tumor growth and eliminate immunosuppressor cells to stop immunosuppression selectively in the tumor. TDCs eliminate cells by toxin delivery and TRIObodies eliminate cells by apoptosis activation. In the cancer treatment landscape TRIObodies and TDCs are new and unique by having tumor-targeting arms essential to eliminate immunosuppression selectively in the tumor. Our lead program aims to treat TNBC and other cancers. Development risk is reduced by using clinically validated targets and clinically validated binders. TRIO's team members developed FDA approved cancer drugs, ADCETRIS and Provenge. TRIO is raising $26M.Biocentury
Eugene 690-0920CEOVasocurewww.vasocuretherapeutics.com2018New York, NY, USAMANAGEMENT Eugene Dinescu, BA Biochemistry, Columbia U., Columbia Executive Management Program, Former Director Flatlands Medical Associates, Founder, CEO Anna Babinka, PhD Microbiology, Professor Department of Medicine SUNY Downstate, Founder, CSO Elizabeth Kornecki, PhD Cell Biology, Former Professor Emeritus Department of Medicine, Founder, VP of R&D Yigal Ehrlich, PhD Cell Biology, Former Professor Emeritus Department of Medicine CUNY, Founder, VP of R&D BOARD Moro Salifu, MD, MBA, MPH, Nephrologist, Chairman of SUNY Downstate Medical Center, Founder Aditya Mattoo, MD, MBA, Former Professor of Medicine at NYU, Nephrologist, FounderSmall Molecule PharmaceuticalsVasocure is a novel platform biotherapeutics company with over 62 drug candidates in nephrologyy, cardiology, and oncology. Vasocure was founded after 25 years of pioneering academic research including hundreds of publications and the discovery of the F11R Receptor, analogous to JAM-A. We are currently in the process of filing an IND for Pedifin, the world’s first drug candidate shown to prevent and reverse neointimal disease in animal models.Company owns and is developing 62 candidates including oral mimetics in nephrology, cardiology, and oncology. • Focusing on neointimal disease (in the renal space due to FDA fast track (high priority indication) Ø Pedifin is a first-in-class, 1st generation, IV investigational drug that is a highly selective competitive inhibitor of F11R, currently seeking IND for FIH (First in human) Phase 1. Ø F11R (F11 Receptor) is over-expressed in neointimal disease and atherosclerotic plaques. Ø By blocking F11R, Pedifin can effectively inhibit narrowing of the lumen, which means better blood flows, better dialysis and better survival for patients. Ø Pedifin, has been shown in animal models to be highly effective at preventing and reversing neointimal hyperplasia as well as atherosclerotic plaque formation. UNMET NEED • 15% of the US population (49 million people) is affected by chronic kidney disease (CKD) with a CAGR of 5.7%.UNMET NEED • 15% of the US population (49 million people) is affected by chronic kidney disease (CKD) with a CAGR of 5.7%. • 45% of CKD patients have diabetes or self-reported cardiovascular disease. • 550,000 Americans suffer from kidney failure and are on hemodialysis through a vascular access. • 100% of dialysis patients will require surgeryCOMPETITION • The only treatment is surgical, Pedifin is the first pharmacologic treatment.INTELLECTUAL PROPERTY Portfolio of Approved Patents: 3 Patent Applications filed: 4 Additional disclosed on slide deckPhase IComplete Phase 1 and 2 Clinical Trials for pedifin and begin Phase 1 for at least two more candidates.Funding to date: $5M Grants, $500K FoundersFinancing sought: $5.5M ($4.5M R&D, $1M Salaries and Legal)MILESTONES • Incorporated (Q4 2018) • START-UP NY company, awarded 10 years tax-free operations (Q1 2019) • Accepted in SUNY Downstate Incubator Labs (Q1 2020) • State-of-the-art facilities in NYC and Lodz, Poland (Q1 2020) • Successful completion of 95% preclinical studies with IND filing (Q4 2021) • Estimated dose studies completed, 25mg/kg administered 1X/week • Multiple IP filings (Q3-Q4 2021)Vasocure-WCBA-Presentation-B.pptx
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Richard 954-9082Chief Marketing OfficerLifespanswww.lifespans.net2015Hong Kong, SARSloan Kulper, PhD CEO and Co-founder, a serial medtech entrepreneur and inventor with multiple international patents Erica Ueda Boles, PhD - Chief Scientific Officer and Co-founder. Erica has a highly cited record of research in biotechnology and is responsible for our R&D objectives and engineering team. A/Prof. Christian Fang, FRCS - Chief Medical Officer and Co-founder. Clinical Assistant Professor in the University of Hong Kong Faculty of Medicine (Dept. of Orthopaedics & Traumatology) Richard Holloway, MBA - Chief Marketing Officer. A medical device industry executive, previously of Stryker and Orthofix.Prof. Frankie Leung, FRCS - Director, Clinical Strategy and Co-founder. Clinical Professor and Assistant Dean in the University of Hong Kong Faculty of Medicine (Dept. of Orthopaedics & Traumatology). Prof. William Lu, PhD - Director, R&D Strategy and Co-founder. A biomedical engineer and Professor in the University of Hong KongMedical Devices / DiagnosticsLifespans designs and develops orthopaedic implants and complementary technologies which provide enhanced resistance to implant migration, in weak, elderly osteoporotic bone. As part of our development process, we have also developed a novel new method to accurately predict implant performance and survivability called The Lifespans Bone Simulator, a new approach which we believe will become the new “gold standard” for implant testing and performance prediction.Our mission is to create world leading orthopaedic implants that improve quality of life for the elderly, the fastest-growing patient segment worldwide.• Lifespans implants reduce stress on bone tissue, resulting in significantly less migration compared to market-leading competitive products. Key benefits include Familiar operational procedures and instrumentation Simple, cost-effective technology Lower manufacturing costs compared to market-leading devices. Our unique Bone Simulator platform greatly benefits the design and validation processes for trauma, spine, and joint recon implants, and is the only known method for accurate implant migration and cut-out testing in computer-simulated cadaveric bone and polyurethane foam. Benefits of using the Lifespans Bone Simulator include 1. Faster time to market for new devices 2. Improved implant effectiveness 3. Uninterrupted implant R&D and regulatory testing by engineers working at homeOur products are marketed to KOL orthopaedic surgeons and institutional payers initially in the United States followed by key strategic markets the Asia Pacific region and EU. The total accessible market for our products is approximately $US 25 BillionOur products compete with the lines developed by global orthopaedic and spine companies. In fact, rather than being competitors, these companies have the potential to be strategic partners and through development work using our Bone Simulator technology and potential acquiring companies looking to further expand their implant portfolios through external product acquisitions, a trend that has become increasingly common in the orthopaedic industry.Lifespans Soft Tip (PCT/CN2016/078336) US Patent Granted, EU, CN pending Lifespans Bone Simulator (PCT/CN2017/100889) US, EU, CN pending Lifespans Soft Thread (PCT19062CN) US, EU, CN pending Lifespans Tensegrity System (HK32020007136.5) US, EU, CN pending Freedom to Operate confirmed for all of the above applicationsPre-clinicalCompletion of US regulatory filing and market launch H1 2022. Initial regulatory filings for ASEAN and Australia with associated market launches progressively from H2 2022$USD 2.5m of private funding + $US 500k of non-dilutive grants$US 2.0mRegulatory Approval US$250,000 to US$350,000 Product development / Portfolio Expansion US$250,000 to US$500,000 Manufacturing US$750,000 to USD$1.0 million Initial Market Launch US$ 350,000 to US$500,00020210520-HK-4th-SAPA-Application.pdf
OtherHKSTP Contact
Sawyer 516-2582CEODaRen Biotechdarenbio.com2015hong kongFounder: Prof. XIE Yong Chief Scientist: Prof. ZHAO Guo Ping CEO: XIE Sawyer Parlin CTO: Dr. WONG Chung Kai CMO: Dr. YANG Rong BingRNA, Peptide & Gene Therapy / Stem Cells / Cellular TherapyCAR-T immunotherapy research and development.We can treat 80% of cancer types (both solid and blood cancers) with our patented CAR-Ts. Compare this to 1% of cancers treatable with currently available approved CAR-T therapies. We also have UCAR-T constructs that can be universally donatable from a single healthy donor. This cuts production time from 14 days to 0 days,Our target market is China. With future plans to license our CAR-T therapy to the US, EU, and JapanOur risks include IP theft, superior new technology, and regulatory changes. Our competitors include Nkarta, Celyad, and Gilead.6 patents for CAR-T and UCAR-TPhase IY0-Y2 begin IIT studies with multiple hospitals for multiple indications of both blood cancer and solid tumors. Generate positive human data and Raise Series A Y2-Y4 Enter Phase II clinical trials for multiple indications and secure licensing and Pharma partners. Raise series B, Potential IPO. Complete IIT study for UCAR-T pipeline. Y5 Begin Sales Phase, Royalties, International Licensing, UCAR-T licensing and Phase II+III1.5M from angel investors10M USD to perform multi-center clinical studies for our lead CAR-T and build an onshore GMP virus and cell manufacturing facilityOur flagship DR CAR-T has completed our pre-clinical work and is ready to begin our first in human study for multiple cancer indications. We have lentivirus production, cell manufacturers, and Hospitals ready to begin our groundbreaking clinical trials upon securing funds.2021-DAREN-DECK-APRIL.pdf
Lewis 677-0650Chief Technology OfficerBloom Standard, Inc Kong SARAnnamarie Saarinen, Founder & CEO: Health economist, policy fellow, inventor, researcher. 20+ years in health innovation, Medtech & biotech design and execution, health policy, and global health, CEO of Int’l NGO developing/scaling cost-effective interventions for resource-challenged settings. Lewis Mcfadyen, CTO: Product development & engineering at Origami Labs, Dyson, and Hayco Paul Saarinen, CMO: 15-year track record in lean startup, health tech & digital marketing, Techstars mentor Jake Colvin, COO: Leader in infant wearable tech, co-founded Owlet Baby Care, redesigning hospital technology with cutting-edge communications and UX, extensive product testing and iteration, developing and implementing global strategy Dr. Alexandra Heath, MD, Chief Medical Officer: 20+ years in pediatric cardiology and medicineMedical Devices / DiagnosticsCongenital heart defects, pneumonia, and respiratory diseases together impact 150 million children under 5 each year. Combined, these are the leading causes of infant and childhood mortality throughout the world - many of which could be avoided with simple, lower-cost diagnostic tools to find these “hidden” conditions sooner. The novel ultrasound technology being developed by Bloom Standard will not only democratize access to essential imaging, but also end excessive use of potentially damaging x-ray imaging in children, lower the cost of imaging by 10x, and combat the current dearth of skilled imaging technicians in remote and underserved settings. Building on other early diagnostic tools already being prioritized for investment by governments around the world – this has the potential to prevent millions of deaths associated with delayed, missed diagnosis, or misdiagnosis, while greatly improving the standard of life for those who may have survived.The Bloom Standard team is working on developing simple but revolutionary wearable technology for babies in intensive care settings, combining artificial intelligence, automation, and cutting-edge communications with ultrasound. This eliminates the need for highly-trained technicians and facilitates automated image acquisition at the point of care by leveraging hundreds of thousands of existing scans. This allows the product to quickly identify what is normal vs. abnormal, aiding health workers to correctly identify problems and direct critically ill infants for further scanning and intervention at regional facilities, leading to (i) early & timely diagnosis of heart and lung conditions, (ii) appropriate referrals and treatment pathways, (iii) improvements to transport and treatment infrastructure, and (iv) lower cost, democratized access to non-radiating imaging technology for young patients in remote or resource-limited settings.The pediatric ultrasound and echo market was surging – even before COVID19, facilities and governments were increasing investments in diagnostics, with an emphasis on lower-cost, portable imaging. We estimate being able to achieve $100M in product sales in our first 3-4 years within our initial target markets (peds heart and lung screening), $1B is peds ultrasound total,$8.4B is the total ultrasound market Serviceable Obtainable Market: Annual Need (only applied to highest need markets, not looking at secondary uses through technology disruption), 1.2 million cases of CHD in infants, 102 million children under 5 with critical lung conditions/pneumonia, 900,000 annual infant/children deaths due to late or misdiagnosis Serviceable Available Market: Global Peds Ultrasound Market, $275.3 Million,6.4% Annual Growth Rate ($421M by 2023) Total Available Market: Global Ultrasound Ecosystem,$6.3 Billion,6% CAGR ($8.4B by 2023)Butterfly IQ, Clarius, Philips Lumify, GE *Cost: 10x (min) reduction in the cost of hardware and software *Designed for resource-limited settings - requires little to no training for front-line health workers to operate and is robust to withstand the harsh environments where it will be used *AI+Machine Learning: The removed need for expertise and specially trained staff in running screening AND current reliance on the availability of medical professionals to diagnose results PRIOR to sending the child on for further screening, diagnosis, and treatment, (results in far too many cases of late diagnosis or misdiagnosis)US Patent and / or PCT filedOtherBench-top testingProduct Development: Product design and user testing, MVP deployment and iteration, Design for manufacturing Regulatory: ISO 13485, Field Clinical Trials, CE MDR, FDA 510K, APAC Local Regulations Commercialization: Manufacturing partners secured, Supply chain, local regulations, support, packaging, labeling Business Development: IP portfolio, LOIs with direct gov't/public purchasers, Tender/Procurements, Clinical direct sales; Channel Partners: Med device distributors Market Entry: Develop Marketing Plan, Strategy, Timeline, Asia Market Introduction, Rural Clinics, and Community Hospitals0Seeking $750K USD to accelerate R&D, ML algorithms, field trials + build a regulatory dossierAutomated Ultrasound device that provides screening of neonatal and peds pneumonia/lung conditions and cardiac conditions (cardiomyopathies, structure, flow) WITHOUT expert medical staff needed to acquire images. A constellation of ultrasound sensors images the thoracic cavity, mapping and interpreting physical markers and distinguishing between artifacts. Processing + software-based AI clusters and benchmarks normal vs abnormal findings providing actionable results and referral guidance.Bloom-Standard_Automated-Ultrasound_NonConfid_Deck_LM_05May2021.pdf
Beau 206-0569CEOSober Grid, Inc.www.sobergrid.com2015DelawareBeau Mann, CEO Wendy Warrington, COO Nick Krasucki, CFO Cassie Branderhors, VP Government Relations Vince Palermo, VP Commercial DevelopmentAI / Machine Learning / Bioinformatics / SoftwareSober Grid is a digital therapeutic. We are currently in two Phase II clinical trials. We have developed artificial intelligence that can accurately predict if an individual is. approaching a higher risk of relapse using natural language processing and deep learning algorithms. We sell coaching to government health care agencies, corporations, and unions throughout the United States.We have the largest mobile facing user base of individuals within the Substance Use Disorder disease state with over 300,000 patients globally.Our target market is those with Substance Use Disorder in the United States with a total addressable market of 45 million.Our competitors are Pear Therapeutics, WeConnect, and WorkIt Health. After 6 years in market and becoming cash flow positive we are substantially de-risked.We have filed provisional IP patents.Phase IIWe have recruited the former head of Google Life Sciences (Verily) opioid initiative to lead our government contracting practice. For business development into the corporate and union space we have brought on a seasoned digital health executive with a successful digital health exit on his resume. We are developing other products and are in contracting with a large Pharmaceutical manufacture to distribute a new CBT module as a distributor using our app and large global user base.$3.5million$2 millionFurther commercialize our current in market offering and add in clinical medical doctors with specialization in addiction medicine and psychiatric medicine.SAPA Email
Andrea 271-5399CEOXylyx Bio, Inc., USAWith success and strategic vision in both life science and consumer markets, the Company’s Board of Directors and leadership are poised to scale and expand its product portfolio toward increased revenue growth. Chief Executive Officer: Andrea Nye, MBA, MPH, brings over 20 years’ leadership and operational expertise in healthcare innovation, with extensive experience building and growing early stage companies successfully bringing products to market. Chief Scientific Officer: John O’Neill, PhD, developed Xylyx Bio’s ground-breaking platform. He is an expert in cell-matrix interactions, stem cell & tissue engineering, regenerative medicine, and organ recovery and repair.OtherAdvanced biomaterials for predictive drug discoveryXylyx Bio is a commercial-stage biopharma company developing next-generation regenerative solutions to combat fibrosis, scarring, and other conditions involving extracellular matrix. In its first indication, the company is leading the evolution in advanced tissue and disease models for more predictive drug discovery by harnessing physiologically relevant tissue-specific extracellular matrix (ECM) for more predictive and actionable antifibrotic drug discovery. Xylyx sells products direct to pharmaceutical & biotech companies involved in drug discovery. No FDA approval is required, accelerating time to market and realization of cash flow. Xylyx’s platform presents the opportunity for upfront multi-year recurring revenue from multiple streams via direct sales, OEM/co-marketing relationships & strategic partnerships, with longer-term potential for conversion to high-value milestone payments.Xylyx Bio’s proprietary platform provides biopharma companies with clarity and confidence that drug development efforts will lead to effective treatments. With valuable applications across multiple stages of the discovery pipeline, Xylyx products enable disease models that are both translatable and scalable, setting the stage for a paradigm shift in drug discovery and increasing the probability of new medicines reaching patients while simultaneously reducing the cost and time of development. Xylyx Bio’s suite of biomaterials, patient-specific data, and specialized R&D services combine the advantages of higher-level biology with workflow compatibility, providing scientists working in drug discovery with the ability to reduce risk and the associated time and money related to drug failure by reliably assessing which drug candidates will be safer and more effectively treat patients.The global addressable market for cell culture in drug development is $15B+, with an immediate serviceable available market made up of sales to companies working in anti-fibrotic drug discovery, estimated at $1.2B and driven by the lack of predictive models of fibrosis and significant need and market opportunity for physiologically-relevant models & services that enable quantitative mechanistic studies for improved compound screening.Competing systems are not physiologic and thus non-predictive, failing to recapitulate human disease and contributing to high cost and late stage failures in drug discovery. Existing products derive from a single component (e.g., collagen I) or rodent extracts (e.g. Matrigel, etc.). Lack of key physiologic benefits hinders predictive value, a major shortcoming that costs pharma time and money in the quest for effective drug candidates. In contrast, Xylyx products bring critical value to drug development efforts by supporting pharma in frontloading attrition earlier in the discovery process and thus reducing substantial costs associated with late-stage attrition due to poor efficacy and toxicity.Xylyx Bio’s proprietary platform is protected by multiple patents, know-how, and unique expertise gained over 10+ years’ development at Columbia University and 5+ years in-house at Xylyx. Patent claims cover composition of matter, technical methods, and products.On marketXylyx targets the largest global players in pharma drug development. We approach the market through direct sales, strategic partnerships, and independent global distributors. In science, validation data equals value. Thus, customer acquisition and retention are achieved via scientific publications, KOL collaborations, conference posters and presentations, and related marketing support. Target purchasers are directors of research seeking to improve their ability to successfully develop & screen compounds. Given the compelling unmet need for predictive models and proprietary de-risked platform technology, the opportunity exists to capture significant market share.The Company has raised $7.5M USD to date from angel investors, in addition to $0.5M USD in non-dilutive federal grant awards.Xylyx is seeking an $8M Series A investment to accelerate its traction in biopharma drug discovery, scale manufacturing to support demand, and explore additional high-value market segments, including scar repair and skin health.Xylyx harnesses the power of extracellular matrix (ECM) – the body’s natural essential cellular microenvironment – to create biomaterials that provide cells with complex structural support and biochemical signals required for cellular function. Xylyx biomaterials comprise both the mechanical properties and complex ratios of the cellular environment specific and unique to organ type and disease state, enabling drug candidates to be investigated in vitro in a human-relevant environment. By recapitulating the defining physiological feature of human disease, Xylyx Bio’s In Matrico™ Platform brings much-needed insight into the efficacy of candidate compounds consistent with clinical results.Xylyx-Bio_Predictive-Drug-Discovery.pdf
Michael 331-3050President/CEOGATTACO Inc.www.gattaco.com2018Delaware C-Corp, HQ: Murrieta, CA USAMichael McNeely, Ph.D., Co-Founder & Pres/CEO: Dr. McNeely was the former founder and Pres/CEO of BioMicro Systems, Inc., a successful life science tools. There he led the development of revolutionary products from concept inception to international sales. BioMicro was sold to Roche Diagnostics in 2010. Later Dr. McNeely worked as a Consultant for life science companies in the APAC region, including managing extended projects in Singapore, Japan and Thailand. Mr. Mahmoud Zubaidi, M.S., Co-Founder & CSO: Prior to joining GattaCo, Mr. Zubaidi spent 14 years with Millipore/Sigma as a Senior Tech Dev Scientist. Mr. Zubaidi received multiple awards for innovation and supported several development efforts leading to multi-million dollar revenue streams. Mr. Philip Luk, B.S., Director of Process Development & Manufacturing: Mr. Luk has held multiple positions as a manufacturing engineer of medical products in regulated environments.Medical Devices / DiagnosticsWe are applying a revolutionary new sample purification technology to the next generation of high-sensitivity and accurate point of care testing products, and with the same technology enabling new home sample collection devices to expand the opportunities of Direct to Consumer Testing, Decentralized Clinical Trials, Telemedicine and Digital Health.The innovation GattaCo has developed is the ability to simplify complex sample processing, or pre-analytical sample collection and processing, needed for roughly 90% of all clinical diagnostic testing applications. Our initial focus is on sample collection and processing of blood for both point of care testing applications and remote sample collection, such as for home sample collection. The simplification GattaCo’s Cap-Reset™ Technology offers opens door to faster, cheaper and more accurate diagnostic testing than has ever been available before, especially for blood testing.GattaCo’s markets include the Point of Care Testing component of the In-Vitro Diagnostic Market, Direct to Consumer Testing Market and Decentralized Clinical Trials Market. These markets have a combined total of approximately US$60 Billion. GattaCo’s addressable market opportunity within these segments is approximately US$5.9 Billion.Our primary competitors for both home sample collection and Point of Care testing applications are the status quo of how these needs are currently being addressed. There is no direct competitor to GattaCo as far as the new capabilities our technology offers. The primary risks we face is missing opportunities because we are not yet ready to address them, and having inferior solutions capture the opportunity and the blocking our near-term ability to compete.5 separate patent families including continuations and continuations in-part (CIP). Our primary core technology patent has been issued internationally including in the US, Canada, Europe, China, and other countries.OtherCommercial under RUO, working on EUA and eventually De NovoScale-up manufacturing of our existing products, secure regulatory approval in multiple markets, continue development and commercialization plans of pipeline products, and commercialize world-wide. This will be done for Point of Care Testing, Direct to Consumer (DTC) Testing, Decentralized Clinical Trials (DCT), Telemedicine and Digital Health applications.We have raised around $1 million from Founders, Friends and Family an Angel level investors (Seed Round)We are currently seeking $500K for a Bridge Financing, followed by a $10million Series A by 4Q21.With the $500K Bridge Financing we will work with outside partners to obtain GMP & ISO13485 certification, apply for an Emergency Use Authorization (EUA) of our A-PON™ Home Sample Collection Kit for Semiquantitative COVID-19 Neutralizing Antibody testing, and begin to scale-up manufacturing of our A-PON Kit. With the $10million Series A financing we will continue scale-up of our manufacturing capacity from several hundred kits per month to over 100,000 kits per month, bring on overseas manufacturing capacity to address opportunities & needs outside the US, and develop complete sample to answer diagnostic test kits, not just sample preparation kits.GattaCo-Investor-v21-0519.pdf
Janos 536-6590CSODanuvius Bioscienceshttps://danuviusbio.com2021New Windsor, Md, USADanuvius Biosciences is led by Janos Luka, who was co-founder of a previous biotechnology company. In the past he implemented FDA approved diagnostic assays for both commercial companies and for in house use in a CLIA and CAP approved diagnostic laboratory under his direction. He was Director of a Diagnostic Laboratory, EVMS from 1995 to 2002. Since then, he was the Director of R&D and proteomics for three separate diagnostic companies. From 2012 to 2018 he was Senior Researcher at Division of Bacterial Diseases, WRAIR. In total, he has been an author on 112 peer-reviewed publications, published book chapters and was invited to multiple international meetings. He also received SBIR grants and grants from Dept. of Defense. The director of microbiology is Yuanzheng Si, MD, Ph.D. She received her medical degree in Clinical Medicine and Ph.D. in China. She worked as Senior Research Assistant Division of Bacterial Diseases, WRAIR in Dr. Janos Luka’ laboratory from 2021 to 2018.Medical Devices / DiagnosticsDanuvius Biosciences is an innovative research and development company pioneering the discovery and development of new breakthrough diagnostics and antibody therapeutics for Multi Drug Resistance (MRD) bacterial infections. The company also develops antibodies against viral agents associated with chronic and neurological diseases. Based on its proprietary in vivo antibody discovery platform and deep experience in immunology, Danuvius Biosciences is capable of correctly identifying important infectious disease targets and isolating human antibodies to accurately strike these targets. Danuvius Biosciences is developing a pipeline of highly promising human antibodies for therapies and companion diagnostic assays. Danuvius Biosciences also utilizes in vivo discovered mouse antibodies for a newly developed rapid Point-of-Care multiplex assay (Liquid Biopsy) which identifies infectious agents and their antibiotic resistance status in patient samples within 15 minutes.Multi-drug resistance in bacteria is spreading rapidly, with resistance often developing swiftly following the introduction of new antibiotics. In addition, treatment with antibiotics has usually been empiric, leading to widespread and sometimes indiscriminate use of broad-spectrum antibiotics which ultimately leads to emergence of bacterial resistance. Hence, there is an urgent need to provide rapid evidence-based diagnostic tests to help clinicians better identify and treat micro-organisms causing infections, and to prescribe the correct antibiotic treatments. Especially it is very important for diseases such as Sepsis were currently no rapid diagnostic assay is available and 60% of the patients die. Our solution to this problem is the availability of a new point-of-care rapid multiplex diagnostics that will inform providers of what is causing the infection and its antibiotic resistance state much faster than is currently possible.Diagnostic tests are usually conducted in laboratories, private or public, equipped with expensive instrumentation and staffed with trained and qualified personnel to perform the tests. Point-of-Care (POC) testing which occurs at or near the site of patient care is sought after in the field of infectious bacterial diagnostics to allow the care team to receive the results more quickly and allow for immediate and informed management decisions to be made. At present no POC test are available for diagnosis of Sepsis which is a life-threatening condition that needs immediate diagnosis and treatment to maximize the chances of survival and to reduce the risk of long-term disabilities. The overall global diagnostics market in 2019 was worth US$ 50–55 billion with POC diagnostics contributing US$ 16–19 billion. The bulk of the POC market for infectious diseases is concentrated in developed countries accounting for over 80% of global sales.The distribution related risks shall be handled by creating distribution partnerships with NGOs and private companies before the initiation of production. User adoption risk can be handled in part by the product development team which shall work in unison with patients and doctors and take their feedbacks in designing a product. Marketing Research Related RiskStep 1 shall involve using market research firms in doing the market research and analysis. Step 2 shall involve forming R&D and production partnerships before going for R&D and production respectively. This shall lead to division of risk in between partners. The diagnostics market is dominated by bioMérieux SA, Becton & Dickinson, Thermo Fisher Scientific Inc., and Cepheid Inc. These companies together accounted for 82.7% of the global diagnostics market. From the microarray technology competition can be expected. However these assays are is DNA based can give false positive results and takes 24 to 48 hours to give results.Patent application in progress for the POC system and the antibodies and target antigens used in the assays.Phase IThe company’s plan comprises of three distinct components. 1. R&D; the focus of R&D team shall be to create a pipeline of products that can be launched one after the other. 2. Manufacturing; in case of extremely high demands the manufacturing may be either outsourced or licensed to an established manufacturing firm. 3. Marketing and Distribution; we would focus on creating partnerships with diagnostic companies for distribution. An exit strategy shall form as a last resort if everything else goes wrong with the current form of the company and its product vision. The exit strategies have been designed keeping in view the two core competencies of the firm which are; Creating innovative Multiplex Diagnostic assay and Creating unique antibodies for diagnosis and therapy. The exit strategy that may be used: Sell R&D in form of patents and intellectual property around the Multiplex assay to rivals and other probable clients. Migrate into a larger diagnostics company.The company presently is founded by private donations and founds from the owners previous company which have been sold in 2019. We are actively seeking SBIR grant from the NSF for the development of Liquid Biopsy method for infectious diseases.The investment sought by the firm is to support the initial fixed assets and to maintain the minimum level of cash balance while also accounting the minimum inventory level, the payables and the receivables. The expected investment needed by the firm to perform R&D and patent fillings for the Liquid Biopsy diagnostic assay is $450,000. However after receiving the initial funding the firm is expected to be self-sustainable in 2-3 years.Differential diagnosis of infectious disease is a complex and challenging task in the clinic. In some infectious diseases, such as encephalitis and sepsis, over 50% of cases cannot obtain a clear pathogenic diagnosis. Microbiological culture-based are the preferred tests, but the turnaround time-to-results period is long (≥ 48 h), and many pathogens are impossible to culture. PCR tests are rapid but typically capture a small number of etiological agents and need a presumptive diagnosis before a test is chosen. However PCR based test frequently give false results because of contamination introduced by the collection of the sample. Our “Liquid Biopsy assay” is a protein based and detects virulence factors which are produced by microbes only when it is attacking the host immune system. Therefore microbes which were introduced as contamination or not associated with infection are not detected. The assay can be performed in 15 minutes and requires only a blood sample from the patient.Danuvius-Biosciences-ceo-pres.pdf
Paul 330-6997CEOPapyrus Therapeutics Inc.www.papyrustherapeutics.com2017Wilmington Delaware, USAProfessor Hani Gabra, MD, PhD, FRCP Dr Paul Blake FRCPBiologicsPapyrus is developing a biotherapeutic that mimics and restores the function of a tumor suppressor, OPCML, that is inactivated in over 40% of all cancers, both liquid and solid tumors, and expressed on the surface of normal cells. Papyrus will initially be targeting advanced stage ovarian cancer given our team’s deep experience and knowledge of this particular tumor type, and the unmet need of this disease.Papyrus is developing a biotherapeutic that mimics and restores the function of a tumor suppressor, OPCML, that is inactivated in over 40% of all cancers, both liquid and solid tumors, and expressed on the surface of normal cells. Papyrus will initially be targeting advanced stage ovarian cancer given our team’s deep experience and knowledge of this particular tumor type, and the unmet need of this disease.Papyrus is developing a biotherapeutic that mimics and restores the function of a tumor suppressor, OPCML, that is inactivated in over 40% of all cancers, both liquid and solid tumors, and expressed on the surface of normal cells. Papyrus will initially be targeting advanced stage ovarian cancer given our team’s deep experience and knowledge of this particular tumor type, and the unmet need of this disease.Our product candidates are engineered biopharmaceuticals mimicking a naturally produced protein in normal cells that is switched off in cancer, we do not expect toxicity to be a challenge as they restore the original human tumor suppressor proteins Our biotherapeutics are ambidextrous against cancer, simultaneously delivering a potent anticancer effect by blocking 8 cancer promoting pathways, while also switching-on anti-cancer immune responses. This multi-pronged approach increases the chances of delivering a clinical therapeutic benefit compared to therapies with a singular mechanism of action. We have identified strong candidate predictive biomarkers (liquid biopsy that identifies somatic promoter methylation of OPCML) that identifies patients with OPCML gene silencing allowing selection of patients that will benefit from extracellular tumor suppressor therapy. our biotherapeutic works on the outside of the cell membrane avoiding the need to be inside of every cancer cell.We have an established IP portfolio, with protection running through late 2031, that we are continuing to build uponPre-clinicalWe plan to file an IND and CTA within 2 years and so enter clinical development within 3 years and generating data from phase 2 studies within 5 years.Approximately $8 million from various charities and academic grants mainly in the UK.We are seeking investment of approximately $5 million to get to approvable IND and CTA submissions.We have identified a novel and important cancer target and a potential treatment method that has been validated in human models of ovarian cancer. It will apply to over 40% of all human cancers. There is a clear development and regulatory path for the first indication in ovarian cancer and two approaches for development in other cancers. We plan to operate largely as a virtual organization with suitable team members already identified for pre-clinical and regulatory development through the CTA/IND stage. We have 2 research agreements already in place, with Oxford Biomedica for a CAR-T delivery and with Targovax for adenoviral delivery, both of which are clinically validated platforms.Biocentury
Parag 250-4526Head Partnerships and InternationalInformDS Technologieswww.doxper.com2015Bengaluru, Karnataka, IndiaRandeep Singh, Ph.D. Co-Founder, Chief Scientist. Prior: Philips Research, SAP Labs, Tata Memorial. Pawan Jain, Co-Founder & CTO. Prior: FirstRain, Snapstick, Visible Alpha, Flywheel. Shailesh Prithani, Co-Founder & CEO. Prior: 10+ years at Schlumberger. Ran large scale operations, strategy, sales organisations and HR. Sanjay Bapna, VP Enterprise Sales. Over 30 years in healthcare. Prior: CEO Philips, Bangladesh & Sri Lanka. Parag Agarwal, Head Partnerships. Prior: Co-founder & CEO at 15 years in health tech in India, Singapore, Scotland.AI / Machine Learning / Bioinformatics / SoftwareInformDS Technologies is India's leading healthcare digitisation solution, and the largest source of longitudinal real world data in the outpatient setting. Its proprietary, AI powered digital pen and paper solution allows doctors to instantly digitise their case sheets without any change in behaviour or workflow. The company is currently serving 1800 clinics and 50 hospitals in India, and has so far digitised over 12 million case sheets since 2016. Doxper has also been used to digitise clinical trial workflows, in remote public health settings and as a valuable source of real world insights for pharma companies.Doxper is an AI powered and cloud hosted data capture solution that allows doctors to instantly digitise their case sheets using a digital pen and encoded paper. There is no change in behaviour or workflow required. Doxper serves as a data input bridge and can integrate with any existing EHR system to plug gaps in data compliance, without compromising the variety and quality of data points that need to be captured. Today, we are helping doctors and hospitals digitise to improve their operational, clinical and patient engagement outcomes. In public health, we are empowering health workers to collect data from remote locations seamlessly. With our growing network of doctors, our platform has the potential for real-time and accurate disease surveillance. Ultimately, we believe insights from the rich, longitudinal and demographic specific data will allow us to contribute to finding cures for cancer and other complex diseases, by accelerating and reducing the costs of drug approvals.Hospitals: Digitise entire OPD, track and plug revenue leakage Clinics: Automate patient engagement and increase follow up visits compliance Public Health: Full accountability and audit trail. Digitise remote locations with no Internet access. Clinical Trials: Intuitive data capture for lengthy case record forms with fully transcribed output. Pharma: Real world insights from aggregated, anonymised longitudinal datasets. Currently, we are India's largest in the OPD setting.Digitisation in healthcare is currently not mandatory in India. Even the National Digital Health Mission (NDHM) is voluntary. However, with our success so far in the private sector (mainly tier 1/2 towns) and recently we have also started work on NDHM Sandbox, we are confident that gradually more providers will come on board. Competitors for data capture: Input Devices: Pen based digital inputs such as Bamboo Input Technologies: Speech based digital inputs such as Nuance, Augmedix We differentiate by not requiring behaviour change, complex or expensive equipment, change in cognitive load Competitors for real world data/insights: IQVIA. We differentiate by having more granular data points, directly from the source (doctor's Rx) and in real-time. Additional analyses possible such as pincode level, sales optimisation, brand launches and tracking.Patent granted in India.On market1. Expand digitization services from current 5000 doctors (1800 clinics, 50 hospitals) to 50,000 doctors. 2. Begin operations in similar large emerging markets, priority: Nigeria, Bangladesh, Indonesia, Southeast Asia 3. Evolve existing, custom real world data projects with pharma companies, into a full fledged, self-service real world insights platform. Currently we are India's largest source of longitudinal RWD in the OPD setting with 12 million records.Total of US$6.12 million raised from PE fund of a major private bank, Alkemi Venture Partners, growX Ventures, Rainforest Venture Network, Vidal Healthcare, Globevestor, Capier Investments.$15 millionPilot with global pharma companies on real world insights use cases. Currently, we are working on pin-code level prescription audit, brand launches and tracking, competition analysis. We would like to further expand in the clinical domain, to test the validity of our datasets on patient profiling, patient journeys, treatment adherence/drop/switch, antimicrobial stewardship. With policy makers, there is the opportunity for public health surveillance from the same data. Further refine our Real World Insights platform which can be queried with multiple parameters using Boolean, elastic search.Doxper-Corporate-Deck_May2021.pdf
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ZHEHOU 178-5841Chief Executive Officer杭州原生生物科技有限公司Yuansheng Biotechnological Co., LTD, Zhejiang, PRCProfessor Cao Tong, Founder, Chief Scientist of Yuansheng Biotech, Chief Scientist of Institute of Life Sciences, National University of Singapore, Honorary Professor of Zhejiang University, Chief Editor of World Journal of stem cells, has published 160 SCI papers with more than 6000 citations. Cao Zhehou, Co- Founder, CEO, Bachelor and Master of Imperial College London,Doctor of neuroscience, University of Edinburgh. Li Mingming, VP of R & D,Doctor of National University of Singapore,MBAof Booth School of Business, The University of Chicago, Head of New Products, Cordlife Group Limited. Yang Jun, VP of Medical , Doctor of molecular genetics,Georgia State University, used to be Vice president, School of Public Health, Zhejiang University,VP of Zhejiang-California International Nanosystems Institute. Has published 110 SCI papers.RNA, Peptide & Gene Therapy / Stem Cells / Cellular TherapyOur core business is Universal Cellular Therapy CDMO. We will base on our technology platform of directional induction and differentiation of stem cells, and the GMP manufacture shop,prodive R & D and production services.We are the first to offer the whole process service of universal cellular drugs,from ESC/iPSC providing in R & D stage, to the manufacture after obtaining new drug registration certificate from NMPA, CE or FDA. We have advanced technology platform, customers can carry out drug research and development based on our platform.Our market is targeted at biotech companies with their own drug targets that can be combined with our CAR-NK and Universal CAR-T or other engineered immune cells, and companies that need express to expand the Universal Cellular Therapy pipelines. Market capacity can be billions of dollars per year.The commercialization process of Cellular Therapy is slower than expected. CRO / CDMO magnates enter this field. Our competitors will be Nuwacell Biotechnological Co., LTD and Wuxi Pharmatech (Cayman) Inc.Our patents mainly focus on cell differentiation, expansion and large-scale production technology, we plan to apply for more patents related to CAR-NK manufacture.On marketWe hope to get more than 10 CDMO service orders in the next 3-5 years,2-3 of them can obtain new drug registration certificate.We have got 10 million yuan of angel investment from Hangzhou Jicheng Venture Capital Co., Ltd. , and 17.8 million yuan of government funding from Xiaoshan District Government of Hangzhou City, Zhejiang Province,PRC,the government funding did not and will not require the stake of company.We are now looking for a 50-100 million yuan or 10-20 million dollar of Series-A funding.After three years of development, we can now provide services to the market, we are looking forward to establishing contac with investors or customers through this roadshow.YS-BPv9.pdf
Ching 354-8248PresidentExcellims Corpwww.excellims.com2005Acton, MA (a Delaware company)Ching Wu, Ph.D. see deckMedical Devices / DiagnosticsLife science tool and medical device (IVD)Novel mass spectrometers instrumentation for point of need measurement for pharma/biopharma process monitoring and point of care clinical mass spectrometryimmediate addressable market in pharma/biopharma area over $1B, product already sold in this area market in the near future, clinical mass spec + point of care mass spec over $4B.Novel miniaturized mass spec with ion mobility separation front end, world first; direct competing with transitional HPLC-MS systems (e.g. Waters, AB Sciex, Agilent, etc.)Excellims owns over 55 patents (include US, China, EU, Japan) on current and future products.On marketcurrently have over 100 systems deployed. further pernitrate pharma/biopharma manufacturing process monitoring market reaching $40/year revenue in year 5, in this market alone. open clinical mass spec in POC market, projecting revenue over $30M/year, in IVD, China market alone.$10M from institutes; total R&D investment in the past over $25M$10M USDUS sales and market development in pharma/biopharma, including vaccine manufacturing monitoring. complete IVD mass spec instrument registration and diagnostic test kit registration.Excellims-Deck-2021-05-09-Short.pdf
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Tianlin 436-7938Chief scientific officerbiopegasusN/A2006Langhorne, PA, USATianlin Ma, PhD, Founder and Chief Scientific Officer Dr. Ma is the innovator of BioPegasus’ transformative expression-interaction cloning technology platform. She had ~$224,000 research grants with 2-person lab. She received her BS in Organic Chemistry from Lanzhou Univ., China, MS in Biochemistry from Peking Univ., China, and PhD in Human Biological Chemistry and Genetics from the Univ. of Texas Med. Branch in Galveston, TX. Peng Gong, Managing Director Mr. Gong leads in fundraising, strategy development and investment portfolio management. He brings over 10 years of experiences in investment portfolio management and startups toward successful exits. Eugenia Trushina, PhD, Executive Advisor Dr. Trushina has been working on Alzheimer’s disease (AD) biomarker discovery and novel therapeutic development for over 10 years and is a professor of Neurology at Mayo Clinic (Rochester, MN). She received her PhD in Chemistry from Saratov State Univ., Saratov, Russia.Medical Devices / DiagnosticsThe present project is “Novel Antibody IVDs for Alzheimer’s Disease” (see attached business plan, BP). Our goal is to develop novel qualitative antibody (Ab) POCT for AD early detection/screening in community settings and quantitative Ab test for AD differential diagnosis. Our core business is in novel Ab in vitro diagnoses (IVD) for autoimmune diseases with long term road map to novel therapeutic development based on BioPegasus' transformative λ phage cDNA expression library construction, screening and interaction cloning technology platform (not phage display technology) (BP p6&7). Dr. Ma is the innovator of BioPegasus' technology platform and has been very successful in discovery, identification and isolation of disease specific antigens (Ags) and their genes with patient serum Abs. She possesses a unique set of knowledge and experience in discovery, identification and isolation of novel proteins and genes with a molecule(s) of interest via expression-interaction cloning.Both of our AD Ab qualitative and quantitative tests will be novel to fulfill an urgent unmet need in accessible, standalone, effective, simple and reliable AD-specific Ab biomarker tests for AD differential diagnosis and early detection/screening. There are no similar products on the market. The estimated value of the business is at $1,000,000,000 at the 4th year (BP p11). There is an urgent need for such tests because FDA may approve Biogen's AD medication Aducanumab. In addition, BioPegasus' expression-interaction cloning technology platform is innovative and unique, with a broad application in novel biomarker, drug target and therapeutics discovery. The technology is also a powerful new tool for biomedical research.The potential market size for seniors (age 65 years old and better) is at $27,776 million worldwide (BP p9). However, the targeted market of our AD Ab POCT product can be extended to population age 55-64 years old because AD starts ~20 years before on-set of symptoms and an individual may take more than one (1) POCT in life-time and could start testing as early as 55 years old for early detection. Therefore, the market size for early detection (POCT) could be much greater than $16,202 million. For example, the size for the age group of 55-64 years old in the United States is 42.2 million in 2020 (United Nations Populations Division). If 50% of the age group take 1 POCT before 65 years of age then the market size would have an additional $2,110 million (42.2 x 1,000,000 x 50% x $100/POCT).The risk is minimal. The experiment evidence and results in AD literature (BP p5) have indicated that our unique and transformative expression-interaction cloning technology will and can identify and isolate those AD-specific neuronal Ags and their genes and there is no risk in achieving the goal successfully as predicted. Dr. Ma has been very successful in discovery, identification and isolation of novel proteins and their genes, including disease specific Ags and their genes with patient serum Abs, on prototype models of the BioPegasus' transformative expression-interaction cloning technology. There is also no known competitor(s).Currently the details of BioPegasus' expression-interaction cloning technology platform remain a secret and there is no known competitor(s). BioPegasus' technology transforms the technology from taking random chances into a technology of a 100% successful rate with predictability. The detailed BioPegasus' technology is built upon Dr. Ma's extensive experiences but differs from all other versions of the cloning technology in the literature and market. However, patent protection for the technology can be filed at a right time if careful consideration and evaluation find that an application(s) for a patent protection(s) is the best option. Moreover, utilities of those to-be identified and isolated AD-specific neuronal genes and proteins in diagnostic and therapeutic development are patentable. AD Ab IVD tests and associated products are also patentable. The filings for patent protection to those product related inventions will be executed as soon as possible.Pre-clinicalIf ~$500,000 seed fund is secured, we will start working on the AD project as outlined in the attached BP to acquire preliminary data for application of future funding from NIH SBIR program by the end of the first year, through submission of IVD premarket approval application to FDA in ~3 years. We plan to bring AD Ab IVD version 1.0 products to consumer market in 3 years for quantitative AD differential diagnosis and qualitative early detection (POCT) for screening AD patients in the general population and in community settings. See BP p10 for additional information.$150,000 has been committed, including $50,000 from Mr. Peng Gong and $100,000 from Dr. J. Fang.We are seeking $350,000. The total seed fund required is $500,000 for 1.5 years (BP p10&11). The fund will be used to identify and isolate neuronal AD specific Ags and their genes from human frontal lobe with AD patient Abs in comparison with control Abs to demonstrate that BioPegasus' transformative expression-interaction cloning technology platform will work for AD. The data will be used to apply for NIH SBIR Phase I/II or fast track funding and beyond (BP p6&10) to complete the project.The lack of effective predictive and diagnostic biomarkers is the major barrier for better AD patient care. AD is an autoimmune neurodegenerative disease, where anti-neuronal specific Abs attack neurons leading to neuronal cell death. tau hyperphosphorylation and Aβ/Aβ plaque formation are down-stream results of neuronal cell damage and death caused by those anti-neuronal Abs (BP p5). Our goal is to identify and isolate those AD-specific neuronal Ags and their genes from frontal lobe and, later, from hippocampus with AD patient serum Abs in comparison with control Abs on BioPegasus' unique expression-interaction technology platform, in turn, to use those AD-specific Ags as the capture reagents to quantitatively and qualitatively detect the presence of their corresponding Ab biomarkers in a patient’s serum for AD diagnosis and early detection. The novel AD Ags, Abs and those AD-specific genes will also have significant impact in facilitating novel AD therapeutic development.BioPegasus-AD-BP.pdf
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Dawei 335-7928PresidentAccufusion TherapeuticsN/A2019DelawareDrs. Dawei Gong, John Xu and Jian HuangBiologicsPeptide fusion proteins, currently Fc-Elabela, and one more in pipeline for diabetes with cardiomyopathy.~$5M, Fc-Elabela fusion proteinThe novel biologic targets patients with heart failure. With 2% of the population worldwide with heart failure and the increase of the aging population, the anti-heart failure drug market is huge. The estimated market is about $100 million a year.The biologic is made of a physiological peptide fused with IgG Fc fragment, a clinically proven safe protein carrier, so the risk in drug development is relatively small, but as a novel drug, it is always associated with some unforeseen risk. Novartis has a similar peptide in Phase II study.Accufusion has exclusively licensed in the IP, and Dr. Gong is the primary inventor of the IP.Pre-clinicalGet approval of IND and complete Phase I study.$500K for large animal studies by CRO and new biologic for diabetic cardiomyopathy (PCT in preparation).$300-$500 million for drug safety evaluationApelin Receptor is a GPCR, and proven target for heart failure. Elabela is a newly discovered peptide ligand for the apelin receptor. Short peptides have an intrinsic shortcoming of short in vivo half-life and are not suitable for therapeutic application. Dr. Gong's research team has engineered a long-acting modified Elabela (Fc-ELA) and demonstrated that it retains the receptor activating activity while exhibited superb anti-heart failure in the myocardial infarction (MI) model of mice, rats and monkeys. Notably, the Fc-ELA treatment reduces MI area by 40%, which is extraordinary among available anti-heart failure and anti-MI drugs. To commercialize the fusion protein, Dr. Gong established Accufusion in 2019, which has exclusively licensed in the IP from the University of Maryland for therapeutic uses of Fc-ELA in cardiovascular diseases治疗心功能衰竭的全新短肽药物Fc-艾菈贝拉(Elabela,1.1类)05182021_pptx.pdf
Yong 723-1968CEOThrone BiotechnologiesThronebio.com2011Paramus, New Jersey, United StatesYong Zhao, MD, PhD - Founder and President - Research scientist at Hackensack Meridian Health, former doctor of internal medicine; 9 patents 52+ publications; Former professor at the University of Illinois at Chicago Gerald Ostrov, MBA - Director - Former Company Group Chairman at Johnson & Johnson; former President of CIBA pharmaceutical (Novartis); Former Chairman and CEO of Bausch and Lomb; Harvard MBA Henry Lozano - VP of Global Relations - Former Deputy Assistant to the President of the United States; Senior member of the White House under 5 presidents; international business executive with extensive network to heads of states Yechin Zhao, MBA(c) - Director of BD - Founder of Skipper Yacht-share; innovation & marketing consultant on project with Fortune 500 companies including McDonald’s, Disney, and Google; MBA at the University of IllinoisRNA, Peptide & Gene Therapy / Stem Cells / Cellular TherapyStem Cell Educator Therapy, is an "immune system reset" that is designed to reverse diabetes and autoimmune diseases at the root level. Autoimmune disease occurs because of a defective immune system. Educator Therapy uses a newly discovered stem cell from the umbilical cord blood to reprogram one’s immune cells through an ex-vivo process very similar to dialysis. The one-time treatment is 8 hours long with virtually no side effects. 200+ patients between the ages of 3 and 70 have been treated in 10 years of clinical research in Spain, China, and US. 70% of type 1 and type 2 diabetic patients demonstrated clinical efficacy. Many patients reduced insulin dosing and some have become insulin independent. The product is ready to use and undergoing FDA commercial approval (phase 2 approved for type 1 diabetes, alopecia areata, COVID-19.'- We are the world's leading practical cure solution for type 1 diabetes as ranked among 594 global technologies - One time treatment with sustained long-term efficacy (4 year follow-up study) - Absolutely unlike any other stem cell technology in that we do not do stem cell transplantation or donor matching - Much safer - Minimally invasive 8 hour treatment with practically no side effectsType 1 Diabetes - 1.6 M people in US Alopecia Areata - 6.8 M people in USMajor Risk: Clinical trial success and FDA approval Competitors in the Type 1 diabetes cellular therapy space: Viacyte, Caladrius, Mesoblast, VertexInternational patent protection in 10 major global territories including Eurpoean Union 4 issued patents and 2 pending patents for other technologies in developmentPhase IISeries A Funding completed in 2021 FDA phase 2 completion 2022 Acquire conditional commercial FDA approval through RMAT fasttrack program 2023 US commercialization simultaneously begin phase 3 studies 2023 Complete FDA phase 3 studies, full FDA registration, International commercialization 2024$11.4M total since inception (grants, donations, investors)- $5M dilutive (angel and corporate) in seed round $1.5M already committed for Series A (VCs and Angel)The $15M Series This will be used to complete phase 2 clinical trials for type 1 diabetes, alopecia areata, COVID-19. We anticipate conditional FDA commercial approval within 2 years after phase 2 through the FDA RMAT program specially designed to fast-track curative cellular therapies.Stem Cell Educator Therapy, is an "immune system reset" that is designed to reverse diabetes and autoimmune diseases at the root level. Autoimmune disease occurs because of a defective immune system. Educator Therapy uses a newly discovered stem cell from the umbilical cord blood to reprogram one’s immune cells through an ex-vivo process very similar to dialysis. The one-time treatment is 8 hours long with virtually no side effects. 200+ patients between the ages of 3 and 70 have been treated in 10 years of clinical research in Spain, China, and US. 70% of type 1 and type 2 diabetic patients demonstrated clinical efficacy. Many patients reduced insulin dosing and some have become insulin-independent. The $15MSeries A amount will be used to complete phase 2 clinical trials for type 1 diabetes, alopecia areata, COVID-19. We anticipate conditional FDA commercial approval within 2 years after phase 2 through the FDA RMAT program specially designed to fasttrack curative cellular therapies.Throne-Biotechnologies-Stem-Cell-Educator-Therapy-5_18_21.pdf
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Michael 570-4515PresidentTelocyte, United StatesMichael Fossel, MD, PhD: Expert on telomeres, aging, and age-related disease, authored both The Telomerase Revolution (which the Wall Street Journal named as one of the best science books of 2015) and the Oxford University Press textbook, Cells, Aging, and Human Disease. Peter Rayson: Experienced global executive in technology, IT, aerospace, and engineering. Mark Hodges: Experienced global executive manager in aerospace and defense. Kimberly Gannon, PhD: Experienced executive in pre- and clinical gene therapy for CNS disease.Genetics & GenomicsUsing telomerase gene therapy to reset cellular aging, targeting age-related disease with Alzheimer's as our strategic initial human trial.We offer a disease-modifying-therapy to both prevent and cure age-related disease, starting with age-related neurodegenerative diseases.Our initial market is the global elderly population at risk for dementias, including Alzheimer's. Our ultimate market is the global elderly population at risk for any age-related disease, including age-related cardiovascular disease, osteoarthritis, osteoporosis, pulmonary fibrosis, chronic renal failure, etc.Our major risk lies in choosing the optimal serotype, cassette, route, and dose to demonstrate clinical efficacy. Our competitors are largely companies with little expertise in gene therapy or regulatory trials (e.g., BioViva, Libella, etc.) as well as alternative, non-gene therapy approaches to telomere lengthening.As with most gene therapy biotech companies, our IP consists of patenting the process rather than the product (e.g., Bluebird Bio, etc.). Our IP attorneys are ready to patent our protocols and data from the scheduled dog study this year, as well as the human trials thereafter.Pre-clinicalThe dog study will be done by InterVivo later this year, to more carefully define POC, IT, route, dosing, distribution, safety, toxicity, and efficacy parameters, preparatory to our FDA meetings for an INR. The phase 1 human trial has been vetted by both our internal and external consultants, including our CRO, PPD and Worldwide Clinical Trials. Phase 1 trial will be done in the US (either at KUMC, Harvard, or USC, as our clinical advisors are neurologists doing AD studies at those institutions), and the phase 2 trials will be done globally.We have contributed half a million internally, with another half million USD in convertible notes from two private investors. We are currently negotiating a $30m investment from a global pharmaceutical investment group.$30m USD.We will spend approximately $1m this year on the canine POC study, $10m on the phase 1 human trial, and $20m on the phase 2 trial.Telocyte-Business-Plan-August-2019.pdf
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Astrid 714-4455CEOQuantum BioTek Inc., GA, USA- Astrid Androsch –CEO. Successful startup and technology entrepreneur. Global executive working with blue-chip corporations. Successfully built, scaled and exited a thriving tech start-up company. - David Yuan– CTO. General Manager and executive in electronic industry & Leading Expert in bio engineering. General Manager Foxconn reporting directly to the chairman Terry Gou. In charge of engineering, design and manufacturing of all Apple and Amazon products for 20 years. - Vladimir Fridman MD – Head of Medical Affairs. Highly accomplished cardiologist at leading hospitals in NY, USA. - Quanbio R&D Center: Team includes leading scientists and bio-engineers for noninvasive hemodynamics based on Photoplethysmogram (PPG). Expertise includes AI, intelligent medical systems, rapid detection and ubiquitous computing, signal processing and analysis. hardware and circuit board layout design, signal processing, sensor technology.AI / Machine Learning / Bioinformatics / SoftwareWe are a late-stage healthcare AI company focusing on non-invasive technology that can rapidly detect the earliest stages of coronary artery disease and its progression. Coronary artery disease kills more people than any other disease and is the single largest healthcare cost driver but it can be prevented. Our QuanBio cardiovascular analytics platform together with our QuanCardio non-invasive medical device are the first affordable and accurate diagnostics solution to measure arterial stiffness indicator (plaque buildup along the artery walls) to early recognize and monitor coronary artery disease. We combine our advanced algorithm with artificial intelligence and proprietary PPG technology (optical method with bio sensors) to obtain human health parameters through pulse waves. Thus rapidly measuring to deeply understanding cardio vascular health in order to treat in time and prevent severe incidents in the future.Our platform and our device are the first of their kind and provide significant cost savings and benefits over other technologies. Primary and preventive care are important for improving and maintaining health, as well as reducing health care costs in the long term. We are equipping primary care with medical technology that is better, faster and more affordable than the technology used by cardiologists, while even enabling remote monitoring. GO-TO-MARKET STRATEGY – Affordable and accessible diagnostics Primary care, health centers, tele health:1st point of contact to identify problems and initiate treatment. Enables primary care in especially rural areas to deliver the same level of care than clinics and physicians in dense urban areas. Enables clinics to provide affordable personalized health care to currently underserved communities.$1 billion per day is the cost of heart disease and stroke to the United States healthcare system. Reducing the number of heart attacks by 20% can save every year $38.9 billion to the healthcare system, $26.2 billion in lost productivity in job market and 60.000 lives. Affordability and accessibility of heart disease diagnostics will over-proportionally save and improve lives of currently underserved communities.This is a white space opportunity. ECG and heart rate monitors cannot detect arterial stiffness, only signs of heart rhythm problems. Current diagnostic tests such as the CT, Carotid Ultrasound and Coronary Angiography have no role in screening. These are mostly used to diagnose when blockage is already 80-90%. In addition, there are not enough machines and these are very expensive. Therefore not available to most doctors and the high price tests are often not covered by the insurance. Such big machines also require skilled personnel/specialist doctor to perform the procedure and a cardiologist/radiologist to analyze the data. In addition, have high dose of radiation and risk involved. As such no role in prevention and early screening and not available to primary care.We are in the process of preparing the filing of utility patents. Our proprietary hardware and QuanBio software platform include: - QuanBio, a web application software for clinicians including analysis, treatment recommendations, drug management. A mobile app for consumers. - QuanCardio, hardware / finger clip technology with optical bio sensors (dual data collection) and system software application measuring pulse wave velocity. Using new types of sensors, paired with deep learning to get a window into heart disease that nobody has ever had before. Pulse wave velocity assessment (Photoplethysmography, an optical technique to detect volumetric changes in blood in peripheral circulation) is performed using an infrared finger clip probe that measures blood volume changes to assess arterial stiffness.Phase III2021: Finetuning of algorithm. Adding functionality to front-end doctor platform. Start larger scale feasibility study (pre-FDA) clinical trials end of 2021. 2022: Adding dual sensor to also measure arrythmia, blood oxygen and blood pressure plus micro-circulation to early identify damage to small blood vessels. FDA submission DeNovo. 2023: Expansion to mental health. Evaluating PPG based stress-dependent indices of vascular changes to assess cognitive load and stress by identifying features of the pulse wave which are indicative of mental stress.  2024: R&D is focused on developing a new method for measuring blood glucose non-invasively, based on a method named metabolic heat conformation.All together $1 million, from angel investors, self funding, government grants.Seeking a total of $5-8 million: - $2M will be used to take platform & algorithm to next level, add more features, begin manufacturing hardware/device . - $3-4M will be used for regulatory processes. This includes a large feasibility study in the United States (inside clinical trials) and to start the FDA application with clinical trials. The company will parallel apply to the CFDA in China. =>a large US hospital group will fund and host all US clinical trials. - $ 500K for patenting and R&D.Our vision is overall screening of the entire vascular system of all patients at the earliest possible stage (at 20-40% blockage). We’re on a mission to bring life-saving, accurate and affordable technology to early detect coronary artery diseases in order to enable treatment in time and stop the progression of cardiovascular disease! Our vision is a world where each patient is getting the needed medical intervention at the earliest possible point in time, personalized to improve outcomes and at affordable prices, with non-invasive technology that can rapidly unlock for physicians a deeper understanding of the state of the disease. Arterial stiffness is a predictor of coronary heart disease but also contributes to the progression of numerous serious health issues such as diabetes mellitus, hypertension, stroke, chronic kidney disease, COPD and COVID-19 Survivors. Early studies are showing that COVID-19 will have long-term consequences for arterial structure and function.QB-investors-pres-05-05-21.pdf
SAPA EmailOur US company Quantum BioTek Inc has a full subsidiary in Hangzhou, China. It is our plan to enter both markets at the same time. Our end-to-end technology will be a De Nova application with the US FDA.
Scott 775-6710CEO + FounderZylö Therapeutics, South Carolina, USAScott Pancoast, CEO: Currently on the board of DermTech [Nasdaq:DMTK]; he has helped guide this company from a raw start-up to its current status as a billion-dollar company. 2005-2014: CEO of Lpath [NASDAQ:LPTN]. BA in economics summa cum laude from the UVA and an MBA with honors from Harvard. Jay Blankenship, MD, VP of BD: Board-certified ER physician with healthcare startup experience (Medical Director of Lucidity Direct). BA in economics from UVA, MD from the U. of South Alabama, MBA from UNC. Charles Hinkle, CFO: Began his career at Bain & Company. 1985-2015: CEO/CFO of an automotive foundry, which he grew from $4M to $50M in sales. BS, summa cum laude from W&L, CPA, Baker Scholar from Harvard. Michael Rabin, VP: Senior Partner at Sawaya Partners, Goldman Sachs, BA U. of Chicago and an MBA from Harvard. Michael Burns PhD, VP: President and COO of Ferndale Pharma, CEO of Repromedix Corp. B.Sc. Honors University of Reading, Ph.D. in Pharmacology University of Cambridge.Nanotechnology / Drug Delivery / FormulationZylö has developed a patented topical drug-delivery technology that enhances bioavailability of a wide variety of actives. The delivery system is based on highly engineered xerogel-derived silica particles called Z-pods™. Our lead active is Nitric Oxide: Our NO-loaded Z-pods provide sustained release of NO into the skin for over 24 hours; the lead indication is erectile dysfunction secondary to radical prostatectomy, which represents a sizable unmet clinical need. Diabetic foot ulcers is likely the next indication. Our 2nd lead is AEA-loaded Z-pods for the treatment of cutaneous manifestations of lupus. The North American rights to this product candidate have been licensed to Hoth. We also have a ketamine-loaded Z-pod product candidate and a CBD-loaded Z-pod product candidate. In both cases, our Z-pod delivery system confers sustained release and enhanced stability, which provides greater bioavailability, which, in turn, will improve clinical efficacy.Zylö has a proprietary topical delivery system that enhances bioavailability of a wide array of active ingredients...and thereby increases efficacy. In a well-regarded CLE model (MRL-lpr)--conducted by a CRO, double-blinded--treatment with AEA slowed the growth of the lesions by a small percentage, but treatment with AEA-loaded Z-pods resulted in significant regression, with many of the lesions disappearing altogether (p<0.01). In a prostatectomy model in rats, where the cavernous nerve is severed such that no amount of sildenafil will restore sexual function, a single topical application of the NO-releasing product restored sexual function. This work was conducted with NIH Phase 1 grant funds; the Phase 2 grant for $1.7M scored a 26 and near-term funding is anticipated in order to advance the program into the clinic. We also have several other signed agreements with various payloads that relate to cosmetics, CBD, ag-chem industries, all relating to enhanced bioavailability.The Erectile Dysfunction market that Zylö is targeting includes 1. men that have undergone prostatectomy and rendered sexually dysfunctional and 2. men that have \'normal\' ED but do not respond to the PDE5 inhibitors or choose, for safety reasons, not to take them. The first market segment is about $1B in the U.S. alone and the second one is $2-3B. The worldwide market size is about three times the U.S. figure. The lupus market is a reasonably large market with about 1.5M sufferers, about 1.0M of whom have cutaneous manifestations. The treatment options have limited efficacy and/or dangerous side effects, so the opportunity for a drug that is efficacious with limited side effects is sizable.Our primary competition includes micelle/lamellar delivery systems, but they do not provide sustained release, so the competition is not direct. The MicroSponge delivery system provides sustained release with a select few actives, but the system is expensive and limited, with little versatility. We compete with these systems only at the periphery. Indirect competition includes other modes of administration, but, when given a choice, clinicians generally prefer the topical route over oral and IV as it delivers the drug directly to site of action, minimizes the risk of drug interactions, decreases side-effects, and improves compliance.One patent is issued; two others have published and are now being prosecuted on a global basis; two others are currently provisional, awaiting conversion.Pre-clinicalWe believe we will receive a Phase 2 NIH grant for $1.7 million (the score was 26), which will advance our Nitric Oxide product candidate into the clinic. The Phase 1 and Phase 2 trials are short and NOT expensive, given how straightforward the clinical endpoints are. The AEA-loaded Z-pod project is in the hands of Hoth (with North American rights only), who plans to advance this product candidate into the clinic. Zylö is now seeking partners in Asia and the EU to advance this program outside of North America. We also have a JV partner with the ketamine-loaded program, but that partner plans to conduct certain non-clinical studies and then find a pharma partner to license the program to.Zylö raised $4 million in an oversubscribed Series A round and is now seeking $4+ million in a Series B round. Additionally, Zylö has been awarded four grants since 2019 (assuming the Phase 2 NIH grant--score of 26--is awarded).$4 million or more in our Series B round.The Zylö Project is to advance our programs through partners. As such, we seek partners in Asia to advance the AEA-Z-pod program to treat cutaneous manifestations of lupus, 2. to advance the NO-releasing Z-pod program to treat ED secondary to prostatectomy (and other forms of ED), and 3. to advance the ketamine-loaded Z-pod program to treat depression and/or other neurological conditions. Generally, we are seeking partners that are looking to enhance the bioavailability and performance of any active payload.Presentation-Zylö-Therapeutics-2021-05-12-v41-SAPA.pptx
SAPA EmailZylö's CEO + Founder was board member (1996-2002) and President (1999-2000) of the San Diego Venture Group; he has been involved in over 20 start-ups, serving on the board of more than 15 of them (including four public ones). He has been interim CEO six times for these start-ups and has been CEO or Executive Chairman five times over. He has built, or helped to build, a world-class management team several times before and is in process of doing it again at Zylö.
Nahum 554-4685CEOSheltagen Medical Ltdwww.sheltagen.com2009AtlitOrit Rosenberg PhD -Founder Nahum Rosenberg MD,MBA -CEOOtherBone tissue engineeringGeneration of live bone tissue in laboratory conditionsAutologous bone generation for clinical use in orthopedic, spine, neuro, and dental surgery.World market above 20 bill $ Target - surgeons and medical facilitiesRisks - regulatory process No such method is currently implimeneted elsewherePatents issued in USA, EU, Switzerland, IsraelPre-clinicalPass the regulatory process Phase 2A clinical studySelf-investment6 mil US $We develop an innovative method to generated live bone tissue in vitro for clinical use as an autologous bone graftEXECUTIVE-SUMMARY-8-20.pdf
SAPA Emailcontact tel +972 54 4685130 email:
LIQUAN 305-2822CEOJinlu Biotechnologywww.jinlubiotechnology.com2015Shaoxing, Zhejiang Province, ChinaDr. Stephan W. Morris, MD and CMO/CSO of Jinlu Biotechnology is a physician with a specialty in oncology, after a successful academic career, entered biotech industry, has co-founded many biotech companies, among them, InsightGenetics was recently acquired. The success of InsightGenetics attributed to its work on ALK diagnostics that was suggested and directed by Dr. Morris. Liquan Xue, Ph.D. and CEO. A research scientist turned entrepreneur, co-founded HealthChart LLC (US) and Jinlu Biotechnology(China), served as CEO and CTO to oversee the development of FISH assays based on a innovative technical platform. Successful registered HER2 FISH probe kit as class III IVD and more 50 others as Class I IVD. Wei (William) Zhao, Ph.D. and COO, a trained clinical pathologist entered the biotech industry focusing on the application of diagnostics in clinical pathology, serving as the COO of Jinlu Bio to direct our efforts on the marketing, sale, and customer service.Medical Devices / DiagnosticsOur core business is molecular diagnostic assay product development via various technical platforms, currently focusing on flourescent in situ hybridization test development and production. Jinlu Bio has successfully obtained registration with National Medical Product Administration (NMPA) of HER2 FISH assay kit as Class III IVD and more than 50 others as the Class I IVDs. One of the goals of Jinlu Bio is to serve as a hub for the exchange of technology and products between US and China. The PTCLtype assay in this proposal was originally developed based the discovery of a US-based Lymphoma/Leukemia Molecular Profiling Project (LLMPP) group. Jinlu has entered an agreement with the current owner of the test IP, HealthChart LLC to commercialize the assay for the Chinese market and the rest of the world.The competitiveness of Jinlu’s products is important for the growth of the business and the company as well. Product quality and cost both are critical factors for success. Innovative product design and production is the only feasible approach to achieve a sustainable business. Therefore, development of all Jinlu products has been based on the technology that is able to maximize the value of the product. For example, Jinlu's FISH probe is based on a platform different from all other competitors in the field, thus allowing Jinlu to produce quality products at reduced cost. PTCLtype assay is based on the IP built upon many years of clinical research works from many physicians and scientists, a valuable asset that demands protection by any measures possible. Innovation determines the value of the company and allows Jinlu to provide valuable products to our valuable customers - patients in dire needs of accurate diagnosis and correct treatment of PTCL.PTCLtype assay is applicable in the diagnosis and treatment of PTCL, about 10-25% cases of Non-Hodgkin's lymphoma newly diagnosed annually. For the Chinese market, there are about 100,000 newly diagnosed PTCL cases each year, with an annual incidence rate of increase at 8.5%. Worldwide, there are about 500,000 newly diagnosed cases annually, with a incidence rate of increase at 4%. The market size in China for the PTCLtype assay is about 200 Million CNY and the worldwide market size is close to 1 billion CNY.Risks for the PTCLtype assay are relatively low and there has been no similar assay on the Chinese market. There are some academic versions of molecular subtyping methods used for clinical research, but all based on the discovery of LLMPP and none is considered as serious competitions since Jinlu holds the IP, and especially the algorithm. Without the proper calculation, all conclusions or observations drawn from these self-developed version of algorithm are biased and incomplete, not suitable for clinical applications. The risks facing PTCLtype is the danger of disclosing the source code of the algorithm therefore preventive measure will be implemented to protect the safety of the algorithm.PTCLtype assay is in the process of being submitted for IP protection in the US. The plan is to file in China and a few selected markets around the world once patent is filled in the US. Avoid countries or regions that require disclosure of the source code of algorithm when filing for IP protection.OtherReady for commercializationPer strong recommendation from one of the key opinion leaders in lymphoma research, the PTCLtype assay shall be first introduced as the Laboratory Developed Test (LDT) due to difficulties and long process for an innovative test to obtain registration as IVD. The commercialization plan for the next 3-5 years are summarized as the following, 1) Introduce the assay as LDT to a few top tier hospitals in China in collaboration with one of more key opinion leaders in the field who will lead the clinical application and suitability studies, publish research findings, and present data at meetings; 2) Once clinicians become familiar with the PTCLtype assay and realize the benefits that the assay can bring to patients under their care, expands the assay to other institutions; 3) Seek partnership with drug companies that are developing treatment for PTCL to promote PTCLtype assay used as the companion diagnostics; 4)Establish data centers to process the data, protect algorithm; 5) Go abroad.Total 4 million CNY have been rasised for the PTCLtype assay development, all through local government support mechanism. Two million have been spent on beta-testing, IP preparation, facility maintenance and personnel support.Ten million CNY (about 1.5 million USD) are sought. PTCLtype assay is ready to launch commercially, all funds will be spent toward production, marketing activities, and the establishment of sales and customer support networks.Commercialization of PTCLtype assay for application in the clinics to accurately diagnose the specific subtypes of PCTL, thus allowing clinicians to select treatment effective to the subtypes of the disease. PTCLtype assay is able to direct and assist pharmaceutical companies in the design and development of drugs targeting specific PTCL subtypes, thus increasing the likelihood of success and improving the effectiveness of treatment in the clinics.PTCLtype-Assay-Business-Plan-Presentation-confidential.pdf
Mark 618-4374VP Business DevelopmentAlephoson Biopharmaceuticals LimitedN/A2019Hong Kong SARBenjamin Lee Mark Yong Yan Feng WangBiologicsAlephoson Biopharmaceuticals Limited is an ophthalmic pharmaceuticals company, dedicated to identifying and developing novel ophthalmic therapies, utilizing our proprietary and patent-pending Cell Penetration Protein Alternation (CePPA) TechnologyFirst in class non-invasive treatment for nAMD, Uveitis and many more A science-driven operating model that collaborates with prestigious institutesOut target market is China, USA and the rest of the world The potential market size is about USD 21 billionOur risk is that we are still at the early stage of development We have no current competitors at this stageWe already have some patents registered in China and USAPre-clinicalWe would like to reach to phase 3 clinical in the coming yearsWe have raised USD 4 million from private investors Details of the investors are confidential at this stageWe are seeking for USD 12 millionOur key product, the topical eye drop provides a safer and unprecedented therapy to overcome the limitations of the current intravitreal injection treatment for sight-threatening eye diseases, including but limited to neovascular age-related macular degeneration (nAMD), otherwise known as wet AMD, and non-infectious uveitis.Alephoson-Teaser_April20212207.pdf
OtherHong Kong Science ParkMy contact phone number is (852) 6184 3747 Just cannot fill out my complete number above
Boris 600-1021CEOManhattan BioSolutions, Inc. York, New YorkDr Boris Shor, Co-founder & CEO (JNJ, Wyeth, Pfizer) Dr Yossef Av-Gay, Co-founder, CSO (UBC) Dr. Jules T. Mitchel, (Target Health) Robert Easton (Bionest, NY BIO, The Wilkerson Group) William Johnson (EMD, Wyeth, Novartis)BiologicsDrug discovery & development. Oncology TherapeuticsDeveloping powerful new treatment approaches to modulate microbial recognition and inflammatory signaling pathways for the treatment of advanced / metastatic cancersSolid tumors. >$1BProof-of-concept studies, IND-enabling studies. No significant competition.patent applications filedPre-clinicalComplete the IND-enabling studies, initiate Phase 1 trials.~$1M non-diluttive capital including angel funding and grants (NIH, NSF)$2M seed roundMonoclonal Antibodies against pattern recognition receptors Bispecific and AI-enabled Antibody Discovery Synthetic microbe-based vaccine platform2021-MABS-Inc-Jan-ACCESS-CHINA-JPM-presentation.pdf
OtherWilliam Johnson / Yafo capital
Peter 461-1617CEOTeamedOn International, Inc.www.teamedon.com2017DelawarePeter Mu, PhD, MBA, President and CEO, former Covance, Lexicon, WuXi AppTec, extensive experience in new drug development. Paul Yang, MD, PhD, Clinical Advisor, PI on numerous ocular gene therapy trials, KOL in ophthalmic genetic and ocular immunology, Casey Eye Institute, OHSU. Andy Lauer, MD, Clinical Advisor, Chair, Department of Ophthalmology, Casey Eye Institute, OHSU, KOL retinal surgeon on numerous ocular gene therapy trials. Gary G. Altman, PhD, Strategic Advisor, experienced C-suite executive in therapeutics, genomics, cell therapy, and medical diagnostics. Jonca Bull, MD, Regulatory Advisor, Vice President, PPD Consulting; Therapeutic Lead Ophthalmology Principal at Strategic Regulatory Consultants. Andy Kiorpes, PhD, Scientific Advisor, former Covance, MGI, WuXi AppTec, IND/NDA experience in new drugs. Alex Lai, PhD, Research Scientist, former Yale, NIH, OriGene, SpeedBio, expert in gene and protein therapeutics research and development.RNA, Peptide & Gene Therapy / Stem Cells / Cellular TherapyWe are advancing a clinical-stage gene therapy for a monogenic orphan ocular disease, X-linked retinoschisis (XLRS). We have evidence of safety in humans and have determined that a novel route of administration is likely to show both safety and enhanced efficacy. We licensed this program from Applied Genetic Technologies Corporation (AGTC), and have engaged two of the lead investigators of the original study as clinical advisors as well as several other subject matter experts to enhance our likelihood of success.XLRS is a rare congenital disease of the retina caused by mutations in the RS1 gene. XLRS is an early onset retinal degenerative disease and is the leading cause of juvenile macular degeneration in males. No products have been approved by regulatory agencies for treatment of this condition.We have licensed AGTC's XLRS program including data and clinical materials. AGTC developed a recombinant adeno-associated virus (rAAV) vector expressing RS1 as a potential product for treatment of XLRS. Study results indicate the product could help the improvement of visual function in XLRS animal models. A phase 1/2 clinical trial results indicate the gene therapy is safe in patients via intravitreal injection. We plan to improve efficacy by using a subretinal route of administration.The annual incidence of XLRS is estimated to be between 1 in 5,000 and 1 in 20,000 males, with an estimated prevalence of 35,000 in the United States and Europe combined. To estimate the market size, we use the data from a comparator drug, Luxturna. Luxturna is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. RPE65-associated IRD is rare, with an estimated prevalence of 5,000 in the United States and Europe combined. Luxturna was approved by US FDA in 2017 and costs $425,000 per eye in the US. In 2019, Roche bought Spark for $4.3 Billion largely based on the approval of Luxturna. For our XLRS therapy, the patient number is 7X of Luxturna, and would be a Billion dollar drug after reach the market. It will be a hot acquisition target when we reach inflection points, such as establishing initial efficacy.Paul Sieving's Lab at NIH/NE is administering an AAV8-hRS1 vector (our vector is rAAV2tYF-CB-hRS1) via intravitreal injection whereas we plan to use the subretinal route of administration. Sieving has completed a Phase 1/2 clinical trial with 11 subjects dosed (1e9, 1e10, 1e11 vg/eye), and found that only one subject (1e11) cavities transiently closed on day 14. Significant immune response was noted at the high dose 1e11 vg/eye with NIH’s vector. Note: we didn’t see significant immune response at 6e11 vg/eye, indicating a higher safety margin with our vector, rAAV2tYF-CB-hRS1. Risk Analysis: 1, Competitive risk: emerging competitors could erode our enterprise value; 2, Regulatory risk: approval may be delayed; may not achieve efficacy endpoints; 3, Market risk: we may not be acquired; 4. Development risk: the subretinal route of administration may not be efficacious or may cause adverse reactions.AGTC has granted to us an exclusive license to the Licensed Product, and a non-exclusive license to the Licensed IP covers the vector capsid. The Licensed Product received US FDA orphan drug designation which gives us 7 years exclusivity post-BLA.Pre-clinical1, Confirm preclinical safety and file an IND within 12 months. 2, Confirm initial safety and proof-of efficacy in a small Phase 1b/2a trial within 24 months.$2M from VCWe seek $5M to advance the asset through a Phase 1b/2a clinical trial. Approximately $2M to confirm preclinical safety and file an IND, and approximately $3M to establish safety and efficacy in human subjects. Exit Strategy: Partnering or Out-Licensing at the conclusion of a successful 1b/2a trial. Valuation as exit: Based on recent acquisitions in gene therapy fields, we determined that a successful gene therapy Phase 1/2 program will be valued at least $400M.We are advancing a clinical-stage gene therapy for a monogenic orphan ocular disease, X-linked retinoschisis (XLRS). We have evidence of safety in humans and have determined that a novel route of administration is likely to show both safety and enhanced efficacy. We licensed this program from Applied Genetic Technologies Corporation (AGTC), and have engaged two of the lead investigators of the original study as clinical advisors as well as several other subject matter experts to enhance our likelihood of success. We seek five million dollars to advance the asset through the first major milestone: a Phase 1b/2a clinical trial. $2M will be used to confirm preclinical safety and file an IND within 12 months. Subsequently, $3M will be used to establish initial safety and proof-of efficacy. Exit Strategy: Partnering or Out-Licensing at the conclusion of a successful 1b/2a trial.SAPA-HQ
Ning 392-2527VPChengdu Hyperway Pharmaceuticals, Sichuan, ChinaYingfu Li, Ph.D, Founder, Chairman and CEO: Dr. Li founded Hyperway in 2019 and has served as CEO since the company’s inception. Before starting Hyperway, Dr. Li was President of Brilliant pharmaceutical research institute, where he has achieved over 60 new products launched in China and advanced several new drugs into clinical trials. Prior to Brilliant, Dr. Li was General Manager in Chempartner (Chengdu), where he established worldwide CRO business and partnership with large pharmaceuticals such as Takeda, Pfizer and AZ. Before that Dr. Li held positions of increasing responsibility at AMRI, Yangzijiang Pharmaceutical, Bayer Japan and Bayer US. He is the key inventor for several clinical candidates and has more than 90 patent applications worldwide. Dr. Li received PhD on Medicinal Chemistry from West China University of Medical Sciences, and was awarded postdoctoral fellowship from Bayer Research (Germany).Small Molecule PharmaceuticalsSince its founding in 2019, Hyperway has grown rapidly into a company of approximately 100 employees, including talents attracted internationally. Hyperway comprises three segments of business: 1, New small molecule drug discovery and development; 2, High value API manufacture process development and production; 3, Pharmaceutical formulation development. Through this three-prone approach, not only do we have a productive research and development team generating an impressive new drug pipeline, but also a steady revenue through various business development and collaborations.Currently our discovery team is working on around 10 different projects. The most advanced ones are two potent and selective reversible BTK inhibitors: one has a best-in-class pre-clinical profile, and another one is a first-in-class drug with high brain exposures. Both compounds are projected to start their clinical trials in late 2021 or early 2022. In addition, a series of NaV1.8 blockers with excellent pre-clinical profiles and efficacies in rodent pain models have been discovered. There is also a series of potent DHODH inhibitors discovered with potent in vivo anti-fungal activities. The latter two projects are aiming for clinical trials in late 2022. The four preclinical compounds are valued at multi-billion dollars based on market assessment. Our cash-generating business segment has already brought certain steadily growing earnings on top of capital investments.Worldwide oncology, pain and anti-fungal markets, estimated around multi-billion dollars.The major risk will come from failures in clinical trials, even with promising preclinical data. Our current major competitors are Merck, Eli Lilly and Vertex.We have already filed 13 patent applications, covering all current projects. We have very a strong worldwide IP position.Pre-clinicalWe plan to advance at least four drug candidates into clinical trials, with one or two new drugs marketing applications before the next 3-5 years. Meanwhile, we are actively seeking collaboration and/or out-licensing opportunities with oversea pharma for global markets.We have raised close to $20 million dollars by far. Hygeia capital is one of our main investors.We are seeking additional $40 million dollars investment for the next round.1, HBW-3-10, a novel second-generation reversible BTK inhibitors that is effective against both wild-type and C481S-mutated BTKs, has a superior preclinical profile than any other known ones, for treating Ibrutinib-resistant CLL and beyond, 2, HBW-3-20, the first-in-class potent reversible BTK inhibitor with high brain permeability for treating B-cell malignancies in brain and autoimmune disorders requiring brain-penetration, such as multiple sclerosis. 3, A series of novel, potent, selective and oral-bioavailable Nav 1.8 channel blockers with best-in-class potentials to achieve non-addictive analgesia used in multiple pain conditions, for which an effective drug treatment remains a huge unmet medical need. 4, A series of novel, potent, selective and oral-bioavailable fungal DHODH inhibitors with best-in-class potentials in treating triazole-resistant fungal infections and other pan-resistant fungal pathogens.SAPA-HQ
Jeffrey Hausfeld MD, 792-8601Chairman of the Board and Chief Medical OfficerBioFactura, Inc.www.biofactura.com2004Frederick, Maryland USAExecutive Management Team Darryl Sampey,Ph.D. President & Chief ExecutiveOfficer - 25 years of process development, scale-up andmanufacturing - Led process development group at Human GenomeSciences - Inventor on StableFastTM and associatedpatents - Founder and visionary of BioFactura for over 15years Jeffrey N. Hausfeld M.D., M.B.A.,F.A.C.S. Chairman of the Board of Directors & Chief Medical Officer - Serial Biotech and Medtech Entrepreneur/Investor - Seasoned physician with experience in conducting clinical trials - President Memory Care Communities - Chairman and Founder of the Society of Physician Entrepreneurs • Founded in2004 • Headquartered in Frederick, Maryland • ~8,000 sq ft of office and lab • ~30Full time employeesBiologicsBioFactura is a clinical-stage biopharmaceutical company that develops high-value biosimilar (generic biologics) and biodefense drugs using its patented StableFast™ Biomanufacturing Platform, the optimal system for bringing these medicines to market with faster, lower cost, superior-quality manufacture. For over 15 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox, Ebola and Marburg, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and inflammatory diseases.Key Differentiators andValue: • Fingerprint matched biosimilars for Stelara, Simponi and other blockbuster products using a proprietary platform • Sole developer of Smallpox Biodefense Therapeutic with full US Government support • Comprehensive in-house development, characterization and manufacturing capabilitiesThe projected Stelara global sales from IQVIA Health data shows $9.5B revenue at the time of reference drug expiration in 2024. There are limited number of companies that have disclosed plans to commercialize a biosimilar to Stelara, most of which are using a CHO platform which will not have the same fingerprinting to the reference drug as BioFactura’s therapeutic does, and based on a review of their published data, they are likely have more residual uncertainties and a higher burden of proof in their Phase III trials. This precise matching of our biosimilar to the branded drug will also give us a significant advantage when marketing our biosimilar to both physicians, patients and payers upon launch of our products. Updated pharmaceutical intelligence regarding the projected sale of Simponi also confirms an upward trajectory of sales, reaching $3.7B in global sales in 2023, the year prior to patent expiration. Simponi Revenues Loss of Exclusivity starts in 2024 (US & EU)Competitive Biosimilars Developers: Formycon, Alvotech, Celltrion and Amgen are developing ustekinumab biosimilars. These products may be subject to comparability issues with CHO which may result in residual analytical uncertainties and extended Phase 3 clinical programs Key Advantages of BioFactura: • Cost of Goods: the optimal NS0 platform for single-use manufacturing • Regulatory: 100% serum-free vs Lonza’s serum dependence • Productivity: multi-fold higher than SP2/0 and Lonza, and lower manufacturing cost • Biosimilarity: fingerprint-like match to innovator product and reduced clinical burdenSelection Marker: •3-ketosteriod reductase(3-KSR) •Rescues cholesterol biosynthetic pathway in NS0 cellline •Cholesterol-free medium –Optimal for single-use disposablesystems CELLLINE •NS0 cell line -Licensed from UK, Commercial mediumadapted •Murine myeloma cell line (as isSP2/0) •Both glutamine and cholesterolauxotroph •Does not express3-KSR CLONING SUPPLEMENT •Proprietary supplement •Supports transfection and single-cell cloning processes •Serum-free PATENT PROTECTED •U.S. Patent 8,076,102 covering cholesterol selection technology •U.S. Patent 10,774,353 covering multi-selection technology •Australian, Singapore, Korean, Chinese and EU patents granted Patent coverage through 2035 in multiple international venuesPhase IComplete Phase 1 for Ustekinumab biosimilar and then conduct Phase 3 bioequivalence study. Submit for BLA and MAA in 2023. Commercial launch in early 2024. Begin Phase 1 trial for Golimumab biosimilar in Q1 2022, followed by a Phase 3 bioequivalence trial. Submit BLA and MAA in Q3/4 2022 and submission to FDA and EMA in Q3/4 2023. Procurement of the Smallpox antibody cocktail for the National Stockpile of the US government.$11M raised from both high net worth individuals and institutional investors.12-$15M in Series C financing round.BioFactura is a clinical-stage company that develops high-value biosimilar (generic biologics) and biodefense drugs using its patented StableFast™Biomanufacturing Platform, the optimal system for bringing these medicines to market with faster, lower cost, superior-quality manufacture. Our first two biosimilar assets are Ustekinumab and Golimumab, which we plan to launch in 2024. We are actively seeking pharma commercialization/distribution partners both on a regional and global basis.BioFactura-Non-Confidential-Ser-C-Presentation-20210511-1.pdf
SAPA EmailWe are currently in discussions with several Chinese pharmaceutical companies in regards to our biosimilar assets and we would like to expand that search as well. Thanks. Dr. Jeffrey Hausfeld
jon 683-5657presidentable cerebral, LLCablecerebral.com2013EphrataDr. Jon (Jun) Xia, Co-Founder and President of Able Cerebral, LLC is a licensed health professional and an inventor with granted patents. Wayne Shentu, Co-Founder, is an expert in administration and export-import of healthcare products.Nanotechnology / Drug Delivery / FormulationAble Cerebral, LLC (ACL) owns patent awarded technologies to overcome Alzheimer's disease. Our medical food product has achieved remarkable therapeutic results for early stage and especially for middle stage AD patients. It saved their independence and dignity from late stage AD. 能脑公司(ACL)拥有克服老年痴呆症AD的专利技术,我们的特殊医学配方食品已经取得了对早期,尤其是中期AD的显著疗效,拯救他们于失去独立和人格尊严的危险边缘。In US dollar value, we believe ACL > $100 M. ACL makes critical connection between brain energy and Alzheimer's disease. In addition, we found the critical timing of the therapeutic window. Recent years, more and more published research results strongly agreed with our practice. For example, many studies showed that less frequency and shorter REM sleep cycle correlate with AD. 我们相信ACL价值达一亿美元。 ACL洞见了脑能与AD之间的关键联系,并找到的治疗AD的关键时间点。近些年,越来越多的发表研究同意我们的实践。比如,有很多研究显示,快眼波睡眠的频率和持续时间低,短,预示AD高发。All stages of Alzheimer's disease, with market size over $100 billion. Besides, our product can benefit the other patients such as diabetic, and those on Chemo therapy. We are also planning to advance our product to FDA phase III clinical study for new drug status. 我们的目标市场为不同阶段AD,其潜在市场达千亿。并且我们的脑能产品对其他疾病也有治疗效果。我们有计划将产品推入FDA 三期临床成为新药。Our main risk is not able to raise investment for our plan. We do not believe monoclonal antibodies can really help AD patients, nor does dietary supplement like Prevagen. 我们的仅有危险在于为我们的计划找到投资。我们相信单克隆抗体类研究不会真正为AD病人带来福音,更不用说像Prevagen天然保健品.We now own 4 rewarded patents. 我们已经有4个获准专利。Phase IIWe have plan to apply phase III clinical study with US FDA. Our plan is to gain FDA approval as a new drug in next 3-5 years. 我们有计划向美国FDA申请三期临床试验,相信能在3 - 5年内获准作为FDA新药上市。About $1.5 M. We are mainly self funded so far by families and friends. Besides, our medical food product has annual sales income. 一百五十万左右。目前我们主要是通过亲友自我投资,我们的特殊医学配方食品已经有销售收入。We hope to raise 5 to 8 million US dollars for clinical study and FDA new drug application. 我们希望能够筹集 5 - 8 百万美元,主要用于临床和新药申请。With patented technologies in both US, China and Cana, Able Cerebral’s circadian brain energy delivery product, BrainGlucose(BG) has shown miraculous therapeutic effects for many Alzheimer’s patients. Our current goal is to advance BG to FDA phase III clinical study as breakthrough new drug. Thus worldwide patients of AD will gain benefits, and at the same time, the value of our products and company will surge. Owing to BG’s intrinsic safety and effective profile, we expect the US FDA would approve BG as new drug within 3 years. We are also planning to manufacture BG and register it with Chinese FDA as “Special Medical formulated Food”. We would like to set up an R&D and/or manufacturing facility in Hong Kong. 能脑公司Able Cerebral拥有美国及中国专利技术和BrainGlucose 产品BG。该产品巧妙利用昼夜缓控释能量投递,达到对早中期老年痴呆症AD的特效控制和恢复作用。我们当下目标是发展BG为美国FDA特许突破性三期临床新药,以尽快让广大AD,DM及PD受益,并巨幅提高我们产品和公司价值。 基于BG安全和特效性,预期美国FDA在三年内批准为新药。 我们也将BG在中国申请备案批准为特医食品,并计划在香港设立研发及生产机构。 希望投资及合作机构与我们分享这个特殊机会。SAPA-DC SAPA-NE Wechat
Gerald 862-5391CEOTodos Medical, USA; IsraelGerald Commissiong - Chief Executive Officer and Director; Mr. Commissiong is currently a director and President & CEO of Amarantus Bioscience Holdings, Inc. and is interim-CEO of Breakthrough Diagnostics, Inc., Todos’ joint venture with Amarantus. Mr. Commissiong has been responsible for Amarantus’ strategic transactions, licensing, research collaborations, mergers & acquisitions in therapeutics and diagnostics, as well as fund raising, having raised over of $50 million since inception. Dr. Jorge Leon, Ph.D. - Consulting Chief Medical and Scientific Officer of Infectious Disease and Oncology; Dr. Leon is internationally recognized for his pioneering work in molecular diagnostics. As Director of Molecular Diagnostics, Senior Director of Biotechnology Development and Vice President of Applied Genomics, Dr. Leon spent 12 years developing Quest’s molecular diagnostics strategy, which is now the world’s largest molecular diagnostics service laboratory.Medical Devices / DiagnosticsTodos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc., in April 2021, to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The COVID-19 pandemic created an inflection point for diagnostic testing, fostering new market awareness. Todos quickly pivoted in early 2020, becoming a full-service solutions provider for COVID-19 testing and immune support, as we take a data driven, scientific approach.Within the early detection/screening universe for breast cancer, Todos is the only spectroscopy-based assay that is mechanism agnostic, solely looking for differences in immune profiling between disease and healthy normal based upon algorithms developed using AI. Screening tests for cancer, specifically breast, colon and lung cancers, have compliance shortcomings due to their scientific limitations, invasive procedures, and expensive nature of more accurate diagnostic methods. More importantly, many of the most effective diagnostic methods remain too expensive for adoption as screening tests for all those at risk are used too rarely and not quickly enough to allow for the most effective treatment. Blood based tests are the future of cancer screening. Todos Medical’s TBIA platform represents a cost effective, scalable, and patient-friendly screening method for cancer screening.The breast cancer market report is segmented on the basis of type, treatment, end user and by geographical levels. The global breast cancer diagnostic and drug market reached $20.9 billion in 2019 and is expected to increase to $28.2 billion by 2024, at a compound annual growth rate (CAGR) of 6.2%. Major factors in driving the growth of the breast cancer market include rising incidents of breast cancer, increasing female geriatric population and growing governmental initiatives for new therapies. Furthermore, growing obesity, lack of physical exercise, overexposure to radiation and drinking alcohol are common causes for the proliferation of the disease.Competitors: Check4Cancer is a provider of cancer detection and genetic services for self-funding patients, insurers & corporate customers; Biosignatures' mission is to transform lives by diagnosing disease early. Biosignatures is an AI Cloud software company. They support advanced blood sample analysis for use in a health ecosystem; MSDx, Inc. is commercializing both Research Use Only (RUO) and In Vitro Diagnostic (IVD) blood test products for neurological disorders. Multiple Sclerosis is the first focus. Ultimately, this technology can be used to monitor patients with conditions such as brain and spinal cord injury, Parkinson’s disease, and chronic fatigue syndrome.We believe TBIA could be commercialized within a year based on the data already gathered in Singapore and our recent partnership with Pathnova to help drive the program forward to commercialization in Singapore. We have gathered data from several hundred subjects to date, including over 200 in Singapore, and are currently adding to that database by recruiting study participants in Europe. We believe that the data gathered to date is sufficient to allow for a commercialization in Europe and Singapore, potentially in other south east Asian jurisdictions as well. The algorithm optimization is the final key to driving commercialization.Phase IIFocus will be on TMB/TMC cancer detection, and LymPRO Alzheimers platform. We also are funding NLC Pharma joint venture which is commercializing a Tollovid dietary supplement and 3CL test for COVID. For Tollovid, we have a clinical trial in Israel that we are funding and we may expand it into Brazil and the US, but those would be government-sponsored efforts. Our other priority is to get our newly acquired lab in the United States, Provista, up and running as a center of excellence, running high volume Covid tests, and eventually bringing to market our proprietary cancer and Alzheimer's tests.Have raised $10mm from a Korean VC fund and a domestic family office$10mmWill need $5mm for 18-months of runway and then the rest of the proceeds used for $2m on Tollovid, $1m on breast cancer, $500,000 on Alzheimer’s test LymPro. Tollovid – have a clinical trial that we are funding (77 people in Israel) and we may expand it into Brazil and the US, but those would be government-sponsored efforts totaling $2m We need to spend $300,000 on equipment for the spectroscopy platform to put that into Provista and then to fund the validation about 100k a month. (reagents, KOLs, personnel), so total for Provista is $1m LymPro – validation cost to get it up and running in another lab is $160,000. However if we do it ourselves at Provista, we have to buy a flow cytometer and run it there and have to hire personnel so that’s where the $500,000 budget comes in.Todos-Medical-TOMDF-Corporate-Presentation-052021.pdf
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Mark 310-2613DirectorVivacitas Oncology Inc.www.vivaoncology.com2016Walnut Creek, California U.S.Mark Suseck: CEO, Director Mr. Suseck is a biotech business leader with significant experience in developing and commercializing new technologies. Jeff Stephens: Co-founder, Director Mr. Stephens is managing partner of Infusion51a, which is an investment fund focused on underappreciated and disruptive technologies. Scott VanderMeer MBA: Co-founder, Interim CFO, Director Mr. VanderMeer is a c-level business leader in the healthcare sector, venture capital space, and private equity. Tina Runk MBA: Co-founder, EVP Clinical Operations, Director Significant experience in research, preclinical/clinical development, and operations with CROs and R&D companies in the biopharmaceutical industry in the US and around the world. Elise Brownell, Ph.D. EVP Portfolio Management Elise Brownell, PhD. has diversified experience in the biopharmaceutical arena where she has played key roles in Discovery, Development, Opportunity Assessment, and Executive Leadership to drive innovation.Small Molecule PharmaceuticalsVivacitas is a biopharmaceutical company pursuing development of a next generation camptothecin (Topoisomerase-1 enzyme inhibitor). As a drug class, camptothecins (e.g., Topotecan, Irinotecan) have demonstrated efficacy in multiple tumor types and are currently approved for use in colorectal, pancreatic, ovarian, and small cell lung cancer. Their use is often limited due to tolerability and side effects.Vivacitas’ lead development candidate (AR-67) is a novel lipophilic compound to target improved efficacy and tolerability employing a proprietary synthesis method. AR-67 has in-vitro, Ph I, and Ph II data in multiple tumor types, and has demonstrated the potential for progression-free survival in glioblastoma of 6-29 months, while significantly reducing severe side effects (e.g., grade 4 diarrhea). AR-67 received U.S. Orphan Drug Designation from the FDA. Vivacitas US Patent 9,447,126 B2 issued in 2015 and includes systems and methods for camptothecin analog synthesis. A methods of cancer treatment patent to reduce adverse events was filed in 2020 and is pending.Cancer is the second-leading cause of death in the United States, and the global market for cancer therapeutics is growing at a fast pace, with CAGR of 7% and revenues projected to reach $161 billion in 2026(source: Allied Market Research 2021). In solid tumor cancers in the U.S, the current standard of care is often surgery and radiation/chemotherapy. Patients with solid tumors and recurrence face a particularly difficult prognosis. Ttreatment considerations include and are limited by the patient’s ability to tolerate additional treatment (e.g., increased dose, additional chemotherapeutic agents). There are a significant number of patients with glioblastoma, colorectal, pancreatic, ovarian, and small cell lung cancer seeking new treatment options (Home | American Cancer Society - Cancer Facts & Statistics ). This is due to limited median survival prospects, especially in recurrent disease.Vivacitas has risks associated with biopharmaceutical development stage companies including failure to capitalize, execution of clinical development/trials/manufacturing/ regulatory filings, inability to attract/retain necessary talent, and biopharmaceutical technology, competition, market access, reimbursement. Competitors include current standard or care(surgery, radiation, chemotherapy) for solid tumors in cancer of the brain, colon, rectum, pancreas, ovaries, and lung.Methods and Systems for Camptothecin Analog Synthesis(US 9,447,126 B2) patent issued, which includes synthesis methods. Expiration 2035. Cancer Treatment Using Camptothecin Derivatives (PCT/US20/61199) is pending, which includes methods to treat cancer and reduce adverse events. Potential coverage through 2040Phase IIVivacitas is seeking financing to complete Ph II clinical study to demonstrate improved efficacy in recurrent glioblastoma compared to current standard of care. Successful study results will position the company for a strategic exit. Vivacitas projects an exit and return to investors at the conclusion of a successful Ph II study. This could be realized through an IPO, external license, or sale to a company focused on oncology therapeutics. It is not Vivacitas’ intent to commercialize the technology.$2.2MM$25MM.Continue Ph II development of AR-67 in recurrent glioblastoma, where Vivacitas has U.S. orphan drug designation and other potential indications(colorectal, pancreatic, ovarian, lung).VivacitasSAPSExecutiveSummary051421.docx
Jason 536-6314ParternerB2Med LLCN/A2020DelawareJim Huang Jason Ge Mark YuSmall Molecule PharmaceuticalsA virtual company developing 505b (2) NDA products targeting unmet medical needs by pursing ultimate cure with clinical proved efficacy of small molecules for blockbuster market opportunities.For chronic diseases from medical doctor’s new findings. New combination and repurpose drugs with new delivery technology.Chronic kidney disease, nephropathy, diabetes and cardiovascular. Potential billion dollar market.Risks in regulatory pathway, clinical strategy and patent protection.Provisional patent applications.Phase IIn next 1-2 years we are planning to build strong IP position and conduct some POC studies to boost company rNPV. In next 3-5 years to partner with big pharma companies to complete clinical studies and regulatory filings for market approvals.We just staredSeeking initial 5 millions angel investment for year 1-2 development plan.LEAD PRODUCT: HYG-001 Indication A combination drug product for the treatment of CKD Clinical Advantages Two small molecules with known safety profile and minimum adverse effect Oral dosage form for easy of administration Clinically significant effect for the chronic kidney disease LEAD PRODUCT: HYG-002 & HYG-003 Indication Optimized treatment of CKD, hypertension, cardiovascular disease and/or diabetes with combination products Clinical Advantages Combination of two small molecules with known efficacy and safety profiles Oral dosage form for easy of administration Clinical proved dosing regiment in hospital prescriptionsB2Med-Presentation.public-version.2021.5.pdf
Xudong 766-9949CEOAcon Pharmaceuticalswww.aconpharma.com2020DelawareXudong Yuan, Ph.D. (CEO & President) Dr. Yuan has 20 years of experience in pharmaceutical field. He held different positions in NAL Pharma, GSK, J&J, and RB. He graduated from University of Georgia with a Ph.D. in Pharmaceutical Science. He also has a M.S. in Pharmacy from National University of Singapore. Christina Li, Ph.D.(CSO ) Dr. Li has 20 years of experience in biotech industry. She was a leading scientist from Vertex Pharmaceuticals and Scripps Research Institute, and Torrey Pine Institute. She graduated from University of Southern California with a Ph.D. in Biology. Nevin Cheng, Ph.D., MBA(Operation VP) Dr. Cheng has 20 year experience in pharma. He was a general manager for Geffosse in China, and a technical director in Colorcon. He has a Ph.D. in Pharmaceutics and a MBA from Tongji University. Yuan Yang, Ph.D.(Biology Manager ) Dr. Yang has 15 years of experience in biotechnology. She obtained PhD in pharmacology in China Pharmaceutical University and did postdoc in NYU.Nanotechnology / Drug Delivery / FormulationAcon Pharmaceuticals Inc. (Acon Pharma) is a specialty pharmaceutical company and focuses on siRNA and mRNA drug delivery, 505(b)(2) NDA, and complex ANDA drug product development with its captive drug delivery system technology platforms. Acon Pharma is a privately held corporation located in Princeton, New Jersey, USA. As a dynamic pharmaceutical company in a vibrant life science research region, Acon Pharma leverages the expertise and experience of highly skilled, multi-disciplinary workforce to accelerate the product development of complex drug delivery systems. The Company’s key managers were primarily educated in US with advanced degrees and trained in the pharmaceutical industry for many years, and have possessed deep professional knowledge, technical know-how, and extensive experiences in pharmaceutical product development.Acon Pharma is currently developing a first-in-class siRNA lipid nanoparticle (siRNA-LNP) inhalation therapy targeting profibrotic genes for the treatment of pulmonary fibrosis, which is a highly unmet medical need area. Acon Pharma is also deveoping novel siRNA LNP inhalation for the treatment of COVID-19 patients. In addition, Acon Pharma has developed novel long-acting microsphere injectables for the treatment of schizophrenia and surgery pain.The target market for pulmonary fibrosis is about 2 billion US$, and for COVID-19 is above 5 billion US$. The target long-acting injectable market for schizophrenia is about 1 billion US$, and for pain is about $1.5 billion US$.There are very few competitors in siRNA therapeutics field, comparing to others, such as antibody and cell therapy. There are very few competitors in long-acting microsphere injectable field, due to the high technical barrier and complex manufacturing process.The patent for siRNA LNP inhalation has already been granted; The PCT patent for long-acting microsphere injectables has been filed and is expected to be granted.Phase IWe are conducting IND-enabling studies in this year and plan to file IND in 2022. We will move long-acting microsphere injectable project into Phase II clincal trial, and siRNA LNP inhalation project into Phase I clinical trial. We plan to conduct Phase III clinical trial for microsphere project and Phase II clinical trial for siRNA LNP project in year 3-5.We have raised about 1 million US dollars so far. The funds are mostly from the founders and angel investors and collaborating partners.We are seeking to raise 8 million US dollars (release 20% share) in the current pre-A round to conduct IND-enabling studies for FDA IND submission and build up clinical supply manufacturing capabilities.Treatment options for idiopathic pulmonary fibrosis are very limited. The market is estimated to reach $4.3 billion by 2025. Acon Pharma has developed inhalation siRNA targeting to fibrosis associated MMP3, CCL12, and HIF1A genes. Efficient silencing effect and downregulation of gene expression were observed. Inhalation delivers siRNA LNP directly to the diseased lung to avoid the first-pass effect in liver and enhance it’s efficacy. Patented complex siRNA LNP biologics formulation makes it difficult for the competitors to make biosimilars in future. The schizophrenia patients need to take drugs everyday over long period, which has patient compliance problem. Acon has developed long-acting microsphere injectables to give once a month, or once two months injection, which is very convenient for patients. The complex microsphere formulation has high technical barrier. The target market is about 1 billion US$. Acon Pharma will move this project to Phase II clinical trial in two years.Acon-Pharma-BP-5-10-2021.pdf
Fantao 536-8678Director of Research and DevelopmentHbO2 Thereapeutics LLC, PA, USAFounder: Zaf Zafirelis, CEO Igor Serov, CFO Brian Dawson, Senior Director of Process Development Gregory Dube, PhD, Vice president Fantao Meng, PhD, Director of Research and Development Arkadiy Pitman, Senior Director of Biostatistics and Data Management Melissa Zafirelis, Director of Regulatory and Clinical OperationsBiologicsManufacture two oxygen carriers (artificial blood): Hemopure and Oxyglobin Oxyglobin is the only oxygen carrying solution approved by the FDA and the European Medicines Agency (EMA) to treat all cause canine anemia. Hemopure is approved in South Africa and the Russian Federation for acute anemia, irrespective of etiology. In the US Hemopure is only available under investigational status through the FDA expanded access program to qualifying patients with severe, life threatening anemia for whom blood transfusion is indicated but not an option.1) Oxyglobin is the only oxygen product approved by the FDA and the EMA to treat all cause canine anemia; 2) Hemopure is currently stocked and used when blood is not an option at 12 FDA authorized centers for Expanded Access; 3) >2,000 patient treated to date in a variety of indication; 4) Peer reviewed clinical outcomes > 250 publications in multiple journals; 5) Proven large scale cGMP manufacturing capability – guaranteed time-frame contract with PROTECS, an experienced pharma & biotech construction management company to manage the projectUS and Europe markets Hemopure: • Military and civilian trauma > $500 million • In-hospital when blood transfusions are not an option ~ $50 million • Liver transplantation: > $40 million (Similar potential for other organs) • Sudden cardiac arrest: > $500 million Oxyglobin: USA and EU canine transfusion > $400 millionOxyglobin no risks, Hemopure is in clinical Phase III. Competitors: Prolong Pharmaceutics: SANGUINATE® is in clinical development to treat the vaso-occlusive crisis of Sickle cell Disease. Hemarina: Derived from sea snails. Lower Hb concentration (4g/dL), high oxygen affinity, cannot deliver oxygen effectively Kalocyte: Nanoparticle encapsulated Hb use as artificial red blood cells---bench scientific research status.Large scale manufacturing technology knowhow, various trade secrets and several product, product and applications patents. Trademarks: Oxyglobin® [hemoglobin glutamer – 200 (bovine)] Hemopure® [hemoglobin glutamer – 250 (bovine)]Phase IIINear term (within 2 years) break-even and profitability from Oxyglobin the only approved product for the treatment of canine anemia (established distribution network); Middle term (2-4 year) FDA clinic trial of Hemopure using as an organ perfusate (liver and kidney transplant) (ex-situ liver perfusion fulfilling 100% transplant success); Long term (2-5 year) FDA clinic trial of Hemopure treating cardiac ischemia and prehospital resuscitation of trauma victims.$20M from 2014. From 4 private investors. Preciously (before 2014) ~$900M invested in technology development, manufacturing and clinical development from a variety of invetors$25M-$50M. This financing round will enable the company to reach profitabilityOxyglobin is the only oxygen carrying solution approved by the FDA and the EMA to treat all cause canine anemia. Hemopure is approved in South Africa and Russian Federation for acute anemia, irrespective of etiology. In the US, Hemopure is only available under investigational status through the FDA expanded access program to qualifying patients with severe, life threatening anemia for whom blood transfusion is not an option, and who have exhausted all other treatment options. Blood transfusion may not be an option due to religious beliefs, or because no compatible blood is available for a patient needing transfusion. Although not yet commercially available in the U.S., several major medical centers (as shown below) have since 2014 maintain inventory of Hemopure onsite as part of the FDA’s Expanded Access program. ⁻ University of Michigan Medical Center, Duke University Medical Center, Johns Hopkins Medical Center, University of New Mexico, University of Miami’s Jackson MemorialSAPA-HQ Wechat
Yajuan 220-4340CEOMolecular Theranostics, LLCwww.mtheranostics.com2014Cleveland OH, United StatesYajuan Li, Zheng-Rong Lu, Michael Tweedle, Betty KaneshiroSmall Molecule PharmaceuticalsCancer specific MRI and PET diagnostic imaging drugsIntegrity, Excellence, RespectLicensed from Case Wester Reserve University, cover United States, Europe and China.Phase ISeries A, Initiate Phase 2, 2021 - 2022, Series B, initiate Phase 3 2023-2026$7.5 M, from China investor and NIH$25 MillionMT218 is a small peptide targeted MRI contrast agent specific to aggressive solid tumors for accurate early detection and risk-stratification of aggressive solid tumors. The targeted contrast agent is comprised of a small peptide of seven amino acids conjugated to a clinical macrocyclic MRI contrast agent Gd(HP-DO3A). MT218 has a T1 relaxivity of 5.5 mM-1s-1, nearly two-fold of that of the corresponding clinical agent ProHance®. The effectiveness of MT218 has been demonstrated in animal models of aggressive breast cancer, colon cancer, pancreatic cancer, prostate cancer, and other types of solid tumors. MT218 can be readily implemented with the existing clinical MRI systems and protocols and does not require any new hardware or software settings. MT218 produces a signal 3-6 times higher in aggressive tumors than the clinical agent at 3T with a dose as low as 0.04 mmol/kg. It can effectively differentiate high-risk tumors from low-grade tumors, compared to a clinical agent that iWechat
Xuanhui 636-0899PartnerYunion Healthcare VenturesNA2016Shanghai, ChinaLuoJingOtherVenture capitalEquity investment, M&A, licensing agreement, partnershipNANAOtherNANANANanaWechat
Andrew 736-1638Chief Executive OfficerCipher Surgical Incwww.ciphersurgical.com2010Chantilly, Virginia; Cleveland, Ohio; Coventry, United KingdomAndrew Newell (Chief Executive), Tony King (Clinical Affairs) and Justin Buch (Operations) together have a significant track record in all aspects of medical device development, sales, manufacture, regulation and financing with specific expertise in surgical technology and in global expansion. The board includes Gerard Wallace, previously regional President at Boston Scientific and Baxter Healthcare, and lead investor in a healthcare syndicate alongside the Angel Co Fund; Professor Mike McMahon, UK lead surgeon and a pioneer of laparoscopy and Nick Johnston of Perella Weinberg a leading healthcare investment bank. The Surgeon Advisory Board includes surgeons Dr Emre Gorgun (Cleveland Clinic), Mr Andrew Ready (University Hospital Birmingham) and Prof Tim Rockall (Royal Surrey County Hospital Guildford).Medical Devices / DiagnosticsDuring laparoscopy, the lens of the scope becomes covered in fluids, blood, tissue, fat or condensation which impairs the surgeon’s view as projected on the external screen. To clean the lens, the scope is removed from the patient. Critically the surgeon’s work flow and concentration is broken, their control over the situation momentarily impaired and there is a risk to patient safety since the surgeon can no longer see the operating field – and often at a critical moment (for example when there is a bleed). Removing the scope for cleaning wastes up to 20 minutes per procedure and can cost a busy hospital upto $5m in costs or lost revenue. It increases risk of surgical error and infection. The OpClear is a patented device comprising a single use disposable sheath that clips onto a laparoscope. On press of a footswitch a mix of medical carbon dioxide gas (CO2) and saline fluid is supplied from a Control Unit at a flow rate and shape to clear the lens. A single use disposable device,Cleared for FDA the OpClear is the only device that clears a laparoscope of all contaminants without its removal from the patient during an operation. The product is designed to be used in all areas of laparoscopy including robotic procedures. The product portfolio will be extended to thoracic, paediatric and specialist bariatric surgery. Using Co2 the Control Unit will add Insufflation and Smoke Evacuation to its core functionality (Lens Clearing), This will further reduce the risks of infection in the OR caused by toxins being released to atmosphere whilst enabling hospital management to economise on the number of medical devices being used in the OR. Developments in the robotic and digital space include full automation of the OpClear platform to reduce operator error and provide a full digital record of all procedures where the platform is being used. These developments enable the deep integration of the OpClear platform with all surgical systems both robotic and non-robotic.The OpClear is for use in Laparoscopy (minimally invasive surgery through the abdomen) which is now the technique of choice in General Surgery, Gynaecology, Urology, Upper GI and Colorectal surgery, and Thoracics. This represents 20m procedures worldwide each year. The company's target customers are hospitals primarily in large health systems such as US, China and Japan. In the US there are over 6000 hospitals and 5000 surgery centers offering laparoscopic surgery. In China there is an estimated 2700 Tier 3 hospitals who would buy the device. Within hospitals the OpClear is sold to both surgeons and to hospital management on the basis of health economic benefits (cost savings or increased revenue) improved surgical quality and elimination of risk of surgical error and infection (with further costs savings deriving from these).There are partial solutions to the problems of lens cleaning (scope warmers, heated scopes, mechanical lens cleaners) but all these require the scope to be removed at some point during a procedure for cleaning. There are no other devices that clear a scope of all contaminants without is removal from a patient (Lens Clearing). There are no other devices in development that can combine Lens Clearing, Insufflation and Smoke Evacuation. Only the OpClear platform is compatible with all the major scope systems( Olympus, Storz, Stryker, Richard Wolf) and robotic platforms (Intuitive, Medtronic and J&J). Only the OpClear is automated to remove operator error.The OpClear is protected by over 40 patent filings in 6 patent families with patents granted in US, Europe, China, Japan, Canada, Australia and Asia. The patent portfolio is constantly being developed as the company adds features to the OpClear and extends its product portfolio. The company also owns design rights and manufacturing tools.On marketThe company has the following priorities by Y3. Launch and roll out in US to over 100 hospitals presenting >$5m in revenue. The OpClear is presently being evaluated in Tier 1 hospitals such as Cleveland Clinic, Barnes Jewish, NY Presbyterian Columbus and Duke University. To find a partner in China who will complete regulatory clearance of the OpClear, form a sales network and launch the device in China. To complete the development of the device to add Insufflation and Smoke Evacuation To drive the company towards $25 in annual sales To exit by trade sale to a large medical device company for a 10x return c>$250m in value representing a multiple of 10x salesThe company has raised c$15m from private investors in US, China and UK exclusively in ordinary shares. There are no institutional investors in the company. The company's largest investor at around 8% is our US partner, a family owned medical device company based near Washington DC , with global sales of a range of medical devices.$5m in ordinary shares to be used in US and China where it is proposed to set up an operating subsidiary.The primary goal of our project is to find an investment partner(s) in China, certainly for sales and marketing of the OpClear and future products (Control Unit), but also potentially for regulatory clearances and manufacture .Cipher-Investor-Presentation-April-2021.pdf
SAPA-HQCipher Surgical successfully presented at the SAPA Annual Conference at Columbus University in 2019 when we won a best in class prize. At the time, we were seeking partners in China to sell and manufacture the OpClear. We have been unable to follow up on the considerable interest shown by prospective partners and investors at the conference because of restrictions caused by Covid.
Judy 496-0327CFOAB Bioscienceswww.abbiosciences.com2008ConcordYen-Ming Hsu, Founder & CEO – Biotech scientist specialized in therapeutic target identification & protein engineering for immune-oncological indications, Dr. Hsu was the head of the drug development group at Biogen for over 20 years before he founded AB Biosciences. Dr. Hsu has 40+ papers published, 150+ proteins engineered, and 40 patents granted. Dr. Hsu obtained his post-doctoral fellow from Harvard University, and Ph.D. in Biochemistry from Michigan State University. Jeng-Shin Lee, Founder & CSO - Molecular biologist in gene transfer technology and early product development in biologics, gene and cell therapy, Dr. Lee was the Deputy Director of Harvard Gene Therapy Initiative where he supported multiple successful IND submissions targeting muscle diseases and cancer. Dr. Lee obtained his post-doctoral fellow from Harvard Medical School, Ph.D. from Harvard University and M.D. from National Taiwan University.BiologicsAB Biosciences (ABB) is dedicated to R&D of niche protein therapeutics for treatment of immune-oncological indications.Our core business is to develop therapeutic biologics for treatment of diseases with unmet needs. Our core competence consists of knowledge base in immunoregulation and the technological expertise in protein engineering.One of the pipelines that we currently have is "Recombinant IVIg program" which targets at a +$4B market for autoimmune indications.For recombinant IVIg program: Risks: Competition & unexpected side effects from clinical trial. Competitors: CSL/Momenta; Pfizer/ GliknikThe company holds the worldwide license to develop and commercialize the Recombinant IVIG technology.Pre-clinicalWith the right partnership and/or investment, we plan to move Recombinant IVIg program into IND enabling phase in the next 18 month. We are also actively working on other POC stage programs, such "a non-antibody drug for treating SARS-CoV2 infection" and "a protein drug to restore effector function of tumor specific T cells".$5M from private investors.+$15MPRIM, a recombinant replacement of traditional IVIg for treating autoimmune disordersWechat
Peikwen 870-5000Co-Founder and CEOYiviva YorkYiviva was co-founded by Yale University, Academician Yung-Chi Cheng (Henry Bronson Professor of Pharmacology, Yale), Shwu-Huey Liu, PhD, Peikwen Cheng, MBA and Sun Ten Pharmaceuticals. Dr Cheng's groundbreaking discoveries have included 4 approved drugs, including the first drugs for Hepatitis B and Cytomegalovirus. SAPA-CT recognized Dr. Cheng for "bringing value to patients through technology advancements and global innovation" and "in recognition for your outstanding contribution and support to SAPA" at the 2016 3rd Annual conference.OtherSystems Biology botanical medicinesYiviva is a clinical-stage biotech, co-founded by Yale University, developing multi-target therapeutics using a systems biology approach to prevent, treat and cure complex, aging-associated diseases, with a focus on cancer and inflammatory diseases. Yiviva's first-in-class platform cancer drug YIV-906 is an immunomodulator that can: 1) Overcome immune resistance 2) Enhance a patient's innate and adaptive immune response in the tumor microenvironment and potentiate anti-tumor activity, 3) Cytoprotect the gastrointestinal tract to reduce non-hematological side-effects and speed up tissue recovery. Yiviva recently launched an international front-line Phase IIB liver cancer study in four regions, including the United States, China, Hong Kong and Taiwan - led by Memorial Sloan Kettering in the US and the National Cancer Hospital in China.First-in-Class platform cancer drug YIV-906 - Versatile immunomodulator that can potentiate the therapeutic index for broad spectrum of cancer therapies (immunotherapy, chemotherapy and radiation) and could become the backbone for cancer regimens. - Systems biology mechanisms of action: o Overcome immune suppression o Enhance the innate and adaptive immune response in the tumor microenvironment o Cytoprotect the gastrointestinal tract and reduce non-hematological side effects o Speed up tissue recovery by promoting progenitor and stem cell growth. STAR (Signal Transduction, Activity and Response) Discovery Platform - Yiviva has built a high-powered discovery platform to develop sophisticated multi-target drugs to treat and cure complex, heterogeneous diseases. Mechanism-Based Quality Control platform - Proprietary platform to manufacture consistent complex mixtures - a breakthrough that opens up the field of botanical medicines.Aging Associated diseases - including cancer, inflammatory and chronic diseases. Promising published data from 170 evaluable patients with solid tumors (liver, pancreatic and colorectal cancers) and preclinical studies at Yale suggest that YIV-906 could be developed as a platform drug in combination with immunotherapies, chemotherapies and radiation therapies to help improve patient survival and quality of life. The US FDA has granted YIV-906 two (2) orphan drug designations for liver and pancreatic cancers. Yiviva is focusing on these opportunities due to their large unmet needs. Hepatitis B is responsible for 60-80% of the world's liver cancer cases, including ~90% in China and 24% in United States. Yiviva's lead clinical program is an international Phase 2b to treat Hepatitis B (+) Hepatocellular Carcinoma.1) First mover risk Yiviva is pioneering a new paradigm for systems biology drugs by leveraging FDA's botanical drug pathway. Historically it has been a challenge (black box) to turn "experienced-based" medicine into "evidence-based medicine - including understanding how botanical medicines work and how to manufacture them consistently. Applying modern science, technology and manufacturing, Yiviva has developed two key platforms, including STAR (Signal Transduction, Activity and Response) to understand complex mechanisms of action, and Mechanism-Based Quality Control to manufacture batch-to-batch consistent cGMP drug product. These two platforms differentiate Yiviva from competitors and create a competitive advantage. 2) Regulatory risk. The US FDA and China NMPA are actively learning about this field and expanding regulations, including the FDA's 2016 Botanical Drug Guidance and NMPA's 2020 new Chinese Medicine guidelines. 3) Competitors include big pharma and TCM companiesYiviva has a holistic IP portfolio that includes international patents, trade secrets and regulatory protections. Yiviva has licensed global, exclusive rights to patents (drug candidates, quality control technology, etc) from Yale University. In addition, Yiviva is applying trade secret strategies used by biologics to prevent biosimilars from reaching the market, such as premarin which has continued to be a blockbuster drug even though it went off patent 50 years ago.Phase IIYiviva is raising a series B to o Accelerate 1st Line Phase IIB Liver Cancer Study - Sorafenib +/- YIV-906 o Initiate new clinical opportunities  Liver Cancer - Vaccine Potential  Pancreatic Cancer - Front-line opportunity  Inflammatory Bowel Disease Prepare for commercial manufacturing Continue to develop pipeline candidates via STAR Discovery PlatformYiviva raised a Series A in 2018 and a Bridge round (from Series A investors) in 2020. Investors include cross-border super angels, foundations and venture capital.Yiviva is raising a Series B of $40M.Corporate Highlights: • Scientific Team lead by Academician Yung-Chi Cheng who has discovered four approved drugs used around the world - including the 1st approved drugs for Hepatitis B and Cytomegalovirus. • Enrolling patients in multi-regional (US, China, Hong Kong and Taiwan) Front-line Phase 2b Liver Cancer Study, led by Memorial Sloan Kettering and China’s National Cancer Center. World first international Phase 2 study for a systems biology cancer drug candidate. • US FDA has granted YIV-906 two orphan drug designations - for liver and pancreatic cancers. • China’s Ministry of Science and Technology is supporting YIV-906’s Phase IIB liver cancer trial with a 13-5 Grant with a designation as a “China National Major Project for New Drug Innovation”SAPA-CT
Brian 222-3333ITSAPAsapaweb.org1993Nyack, NY, USAJohn SunOtherNGOMemberProfessionalsN/AOn marketContinue$1,000,000$2,000,000RoadshowSAPA-HQ
Shouming 220-3240CEOBrainXellwww.brainxell.com2015Madison, WI, USAsee attached teaserRNA, Peptide & Gene Therapy / Stem Cells / Cellular TherapyProduce defined, high purity, and large scale human neural cell populations for research and cell therapy.Using small molecules, our technologies to expand defined nerve progenitors in high purity and large quantities suit well in GMP production in terms of cost and capacity. Our top-line publications have shown that our DA neurons are highly enriched and specific for PD: attached teasersee attached teaserBrainXell's own IP and ones licensed from WARFPre-clinicalIND filing by Q4 2023.Engagement stage$8-10MAdapt our cell production technologies to the cGMP environment for Parkinson’s disease and conduct IND enabling animal studies.BrainXell-teaser-April-2021.pdf
Don 505-2281CEOMisum Biotechwww.misumbio.com2017HOUSTON TEXASDon LiuMedical Devices / DiagnosticsCompanion diagnosticsMachine learning to predict the efficacy of immunotherapyIP Granted alreadyOn marketRaise 50 millionsNo fund. Support from friends50 millionsArtificial intelligence to predict the efficacy and toxicity of immunotherapy including CAR and PD-1 blockadesOtherXiaodong Chen reconnection
Jeffrey 642-3114CEONotitia Biotechnologies Companynotitiabio.com2019Monmouth Junction, NJ, USAJeffrey Zhao is the co-founder and CEO of Notitia Biotechnologies. Jeffrey is an entrepreneur with experience in health & wellness startups. He has previously managed marketing operations in multiple international markets and skilled in performing wet and dry-lab benchwork in microbiome-related research. Dr. Liping Zhao, Scientific Cofounder and President, is the Eveleigh-Fenton Chair of Applied Microbiology from Rutgers University. He is the world's leader in microbiome and the discoverer of the Foundation Guildâ„¢ concept. His previous works featured in the prestigious Science journal.Microbiome / BacteriomeNotitia (“NO-TEE-SHA”) means “data” in Latin. We are a microbiome company that applies a data-driven approach to develop innovative products for the ecological restoration of a healthy gut microbiome. Our mission is to promote health by protecting and/or restoring the Foundation Guild™ of the gut microbiome. Our vision is to maximize everyone's healthspan by keeping their gut microbiome to the healthiest possible status for the longest possible time.The work of Dr. Liping Zhao, co-founder of Notitia, shows that a healthy gut microbiome is dominated by a specific group of beneficial bacteria named the "Foundation Guild." The Foundation Guild™ not only produces beneficial compounds essential to human health but also creates an environment that can suppress the overgrowing pathogens. Restoration and maintenance of the Foundation Guild™ are fundamental to improve health and wellness in patients with unmet medical needs and the generally healthy population. Notitia has developed a revolutionary Foundation Guild™ R&D platform which consists of three technologies: identification, isolation & preservation, and nutritional formulas to support the Foundation Guild™ bacteria. Notitia uses the Foundation Guild™ R&D platform to create several products under the Foundation Guild™ Wellness Program for the generally healthy population as well as the Foundation Guild™ Clinical Program for patients with unmet medical needs.Taken together, the Foundation Guild™ Wellness Program and the Clinical Program Products can capture all segments in the human microbiome market, including Pro & prebiotics, food & supplements, medical foods & drugs, and diagnostic tests. The human microbiome market is expected to reach $1.7B in 2027 with a compound annual growth rate of 22.5%.The Wellness Program products have low regulatory risks, as they are in the neutraceutical market. Clinical Program products (two lead drug candidates) are in early phases with one drug, NBT-NM108, in phase 2 and the other, NBT-BM306, preparing for IND and Phase 1. These products have risks in regulatory approval. Main competitors are Viome, Thryve, and Biohm in the neutraceutical market, and Seres and Synlogic in the pharmaceutical market. Compared to other microbiome companies whose technologies force them to pick and choose which segment they can join, our Foundation Guild™ technologies enable us to play in all market space areas.We currently have one PCT application filed to protect the formulation, manufacturing and uses of the NBT-NM108 drug. We have additional IP application under preparation.Phase IIDuring the next 3 - 5 years, we will complete the phase 3 clinical trials for NBT-NM108 and NBT-BM306. Our wellness program will also have at least 5000 to 10000 monthly subscribers.We have raised $1.5 million in seed round from private investors.We are looking for $8 million from Series A investors.$8 million series A funding from VCs with connections and experiences in the healthcare and biotech industry will help us expand our management team, propel our drugs to their next stages, and dramatically expand the scale of the Foundation Guild Wellness Program for the general public. Series A will help us to finish the early phase trials for NM108 and BM306, as well as scaling up the Wellness Program. After series A, we will have another series B round for addition funding which will mainly support the late phases of our investigational drugs.Notitia-BP-deck-9-mins-04222021.pdf
jon (jun) 683-5657presidentable cerebral, LLCablecerebral.com2013Ephrata, Pennsylvania, USAJon Xia, President, licensed pharmacist, PharmD, MS, Biopharmaceutical major, broad experience in regulatory affair, Research and development of pharmaceuticals, medical device, scale ups, manufacturing, and retail marketing; Wayne Shentu, Vice president of sales, mathematics major, broad experience in medical device and equipment sales, import and export, and admin in food industry. Other team members such as Dr. Braxton and Mr. White with experience in R&D and legal services are committed and ready to join as soon as the investment comes in. We also welcome the investment entity to participate in our management team.Medical Devices / DiagnosticsThe core business of Able Cerebral is utilizing timed delivery of brain energy to prevent the deterioration of early stages Alzheimer’s patients; developing a groundbreaking system to restore and recovery the lost memory and the recalling ability for patients of Alzheimer’s and traumatic brain injury.Able Cerebral have 4 patents awarded. Our technologies are based on worldwide unique and solid foundation of brain energy and memory relationship. Two of the world’s largest pharmaceutical companies terminated their internal programs on Alzheimer’s R&D after learning our product and project.Our memory recovery system AddMem is targeting the institutionalized Alzheimer’s community, especially in US and Canada, the “memory homes” mainly. However, in China, the main market is the families who are taking care of those late stage Alzheimer’s patients. We estimate the potential market size is in billions of US dollars.Basically, there is no company in the world, except Able Cerebral LLC, working on recovery for lost brain memory. There are two competitor sources for delaying the progression of Alzheimer’s disease: one is the dietary supplement products such as the Prevegen, which is based on heavy advertisements and getting less and less satisfactory customers besides FDA on its heel; the other one is from the pharmaceutical industry, such as Lilly, which lost one monoclonal antibody candidate a couple of years ago and second one is not promising either. Without solid foundation, both of them are really not competitors, since they only delays the Alzheimer’s problem unsolved and providing our patients source for memory recovery AddMem.We already have 4 patents awarded so far. In addition, we have patents pending and technical knowhow. Since we are the originator and pioneer in brain energy delivery arena, we are in a very strong IP position.Phase IIWe plan to bring AddMem medical device system to the market in 3 years. There are two major tasks left for the development of the system: integration of the electronic portion of the system, which to combine the monitoring, the execution software, and the stimulation delivery unit together; and the clinical study to satisfying the FDA approval as a non-invasive medical device for memory recovery.So far, the company has costed about a million US dollars, mainly from the sources of families and friends.We are seeking about $ 2.5 million.AddMem is a non-invasive medical device for memory consolidation and recovery for patients of mid to later stages of Alzheimer's, PD, and TBI. AddMem is composed of two portions: BioChem portion (timed supply brain energy); plus, the Electronic portion (monitoring and individualized stimulation message). The BioChem portion includes a delayed-sustained release of one of the 4 brain energy molecules, and as needed using a sleep aid medication. It is necessary for the late stage memory loss patients to generate REM sleep cycle. The Electronic portion including a sleep cycle monitor-detection unit (such as an EEG), an execution software, and a pre-recorded individualized message unit. Since the brain memories are holographic in nature, our system not only recovers the lost memories, also improves recalling abilities. Eventually AddMem can provide relatively independent lifestyle for those who have memory problems, and reduce the burden for the families, caregivers, and the society.SAPA-HQ
Jeff 265-6700Chief Investment OfficerInfusion 51awww.infusion51a.com2015Delaware, USA invest in multiple spaces within HealthCare. Primarily precision based.We are an impact investment fund which invest in the HealthCare space. We are in process of growing our portfolio. In addition, we look for opportunities of which we can help with operations and leadership.The value is we invest capital in addition to investing time and human capital of proven leaderships who can help companies drive value. We plan a capital strategy and help make sure that the companies we invest in are better position for being capitalized while making sure the company has a clean and clear pathway to move forward.We invest between $1m-$5m and look for later stage assets. We then bring in our team to help capitalize the larger raise. Ideally, we are looking at acquisitions of companies that have large markets with a good proof of concept. We have been working a lot in Oncology across multiple indications.Risk is growth and execution along the side of capitalization needs. Competitors are other emerging funds within this space.We have our own team of IP attorneys who have a focus on Bio tech. Our portfolio companies have strong IP with a good patent life.Phase IIWe plan to buy and run between 10-20 bio techs, or pharmaceutical companies leveraging our team and process within the precision space.all together in the fund and portfolio companies roughly $15M. Investors are a mix of retail and institutions.We are raising $20M.We are looking to expand operations into other existing portfolio companies. We are leveraging companies with strong science that needs help with operations and capitalization. Through the use of precision technology, we believe we will gain more qualitative data which will result in better investment selection. In addition, we have built a back an analytical team who are building our own internal AI process to help track and gather intelligence.Infusion-51a-Presentation.pdf
SAPA-MW OtherWeChatThank you for your help and we look forward to participating. We are working with Hong Li
Grace 000-0000IRKintor Pharmaceutical, Jiangsu, ChinaFounder: Dr. Youzhi Tong, founder, chairman and CEO of Kintor. He has been recognized as a “State Specially Recruited Expert” in the eighth batch under the “One Thousand Foreign Experts Program”. Prior to founding our Group in 2009, Dr. Tong served as an assistant professor of Albert Einstein College of Medicine from 1999 to 2001. He was a vice-president of Angion Biomedica Corp. from 2002 to 2008. He has also received multiple designated funds from the National Institutes of Health (US) and the Chinese government. Dr. Tong graduated from Peking University with a bachelor’s degree and a master’s degree in chemistry in July 1984 and July 1988, respectively. He received his Ph.D. in pharmacology from Cornell University in January 1997. Management: CMO- Dong Xunwei CFO- Lu YanSmall Molecule PharmaceuticalsKintor Pharmaceutical Limited aims to become a leading enterprise in the R&D and commercialization of “best-in-class” and “first-in-class” innovative therapies. The Company initially focused on androgen receptor (AR) related diseases and researched and developed product portfolios in multiple channels covering cancers with a globally high incidence and illnesses yet to meet their clinical requirements, such as COVID-19, prostate cancer, breast cancer, liver cancer , hair loss and acne. Kintor Pharmaceuticals has prospectively developed a diversified product pipeline that includes small molecule innovative drugs, bio-innovative drugs and combination therapies.One of our core product Proxalutamide is a second-generation AR antagonist and is a potential best-in-class drug. It has three advantages: i)Higher in-vitro binding affinity ; ii)Dual-acting mechanism, not only inhibits androgen from binding to AR, but also exhibits the biological effect of reducing AR expression; iii)Favorable safety profile, zero incidence of triggering seizure among over 1000 users, and suitable for combination therapy. It is now indicated in COVID-19 (AR signaling pathway), mCRPC, and mBC. The second core product Pyrilutamide is a topical use AR antagonist. It is indicated in alopecia and acne. For alopecia, it has safer profile compared with finasteride and better efficacy and more clear mechanism than minoxidil. The third core product ALK-1 is a potential first- in- class biological drug, and it's a fully humanised IgG2 neutralising monoclonal antibody, and may also be a complementary angiogenesis pathway to be activated upon VEGF resistance.Our target market is COVID-19, prostate cancer, breast cancer, liver cancer , hair loss and acne. For COVID-19, there are more than 136 million cases globally. Breast cancer, prostate cancer, and liver cancer ranked 2, 5, 7 respectively in terms of new incidence in 2019. More than 134 million people are bothered by androgenetic alopecia in China, while it is 83 million in US. For acne, there are 118 million patients in China and 31 million patients in US.We are a pre-revenue biopharmaceutical company with a history of losses. Our financial prospects in the foreseeable future depend on the successful commercialisation of our drug candidates. For COVID-19, many drugs has obtained EUA, but we shared a huge market. For mCRPC, competitors are other AR antagonists, such as enzalutamide. For alopecia, no same mechanism been approved. But we still face the challenge from existing therapies for hair loss. For acne, a Italian company Cassiopea just got approval from FDA. For HCC(liver cancer), no drug with same target has been approved.Just as described above, we develop first- in- class and best-in-class small molecule and biological drugs.Phase IIIExpect to bring Proxalutamide to commercialization for COVID-19 in 2021, and for mCRPC next year.Angel: USD 2mn, Legend Star Series A: USD 3 mn, Bioventure Series B: USD 10 mn, Highlight/Joinne Ming Yuan Series C: USD 41mn, Green Pine/Highlight/Dongzheng Tengcong/Bexin/CCB Investment Series D: USD 44mn, FTZ/ Huajin/ CCBI Tech/ Yicheng Hongtai/Guangzhou Chengfa/Hightlight IPO: USD 240mn, Gree/Foresight Orient/HighlightTo be confirmed.Same as the company introducation.2020-Annual-Results-Conference-Call_Kintor.pdf
Yechin 470-0034Director of Strategic Business DevelopmentThrone BiotechnologiesThronebio.com2011Delaware, United StatesYong Zhao, MD, PhD, Founder, President Dr. Yong Zhao is an internationally acclaimed scientist, immunologist, and former physician. Dr. Zhao is the inventor of 9 patents and has authored more than 52 peer-reviewed articles. His work has been celebrated by major news networks and global heads of states. Gerald Ostrov, MBA - Director Mr. Ostrov was the former Chairman at Johnson & Johnson. He has served as a senior executive to major health organizations including Novartis, Bausch & Lomb, and Proctor and Gamble. He received his MBA from Harvard. Henry Lozano - Vice President of Global Relation Mr Lozano was the former Deputy Assistant to the President of the United States. Mr. Lozano is an accomplished international business executive with an expanse network of diplomatic partners. Yechin Zhao MBA(c) - Director of BD Yechin is an experience entrepreneur with a trackrecord of global successes. He was an innovation consultant to Fortune 500 companies such as McDonalds and DisneyRNA, Peptide & Gene Therapy / Stem Cells / Cellular TherapyWe are an American therapeutic company with a disruptive stem cell technology that can fundamentally reverse diabetes, alopecia areata and other autoimmune diseases through immune education. Our patented technology is recognized as the leading “practical cure project” for type 1 diabetes out of 594 global projects (JDCA 2020). Stem Cell Educator therapy is a single dialysis-like, in vitro treatment that “resets” a patient’s immune system and correct the root issue behind the autoimmune disease.Our technology, Stem Cell Educator Therapy, is an "immune system reset" that is designed to reverse diabetes and autoimmune diseases at the root level. Autoimmune disease occurs because of a defective immune system. Educator Therapy uses a newly discovered stem cell from the umbilical cord blood to reprogram one’s immune cells through an in-vitro process very similar to dialysis. The one time treatment is 8 hours long with virtually no side effects. We've done 10 years of laboratory and clinical research in Spain, China, and US. 200+ patients between the ages of 3 and 70 have received the treatement demonstrating safety and efficacy. The product is ready to use and waiting for FDA commercial approval (phase 2 approved for type 1 diabetes and alopecia areata).Type 1 Diabetes - 1.6 M people in US Alopecia Areata - 6.8 M people in USViacyte, Caladrius, Mesoblast, VertexPortfolio of 4 granted patents and 2 pending - Coverage in 10 global territoriesPhase IISeries A Funding completed in 2021 FDA phase 2 completion beginning 2022 FDA phase 3 completion 2023 FDA approval 2024 International commercialization11.4M from Angel investors, foundations, government grants, licenses, and donations.$10M $3M to complete phase 2 clinical trialsOur technology, Stem Cell Educator Therapy, is an "immune system reset" that is designed to reverse diabetes and autoimmune diseases at the root level. Autoimmune disease occurs because of a defective immune system. Educator Therapy uses a newly discovered stem cell from the umbilical cord blood to reprogram one’s immune cells through an in-vitro process very similar to dialysis. The one time treatment is 8 hours long with virtually no side effects. We've done 10 years of laboratory and clinical research in Spain, China, and US. 200+ patients between the ages of 3 and 70 have received the treatement demonstrating safety and efficacy. The product is ready to use and waiting for FDA commercial approval (phase 2 approved for type 1 diabetes and alopecia areata).Throne-Biotechnologies-Stem-Cell-Educator-Therapy.pdf
OtherDirect referral by Dr. Xiao Dong Chen - Elect President of SAPA
Frank 920-6990Strategic AdvisorApeximmune Therapeutics Incwww.apeximmune.com2017Delaware, NJLi-Fen Lee is deeply versed in the fields of immunology and immuno-oncology (IO) and has successfully carried several drug candidates from target validation all the way to clinical trials. She previously led a drug discovery group at Rinat-Pfizer and made significant contributions to the development of therapeutic antibodies against IL-7R and various costimulatory molecules aimed at treating autoimmune diseases and cancer. Her work, which included several IND filings and patents as well as numerous high impact publications, was recognized with the prestigious Pfizer Achievement Award. Later, Li-Fen joined NGM Biopharmaceuticals as an Associate Director where she established the core IO infrastructure and helped build the IO pipeline. Following that, she served as the Director of IO at Pharmacyclics, an Abbvie company. Prior to joining industry, Li-Fen held a 5-year NIH career development grant and a faculty position at the Stanford University School of Medicine, where she studied aBiologicsApeximmune seeks to be a preeminent leader in the discovery and development of novel biologics that modulate the immune system for the treatment of a broad spectrum of indications including cancer, autoimmune disease, and transplantation. We focus on the science underlying what we believe to be the most powerful biological mechanisms driving disease pathophysiology. Our technology platform combines bioinformatics with biological assays to enable identification of novel immune modulating targets. With a team encompassing expertise in immunology, cellular and molecular tumor biology, protein characterization and optimization, and pharmacokinetics, we are developing biologics/antibodies to treat disease through these mechanisms.Apeximmune focuses on the discovery and development of novel antibody therapeutics for oncology to modulate the tumor microenvironment. Using its proprietary target discovery platform, Apeximmune is well-positioned to identify and develop antibodies against new, next-generation targets involved in cancer immune modulation.1B USDUSAPre-clinicalIPOSeed 4M PerA 6MA round 30MThe recent emergence of immune checkpoint inhibitors (CI) has reshaped the cancer therapy landscape. However, their overall efficacy remains unsatisfactory as a majority of patients still fail to experience meaningful and durable responses. Our unique bioinformatics approach coupled with robust biological validation has allowed us to identify and develop inhibitors against novel, previously unrecognized immune checkpoints that contribute to immune suppression and tumor progression. These new drugs have the potential to overcome checkpoint inhibitor resistance or even supersede current checkpoint inhibitorsSAPA-HQ