Predictive Oncology (NASDAQ: POAI) is a knowledge-driven precision medicine company focused on applying data and artificial intelligence (AI) to personalized medicine and drug discovery. The company applies its smart tumor profiling and AI platform to extensive genomic and biomarker patient data sets to build predictive models of tumor drug response to improve clinical outcomes for the cancer patients of today and tomorrow. The company has several tools that support its mission of bringing precision medicine to the treatment of cancer.

Through its subsidiaries, Predictive Oncology’s portfolio of assets includes the following:

• A database of clinically validated historical and outcome data from patient tumors
• An in-house Clinical Laboratory Improvement Amendments (CLIA)-certified lab
• A “smart” patient-derived tumor profiling platform
• An in-house bioinformatics artificial intelligence (AI) platform
• A new computerized approach growing tumors in the lab to rapidly develop patient specific treatment options
• An FDA-approved fluid collection and disposal system

Using these resources, and in collaboration with key players in the pharmaceutical, diagnostic and biotech industries Predictive Oncology is working to determine the best pathways for more individualized and effective cancer treatment.

Subsidiaries

Predictive Oncology leverages the synergies of its three wholly owned subsidiaries to bring precision medicine to the diagnosis of cancer.

Helomics applies artificial intelligence to its rich data gathered from the company’s trove of more than 150,000 tumors to personalize cancer therapies for patients as well as drive the development of new targeted therapies in collaborations with pharmaceutical companies. This database, the largest of its kind in the world, is comprised of ovarian, head and neck, colon and pancreas tumors. Helomic’s CLIA-certified lab provides clinical testing that assists oncologists in individualizing patient treatment decisions, by providing an evidence-based roadmap for therapy.

In addition to its proprietary precision oncology platform, Helomics offers boutique CRO services that leverage its TruTumor™ patient-derived tumor models coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and an AI-powered proprietary platform (D-CHIP) to provide a tailored solution to its clients’ specific needs.

TumorGenesis is developing a new, rapid approach to growing tumors in the laboratory without the use of rats or mice, allowing for the identification of biomarkers indicative of cancer. This methodology “fools” the tumor into thinking it is still in the body. As a result, the tumor reacts as it naturally would, thereby increasing the accuracy of the biomarker. Once the biomarkers are identified, they can be used in TumorGenesis’ Oncology Capture Technology Platforms which isolate and helps categorize an individual patient’s heterogeneous tumor samples to enable development of patient-specific treatment options.

Skyline Medical’s patented, FDA-cleared STREAMWAY® System is the first true, direct-to-drain fluid disposal system designed specifically for medical applications such as radiology, endoscopy, urology and cystoscopy procedures. The STREAMWAY system is changing the way healthcare facilities collect and dispose of potentially infectious waste fluid by connecting directly to a facility’s plumbing system to automate the collection, measurement and disposal of waste fluids.

The STREAMWAY minimizes human intervention for better safety and improves compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. The STREAMWAY eliminates canisters, carts and evacuated bottles, which reduces overhead costs and minimizes environmental impact by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the United Sates.

Skyline has achieved sales in five of the seven continents through both direct sales and distributor partners.

Competitive Advantage

Precision medicine has become the holy grail of cancer therapeutics. Data driven predictive models of tumors and their responses are critical in both new drug development and individualized patient treatment. The race has begun to model various tumors, which takes 5 to 7 years of clinical evaluation to establish historical and outcome data.

Predictive Oncology enjoys significant competitive advantage. The company already has a vast historical collection of tumors and related data, plus the ability to obtain existing associated outcome data. While others wait for outcome data, Predictive Oncology is in a unique and powerful position, working to deliver the promise of precision medicine to reality. Predictive Oncology already has the clinical data, including how a tumor responded to certain drugs, an in-house bioinformatics AI platform, and only needs to do the tumor sequencing. The significance is underscored by the collaboration with UPMC Magee-Women’s Hospital, designed to reveal which mutations responded to which drug then develop powerful predictive models for future testing and treatment.

Leadership Team

Dr. Carl Schwartz was appointed to Skyline Medical’s board of directors in March 2015 and became interim president and CEO in May 2016. Dr. Schwartz became CEO of Plastics Research Corporation in 1988, leading the company to become the largest manufacturer of structural foam molding products in the U.S. with more than $60 million in revenues and 300 employees by the time he retired in 2001. He holds a bachelor’s degree and DDS degree from the University of Detroit.

CFO Bob Myers has over 30 years of experience in multiple industries focusing on medical device service and manufacturing. He has spent much of his career as a CFO and controller. Myers holds an MBA in Finance from Adelphi University and a BBA in public accounting from Hofstra University.

Gerald Vardzel, President of Helomics, has over 25 years of healthcare executive management experience developing and implementing commercialization strategies and models for technology launches. His Go-To-Market expertise includes equity financing, strategic planning, market intelligence, M&A, and new market development in both start-up and established settings including fortune 500 market leaders. He has developed innovative solutions for both CLIA and FDA regulatory paths defining the delivery chains from discovery to clinical acceptance. Mr. Vardzel also has significant experience designing and implementing sales and marketing programs tailored not only to expand market share, but to empirically assess client satisfaction, strengthen business processes, and maximize profitability. Mr. Vardzel was previously Vice President of Corporate Development and Strategic Initiatives at Global Specimen Solutions. Furthermore, as an executive affiliate to the healthcare industry, he routinely consults for several small-to-mid sized private equity firms advising on, in part, the feasibility of acquisition targets. Mr. Vardzel graduated from the University of Pittsburgh.

Dr. Mark Collins, Chief Information Officer of Helomics, has held multiple executive roles in a variety of discovery, informatics and bioinformatics functions within global pharma, and founded three startup software companies in the machine learning and drug discovery space. In 2001, Dr. Collins worked for Cellomics (now part of Thermo Fisher Scientific), where he played a pivotal role in establishing the High-Content Cell Analysis market, building and commercializing several key informatics and bioinformatics products. After leaving Thermo Fisher, Dr. Collins developed and commercialized informatics solutions for clinical and translational research, specifically in the specimen tracking, omics data management and NGS analysis space, through key roles at BioFortis, Global Specimens Solutions and Genedata. Dr. Collins received his undergraduate degree in Applied Science from the University of Wolverhampton, UK and his Ph.D. in Microbiology from the University of Surrey, UK.

Investment Considerations

• Helomics is collaborating with the University of Pittsburgh School of Medicine to study the use of artificial intelligence to improve clinical decision making for ovarian cancer patients. More than 22,000 women are diagnosed with ovarian cancer in the U.S. each year.
• Entered an agreement with Interpace Diagnostics Group Inc. (IDXG) and Helomics to develop products to diagnose and assess the risk for thyroid cancer as well as provide appropriate therapeutic recommendations. The treatment market for thyroid cancer is expected to reach $2.1 billion by 2025.
• Skyline Medical has received its first order for four STREAMWAY machines to be sold to local hospitals in India. The Indian healthcare industry is estimated at more than $100 billion, with the nation’s medical device industry valued at more than $6 billion.
• Helomics signed a collaborative research agreement with Pittsburgh-based molecular imaging company, ChemImage, to expand personalized medicine to prostate cancer diagnosis and treatment.
• TumorGenesis and partner 48Hour Discovery received the Alberta Innovates grant for development of novel cancer treatments.