US Capital Global Securities (“USCGS”) is offering 275 Membership Units in USCIM Fund XLVII OncoGenesis, LLC (the “Issuer”), a pooled investment vehicle on a “best efforts” basis. Fund XLVII will be managed by San Francisco-based asset management firm US Capital Investment Management, LLC (“USCIM” or the “Manager”), investing in Class A-1 preference shares of OncoGenesis, Inc. (the “Company”). The Company will use the new primarily for financing its next phase of growth.
One woman dies every 2 minutes from Cervical Cancer. In 2018, there were 311,000 deaths and 570,000 new cases estimated by the World Health Organization.
OncoGenesis is a revolutionary protein-biomarker-based self-collection and detection system for cervical disease that advances point-of-care screening for disease detection and progression. Reporting on evidence of both high-risk human papillomavirus (hr-HPV) and cervical intraepithelial neoplasia (CIN2+), precursors to invasive cervical carcinoma.
PRODUCT & DISTIBUTION STRATEGY
The OncoGenesis System
The Company’s proposed clinical solution incorporates the following:
• Cervical protein-based biomarker detection
• Collection Device which allows patient samples to be accessed nearly anywhere in the world
• Diagnostic Equipment for established Lab-Based & Point-of-Care settings
Based on the above, key products that can be offered in the future contingent on successful funding:
• Cervical Sampling Collectors: Patented cervical sample collector for personal use. It can be used for collection of various samples from cervical cells to STD’s.
• CerMark™ Cervical Cancer Assays: The program leverages specific cervical biomarkers, materials, and instrumentation for detection of cervical disease, including assays for evidence of HPV (HPV-E7 assay), prognostic cancer risk (K17) and precancerous lesions (CerMark™ 4-Plex assay).
• CerMark™ for Clinical Laboratory: Plans to leverage existing partner instrumentation, to develop an automated, low sample volume, multiplex analyser designed to capture signals from each biomarker reflecting the status of cervical disease
• CerMark™ Point-of-Care: Using microfluidic cartridge technology, the POC products will be co-developed leveraging partner’s existing and licensed POC technology.
Commercial Strategy & Plan
Targeted Market Launches
• Launch Targeted Markets (India, Mexico, China, South Africa, Germany) with Lab Based System (LBS).
• Deploy Business Partners & Best Practices to kick start each market.
• Combine market access (through iPap Collector) with LBS System for growth.
• Place systems w/ volume contracts to eliminate cost barriers & accelerate adoption.
• Management believes low cost equipment position should allow Company to grow rapidly with strong margins.
Sales Model: Direct plus Distribution
• Direct Sales Reps aligned to each launched market to drive the business.
• Establish Business Partners (Lab Companies/Distributors/Sales Agents) in all Markets.
• Business partner teams to drive country access to channels, customers & adoption.
• Govt’s / GMOs / NGOs / Foundations provide a key resource to accelerate market penetration.
Lab Based (LBS) to Point of Care (POC) Directed Approach
• Use LBS to convert existing market, build clinical data, market position & brand.
• Transform market with POC approach (Accuracy, Care, Costs, Clinic Revenues).
• Utilize POC breakthrough to reach new markets & convert US Market through OB/GYN sites.
A number of competitor products are available, most however, to a greater or lesser extent, leave significant unmet needs in the diagnosis of cervical cancer.
The table below compares OncoGenesis with current market practices.
Cost estimates for competitors have been estimated by related parties with previous experience in the industry.
Transaction Description: Seeking to raise ~$5.5 Million in Equity to manufacture iPap Collectors, and assay kits, complete lab testing and POC sensor development, and finalize Strategic Partner funding as well as other working capital needs.
Peter Gombrich, Founder, Executive Chairman
Peter Gombrich, is a serial entrepreneur having founded three medical device companies raising over $200 million and taking several companies public. He founded, led and exited many successful exists in career such as AccuMed/Molecular Diagnostics, a cytopathic laboratory products company, CliniCom, a provider of bedside clinical information, St. Jude Medical, the largest heart valve company in the world. Prior to St. Jude, he held various sales and marketing positions in several medical device companies including Medtronic and Beckman Instruments. Peter holds an MBA and BSc degree in electrical engineering from the University of Denver.
Paul Vichi, PhD, Co-Founder, CTO
Over 25 years of experience with roles in academia and industry related to pharmacology, oncology, biomedical technologies and materials sciences. Dr Vichi is a co-founder of Oncogenesis, as well as co-founder, VP and Chief Scientific Officer for MATRX Pharmaceuticals, Inc. Earlier roles included Senior Scientist for R&D at Diffraction, LTD., and Creative Microsystems Corp, which specialize in microfabrication and Nano structuring for prototype microfluidic and optoelectronic devices. A former faculty member in the Department of Biomedical Technologies at the University of Vermont (UVM), Dr. Vichi earned a Ph.D. in Cellular & Molecular Biology from UVM and completed postdoctoral fellowships in Molecular Physiology and Biophysics at UVM, and Cancer Biology at the Institut de Genetique et de Biologie, Moleculaire et Cellulaire (IGBMC), Strasbourg, France.
Scott Christensen, CEO
Mr. Christensen brings than 35 years of medical device and diagnostics industry experience including positions at Johnson & Johnson, 3M Healthcare and Medtronic. Scott served as CEO of Bentec Medical leading to a successful exit to a strategic buyer. Scott also served as CEO of start up Dynatherm Medical bringing the company from concept to market to successful acquisition by Care Fusion. As President of Oridion Medical, he built market presence and revenues leading to a successful IPO in Europe. Scott is active on the Board of the diagnostics company Coagusense.
Gary L. Gregory, COO
Gary Gregory brings over 30 years of medical diagnostic & device experience to OncoGenesis, having led operations at 4 growth-driven start-ups (3 in POC diagnostics), posting significant growth and yielding strong exits. Gary has served in executive & operational leadership positions across multiple Fortune Medical Companies (Johnson & Johnson, Baxter Healthcare, Kendall Healthcare).
Wendell W. Jones, II – Consulting CFO
Mr. Jones has over thirty-five years of financial management and accounting experience in multiple technology related industries including biotechnology, medical device, and other bioscience related companies.
RISKS & DISCLOSURES
Below mentioned Risk Factors are not exhaustive and the list is only indicative of most significant risks.
- Lack of full amount of funding could continue to delay the validation phase of the final product/assay configuration.
- The Company’s product could potentially not perform as represented, which could have significant effects on the Company’s expected growth.
- The success of the product is partially reliant on the Company’s use of other parties’ intellectual property. If the Company is unable to secure or maintain licensing agreements for such intellectual property, it could have an adverse effect on the Company’s performance.
- The company currently has a draft agreement for distribution of its production in India. If the counterparty, Core Dx, chooses not to execute the contract, there could be a significant delay or reduction to the Company’s growth.
- Regulatory requirements for initial country launch markets. If the Company is unable to receive all necessary regulatory approvals, this could significantly affect their revenue.
- The Company has almost $1,000,000 in outstanding liabilities and creditors could pursue legal action to collect their debts.
- There is no assurance of when the Company’s products will gain market acceptance, if they ever do. Lack of market acceptance could hurt the Company’s performance.
- Technological changes may render product obsolete and hurt the Company’s performance.
- The difficulties Company faces in managing rapid growth in personnel and operations. Pricing pressure could adversely impact Company’s planned pricing structure and have an adverse effect on Issuer’s results of operations.
- For the Company to successfully compete and grow, it must retain, recruit and develop the necessary personnel who can provide the needed expertise across the entire spectrum of its intellectual capital needs.
- Company relies on 3rd party for product supply and distribution which may impact the Company’s ability to execute on its product development plan.
- Competitors may be much larger than the Company, have better name and/or brand recognition than the Company, and have far greater financial and other resources.
- The Company’s products and services will be subject to the changing technology and failure to improve, introduce, or otherwise perform new technology will negatively impact market acceptance of its products and services.
- Future results will depend on the Company’s ability to provide products and services that compare favorably on the basis of accuracy, market acceptance, market dynamic and cost with the products and services of its competitors.
- Company will be exposed to the regulatory environment.
- The competition the Company experience from other companies ranges in size from large, diversified providers to small, highly specialized providers.
- The Company is dependent on market acceptance of new technology introductions and innovations for revenue growth.
- Sales to customers outside the United States expose the Company to risks inherent in international sales.
- The risks and challenges associated with sales to customers outside the United States include:
- • Localization of its service, including translation into foreign languages and associated expenses.
- • Laws and business practices favoring local competitors.
- • Compliance with multiple, conflicting and changing governmental laws and regulations, including employment, tax, privacy and data protection laws and regulations.
- • Foreign currency fluctuations.
- • Different pricing environments.
- • Difficulties in staffing and managing foreign operations.
- • Longer accounts receivable payment cycles and other collection difficulties; and
- • Regional economic and political conditions.
- The Management will have broad discretion in the application of Distributable Cash.
- The Company is permitted to utilize funds raised in the Offering prior to the entire amount of the Offering being completed.
- The Company's management shall have wide discretion as to the exact priority and timing of the allocation of funds raised from this Offering.
- The Company's Management may invest the proceeds from this Offering in ways in which not all the Shareholders, and/or members of the Issuer may agree.