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Aphios Pharma LLC, a wholly-owned subsidiary of Aphios Corporation, is dedicated to the discovery, delivery, development and commercialization of drugs to treat Central Nervous System (CNS) and other disorders with a focus on Opioid Addiction.
Aphios Pharma operates in a Drug Enforcement Agency (DEA) licensed Schedule 1 facility with the goal of producing Food and Drug Administration (FDA) approved prescription drugs using cannabinoids as the active ingredient. We intend to utilizethe funds raised in this offering to move us toward clinical trials.
Aphios Pharma utilizes supercritical fluid technologies to improve drug discovery, manufacturing and formulation in a sustainable, environmentally-friendly manner.
- Natural Alternative to Synthetic Prescription Drugs: Currently, CNS disorders such as pain and opioid addiction are only treated with synthetic drugs, such as opioids, that have significant adverse side-effects.
- Improve Cannabinoid Formulation: Until now, cannabinoids have been hard to work with because they are hydrophobic with poor bioavailability which results in over 90 percent loss in excretions from the body.
- Enhance Therapeutic performance: Cannabinoids are oxygen sensitive and unstable which causes reduction in bioactivity and therapeutic efficacy.
- Develop better quality technology platform and process: Current DEA, NIH and FDA regulatory environments are burdensome for the development of cannabis-based drugs
- Manufacture pharmaceutical-grade pure natural cannabinoids following cGMP guidelines of the FDA in compliance with the DEA
- Nanoencapsulate pure natural cannabinoids in biodegradable polymer nanospheres to improve stability and bioavailability
- Conduct clinical trials on nanoCBD for target indication
- Utilize FDA 505(b)(2) FDA regulatory pathway to accelerate development based on the recent FDA drug approval of CBD
Opioid addiction has grown to epidemic proportions. Current statistics indicate that heroin overdoses have more than tripled in four years. The CDC reports that the rate of deaths from drug overdoses in the US has increased 137%, with a 200% increase in the rate of deaths involving opioid pain relievers and heroin over the period 2000-2014. It is estimated that between 26.4 million and 36 million people abuse opioids worldwide (UNODC, 2012) with an estimated 2.1 million people in the US suffering from substance use disorders related to prescription opioid pain relievers in 2012 and an estimated 467,000 addicted to heroin (SAMHSA, 2013). By 2020, spending on prescription opioid addiction drugs is estimated to be $1.8 billion.
Unlike buprenorphine and methadone, CBD is not an opioid and does not exhibit any psychotropic effects. CBD acts as an activator of 5-HT1A serotonin receptors, is an anxiolytic and accelerates the agonist effects of naloxone. CBD has been shown to alleviate cue-induced opioid addiction behaviors and allosterically modulate the μ and δ-opioid receptors. All currently FDA approved opioid addiction drugs in the US, such as methadone, are classified as opioids. We plan to displace these opioids with the non-psychotropic CBD to improve efficacy and reduce recidivism.
A significant amount of opioid addiction is driven by poor pain management which impacts 100 million Americans. Fortunately, CBD also has a significant impact on pain with a global market of approximately $60.2 billion in 2015 expanding at a 3.7% CAGR to US$83.0 B by 2024 (Transparency Market Research, 2016).
- Primary Competition: GW Pharma of England which is developing a mixture of CBD and THC for multiple sclerosis, and is clinically investigating a purified CBD product for childhood epilepsy. We differ from GW Pharma by using nanotechnology to improve the delivery and efficacy of cannabinoids and facilitate compliance through oral and topical administration.
- Secondary Competition: Includes pharmaceutical companies with synthetic cannabis drugs such as AbbVie, Par Pharmaceuticals and Insys. We differ from these companies in that we are producing natural cannabinoids and delivering them to patients using nanotechnology.
- Tertiary Competition: Pharmaceutical companies that have non-cannabis-based drugs against similar disease targets such as Biogen, Sanofi, Pfizer and Merck. We are providing natural alternatives with reduced side-effects and toxicities.
- Out-license select products to pharmaceutical and biotechnology companies
- Alternatively, launch product after FDA approval with a direct sales force
We plan to develop, in compliance with the Drug Enforcement Agency (DEA), FDA-approved cannabinoid therapeutics targeted CNS disorders through:
- Investigational new drug (IND) application with FDA
- Conduct Phase 2 clinical trial on humans
- License Phase 2 drug to biotechnology or pharmaceutical companies
- Alternatively, conduct Phase 3 trials and file New Drug Application (NDA) with the FDA
- Product launch and customer acquisition with direct sales force
We plan to accelerate this process by through the FDA’s 505(b)(2) regulatory approval pathway based on the recent FDA drug approval of CBD.
Relevant successes of Aphios Pharma’s have been the following grants and patents awards
- $1.71 Million Small Business Innovative Research (SBIR) Grant 5R44DA038932-03 from National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) for “Development of cGMP Manufacturing Process for CBD.”
- $225,000 Small Business Innovative Research (SBIR) Grant 1R43AT008304-01 from National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH) for “Development of Automated SuperFluids Fractionation Equipment.”
- $109,000 Small Business Innovative Research (SBIR) Grant 1R43DA024552-01 from National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) for “D9-THC for Marijuana Addiction.”
- $235,000 Small Business Innovative Research (SBIR) Grant 1R43CA092855-01A1 from National Cancer Institute (NCI), National Institutes of Health (NIH) for “Development of a Natural Cannabinoid Product.”
- US Patent No. 8,703,727 for “Nanotechnology Formulation of Poorly Soluble Compounds.”
- US Patent No. 8,637,074 B2 “Methods for Co-Encapsulation of Combination Drugs & Co-Encapsulated Combination Drug Product.”
- US Patent No. 8,629,177 B2 for “Nanoencapsulated Δ-9-Tetrahydrocannabinol.”
- Special Report on Neuroscience: Beyond ‘reefer madness.’ April 2018.
- Why the US decision to expand marijuana supply for research matters. Nature. 21 Aug 2016.
- Aphios Pharma Raising Equity Capital to Develop FDA-Approved, Cannabis-Based Drug for Opioid Addiction.
- Aphios Pharma to Develop FDA-Approved, Cannabis-Based Drugs for Opioid Addiction, Epilepsy and Multiple Sclerosis.
- Aphios Pharma to Develop FDA-Approved, Cannabis-Based Drugs for Opioid Addiction, Epilepsy and Multiple Sclerosis.
- Aphios Corporation Utilizes Medicinal Plants and Marine Organisms to Develop Enabling Technology Platforms.
- Natural high: Aphios profits by taming wild compounds.
- Marijuana Business Magazine - April 2017 - page 118.
- The 2017 March Meeting - The NYC Family Office Meetings.
- Cannabis-Based Pharmaceuticals: The Next Frontier? Life Science Leader. November 2014.
Our current KPIs are manufacturing and nanoformulation of CBD.
- These activities are being performed following current Good Manufacturing Practices in a DEA Schedule 1 environment, which is renewed annually
- Completed the process development for both the manufacturing and nanoformulation
- Granted a specific patent for the nanoencapsulation of THCA in polymer nanospheres in 2014
- Currently scaling up the CBD manufacturing process to the 40 kilogram cannabis feed to produce approximately 2 Kg 98.5% CBD per run following cGMP guidelines
We are a unique and experienced management team with a diversity of backgrounds and experiences from well-honed entrepreneurial skills to teaching entrepreneurship at MIT, natural products drug discovery to manufacturing and directorships at the top echelon of the National Cancer Institute, regulatory and medical as well as financial and accounting for multinationals such as Pfizer to startups.
He has over 30 years of diversified business experience from management, marketing and finance to technology and business development in the energy, environmental and biopharmaceutical industries. Dr. Castor graduated from the University of California, Berkeley with a Ph.D. in Mechanical Engineering and a Master of Science degree in Chemical Engineering. He graduated summa cum laude with a Bachelor of Science degree in Chemical Engineering from University of Toronto, Canada. He studied Business Administration at St. Mary’s College, Brooklyn, NY, and Management, Marketing and Finance at Harvard University Extension. He is the primary author of 48 issued US and international patents, 11 pending patents and several registered trademarks. Dr. Castor has collaborated with and consulted to several companies/institutions including Baxter, Bayer, Bristol-Myers Squibb, Eli Lilly, General Electric, Novartis, Pfizer, NIH and the United Nations.
Mr. James J. Falese has over 30 years of experience in all areas of accounting, cost and financial analysis, strategic planning, budgeting, inventory, financial controls and reporting with a strong expertise in manufacturing cost accounting, implementation of accounting systems, and information technology and human resources management. Prior to joining Aphios, he worked as Controller of Serica Technologies, Inc., Medford, MA (acquired by Allergan), Plant Controller at Wyeth Biopharma, Andover, MA (acquired by Pfizer) and Controller of Endogen, Inc., Woburn, MA (acquired by Thermo Fisher Scientific). He holds a Bachelor of Science in Accounting from Merrimack College, North Andover, MA. Jim has been the Controller of Aphios Corporation since 2011, and Chief Financial Officer and Controller of Aphios Pharma since July, 2018.
Dr. Judith Palmer-Castor is a behavioral health scientist with over 20 years of research, clinical and regulatory experiences in industry and academia. Dr. Palmer-Castor was a Project Director on a NIH-funded Adolescent HIV/AIDS Clinical Trial Network Project at Children’s Hospital, Boston, MA, a consulting scientist for Mass General Hospital- Division of Global Health and Human Rights, Boston, MA, as well as holding similar behavioral health and research and clinical positions at Northeastern University, Boston, MA, SAMSHA, CDC and other non-profit health and human service agencies. Dr. Palmer-Castor graduated with a Ph.D. in Policy with an emphasis on Behavioral Health and Adolescent Development from Brandeis University, Waltham, MA, and M.S. and B.S. degrees in Psychology from Santa Clara University, CA. She has been the Director, Clinical and Regulatory Affairs of Aphios Corporation since 2007, and of Aphios Pharma since July, 2018.
Advisors and Investors
Mr. Joseph F. Faris has served as a transitional hands-on CFO/Controller to several different industries on a time-sharing/consulting basis over the last 30 years. Some of his clients include Hemagen Diagnostics, Inc., Medical Research, Inc., T Cell Sciences, Inc., Innovative Polymers, Inc. and Neurogen, Inc. He holds a Bachelor of Science in Accounting, cum laude, from Northeastern University, Boston, MA. He has served as the Chief Financial Officer of Aphios Corporation since 1997, and of Aphios Pharma since July, 2018.
Dr. Jonathan Steven Alexander received his B.S. in Biology from Boston University, Boston, MA and his Ph.D. in Vascular Biology in the area of on mechanisms of endothelial barrier and inflammation also from Boston University. He was a Postdoctoral Fellow in Pulmonary Medicine/Biomedical Engineering at Vanderbilt University, Nashville, TN,before joining the faculty at LSUHSC-S in 1994. As an endothelial biologist working on mechanisms of central nervous system injury in stroke, Multiple Sclerosis and Alzheimer's disease at LSUHSC-Shreveport, Dr. Alexander has developed assays, models and methods for evaluating neuron, astrocyte and endothelial mechanisms in different forms of neurovascular inflammation. He is an executive member of the International Society for Neurovascular Disease (ISNVD). Dr. Alexander is the author of more than 200 peer-reviewed publications and the author of several patents, one of which is licensed to Aphios Corporation and others which were co-invented with scientists and engineers at Aphios Corporation. Dr. Alexander, Ph.D. is currently employed at LSU Health Sciences Center, Shreveport, LA, and has been a Scientific Advisor to Aphios Corporation since 2012 and to Aphios Pharma since July, 2018.
Previously, Mr. Anthony Janiuk was Of Counsel at Lathrop & Gage, LLP, Boston, MA and Partner at Pearl Cohen Zedek Latzer, Boston, MA. Prior to that, he was Corporate Attorney for Waters Corporation, Milford, MA, where he was entrusted to establish a law office for this public company and in which he was involved in the maintenance of corporate records, contracts, litigation, planning, intellectual property issues and acquisitions. Atty. Janiuk served as Of Counsel for Wolf, Greenfield & Sacks, P.C., Boston, MA, Chief Legal Counsel of Gene-Trak Systems Corporation, Framingham, MA, Patent Attorney for Amoco Corporation, Chicago, IL and Patent Attorney for Emrich and Dithmar, Chicago, IL. Atty.. Janiuk received his Bachelor of Science in Pharmacy from the University of Wisconsin, Madison, WI, and his Juris Doctor from DePaul University College of Law, Chicago, IL. Now retired, Mr. Janiuk's employment over the last three years has been with Wellesley IP and Lathrop & Gage, LLP. He has been a Director of Aphios Corporation since 2002 and of Aphios Pharma since July, 2018.
Dr. Val R. Livada which is focused on successful technology commercialization. Dr. Livada was also a Senior Lecturer (retired) on Corporate entrepreneurship at the Sloan School of Management, MIT, Cambridge, MA. There he has led a joint research project, with the Wharton Business School, on Corporate Venture Capital, is a Catalyst at the Deshpande Center, and a consultant at the Cambridge University/MIT Institute. Prior to establishing Weybridge Partners, Dr. Livada was a Director at Braxton Associates, an international strategy planning consulting firm, and a Vice-President at Pugh-Roberts Associates, a technology management firm. With over over 30 years of experience in the areas of strategic planning and organizational dynamics with detailed knowledge in the areas of innovation, product development and R&D management. Dr. Livada’s clients have included Fortune 500 companies such as GM and Eli Lilly. He received his undergraduate degree from MIT and his M.A. and Ph.D. from Tufts University, Boston, MA. Dr. Livada recently retired form MIT, has been employed at Weybridge Partners since 1996, and is a Director of Aphios Corporation since 2012 and of Aphios Pharma since July, 2018.
Dr. Arthur D. Lander is the Donald Bren Professor of Developmental and Cell Biology, and Professor of Biomedical Engineering, at the University of California, Irvine. He is also the Director of the Center for Complex Biological Systems, an NIGMS National Center for Systems Biology. Dr. Lander is a fellow of the American Association for the Advancement of Science. He received his B.S., summa cum laude, in Molecular Biophysics and Biochemistry, Yale College, New Haven, CT, and Ph.D. in Neuroscience and M.D. degrees from University of California, San Francisco. He is the author of over a hundred peer-reviewed publications, and four patents, including two that were co-invented with scientists and engineers at Aphios. Dr. Lander is currently employed at the University of California, Irvine, and has been a Scientific Advisor of Aphios Corporation since 1993 and of Aphios Pharma since July, 2018.
Dr. Gordon M. Cragg, Ph.D. obtained his undergraduate training in chemistry at Rhodes University, South Africa, and his D. Phil. (organic chemistry) from Oxford University in 1963. After two years of postdoctoral research at the University of California, Los Angeles, he returned to S. Africa to join the Council for Scientific and Industrial Research. In 1966, he joined Chemistry Department at the University of South Africa, and transferred to the University of Cape Town in 1972. In 1979, he returned to the US to join the Cancer Research Institute at Arizona State University working with Professor G. R. Pettit. In 1985, he moved to the National Cancer Institute (NCI), National Institutes of Health (NIH) in Bethesda, Maryland, and was appointed Chief of the NCI Natural Products Branch in 1989. Dr. Cragg has established collaborations between the NCI and organizations in many countries promoting drug discovery from their natural resources. He has published over 150 chapters and papers related to these interests. He retired from the NCI in December, 2004, and is currently serving as an NIH Special Volunteer. Dr. Cragg has been a Scientific Advisor to Aphios Corporation since 2013 and to Aphios Pharma since July, 2018.
Dr. Glenn T. Hong, Sc.D. is Founder and Vice President, CounterCurrent Systems, Inc., Westborough, MA, a company that provides consulting services in the areas of chemical engineering, supercritical fluids, and biotechnology. He received his B.Sc. in Biology from the State University of New York at Albany, NY and his Sc.D. in Chemical Engineering from the Massachusetts Institute of Technology, Cambridge, MA. Dr. Hong is a Senior Technology Consultant, General Atomics, San Diego, CA where he contributes to all aspects of the development of supercritical water technology, especially including supercritical water oxidation (SCWO) and supercritical water gasification (SCWG). He has utilized computational fluid dynamics (CFD) as an aid in designing the scaled-up plant. Previously, he was Vice President, Engineering, Aphios Corporation, Woburn, MA where he directed research and engineering in environmental and biotechnological applications of supercritical fluids. Prior to being employed by Aphios, Dr. Hong served as a consultant to Aphios and its predecessor companies for approximately 10 years. Dr. Hong is the author/co-author of numerous publications in the field of supercritical fluids as well as 16 US patents, some of which are assigned to Aphios Corporation. Dr. Hong is currently employed at Counter Current Technologies LLC, and has been a Scientific Advisor to Aphios Corporation since 2002 and to Aphios Pharma since July, 2018.
Financial and Exit Strategy
- Raise $1.07M to establish operations and support services required to roll Company out.
- Raise $3.93M to take the developed cannabinoid nanoformulations through the IND development cycle
- Raise an additional $20 million in 2019 to conduct Phase 2 clinical trial
- If feasible, license APH-1501 to pharmaceutical or biotechnology company
- If license deal is not feasible, raise $100M through an IPO within a 2-year period to conduct Phase 3 clinical trials and FDA approval and commercialize APH-1501 product
- Investors can exit at product license, IPO or at a later stage
Use of Funds
Use of Proceeds
If the offering's maximum amount of $1,070,000 is raised:
|Use||Value||% of Proceeds|
|General & Administrative||$224,250||21.0%|
|Research & Development||$463,300||43.3%|
This is an offering of Common Units, under registration exemption 4(a)(6), in Aphios Pharma LLC. This offering must raise at least $10,000 by January 31, 2019 at 3:00pm ET. If this offering doesn’t reach its target, then your money will be refunded. Aphios Pharma may issue additional securities to raise up to $1,070,000, the offering’s maximum.
If the offering is successful at raising the maximum amount, then the company’s implied valuation after the offering (sometimes called its post-money valuation) will be:
These financial statements have been reviewed by an independent Certified Public Accountant.
The Offering Statement is a formal description of the company and this transaction. It’s filed with the SEC to comply with the requirements of exemption 4(a)(6) of the Securities Act of 1933.
We’re also required to share links to each of the SEC filings related to this offering with investors.
- Jan 31, 2019Primary offering closed, sellingunitsSold $1.00 for a total of $46,502.00units at
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