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Inventory - 88% of assets; 3-mo revenue of $16K, increase of SG&A of $43K
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Arch Therapeutics, Inc. (Arch) is a biotechnology company developing an innovative, elegant, and superior approach to the rapid cessation of bleeding (hemostasis*) and control of fluid leakage (sealant) during surgery and trauma care. The underlying technology, exclusively licensed from a leading university, supports an innovative platform of smart materials that fulfill the criteria as a solution for a specialized field we call, “stasis and barrier applications.”
Physicians, industry and patients could benefit greatly from a universal sealant for the challenges presented when an opening is created in the body, whether via surgery, trauma, colonoscopy biopsy, device implantation, or in a variety of consumer settings. The surgeon must manage and preferably prevent bleeding and leakage, as well as other challenges. Currently available tools designed to resolve these problems are often inadequate.
Arch intends to transform the landscape of interventional healthcare with products to seal and protect leaking and bleeding tissue. Arch’s solution elegantly controls the movement of these fluids and substances.
Arch’s products are currently progressing in preclinical development. The first product, AC5 Surgical Hemostatic Device,™ is designed to achieve hemostasis in minimally invasive (laparoscopic**) and open surgical procedures and is intended to be regulated as a medical device.
Surgeons would deem the product a “must have” because of its tremendous features, making it very different and far advanced compared to anything currently on the market.
AC5™ stops bleeding promptly. Unlike many competitive products, it conforms to irregular wound geometry, allows for normal healing, and helps maintain a clear field of vision directly into the wound area.
Because it is not sticky or glue-like, it is ideal for use in the laparoscopic setting – a challenge for much of the competition. Furthermore, it is transparent, enabling a surgeon to operate through it in order to prophylactically stop bleeding as it starts – an important advancement we have branded as Crystal Clear Surgery™.
Most importantly, time to hemostasis (TTH) for AC5™ is typically measured in seconds, rather than the many minutes as provided by much of the competition.
In preclinical tests, the AC5 Surgical Hemostatic Device™ has been simple, effective, and versatile. To date, biocompatibility has been excellent and healing of tissue treated with the device has been normal. This extraordinary concept, if successfully proven clinically, could eventually lead to product adoption available in every surgical setting across the globe.
*Hemostasis or haemostasis (from the Ancient Greek: α?μ?στασις haimóstasis "styptic (drug)") is the process of stopping bleeding, or preventing blood from leaking from damaged blood vessels and tissues. (The opposite of hemostasis is hemorrhage.)
**Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a modern surgical technique in which operations are performed through small incisions (usually 0.5–1.5 cm) as opposed to the larger incisions needed in open surgery. Keyhole surgery makes use of images displayed on TV monitors to magnify the surgical elements.
Address:
235 Walnut Street
Suite 6
Framingham, MA 01702 US
Telephone:
855-340-2784
Sector:
Industrials
Industry:
Conglomerates
NAICS:
Offices of Other Holding Companies (551112)
SIC:
Offices Of Holding Companies, Not Elsewhere Classified (6719)
Arch Therapeutics, Inc. (Arch) is a medical device company developing an innovative, elegant, and superior approach to the rapid cessation of bleeding (hemostasis*) and control of fluid leakage (sealant) during surgery and trauma care. The underlying technology, exclusively licensed from a leading university, supports an innovative platform of smart materials that fulfill the criteria as a solution for a specialized field we call, “stasis and barrier applications.”
Physicians, industry and patients could benefit greatly from a universal sealant for the challenges presented when an opening is created in the body, whether via surgery, trauma, colonoscopy biopsy, device implantation, or in a variety of consumer settings. The surgeon must manage and preferably prevent bleeding and leakage, as well as other challenges. Currently available tools designed to resolve these problems are often inadequate.
Arch intends to transform the landscape of interventional healthcare with products to seal and protect leaking and bleeding tissue. Arch’s solution elegantly controls the movement of these fluids and substances.
Arch’s products are currently progressing in preclinical development. The first product, AC5 Surgical Hemostatic Device,™ is designed to achieve hemostasis in minimally invasive (laparoscopic**) and open surgical procedures.
Surgeons would deem the product a “must have” because of its tremendous features, making it very different and far advanced compared to anything currently on the market.
AC5™ stops bleeding promptly. Unlike many competitive products, it conforms to irregular wound geometry, allows for normal healing, and helps maintain a clear field of vision directly into the wound area.
Because it is not sticky or glue-like, it is ideal for use in the laparoscopic setting – a challenge for much of the competition. Furthermore, it is transparent, enabling a surgeon to operate through it in order to prophylactically stop bleeding as it starts – an important advancement we have branded as Crystal Clear Surgery™.
Most importantly, time to hemostasis (TTH) for AC5™ is typically measured in seconds, rather than the many minutes as provided by much of the competition.
In preclinical tests, the AC5 Surgical Hemostatic Device™ has been simple, effective, and versatile. To date, biocompatibility has been excellent and healing of tissue treated with the device has been normal. This extraordinary concept, if successfully proven clinically, could eventually lead to product adoption available in every surgical setting across the globe.
*Hemostasis or haemostasis (from the Ancient Greek: α?μ?στασις haimóstasis "styptic (drug)") is the process of stopping bleeding, or preventing blood from leaking from damaged blood vessels and tissues. (The opposite of hemostasis is hemorrhage.)
**Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a modern surgical technique in which operations are performed through small incisions (usually 0.5–1.5 cm) as opposed to the larger incisions needed in open surgery. Keyhole surgery makes use of images displayed on TV monitors to magnify the surgical elements.
The Mission of Arch Therapeutics is to develop products that will improve the lives of patients and enhance the quality of care offered by healthcare personnel. We intend to offer compelling options to healthcare institutions facing limited resources.
Arch Therapeutics strives to be a leader in the field of stasis and barrier applications. This includes, but is not limited to, hemostasis and sealant products. We intend to develop products with dramatically improved profiles and characteristics over products on the market or in development. We intend to broaden the scope of the field by developing improved solutions to problems beyond the traditional hemostasis and sealant realms.
Arch Therapeutics is focused on capital efficiency. Our operational plans are geared toward achieving value-creating milestones in a manner that optimizes quality, probability of success, and cost effectiveness.
Arch Therapeutics believes in the value of intellectual property. We intend to file and defend patents and other intellectual property as required, in order to vigorously protect our assets, ideas, and inventions.
Arch Therapeutics plans to achieve its mission with a small core team. The realization of our business objectives amidst the challenges of the modern healthcare environment requires that the best supporting people surround us. We value a healthy mix of seasoned entrepreneurs, scientists, business people and investors in a disciplined environment.
Arch Therapeutics believes that by focusing on the above objectives, we will achieve the goal of providing an optimal return for our investors, to whom we are thankful.
Over 35 million US and 100 million worldwide annual surgeries are driving positive ambulatory and laparoscopic surgical trends
According to MedMarket Diligence, LLC, approximately 114 million surgical and procedure-based wounds occur annually worldwide, including 36 million from surgery in the US, which can benefit from sealants and/or hemostatic* agents.2
These figures are consistent with internal estimates, derived from published data3,4,5
Trends that support the increasing demand in “biomaterials” include:
Use of hemostatic agents and sealants is increasing. The market achieved $2B in 2010 worldwide sales and was projected to reach $4B in 20156. Current projections now indicate sales may exceed $4B in 2013 and $7B in 2017. Over two-thirds of these sales are for hemostats, but a greater sealant growth rate is projected due to a relative paucity of products and an even larger unmet need.
The most useful hemostatic agents can cost upwards of $500/application. Yet a relatively small percent of surgeons use them, often citing their limitations. Supported by views of thought-leaders, improved products would see better uptake, thus growing the already large market.
Another trend is the shift over the past two decades to performing surgery in the less expensive outpatient setting. While this trend continues, bleeding risks force many otherwise straightforward cases to be performed in the hospital inpatient setting, which typically provides greater support for significant potential complications.
The biggest trend is to perform surgery less invasively. Less invasive procedures produce shorter recovery times, faster discharges, less scarring, less pain and less need for pain medications. Open surgery has moved to laparoscopic surgery (25% of procedures). Traditional laparoscopic surgery (three openings) is slowly moving to single-port laparoscopic surgery (one opening), which is more difficult to perform. While still in its infancy, there is a move afoot to advance the techniques of NOTES (natural orifice translumenal endoscopic surgery), which is a method of performing surgery without creating openings in the exterior of the body, by using natural orifices to reach the intended surgical destination instead.
The implication of these trends is that physicians need more advanced materials that are precisely deliverable, easily controlled, maintain a clear field of vision, and work reliably and promptly. Furthermore, the concern of leaking anastomosis in a patient who underwent laparoscopic surgery is prevalent. Some suggest that one of the main hurdles to the uptake of NOTES is concern over leaks after the “opening inside the orifice” is closed. Many physicians stated they could use our product in the majority of their laparoscopic procedures, especially as prophylaxis against leaks that occur after the patient has moved to a post-operative environment.
“Surveys of general, vascular, thoracic, and neurosurgeons affirm the need for products that will work within one minute (preferably 15-30 seconds), remain effective for 10-14 days, and absorb within 8 weeks…”
Surgical “biomaterials” for hemostasis and sealant are out of date. Surgical (and trauma) patients are at significant risk for morbidity and mortality from bleeding and/or leaking body fluids. While surgical techniques, instrumentation and technology have made tremendous strides over the last couple of decades, the majority of hemostatic agents and sealants that surgeons rely on to help stop bleeding and seal leakages have not kept up. Even though some companies have made incremental improvements on first-generation hemostatic products (example: a recombinant version of thrombin to eliminate adverse effects associated with animal-derived blood products), revolutionary advances have been elusive because the underlying technologies have basic limitations.
Fortunately, thought leaders have been vocal about what is missing, and that is where Arch steps in. Surgeons agree that the ideal agent to stop bleeding or leaking does not currently exist. Surveys of general, vascular, thoracic, and neurosurgeons affirm the need for products that will work within one minute (preferably 15-30 seconds), remain effective for 10-14 days, and absorb within 8 weeks, among other needs. A product exceeding these customer expectations should achieve a high level of success. If it possesses both sealing and hemostasis crossover potential, the opportunity should be further enhanced.
Starting with surgical hemostasis, Arch intends to transform the landscape of interventional care. Whether due to surgery or trauma, burn or biopsy, any hole made in the body must be properly sealed and managed. Customers desire a democratic, multipurpose technology to seal and protect that hole without interfering with normal healing.
While surgeons and trauma care providers have available products to stop bleeding, they are often “me-too” products that are largely variations on relatively narrow and very old themes or classes. These possess significant drawbacks. The underlying technologies confer inherent performance limitations, with implications for the surgeon and the patient.
Drawbacks of these products can include a combination of the following:
| Category | Composition | Drawbacks | Products |
|---|---|---|---|
| Fibrin/Thrombin, Collagen/Gelatin | Proteins mostly from animal or human |
| Tisseel, Evicel, Evithrom, Thrombin, SurgiFoam, Floseal, Avitene, Cellerate |
| Cellulose/polymer hydrogels | Plant cellulose, Polymer hydrogels |
| Surgicel Others |
| Desiccants/Concentrators | Clay, chitin, starch powders |
| Perclot QuikClot -Field trauma |
| Of Peripheral Interest: | |||
| Cyanoacrylates | Cyanoacrylates |
| Dermabond Omnex Neucrylate |
| PEG | Polyethylene Glycol |
| Duraseal Coseal RTP |
The mechanism by which the AC5 Surgical Hemostatic Device™ and other Arch planned pipeline products achieves its desired effect resides in the domain of the nanoscale. The design and control of AC5TM provides the desired high ordered nanostructures.
Simpler manufacturing methods are important
Important determinants of product value are its manufacturing methods, type and source of ingredients, and burden of waste byproduct elimination. Industry is keenly aware of the downside of technologies that rely on expensive biotechnology techniques and facilities for manufacture, onerous and expensive programs to eliminate complex materials, or ingredients that are sourced from the complicated process of human or other animal plasma separation.
Such products typically are expensive, infrastructure intensive, burdensome, and at greater risk for failing regulatory oversight versus simpler options. Arch’s manufacturing methods avoid these complexities.
Arch’s planned products will be synthesized of naturally occurring ingredients that are not sourced from humans or other animals. These ingredients, which are the building blocks of the human body, are categorized as GRAS (Generally Recognized as Safe), convey a lower risk of adverse effects, and exist in their natural state in humans.
The hemostasis market is clearly in search of products that work better, faster, and more reliably. The AC5 Surgical Hemostatic Device™ is designed to do that. Arch believes its products will be significantly superior to what is currently available.
AC5™ is a synthetic peptide comprising naturally occurring amino acids. Evidence to-date supports that it is biocompatible. When squirted or sprayed onto a wound, AC5™ promptly intercalates into the nooks and crannies of the connective tissue where it builds itself into a physical, mechanical structure. That structure provides a barrier to leaking substances, including blood and other bodily fluids, regardless of type of surgery or, based on early data, clotting ability. Healing occurs normally.
The structural building process is called self-assembly, and it provides a new and improved approach to addressing “stasis and barrier applications.”
Every day, around the world, millions of surgical procedures are taking place. Many are planned months in advance, while many more are in response to emergency needs.
Because these procedures are invasive, surgeons and other medical specialists focus on optimizing patient outcomes – and they constantly strive for fewer complications, including reduced fluid and blood loss in order to obtain the best results while maximizing safety and minimizing time to recovery. They also operate today through smaller incisions in the body, in procedures known as minimally invasive or laparoscopic surgery.
AC5™ itself is designed at the nano-scale. It's a synthetic peptide comprised of naturally occurring, non-animal, amino acids using straight-forward manufacturing techniques.
AC5™ is applied directly onto a surgical or traumatic wound, where it rapidly creates a physical barrier in the nooks and crannies of the tissue and promptly stops bleeding and fluid leaks.
It's not sticky or glue-like, and is very easy to prepare and handle. It's also a clear transparent gel enabling doctors to see through it as they work, performing “Crystal Clear Surgery™.”
Once applied, AC5™ works quickly to stop bleeding with rapid onset of hemostasis.
With AC5™, surgeons are able to perform surgery through the protective barrier safely.
Once the incision heals, AC5™ is naturally absorbed and passes from the body.
 | Investor Presentation |
President, Chief Executive Officer and Director
Terrence W. Norchi, MD, our co-founder, serves as our President and Chief Executive Officer, and he is a director on our Board of Directors. Dr. Norchi has served in similar positions since co-founding Arch Therapeutics. Prior to Arch, Dr. Norchi was portfolio manager of one of the world’s largest healthcare mutual funds and pharmaceutical analyst at Putnam Investments. Prior to that he served as the senior global biotech and international pharmaceutical equity analyst at Citigroup Asset Management, and as a sell-side analyst covering non-U.S. pharmaceutical equities at Sanford C. Bernstein in New York City.
Dr. Norchi earned an M.B.A. from the Massachusetts Institute of Technology, Sloan School of Management in 1996. Dr. Norchi earned an M.D. degree in 1990 from Northeast Ohio Medical University and completed his internal medicine residency in 1994 at Baystate Medical Center, Tufts University School of Medicine, where he was selected to serve as the Chief Medical Resident.
Dr. Norchi brings to our Board of Directors and management team invaluable experience and knowledge of our core technology and proposed product candidates as a result of his first-hand experience with the development of that technology, having ushered it from the research laboratory to its current stage of development. His investing experience as a former public company analyst and a portfolio manager provides further insights and value as the company advances toward commercialization.
Dr. Norchi serves on the Board of Overseers of the Boston Museum of Science. He also serves on the Board of Overseers of Newton-Wellesley Hospital, a member of Partners HealthCare, a network founded by Massachusetts General Hospital and Brigham and Women’s Hospital.
Director
Mr. Sulat joined our Board of Directors in August 2015. Mr. Sulat also serves as the Chairman of the Board of Directors for Momenta Pharmaceuticals, Inc., a biotech company focused on the analysis, characterization and design of complex pharmaceutical products. Mr. Sulat has served as a member of the Supervisory Board for Valneva SE or its predecessor company, Intercell AG, both European biotech companies focusing on vaccines, since 2005. Mr. Sulat has served as a member of the Board of Directors for AMAG Pharmaceuticals, Inc., a pharmaceutical company focused on the development and commercialization of specialty pharmaceutical products, since 2014. Mr. Sulat has served as a member of the Board of Directors for diaDexus, Inc., a molecular diagnostics company focused on cardiovascular disease, since 2015. Previously, Mr. Sulat served as the Chief Executive Officer and Chief Financial Officer for Maxygen, Inc., from 2009 to 2013. Mr. Sulat also served as a member of the Board of Directors for Maxygen, Inc., from 2003 to 2013. Prior to that, Mr. Sulat served as the Chief Executive Officer, Chief Financial Officer and a member of the Board of Directors for Memory Pharmaceuticals Corp., from 2005 to 2008. Mr. Sulat previously served in senior executive roles for R.R. Donnelley & Sons, Co., Chiron Corporation, Stanford Health Services, Inc., and Esprit de Corp, Inc. Mr. Sulat also previously served as a member of the Board of Directors for Codexis, Inc., Ariat International, Inc., General Surgical Innovations, Inc., and Vans, Inc. Mr. Sulat received a B.S. in Administrative Sciences from Yale University, and an M.B.A. and an M.S. in Health Services Administration from Stanford University.
Chief Financial Officer
Mr. Davis brings a proven and successful record of more than 25 years of progressive and diversified business, financial and operational leadership within both publicly traded and privately held, domestic and multinational companies. Most recently, he has been an advisor to small and mid-size companies assisting them in their accounting, financial reporting, investor and banking needs. Prior to that, he was President, Chief Operating Officer and Chief Financial Officer at NMT Medical, Inc., a NASDAQ-traded medical device company. In this role he developed and executed strategic and operational plans that resulted in revenue growth of 35 percent, 13 consecutive quarters of profitability, increased stock price and analyst coverage from five major investment firms; directed the stabilization of a French subsidiary and led successful efforts in raising $6 million from institutional investors to fund ongoing FDA-approved clinical trials. Prior to that, he was Vice President and Chief Financial Officer at Q-Peak, Inc., where he oversaw all financial and administrative functions. Earlier, he worked in a variety of senior level positions at the Coleman Company, The TJX Companies, Inc. and Wang Laboratories. He holds a Master of Business Administration degree with a Finance concentration from Babson College and a Bachelor of Business Administration degree from the University of Massachusetts Amherst.
Chief Operating Officer
Mr. Cotter was appointed Chief Operating Officer in July 2013. He is an industry veteran who brings expertise in operations and product development in his role with the Company. Mr. Cotter has over 30 years of operational experience with various medical device, diagnostics, biologics and life science companies, ranging from early stage start-ups to large multinational corporations. Most recently, Mr. Cotter has provided consulting and advisory services to early stage biomaterials and medical device companies, including providing advisory services since 2011 to ABS, a wholly owned subsidiary of the Company. Prior to that, Mr. Cotter served in senior operations and development roles for various companies including Cohera Medical from January 2009 to January 2012, Helicos Biosciences from May 2007 to June 2008, Closure Medical Corporation (acquired by Johnson & Johnson) from June 1997 to June 2007, Sanofi Diagnostics Pasteur (acquired by Beckman Coulter) from June 1989 to June 1997, Genetic Systems Corporation (acquired by Bio-Rad) from June 1984 to June 1989 and Advanced Technology Laboratories (acquired by Philips HealthCare) April 1980 to June 1984. While with Closure Medical Corporation, Mr. Cotter served as the Vice President of Operations and had direct responsibility and accountability for all product transfers from R&D, Engineering, Quality Control, Document Control, Production and Logistics. During that tenure, Mr. Cotter was part of a team that developed Closure Medical Corporation's Dermabond®, the first synthetic topical skin adhesive approved by the U.S. Food and Drug Administration, and was the development project leader and co-inventor of the Dermabond TSA ProPen delivery applicator, which won the 2004 Medical Design Excellence Gold Medal Award. Mr. Cotter was also an integral part of the Closure Medical Corporation senior management team that led to a successful acquisition by Johnson & Johnson in June 2005. Prior to his tenure at Closure Medical Corporation, Mr. Cotter spent eight years with Sanofi Diagnostics Pasteur, where he had direct responsibility for all North American industrial sites and chaired that company's World Wide Manufacturing Committee. Mr. Cotter is listed as co-inventor on eight U.S. patents, and is a graduate of Ohio University.
VP of R&D Engineering and Quality Systems
Chirag B. Shah, PhD is Vice President of Research and Development Engineering and Quality Systems at Arch Therapeutics. Dr. Shah brings broad 20 years of proven record of technology and product development, advanced research and device performance evaluations covering vascular, advanced wound care and infection control products. Prior to joining Arch Therapeutics, Dr. Shah was a Senior Director of Biomaterials R&D Center of Excellence in Vascular Therapies GBU at Covidien for 10 years and contributed to peripheral and neurovascular, wound care and renal access products and technologies development. Earlier, Dr. Shah worked at Biolink Corporation focusing on development of a liquid device product for infection and clotting prevention. Prior to that, Dr. Shah worked at USCI division of C.R. Bard, focusing on myocardial bioactive implant and thromboresistant stent coating technologies.
Dr. Shah earned a PhD from University of Rhode Island in 1993 and Executive Leadership Certificates from Cornell and MIT in 2011 and 2009, respectively. Dr. Shah is listed as co-inventor on 25 US issued patents and published applications.
VP of Technology
Steven Kates, PhD has worked with Arch Therapeutics since 2007. He is a highly experienced pharmaceutical executive with over twenty years in R&D for both life science products and human therapeutics, Dr. Kates is regarded as a world leading chemist and industry expert in peptide design and manufacture in the biopharmaceutical industry. He has advanced several compounds through drug development from early pre-clinical to early clinical development. He was responsible for the successful development of clinical candidates for both 505(b)2 and NCE applications. He has held senior positions at Ischemix, Citius Pharmaceuticals, Surface Logix, Consensus and Millipore Corporation.
Dr. Kates has authored or co-authored over 100 articles, reviews, and patents, and is a member of the American Chemical Society, the American Peptide Society, and the Association of BioMolecular Research Facilities. Dr. Kates has served as editor of Solid-Phase Synthesis: A Practical Guide and ADMET for Medicinal Chemists: A Practical Guide; guest editor of Biopolymers; co-editor of ADMET for Medicinal Chemists, A Practical Guide; a member of the Editorial Board of International Journal of Peptide Research and Therapeutics (formerly Letters in Peptide Science); and is an ad hoc reviewer for the NIH bio-organic and natural products study section.
An Adjunct Professor in the Bouvé College of Health and Sciences, Center for Drug Discovery and College of Professional Studies at Northeastern University, and Visiting Professor of Chemistry at Brandeis University, Dr. Kates earned his B.S. in chemistry from Bates College and his Ph.D. in Synthetic Organic Chemistry from Brandeis University, and conducted post-doctoral studies at The Massachusetts Institute of Technology. His research interests include solid-phase peptide and organic synthesis as well as synthesis of peptides and small molecules with therapeutic activities for stroke, coronary artery bypass graft (CABG), myocardial infarction (MI) and inhibitors and substrates for kinases, proteases and G-protein coupled receptors.
VP of Regulatory Affairs
Elaine Whitmore, PhD., brings over 25 years of extensive history in the medical products industry to Arch Therapeutics, with whom she started working in late 2010 focusing on regulatory planning and strategy. In addition to regulatory submissions, Dr. Whitmore’s experience includes development, testing, technology evaluation, and clinical planning for a variety of hemostasis products (fibrin sealants; bovine, human and recombinant thrombin products; cellulose; collagen; etc.), adhesion prevention products, and infection prevention products.
Dr. Whitmore is the author of Development of FDA-Regulated Medical Products—A Translational Approach (ASQ Quality Press, 2012) and has numerous patents for medical product technologies. Prior to becoming a product development and technology consultant, she held executive management industry positions in a variety of functions, including New Product Development, Regulatory and Clinical Affairs, Scientific Affairs, and Business Development. Dr. Whitmore received her PhD degree from Northwestern University.
Board of Directors
Chairman of the Board of Directors
Dr. Dhillon has served as the Chairman of our Board of Directors since April 2013 and has been on the Board of Directors of ABS since May 2011. Previously, Dr. Dhillon was the President and Chief Executive Officer of Inovio Pharmaceuticals, Inc. (formerly Inovio Biomedical Corporation) (NYSE Euronext: INO) from October 2001 to June 2009, as President and Chairman of Inovio from June 2009 until October 2009, as Executive Chairman until August 2011, and as Chairman from September 2011. During his tenure at Inovio, Dr. Dhillon led the successful turnaround of the company through a restructuring, acquisition of technology from several European and North American companies, and a merger with VGX Pharmaceuticals to develop a vertically integrated DNA vaccine development company with one of the strongest development pipelines in the industry. Dr. Dhillon led multiple successful financings for Inovio and concluded several licensing deals that included global giants, Merck and Wyeth (now Pfizer). Prior to joining Inovio, Dr. Dhillon was vice president of MDS Capital Corp. (now Lumira Capital Corp.), one of North America's leading healthcare venture capital organizations. In July 1989, Dr. Dhillon started a medical clinic and subsequently practiced family medicine for over 12 years. Dr. Dhillon has been instrumental in successfully turning around struggling companies and influential as an active member in the biotech community. From March 1997 to July 1998, Dr. Dhillon was a consultant to Cardiome Pharma Corp. (NASDAQ: CRME), where he lead a turnaround based on three pivotal financings, establishing a clinical development strategy, and procuring a new management team. In his role as a founder and board member of companies, Dr. Dhillon has been involved in several early stage healthcare focused companies listed on U.S. or Canadian stock exchanges, which have successfully matured through advances in their development pipeline and subsequent M&A transactions. Most recently, he was a founding board member (May 2003) of Protox Therapeutics, Inc. (TSX-V: SHS) (now Sophiris Bio Inc.), a publicly traded specialty pharmaceutical company. Dr. Dhillon maintained his board position until the execution of a financing of up to $35 million with Warburg Pincus in November 2010. Dr. Dhillon currently sits on the Board of Directors of BC Advantage Funds, a Venture Capital Corporation in British Columbia, and since March 2012 has been the Chairman of the Board of Directors of Stevia First Corp. (OTCQB: STVF), an agricultural biotechnology company engaged in the cultivation and harvest of stevia leaf and the development of stevia products. Since March 2011, Dr. Dhillon has also served as the Chairman of the Board of Directors of of OncoSec Medical, Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid tumor and metastatic cancers. Dr. Dhillon adds value to our Board of Directors with his extensive experience as a member of boards of directors and senior management of other public companies and with his experience in company building, financing, and licensing with large industry partners.
Director
Dr. Rosenthal has been appointed as a director of the Company upon the consummation of the Merger, and has served as the Chairman of the Board of ABS since April 2011. He has served for 40 years in senior research and product development executive roles for medical technology companies and in those roles has successfully directed commercialization efforts for hundreds of novel medical products. He was Chief Scientific Officer at Boston Scientific from January, 1994 to January, 2005, Vice President of Research and Development at Johnson and Johnson Medical Products, Inc. from April, 1990 to January, 1994 and more recently Chief Executive Officer of two start-up companies, Labcoat, Ltd. and Cappella, Inc., both developing cardiovascular medical devices. He is currently, and has been since January 2010, a Professor of Practice in Translational Research in Boston University's College of Engineering, where he oversees biomedical engineering innovation. Dr. Rosenthal received his Ph.D. in biochemistry from the University of Massachusetts, Amherst, 1973. Currently, Dr. Rosenthal serves as Non-Executive Director and as Chairman of the Compensation Committe and member of the Audit Committee for Cyberonics, Inc. (NASDAQ: CYBX), having joined its Board of Directors in January 2007. Dr. Rosenthal is a valuable member of our Board of Directors because of his high-ranking roles in private and public medical device companies, his extensive experience overseeing research and development and commercialization of a large number of products in the medical field, and his company-buil
Advisors
Scientist, Co-Founder
Dr. Ellis-Behnke is the Director of the Nanomedicine Translational Think Tank at the Medical Faculty Mannheim of the University of Heidelberg in Germany. In addition, he holds affiliate faculty positions at M.I.T., as well as Wake Forest and University of South Florida medical schools. His research is focused on reconnecting the disconnected parts of the brain—with the goal of being able to provide a prescription to restore quality of life after brain or spinal cord trauma, or stroke. In animals he was the first to repair the brain showing reversal of blindness; to stop bleeding in less than 15 seconds without clotting; to preserve stem cells; and to immobilize prostate cancer stem cells. Previously, he was Associate Professor in the Faculty of Medicine at the University of Hong Kong, as well as Associate Director of the Technology Transfer Office. Prior to returning to school to pursue his PhD, Ellis-Behnke held various management positions including Senior Vice President of Huntingdon, a public company for pharmaceutical testing and consulting services; and in 1995 was co-founder/CEO of one of the first internet companies in the world to do online commerce. Ellis-Behnke is an Associate Editor for the journal Nanomedicine and is on the Editorial Board of Nanomedicine & Biotherapeutic Discovery. He is a member of the International Society of Nanomedicine and the Scientific Advisory Board of the Glaucoma Foundation. He has multiple worldwide patent applications and his “Nano Neuro Knitting” and “Immediate Hemostasis” technologies have each been licensed to companies for translation to humans. Technology Review named his “Nanohealing” discoveries one of the “Top 10 Emerging Technologies.” Ellis-Behnke received a PhD from MIT in Neuroscience; a Bachelor of Science from Rutgers University and graduated from Harvard Business School’s Advanced Manager’s Program (AMP).
Scientific Advisor
Roger Gregory, PhD, Professor of Chemistry and Biochemistry, Kent State University, has been working with Arch Therapeutics since late 2011. He has provided expertise in product formulation and the relationship between the structure and properties of peptides. Dr. Gregory is a physical biochemist with over 30 years of experience in protein chemistry and analysis. His research interests include protein dynamics, protein hydration, and protein-solvent interactions. He recently returned to the Kent State faculty after serving over seven years as Chair of the Department of Chemistry. As Chair, he helped establish core facilities in genomics, proteomics, bioimaging and 3D visualization. Dr. Gregory earned his BSc and PhD in Biochemistry from the University of Sheffield, England, and performed his postdoctoral work in Protein Chemistry at the University of Minnesota.
Scientific Advisor and Consultant
Victor Garsky, PhD, Past Head of Merck Peptide Synthesis Laboratory, is an advisor and consultant to Arch Therapeutics, bringing his expertise in peptide-based therapeutic design; peptidomimetics; peptide synthesis and purification; scale-up and cGMP production of peptides.
Dr. Garsky‘s career spans 35 years in the Pharmaceutical and Biotechnology industry. During those years, he has been with Wyeth Laboratories, Bachem California, and most recently with Merck Research Laboratories from where he recently retired after 25 years. While at Merck, he headed the Peptide Synthesis Laboratory. Among his research team’s contributions are an experimental early phase clinical vaccine for the treatment of Alzheimer’s disease and to the development of Aggrastat®. While at Bachem California in the mid 1980’s Dr. Garsky served as Director of Chemistry. His responsibilities included the establishment of a cGMP facility and the overseeing of the production-scale synthesis of numerous biologically important peptides such as leutinizing hormone releasing hormone (LHRH) and somatostatin (SRIF).
Dr. Garsky earned his PhD in Organic Chemistry from Southern Illinois University and his BS from Fairleigh Dickinson University. He is a member of the American Chemical Society and American Peptide Society. He serves on the National Institutes of Health Contract Review Committee for peptide facilities. Dr. Garsky holds 32 United States issued patents and 105 peer reviewed publications.
Medical Advisor
Dr. Denman started advising Arch Therapeutics in 2012. He is a Massachusetts General Hospital Anesthesiologist, Clinical Trial Investigator and past Chief Medical Officer of Covidien and GE Healthcare.
Dr. Denman received his medical training in the United Kingdom, completing residency at St. Bartholomew’s Hospital in London, followed by a fellowship at Massachusetts General Hospital, remaining on staff. In 2000 he became Chief of Pediatric Anesthesia at the Floating Hospital for Children in Boston. During his full-time medical practice he was involved in multiple clinical trials and development of pharmaceuticals and devices. He filed and was awarded several patents while focusing on solutions for unmet clinical needs.
In 2003, he began his career at Tyco Healthcare, now Covidien, becoming the Chief Medical Officer and VP for Medical Affairs in 2007. He guided development and implementation of the medical functions throughout Covidien, built a medical affairs, clinical affairs, healthcare economics and reimbursement team; focused these functions on ensuring compliance with new regulations and driving the medical voice into all aspects of the business. In From 2010 to 2012, he was the Chief Medical Officer at GE Healthcare. In this role he strove to ensure a patient-centered culture while focusing on healthcare providers and his team was embedded in all facets of the business; R&D, clinical trials, training, compliance, business development and risk management.
He continues a clinical practice at Massachusetts General Hospital and an academic affiliation at Harvard Medical School, both in Boston. He continues to publish and has recently been granted several more patents. He is co-leader of an annual mission to Vietnam where he provides care to children and medical teaching to those who care for children.
Medical Advisor
Dr. Floyd D. Loop has been an advisor to Arch Therapeutics since 2008. Dr. Loop served as Chief Executive and Chairman of the Board of Governors of the Cleveland Clinic Foundation from 1989-2004.
Dr. Loop graduated from Purdue University in 1958 and received his M.D. degree from The George Washington University, Washington, D.C., in 1962. His postgraduate surgical training was received at The George Washington University, the U.S. Air Force at Andrews Air Force base and at The Cleveland Clinic Foundation.
He joined the Cleveland Clinic staff in 1970 and was appointed Chairman of the Department of Thoracic and Cardiovascular Surgery in 1975, a post he held until 1989 when he was named Chief Executive Officer of the Cleveland Clinic and Chair, Board of Governors.
Dr. Loop gained an international reputation in cardiac surgery. He assembled a group of skilled, experienced thoracic and cardiovascular surgeons who have earned an unsurpassed reputation in their own right. Dr. Loop and colleagues were responsible for today's widespread use of arterial conduits in coronary artery surgery, innovations in valve repair, and they pioneered technical improvements for reoperations. During his career as a surgeon, Dr. Loop has performed more than 12,000 open-heart operations and is author of 350 papers on all aspects of cardiovascular surgery.
Dr. Loop has served on editorial boards of numerous scientific journals. He has been a guest lecturer at many cardiology and surgical meetings internationally, and has demonstrated surgical technique in many countries. Among the awards and honors accorded him, Dr. Loop received the American College of Cardiology Cummings Humanitarian Award in 1975, the American Heart Association Citation for International Service in 1980, and in 1982 the Order of Merit, Brazil’s highest civilian award given. He chaired the Residency Review Committee for Thoracic and Cardiovascular Surgery in 1993, and was President of the American Association for Thoracic Surgery 1997, and a Director of the American Board of Thoracic Surgery, 1993-1999. From 1999-2002, Dr. Loop served on the Medicare Payment Advisory Commission (MedPAC). He has received Honorary Doctor of Science degrees from Cleveland State University, St. Louis University, and Purdue universities.
During this 15 year tenure as chief executive, Dr. Loop selected a new administrative team which reorganized the clinic and added greatly to the academic enterprise. A new health delivery system was established in Cleveland by acquiring eight Cleveland hospitals and building 14 outpatient clinics. In Florida, new clinics and hospitals were built in Ft. Lauderdale and Naples. The revenues grew from 645 million in 1989 to 3.6 billion in 2004. The Cleveland Clinic is consistently recognized as one of the 10 top hospitals in the United States and honored as one of the best managed medical centers. Beginning in 1990, each year has brought a new record for patient activity and overall academic performance. He authored Leadership and Medicine in 2009. Dr. Loop serves on the boards of one public corporation and several private corporation boards.
Medical Advisor
Steve Schwaitzberg, MD, FACS, is an advisor to Arch, bringing his expertise in surgery, clinical trials, and biomaterials for hemostasis and sealing. He is Chief of Surgery at Cambridge Health Alliance, adjunct professor at Tufts University, and Visiting Associate Professor at Harvard Medical School. He is Past President of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), a world-class laparoscopic surgical association.
A key opinion leader, Dr. Schwaitzberg has a distinguished reputation in surgery. He was initially trained as a trauma and surgical infection expert and then became an early leader in the minimally invasive surgery (MIS) revolution. Dr. Schwaitzberg is an innovator who teaches surgical technique around the world. He has served in key leaderships positions in major surgical organizations and received international recognition as a leader in technology in the operating room and for the introduction of novel MIS technology.
Dr. Schwaitzberg is a seasoned clinical researcher with a deep interest in technology development. He is widely published and has been invited to present and teach courses around the world for over 25 years. Dr. Schwaitzberg earned an MD from Baylor College of Medicine and a BA in biology from The Johns Hopkins University.
Scientific Advisor, Preclinical Sciences
Dr. Ollerenshaw is the Technical Leader in Clinical Affairs at Kimberly-Clark Health Care. He is a seasoned scientific leader in clinical and preclinical research and has supported pharmaceutical and medical device development in cardiovascular disease, tissue regeneration and critical care medicine. Prior to joining Kimberly-Clark, Dr. Ollerenshaw was a director of preclinical research and physician training at Saint Joseph’s Translational Research Institute in Atlanta. He also was Director of Vascular Technologies at CryoLife, Inc. from 1995-2003 where he managed a team that developed the world’s first unfixed xenogenic vascular graft for use in hemodialysis patients. Prior to industry Dr. Ollerenshaw built a strong 11-year academic career in medical research at the University of Leicester in the UK, where he obtained his PhD in 1989 in Vascular Biology, and later at Emory University in Atlanta where he was Instructor in Medicine. He has published widely in vascular disease and tissue engineering and is credited with 6 book chapters and review articles, and 53 peer-reviewed manuscripts and abstracts. He has three issued US patents and two issued European patents.
Transfer Agent
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1859 Whitney Mesa Dr
Henderson, NV 89014
Tel: 702-818-5898
FAX: 702-974-1444
info@empirestock.com
Auditors
MFA - Moody, Famiglietti & Andronico, LLP
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ARTH Security Details
Market Value1 | $59.4M a/o 2/12/2019 | |
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Shares Issued | 110,423,588M a/o 03/31/16 | |
Public Float | 90.99M a/o 03/31/16 | |
Authorized Shares | 300M a/o 03/31/16 | |
Shares Outstanding | ~165M a/o 2/12/2019 |
Shareholders of Record | 100 | a/o 6/13/2016 |
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