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Arth april2015
The document discusses a new hemostatic device called AC5 for faster and safer surgery. It notes the large market opportunity for hemostats and sealants which is projected to grow to $6.7 billion by 2017. The device uses a self-assembling peptide technology that creates a hemostatic barrier and has shown effectiveness in animal studies even in the presence of blood thinners.
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Arth april2015
- 1. 1 F A ST E R , S A F E R , S I M P L E R S U R G E R Y Terrence Norchi, M.D. President - CEO
- 2. 2 Cautionary Statement RegardingForward-Looking Statements This presenta,on includes forward-‐looking statements. We make forward-‐looking statements, as defined by the “safe harbor” provisions of the Private Securi,es Li,ga,on Reform Act of 1995, and in some cases, you can iden,fy these statements by forward-‐looking words such as “if,” “shall,” “may,” “might,” “will likely result,” “should,” “expect,” “plan,” “an,cipate,” “believe,” “es,mate,” “project,” “intend,” “goal,” “objec,ve,” “predict,” “poten,al” or “con,nue,” or the nega,ve of these terms and other comparable terminology. These include statements regarding: our ability to leverage our technology plaLorm in the development of our lead and poten,al pipeline product candidates; our ability to design and conduct development ac,vi,es and studies and clinical trials for our lead and poten,al pipeline product candidates; the poten,al ,ming and results of any such clinical trials we may conduct; our ability to obtain regulatory approvals in order to market any planned products; our ability to achieve financial projec,ons; and our ability to achieve milestones. The forward-‐ looking statements in this presenta,on are based on management’s current expecta,ons, es,mates, forecasts and projec,ons about the Company and its business, all of which could prove to wrong. Because such statements deal with future events, they are subject to various risks and uncertain,es and actual results for our current and future fiscal years could differ materially from the Company's current expecta,ons. Factors that could cause the Company's results to differ materially from those expressed in forward-‐looking statements include, without limita,on, the following risks: we have es,mated that we will have sufficient cash to operate our business through November 2014, and we may not be able to obtain sufficient financing and/or establish necessary rela,onships with third par,es to con,nue to pursue our business plan; the stockholder dilu,on that may result from future capital raising efforts and the exercise or conversion, as applicable of Arch’s outstanding op,ons and warrants; an,-‐dilu,on protec,on afforded investors in prior financing transac,ons that may restrict or prohibit Arch’s ability to raise capital on terms favorable to the Company and its current stockholders; any development ac,vi,es or clinical trials we may conduct may not produce favorable results; regulatory agencies may require that we undertake addi,onal or more costly studies or clinical trials than we presently an,cipate; we may never gain regulatory approval for any of our product candidates; we may not be able to protect our intellectual property rights; the intellectual property of others and any asserted claims of infringement; general business and economic condi,ons may limit our ability to obtain necessary capital; the consequences of compe,,ve factors in the industry in which we operate may restrict the success of any product candidate we are able to commercialize, and we may not be able to aract or retain key personnel. More detailed informa,on about us and the risk factors that may affect the realiza,on of any forward-‐looking statements is set forth in our filings with the Securi,es and Exchange Commission, including our Annual Report on Form 10-‐K filed on December 12, 2014 and subsequent filings with the SEC . Such documents may be read free of charge on the SEC’s internet site at hp://www.sec.gov. You are cau,oned not to place undue reliance on any forward-‐looking statements we make in this presenta,on given these risks and uncertain,es, and all such statements are qualified in their en,rety by this cau,onary statement. All forward-‐looking statements speak only as of the date hereof, and we undertake no obliga,on to revise or update any forward-‐looking statement to reflect events or circumstances acer the date hereof, except as otherwise required by law.
- 3. 3 Highlights Investment Themes Potential highmargin (~biopharma) novel product entering a growing $5B market in early 2016 with relatively low (device) capital requirements First Planned Product AC5 Surgical Hemostatic DeviceTM; simple, effective, versatile, safe Unique Technology MIT-licensed self-assembling peptide creates hemostatic barrier on wound Recent News Animal studies efficacy in presence of “blood thinners” faster time to stop bleeding vs branded hemostats of varying mechanisms Safety study -no sign of interaction with human cell receptors or cell kinase enzymes Medical device pathway confirmed in Europe Activities Scale-up, biocompatibility, initiate first human trial Pipeline Potential Applications in surgery, trauma, wound care, military medicine, other OTCQB ARTH
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- 5. 5 The Burden ofBleeding Bleeding is common in open / laparoscopic surgery 30-50% of procedure time can be spent controlling bleeding Visual field loss and increased error risk Increased length of stay Use of expensive resources (transfusions cost $500-1000/unit) Abnormal healing, adhesions Hematomas and seromas Cautery and biomaterials present safety, efficacy, ease of use challenges Anticoagulant / antiplatelet therapy increases bleeding risk
- 6. 6 Market Opportunity Hemostat andsealant worldwide market revenues are projected to grow from $4.5B in ’13 to $6.7B in ’17 (10% annual growth) Cardiovascular 51.4 GeneralSurgery 27.4 Cosmetic 12.6 Neurological 16.0 Source: MedMarketDilligence,LLC;“SurgicalSealants,GluesWorldwide.” SurgicalProcedureswithPotentialfortheUseof Hemostats,Sealants,GluesandAdhesionPrevention Products,Worldwide(Millions). 2011 Urological 1.4 Digestive 20.9 Orthopedic &Arthroscopic 10.7
- 7. 7 Competition: No IdealSolution Cautery Gelatin Collagen Cellulose Polymers Thrombin Fibrin sealants Product Classes Unreliable, slow onset of action Foreign body reaction, infection, granuloma Inflammatory responses Adhesions Difficult to prepare and use Intact clotting cascade required Animal/human sourcing Handling restrictions Antibody formation Common Drawbacks
- 8. 8 Planned Advantages ofAC5 Physicians desire these characteristics • No special storage requirements or supply • Easily prepared and applied • Not sticky, not powdery, not bulky, does not gunk-up instruments • Supports clear visual field Simple • Provides rapid, reliable hemostasis • Conforms to irregular wound geometry to create a barrier that stops leakage • Integrates easily into procedure Effec,ve • Open and minimally invasive surgery • Works in range of bodily fluids and tissues • Prophylactic effects; may control local bleeding while operating through it Versa,le • Made of natural building blocks without animal or human constituents • Biocompatible, inert, may be left in body, absorbable • Allows for normal healing • No evidence of adhesion, infection, immunogenicity Safe
- 9. 9 Solution: AC5 SurgicalHemostatTM Synthetic peptide Clear liquid, squirted or sprayed Physical mechanical barrier Bleeding stops promptly Blood thinner agnostic Can see and operate through it Bioasborbable Enables normal healing Arch Therapeu,cs, Inc. © 2015 Arch Therapeu,cs, Inc. © 2015
- 10. 10 Liver Arch Therapeu,cs, Inc. © 2014 Arch Therapeu,cs, Inc. © 2014 Novel Mechanism: Self-Assembly Composition Delivered Locally Assembled Into Network Arch Therapeu,cs, Inc. © 2014 Arch Therapeu,cs, Inc. © 2015 Cormier et al, ACSNano, 2013
- 11. 11 0% 100% 200% 300% 400% 500% 600% Unmedicated Control Unmedicated AC5 Heparin Control Heparin AC5 Heparin 0% 100% 200% 300% 400% 500% 600% Unmedicated Control Unmedicated AC5 Ticagrelor Control Ticagrelor AC5 Ticagrelor 0% 100% 200% 300% 400% 500% 600% Unmedicated Control Unmedicated AC5 Plavix Control Plavix AC5 Plavix 0% 100% 200% 300% 400% 500% 600% Unmedicated Control Unmedicated AC5 ASA Control ASA AC5 Aspirin (ASA) 0% 100% 200% 300% 400% 500% 600% Unmedicated Control Unmedicated AC5 ASA/Plavix Control ASA/Plavix AC5 Aspirin + Plavix AC5 Stops Bleeding in Presence of Anticoagulants Rat Liver Bleeding Model (4 mm Diameter Penetrating Full Thickness Wound) Time to Hemostasis Difference With Reference to Unmedicated Control
- 12. 12 Bleeding in AnticoagulatedPatients Is Challenging "There are an increasing number of patients on long-term therapy with antiplatelet agents and other anticoagulants. We are often required to perform procedures and operations on patients with active antiplatelet and anticoagulation therapy. Hemostasis for bleeding control in these patients is extraordinarily challenging. None of the hemostatic agents available today have demonstrated enhanced efficacy in the setting of antiplatelet therapy. The results described in this study are extremely promising because we surgeons need improved hemostatic control in the setting of antiplatelet therapy, which many of our patients are required to stay on for its cardioprotective effects.” Dr. Paresh Shah, Director General Surgery and Vice Chair of Surgery at NYU Langone Medical Center "There is a great need to continue to develop novel hemostatic agents and sealants that are efficacious in surgical and trauma patients. In particular, the need is greatest in those patients whose underlying coagulation cascade or platelet status is abnormal, whether due to concurrent antithrombotic therapy or an underlying disease. Increasing numbers of patients are on anticoagulant or antiplatelet medications. This can present a challenge to surgeons and other interventionalists when procedures are needed on these patients. These initial findings on the activity of AC5 in this setting are very encouraging and may lead to significant benefit in the future.” Steven Schwaitzberg, MD, Professor of Surgery at Harvard Medical School; advisor to Arch Therapeutics
- 13. 13 Clinical Regulatory Expected regulatorypath: medical device CE Mark EU (first focus) PMA USA Non-US clinical trial AC5 Surgical HemostatTM for hemostasis Likely primary endpoint: time to hemostasis
- 14. 14 Market Size US: ~15%of ~26M diabetes patients develop foot ulcers US: ~2.5M pressure ulcers in US Global: ~$13B annual wound management revenues Market Needs Better treatment options to safely and effectively prevent leakage control bleeding after debridement maintain moist wound environment reduces infection risk enable healing Pipeline: Barrier for Chronic Cutaneous Ulcers
- 15. 15 Intellectual Property: BroadPortfolio Licensed from Massachusetts Institute of Technology EXCLUSIVE (Arch Is Sole Licensee Worldwide) Two patent families cover compositions and methods for hemostasis and controlling movement of bodily substances Expected expiry 2026 – 2028 NON-EXCLUSIVE 5 patent families providing freedom to operate Expected expiry 2014 – 2026 Arch Therapeutics Treatment of damaged tight junctions and enhancing extracellular matrix Compositions for prevention of adhesions and other barrier applications Additional IP filed
- 16. 16 Board of Directors AvtarDhillon, MD Chairman MDS Capital Corp (Lumira), Protox (Sophiris Bio), BC Advantage Funds, Stevia First, Inovio, Oncosec Arthur Rosenthal, PhD Director JNJ, Boston Scientific (past CSO), Labcoat, Capella, Cyberonics, Boston University Terrence W. Norchi, MD, MBA Director, President, CEO, Founder NEO Medical Univ., MIT, Tufts School of Med., Sanford Bernstein, Citigroup, Putnam
- 17. 17 Leadership Team William M.Cotter Chief Operating Officer Genetic Systems, Sanofi Diagnostics Pasteur, Closure Medical (JNJ), Helicos, Cohera Richard E. Davis Chief Financial Officer NMT Medical, Rolling Management, TJX Companies, Wang Laboratories Chirag Shah, PhD VP of R&D Engineering and Quality Covidien, Biolink, Bard Steve Kates, PhD VP of Technology Brandeis, Millipore, Surface Logix, Ischemix, Northeastern, NIH, Am. Chem. Soc., Am. Peptide Soc. Elaine Whitmore, PhD VP of Regulatory Affairs Northwestern Univ., JNJ, Haemacure, Scivance Terrence W. Norchi, MD, MBA Director, President, CEO, Founder NEO Medical Univ., MIT, Tufts School of Med., Sanford Bernstein, Citigroup, Putnam Advisors and Consultants include highly regarded scientists and physicians
- 18. 18 Milestones Planned for2015 Data Obtain and disclose safety and performance data Team Commence collaboration with CÚRAM (Ireland) Regulatory Confirm CE Mark pathway plan Clinical Initiate human clinical trial Finance Secure capital including SFI grant for CÚRAM - Arch collaboration Sales/Mkt Develop appropriate commercialization strategy / partnership Pipeline Advance Chronic Cutaneous Ulcer and other Programs IP Advance intellectual property portfolio
- 19. 19 Contact Information 235 WalnutStreet, Suite 6 Framingham, MA 01702 USA Investor Relations Tel: 1.855.340.ARTH (2784) investors@archtherapeutics.com