FASTER, SAFER, SIMPLER SURGERY Terrence Norchi, M.D ... · Wound care products are small portion of...
Transcript of FASTER, SAFER, SIMPLER SURGERY Terrence Norchi, M.D ... · Wound care products are small portion of...
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F A S T 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
OTCQB: ARTH
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This presentation includes forward-looking statements. We make forward-looking statements, as defined by the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, and in some cases, you can identify these statements by forward-looking words such as “if,” “shall,” “may,” “might,” “will likely result,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “goal,” “objective,” “predict,” “potential” or “continue,” or the negative of these terms and other comparable terminology. These include statements regarding: our ability to leverage our technology platform in the development of our lead and potential pipeline product candidates; our ability to design and conduct development activities and studies and clinical trials for our lead and potential pipeline product candidates; the potential timing and results of any such clinical trials we may conduct; our ability to obtain regulatory approvals, our ability to produce commercial quantities of our products within projected timeframes in order to market any planned products; our ability to achieve financial projections; and our ability to achieve milestones. The forward-looking statements in this presentation are based on management’s current expectations, estimates, forecasts and projections 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 uncertainties and actual results for our current and future fiscal years could differ materially from the Company's current expectations. Factors that could cause the Company's results to differ materially from those expressed in forward-looking statements include, without limitation, the following risks: we have estimated that we will have sufficient cash to operate our business for the near future, and we may not be able to obtain sufficient financing and/or establish necessary relationships with third parties to continue to pursue our business plan; the stockholder dilution that may result from future capital raising efforts and the exercise or conversion, as applicable of Arch’s outstanding options and warrants; anti-dilution protection afforded investors in prior financing transactions that may restrict or prohibit Arch’s ability to raise capital on terms favorable to the Company and its current stockholders; any development activities or clinical trials we may conduct may not produce favorable results; regulatory agencies may require that we undertake additional or more costly studies or clinical trials than we presently anticipate; 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 conditions may limit our ability to obtain necessary capital; theconsequences of competitive factors in the industry in which we operate may restrict the success of any product candidate we areable to commercialize, and we may not be able to attract or retain key personnel. More detailed information about us and the risk factors that may affect the realization of any forward-looking statements is set forth in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed on December 19, 2019 and subsequent filings with the SEC. Such documents may be read free of charge on the SEC’s internet site at http://www.sec.gov. You are cautioned not to place undue reliance on any forward-looking statements we make in this presentation given these risks and uncertainties, and all such statements are qualified in their entirety by this cautionary statement. All forward-looking statements speak only as of the date hereof, and we undertake no obligation to revise or update any forward-looking statement to reflect events or circumstances after the date hereof, except as otherwise required by law.
Cautionary Statement Regarding Forward-LookingStatements
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OTCQB: ARTH
Shares Outstanding (as of December 31, 2019) ~187 million
Shares / Options Held by Mgmt. (~12%) ~23 million
Stock Options – Outstanding and Available ~19 million
Trading Volume (90 day average) ~260,000
Cash (as of December 31, 2019) ~$3.0M
Current Cash Burn/Qtr. ~$1.7M
Debt ---
Key Statistics
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We are developing an innovative platform of peptides to seal and protect bleeding, leaking and injured tissues in a range of procedures.
Our initial products, based on the AC5® self-assembling peptide technology platform, rapidly generate nanofiber networks that control the
movement of fluids and substances while enabling healing.
Pipeline
Pipeline
Dermal Sciences Biosurgery
Arch Therapeutics—transforming advanced interventional wound care
Our FocusImproving lives with self-assembling technology
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Ø Receive pending CE Mark for AC5® Topical Hemostat
Ø Receive pending FDA clearance for additional manufacturer & process for AC5®
Topical as part of supply chain harmonization
Ø Ship initial inventory to KOL centers after receipt of final marketing authorizations
Ø Receive observational clinical data and feedback from KOLs in US and EU
Ø Execute initial commercialization rollout and partnering strategy
Ø Select one of two biosurgery applications to advance to clinic
Ø Raise capital to support commercialization and development
Ø Continue intellectual property portfolio development (file additional IP)
2020 Objectives
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Licensed by Arch
Assigned to:Massachusetts
Institute of Technology
& Versitech Ltd/
U. of Hong Kong
EXCLUSIVE (Arch Is Sole Licensee Worldwide)Two patent families cover compositions and methods for hemostasis
and controlling movement of bodily substancesExpected expiry 2026 – 2028
NON-EXCLUSIVE5 patent families providing freedom to operate
Expected expiry to 2030
Assigned to:
Arch Therapeutics
Treatment of damaged tight junctions and enhancing extracellular matrixExpected expiry 2029
Compositions / methods for prevention of adhesions and other barrier applicationsExpected expiry 2026
Compositions / methods for solid forms of SAP products Expected expiry 2034
Compositions / methods for ophthalmic indicationsExpected expiry 2038
Compositions / methods for inflammatory indicationsExpected expiry 2038
Additional IP filed – topic not net disclosedExpected expiry ~2039 if issued
Broad Intellectual Property PortfolioValue creation from range of protected uses/compositions
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How Are We Reaching Our Goals?With solid experienced leadership
Chirag Shah, PhD VP of R&D Engineering and QualityCovidien, Biolink, Bard
Richard E. Davis Chief Financial OfficerNMT Medical, Rolling Management, TJX Companies, Wang Laboratories
Terrence W. Norchi, MD, MBA Chairman, President, CEO, FounderNEO Medical Univ, MIT, Tufts School of Med, Sanford Bernstein, Citigroup, Putnam
James Sulat DirectorMomenta, Valneva (Intercell), AMAG, Diadexus, Chiron
Punit Dhillon DirectorOncosec, Inovio, Emerald Health Therapeutics
Daniel Wadsworth VP of Dermal SciencesCR Bard, KCI, Medical Device Consulting
Details available at http://www.archtherapeutics.com/about/leadership
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How Are We Reaching Our Goals?And a “deep bench” of advisors
John Richards, DPhil The Medicines Company (President Global Pharmaceutical Development), ImmuLogic, ICI Pharmaceuticals, Oxford
Rutledge Ellis-Behnke, PhD Medical Faculty Mannheim, Univ of Heidelberg (Germany), MIT, Univ of Hong Kong, Int’l Soc of Nanomedicine, Glaucoma Foundation
Steve Schwaitzberg, MD, FACSJacobs School of Medicine (U Buffalo SUNY), Cambridge Health Alliance, Tufts, Harvard Medical School, SAGES (past president)
William Denman, MBChB, FRCAMassachusetts General, Harvard Medical School, Covidien (past Chief Medical Officer), GE Healthcare
Roger Gregory, PhDKent State University (past Chairman of Department of Chemistry), University of Sheffield, England, University of Minnesota
Avtar Dhillon, MDEmerald Health, MDS Capital Corp (Lumira), Protox (Sophiris Bio), BC Advantage Funds, Inovio, Oncosec
Arthur Rosenthal, PhDBoston Scientific (former Chief Scientific Officer), JNJ, Boston University
Daniel Kapp, MDPalm Beach Gardens Medical Ctr (Chief of Plastic Surgery), Jupiter Medical Wound Healing (Medical Director), Recros Medica
Robert Williams, PhDColorado State University (University Distinguished Professor), Harvard University
Dmitry Nepomnayshy, MDLahey Hospital and Medical Center (Dir. Bariatric Surgery Fellowship, Assoc. Prog. Dir. Gen. Surgery Residency), Tufts College of Medicine
Steve Kates, PhDBrandeis, Dicerna, Millipore, Surface Logix, Ischemix, Northeastern, NIH, Am Chem Soc, Am Peptide Soc
Details available at http://www.archtherapeutics.com/about/leadership
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Mechanism & Profile of AC5® Technology
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Properties Advantages
Synthetic single peptide sequenceNon-animal
BiodegradableInert
Clear liquidConformable
Moisture donatingCan see and operate through it
Self-assembling mechanism ECM-like contiguous protective networkAnti-thrombotic agnostic
Non-covalent bonds Cohesive, not adhesive
BarrierBleeding stops promptlyInhibits microbial growth
Inhibits inflammation
Biodegradable scaffold Permits cellular migration and proliferation
AC5® Platform: Technology Drives PropertiesProperties provide distinct advantages
11Cormier et al, ACSNano, 2013
Space Filling Model
Arch Therapeutics, Inc.© 2018
Assembly Demonstration
Arch Therapeutics, Inc.© 2019
Electron Micrograph of Assembled Network
Arch Therapeutics, Inc.© 2016
Contiguous Cohesive Nanofiber Network
AC5® Technology Mechanics of ActivityCharge-induced self-assembly; a medical device
Arch Therapeutics, Inc.© 2019Arch Therapeutics, Inc.© 2019
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Dermal Sciences
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$0
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
$14,000
2018 2019 2020 2021 2022 2023 2024 2025
Reve
nue
($M
illio
n)
Year
Dynamic Compression Therapy
Static Compression
Negative Pressure Wound Therapy
Advanced Dressing
Traditional Wound Dressing
Wound Closure
Wound Dressings
2018 Revenue($Million)
% CAGR('18-’25) ASP per unit
Advanced $1,802 6.2% from <$10 to >$1,500
Traditional $1,130 1.2 <$10
Dermal Sciences: Large Wound Management MktWound care products are small portion of overall market
US Wound and Tissue Management Revenue (est.)
Commercially Available Wound Dressings US Wound/Tissue Management Market Overview
Source: US Market Report for Wound and Tissue Management, 2018, iData Research
Ø Overall cost of wound management exceeds $40B
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Dermal SciencesTargeting the vast array of skin wounds
AC5® Products Indications for UseUS: Under the supervision of a health care professional, AC5® Topical is indicated for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.
EU: AC5™ Topical Hemostat is intended for use locally as a dressing and to control mild to moderate bleeding, each during the management of injured skin and the micro-environment of an acute surgical wound.
Computer generated depiction of mechanism and use of AC5® Technology PlatformArch Therapeutics © 2019
Competitive Technologies
Utility Across Healing Phases
ConformsModulates
Inflammatory Response
Scaffold Enables Cell Migration& Proliferation
Resorbs / Incorporates Antigenic
AC5® Technology Yes Yes Yes Yes Yes No1
Negative Pressure Wound Therapy
No
No
No
No No
Yes
Collagen Matrices Yes Some
Foams
No NoTransparent Films
Alginates Partially
Hydrocolloids
NoBiomaterials some, in combination with adjunctive materials
YesSome
Skin Substitutes Yes
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SimpleEasy to use
Easy to prepareEasy to understand
EffectiveRapid
Works in presence of blood thinners
Assembles on Wound
Versatile
Broad tissue applicabilityOpen & closed procedures
Prophylactic effects
SafePermits normal healingNatural amino acids, non-animal sourced
Synthetic
AvoidSlow onset of action, preparation challenges, handling restrictions
Adhesions, foreign body reaction, infection, granulomaAnimal/human sourcing, antibody formation
Inflammatory responses, painNeed for intact clotting cascadeSurgical Sealing Technology History
Source: Arch Therapeutics, data on file Images: © 2019 Arch Therapeutics, All Rights Reserved
AC5® Technology FeaturesMatching the clinician’s specified performance needs
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Images courtesy of Tami Siewinski, RN, BSN,
M.Ed ©2018
AC5® Topical – A Wound Management SolutionLaunching a product during a pandemic
Clinician Focus ChangesØThroughputØResourcesØComplications
Clinical Audience ShiftsØToward urgent proceduresØAway from elective procedures
Earliest Adoption Likely Remains Management of Wounds that areØAcuteocomplicated surgical incisions
ØChronicosharp debridementowound bed preparation
ØOther at-risk scenariosodelayed healingopatients on anti-thrombotic medicationsoetc.
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Ø RegulatoryØ 510(k) receivedØ CE Mark pending
Ø PartneringØ Commercialize products across various markets (clinical and geographic)Ø Co-develop additional products/product linesØ Leverage advanced product features and potential mix shift upgrade
Ø RolloutØ Initial inventory in possession can proceed through release processes (labels, etc.)Ø Clinician engagement now focused on supporting their needs in pandemic
Ø KOL centersØ Private & Government facilities
Ø Partnerships to drive market penetrationØ Pricing
Dermal Sciences: CommercializationPreparing for market release
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Biosurgery
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Biosurgery: EMR Market Projected to GrowLarge and growing market demands better tools
Endoscopic Mucosal Resection Market Size & Growth
ESD opportunity: incremental upside
Source: Endoscopic Mucosal Resection Market: Global Industry, Persistence Market Research
20.8%
41.6%8.1%
29.5%
20.6%
41.9%
7.5%
29.9%Esophageal Cancer
Colon Cancer
Duodenal Cancer
Stomach Cancer
Endoscopic Mucosal Resection by Indication
Region 2017 Revenue($Million)
2025 Revenue($Million)
% CAGR(‘17-‘25)
Global Mkt Share
North America 539 968 7.6% 37%
Latin America 160 263 6.4% 11%
Europe 349 598 7.0% 24%
APAC 307 566 7.9% 21%
MEA 102 174 6.9% 7%
Total $1,457 $2,569 7.2% 100%
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AC5-GTM: a hemostatic lift agent for EMR & ESDPipeline candidate for complicated endoscopic procedures
Problem to solveØ Removing gastrointestinal cancerous and precancerous lesions by the least invasive approach possible
Drivers of EMR/ESDØ Increasing elderly populationØ Increasing incidence of gastrointestinal malignancies Ø Increasing demand demand for endoscopy
Risks of EMR/ESDØ PerforationØ BleedingØ Incomplete removal of polyp
Arch’s planned solution: AC5-GTM
Ø Self-assembling peptide to enable better visualization and tissue separation while lowering risks Ø Durable lift that lasts hours and minimizes reinjectionsØ Hemostatic, unlikely commercially available optionsØ Deliverable through long, narrow gauge injection needles (catheters)Ø Abstract selected for video presentation Society of American Gastrointestinal and Endoscopic Surgeons
(SAGES) Emerging Technology Session April 2, 2020
Endoscopic Mucosal Resection (EMR) & Endoscopic Submucosal Dissection (ESD)Endoscopic techniques to remove early-stage cancer and precancerous growths from the lining of the digestive tract.
Performed with a long narrow tube equipment which consist of light and video camera.
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AC5-GTM Demonstration in Endoscopic ResectionDurable lift, hemostasis in swine models
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AC5-GTM in Endoscopic DissectionDurable lift, hemostasis in swine models
Images: © 2020 Arch Therapeutics, All Rights ReservedInvestigational device. Limited by Federal law to investigational use.AC5-GTM is presently not commercially available.
23Source: MedMarket Diligence, LLC, Report #S290, July 2016
Biosurgery: Traditional HemostasisHemostat and sealant markets are large and growing
$0.0
$1.0
$2.0
$3.0
$4.0
$5.0
$6.0
$7.0
$8.0
2018 2019 2020 2021 2022
Worldwide Hemostat and Sealant Market (Revenue in $ billion)
Hemostats Fibrin and Other Sealants Total Hemostats and Sealants
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Unreliable, slow onset of action
Difficult to prepare and use
Foreign body reaction, infection, granuloma
Inflammatory responses / pain
Adhesions
Intact clotting cascade required
Animal/human sourcing (possible infectious agents, variable & costly manufacturing)
Handling restrictions
Antibody formation (proteins)
Limitations
Cautery
Gelatin
Collagen
Cellulose
Polymers
Thrombin
Fibrin sealants
Product Classes
Hemostatic Agents & SealantsNo ideal solutions for bleeding or leaking tissue
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Ø Received FDA clearance for additional manufacturer and process for AC5® Topical
Ø CE Mark for AC5® Topical Hemostat is pending
Ø Pandemic adjusts clinical discussion to how AC5 Topical can address new needs
Ø Partner planning ongoing
Ø GI application advancing
Ø New patent filed
Summary
235 Walnut Street, Suite 6Framingham, MA 01702 USA
Investor RelationsTel: 1.855.340.ARTH (2784)[email protected]
Contact Information