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FASTER, SAFER, SIMPLER SURGERY Terrence Norchi…pcgadvisory.com/wp-content/uploads/2017/07/Investor_Presentation... · FASTER, SAFER, SIMPLER SURGERY Terrence Norchi, M.D. President

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Page 1: FASTER, SAFER, SIMPLER SURGERY Terrence Norchi…pcgadvisory.com/wp-content/uploads/2017/07/Investor_Presentation... · FASTER, SAFER, SIMPLER SURGERY Terrence Norchi, M.D. President

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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

Page 2: FASTER, SAFER, SIMPLER SURGERY Terrence Norchi…pcgadvisory.com/wp-content/uploads/2017/07/Investor_Presentation... · FASTER, SAFER, SIMPLER SURGERY Terrence Norchi, M.D. President

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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 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; the consequences of competitive 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 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 5, 2016 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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Arch Therapeutics is developing innovative self-assembling barrier technologies to improve wound

care outcomes, enhance the quality of patient care by healthcare personnel, and offer compelling options to

healthcare institutions facing limited resources.

Arch Therapeutics—transforming the landscape of advanced interventional wound care.

Our Purpose?

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Investment Themes

Significant growth potentialBiotech company uniquely positioned to develop significant IP estate for large markets

Attractive regulatory pathwayExpecting multiple products regulated as medical devices

Near term opportunityUS, EU regulatory filings in ‘17 for innovative device in area of recognized medical need

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OTCQB: ARTH

Shares Outstanding (as of May 3, 2017) ~151 million

Shares / Options Held by Mgmt. (~19%) ~31 million

Stock Options – Outstanding and pursuant to “Plan” ~14 million

Trading Volume (90 day average) ~390,000

Cash (as of May 3, 2017) ~$7.2M

Current Cash Burn/Qtr. ~$1.5M

Debt ---

Key Statistics

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Ø Clinical Trial – Western Europe

Ø Initiated FDA regulatory process

Ø Obtained ISO 13485 Certification

Ø Human repeat-exposure skin trial to assess irritation potential

Ø Additional biocompatibility data for CE Mark application

Ø Intellectual Property (USPTO) Grants for self-assembling peptidesØ Barriers composition of matter patentØ Hemostasis method of use patent Ø Adhesions method of use patent Ø Leaky tight junctions method of use patent Ø Solid forms composition of matter and methods of use patent

2016 Accomplishments

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AC5™ Topical (skin)

AC5™ Surgery (internal) Platform Pipeline

Market Opportunities

• Surgery and trauma

• Hemostat• Wound care• Contaminant barrier

• Surgery and trauma

• Hemostat• Sealant• Laparoscopic procedures• Open procedures

• Adhesion prevention• Gastrointestinal anastomosis• Burns• Diabetic ulcers• Pressure ulcers• Ready-to-use and solid forms• Other

Medical Device

• US: 510k• EU: CE Mark

• US: PMA• EU: CE Mark

• Medical Devices

R&D

• Obtained human clinical data for safety and performance in cutaneous surgery

• Obtained preclinical, biocompatibility, repeat human exposure data

• Preclinical studies • Preclinical studies

IDE= Investigational Device Exemption; PMA=premarket approval; CE=European Conformity

Products in Development and Pipeline

Effective in presence of antithrombotic therapy

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Ø Announce grant for self-assembling peptidomimetics patent

Ø Raise Capital

Ø Submit 510(k) filing for external use to US FDA ~mid-year 2017

Ø File CE Mark for EU commercialization

Ø File IDE for internal surgical clinical trial (for planned PMA application)

Ø File additional patent application(s)

Ø Establish commercialization strategy

Ø Provide data from multiple preclinical programs in pipeline

2017 Planned Milestones

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How are we reaching our goals?With solid experienced leadership

Richard E. Davis Chief Financial OfficerNMT Medical, Rolling Management, TJX Companies, Wang Laboratories

Terrence W. Norchi, MD, MBA Director, President, CEO, FounderNEO Medical Univ, MIT, Tufts School of Med, Sanford Bernstein, Citigroup, Putnam

Avtar Dhillon, MD ChairmanMDS Capital Corp (Lumira), Protox (Sophiris Bio), BC Advantage Funds, Stevia First, Inovio, Oncosec

Steve Kates, PhD VP of TechnologyBrandeis, Millipore, Surface Logix, Ischemix, Northeastern, NIH, Am Chem Soc, Am Peptide Soc

Chirag Shah, PhD VP of R&D Engineering and QualityCovidien, Biolink, Bard

James Sulat DirectorMomenta (Chairman), Valneva (Intercell), AMAG, Diadexus, Chiron

Jayne Prats, PhD VP of Medical and Technical MarketingThe Medicines Company, ProMetic Biosciences, American International Chemical

Detailsavailableathttp://www.archtherapeutics.com/about/leadership

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How are we reaching our goals?And a “deep bench” of scientific/clinical advisors

Robert Williams, PhDColorado State University (University Distinguished Professor), Harvard University

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 Socof Nanomedicine, Glaucoma Foundation

Arthur Rosenthal, PhDBoston Scientific (former Chief Scientific Officer), JNJ, Boston University

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

Paresh Shah, MDNYU Langone Med Ctr & School of Med (Director of Gen Surgery, Vice Chair of Surgery), Lahey Clinic, Lenox Hill, ACS, SSAT, SAGES, Presidential Task Force for Health Care IT

Detailsavailableathttp://www.archtherapeutics.com/about/advisors

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Spleen - PigA challenging organ for bleeding

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Bleeding is common and poses problems in surgical procedures and traumaIssues for surgeons

Considerable time/resources to control bleeding during / after procedures

Visual field loss and increased error risk

Increased risks and morbidity for patients

Abnormal healing and adhesions

Hematomas and seromas

Patient population contributes to increased risk

Patients on ‘lifetime’ anticoagulant, antiplatelet agents

Increased risk in patients with co-morbidities (diabetes, renal disease, etc.)

Bleeding is costly

Increased length of stay

Use of expensive resources include OR time, transfusion risks, etc.

Bleeding A significant clinical and economic burden

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13Source: MedMarket Diligence, LLC, Report #S290, July 2016

Global Hemostat and Sealant Market is Growing

$0.0

$1.0

$2.0

$3.0

$4.0

$5.0

$6.0

$7.0

$8.0

2015 2016 2017 2018 2019 2020 2021 2022

GlobalHemostatandSealantMarket2015-2022 ($billion)

Hemostats FibrinandOtherSealants TotalHemostatsandSealants

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Cautery

Gelatin

Collagen

Cellulose

Polymers

Thrombin

Fibrin sealants

Product Classes

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

Currently No Ideal Solutions

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U.S. Wound Management Market, 2011-2020, $ millions

Wound Management Market is Growing

Source: MedMarket Diligence, LLC; Report #S249.

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Simple

Easy prep

Easy to use

Easy to understand

Effective

Rapid

Reliable

Assembles on Wound

Versatile

Broad tissue applicability

Open & closed procedures

Prophylactic effects

Safe

Biocompatible

Permits normal healing

Natural amino acids, non-animal source

What do physicians want in a hemostatic/barrier device?

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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

ArchTherapeutics,Inc.©2017

Solution: AC5 Topical HemostatTM

And Arch’s self-assembling peptide technology

ArchTherapeutics,Inc.©2017

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Hydrogel Fills Voids, Does Not Disrupt Cells

ArchTherapeutics,Inc.©2016

ArchTherapeutics,Inc.©2016

AC5 Delivered Locally, Simply

Locally Assembled Biocompatible Nanofiber Network

ArchTherapeutics,Inc.©2016

Novel MechanismSelf-assembly into a hemostatic barrier

ArchTherapeutics,Inc.©2016

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BeforetreatmentCoreremoved,woundtreatedwithAC5

saline saline nothing AC5-H AC5-H AC5-L AC5-L no HEP HEP HEP no HEP HEP no HEP HEP

n=6 n=5 n=4 n=9 n=6 n=5 n=5

* ✝

Rat Liver Model

Randomized treatment groups: AC5-H, AC5-L = high or low concentration formulations, HEP = heparin treated animal*p<0.0001: (AC5-H +/- HEP) vs (saline + HEP); (AC5-H +/- HEP) vs (nothing + HEP)✝ p<0.001: (AC5-L +/- HEP) vs (saline + HEP); (AC5-L +/- HEP) vs (nothing + HEP)

AC5 +/- Blood ThinnerTime to hemostasis (TTH) comparable +/- heparin

Source: Arch Therapeutics, data on file

Rat Liver Punch Biopsy, Heparin(4mm full thickness penetrating wound)

ArchTherapeutics,Inc.©2017

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AC5 saline ORC2 FG FGT ORC1 FbS

*

***

*

AC5 vs. Other Hemostatic AgentsFaster time to hemostasis (TTH) for AC5

Rat Liver Model

Source: Arch Therapeutics, data on file

n = 5 / group

AC5 = AC5TM

ORC1, ORC2 = oxidized regenerated cellulose type 1 or type 2 FG, FGT = flowable gelatin, flowable gelatin plus thrombinFbS = fibrin sealant

*p<0.02 for comparisons with AC5

Median TTH: AC5 <15 sec.; Control ~12x longer

Rat Liver Punch Biopsy (4mm full thickness penetrating wound)

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AC5 vs. Other Hemostatic AgentsHemostasis and adhesion profile best with AC5

I=ischemic areasA=adhesions

ventral aspect dorsal aspect

1 day after AC5 treatment

1 day after fibrin sealant treatment

Time to Hemostasis (TTH) vs Adhesions

TTH

(seco

nds)

Rat Liver Punch Biopsy (4mm full thickness penetrating wound)

AC5 = AC5TM

ORC1, ORC2 = oxidized regenerated cellulose type 1 or type 2 FG, FGT = flowable gelatin, flowable gelatin plus thrombinFbS = fibrin sealant

adhesion severity profile

SALINE

ORC1

FbS

FGT

FG

ORC2

n = 5 / group

Source: Arch Therapeutics, data on file

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Comparative Profiles:Topical agents for wound application

AC5™Platform

*

Biological✝ Physical✝

Fibrin Thrombin Gels Cellulose Collagen

Consistent, rapid barrier formation ✔ ✖ ✖ ✔ ✔ ✔

Hemostatic action ✔✔ ✔ ✔ ✖ ✖ ✔

Performs despitecoagulation/antithrombotic status ✔ ✔ ✖ ✖ ✖ ✖

Clear seal on wound ✔ ✖ ✖ ✖ ✖ ✖

Synthetic source limits animal protein/virus transmission ✔ ✖ ✖ ✖ ✔ ✖

Consistent and low cost manufacturing ✔ ✖ ✖ ✔ ✔ ✖

Non-immunogenic ✔ ✔ ✖ ✔ ✖ ✖

Non-irritating/ non-pyrogenic ✔ ✔ ✔ ✔ ✖ ✔

Biocompatible (resorbable) ✔ ✔ ✔ ✔ ✔ ✔

Non-swelling (vasoconstriction or secondary tissue damage not seen) ✔ ✔ ✔ ✖ ✖ ✖

* Arch Therapeutics, data on file; ✝Howe, J Am Acad Dermatol 2013;69:659.e1-17.

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Medical device pathway

EU and US Regulatory interactions begun

Device met primary and secondary endpoints of EU clinical (human) trial46 pts. with 10 on antiplatelet therapy (blood thinner)Safety outcomes comparable between AC5 and control; no serious adverse effects41% improvement in median time to hemostasis (TTH) versus controlTTH ≤30 seconds in groups of AC treated wounds (+/- antiplatelet therapy)

Regulatory filingsUS

510(k) for external topical useAdvanced filing plans to mid-2017Internal resources focusedBenefits include business opportunities, technology validation

PMA for internal useFile IDE for surgical trial in 2017

EUCE Mark – file application as soon as possible in 2017Potential use of US surgical data for internal use application

Clinical-Regulatory Plan for AC5Adding 510(k) to US regulatory strategy

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MassachusettsInstitute of Technology

Assigned to MITLicensed by Arch

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 operateExpected expiry to 2030

Arch Therapeutics

Assigned to Arch

Treatment of damaged tight junctions and enhancing extracellular matrixExpected expiry 2029

Compositions for prevention of adhesions and other barrier applicationsExpected expiry 2026

Composition of matter and methods of use for solid forms of SAP products Expected expiry 2034

Broad Intellectual Property PortfolioValue creation from range of protected uses /compositions

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HemostasisandSealants

Generalsurgery

Antithrombotics

Vascularpatch

Specialtysurgery

CNS

Microsurgery

Largesheathremoval

Trauma

Military OtherBarrierApplication

Pressureulcers

Adhesions

Diabeticfootulcers

Burns

Renalstoneantiretropulsion

WhiteSpace

Post-hemodialysis

Leakytightjunctions

NOTESprocedures

NewCompositions

Tissueregeneration

Hemostasis

Sealant

Adhesions

Pipeline Potential: Stasis & Barrier ApplicationsOpportunities for Arch and/or potential partners

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Examples (US)Pressure ulcers: 2.5M patients/yearDiabetic foot ulcers: 1-1.5M patients/yearBurns

US Figures

Prevalence: ~2% of population (~6-7M)Afflicts ~15% of elderlyAnnual costs surpass $50B Annual spend on wound care products surpasses $15B

Growth Drivers Aging populationPrevalence of underlying conditions, including diabetes, vascular disease, obesity

Problems

⬆ Morbidity, including amputation, and co-morbidities⬆ Mortality⬆ Hospital length of stay and re-hospitalization ⬆ long term use of expensive resources and medical infrastructure

Needs Organic biocompatible barrier to lessen bleeding/leaking, protect, promote moist environment, enable healing

Opportunity ~$1-2B

Pipeline: Chronic Cutaneous WoundsThe burden on public health

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Adhesions

2.5M patients/year in USForm after 70-90% of major abdominal surgery & in 50-100% of women after pelvic surgeryMarket growing ~ 15%Need: Cover, protect, promote moist environment, enable healingOpportunity: ~$1-2B

GI Sealant

~2-15% leak rate in anastomosesSignificant morbidity and mortalitySignificant reoperation rate with added expensesOpportunity: ~$0.5-1B, and potentially greater

Burns

500K patients/year in USLong term expensive treatmentNeed: Barrier to cover, protect, mitigate infection, lessen scarring, enable healingOpportunity: ~$1B

Broad Pipeline PotentialPre-clinical studies initiated in these and other areas

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235 Walnut Street, Suite 6Framingham, MA 01702 USA

Investor Relations

Tel: 1.855.340.ARTH (2784)[email protected]

Contact Information