November 2014 - Jefferies...Feline Calicivirus AT‐009 Mast Cell Tumor AT ‐011 Canine Parvovirus...

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Corporate Presentation November 2014

Transcript of November 2014 - Jefferies...Feline Calicivirus AT‐009 Mast Cell Tumor AT ‐011 Canine Parvovirus...

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Corporate PresentationNovember 2014

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Special Note Regarding Forward‐Looking StatementsThis presentation contains forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward‐looking statements, including statements regarding our expectations regarding the approval of products; expectations regarding development programs, trials, studies, approvals and commercialization; the sufficiency of financial resources; expected future cash balance and liquidity; expectations regarding in‐license initiatives, collaborations and partnerships; and expectations regarding the Company’s plans and opportunities.

These forward‐looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward‐looking statements, including, but not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; our lack of commercial sales; our failure to obtain any necessary additional financing; market conditions and our ability to raise capital under the shelf registration statement from the sale of our securities; our substantial dependence on the success of certain of our lead product candidates; our inability to identify, license, develop and commercialize additional product candidates; our inability to obtain regulatory approval for our existing or future product candidates; the lack of commercial success of our current or future product candidates; uncertainties regarding the outcomes of studies regarding our products; our inability to realize all of the anticipated benefits of our acquisitions of Vet Therapeutics and Okapi Sciences; effects of competition; our failure to attract and keep senior management and key scientific personnel; our reliance on third‐party manufacturers, suppliers, partners and other third parties which conduct our target animal studies and certain other development efforts; our lack of a sales organization; our significant costs of operating as a public company; our current exemption from the requirement to maintain internal control over financial reporting, and any failure to achieve or maintain effective internal control over financial reporting in the future; changes in distribution channels for pet therapeutics; consolidation of our customers; impacts of generic products; limitations on our ability to use our net operating carryforwards; unanticipated safety or efficacy concerns; our limited patents and patent rights; our failure to comply with our intellectual property license obligations; our infringement of third party patents and challenges to our patents or rights; our failure to comply with regulatory requirements; our failure to report adverse medical events related to our products; legislative or regulatory changes; the volatility of our stock price; our status as an “emerging growth company,” as defined in the JOBS Act; the potential for dilution if we sell shares of our common stock in future financings; the significant control over our business by our principal stockholders and management; the potential that a significant portion of our total outstanding shares could be sold into the market in the near future; effects of anti‐takeover provisions in our charter documents and under Delaware law; and our intention not to pay dividends. These and other important factors discussed under the caption "Risk Factors" in the Company’s Annual Report on Form 10‐K for fiscal year ended December 31, 2013 filed with the Securities and Exchange Commission, or SEC, on March 26, 2014, along with our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward‐looking statements made in this presentation. Any such forward‐looking statements represent management's estimates as of the date of this presentation. While we may elect to update such forward‐looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward‐looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation.

Safe Harbor Statement

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Investment Highlights

Large, growing market

De‐risked drug development

Private‐pay

Portfolio approach

Scalable and capital‐efficient

First mover, pure‐play

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Defining Pet Therapeutics

2010 2013 2014

Founded(2 product candidates)

Completed IPO (3 product candidates)

Portfolio Expansion: Option Deals Vet Therapeutics Okapi Sciences Advaxis Vet‐Stem Atopix

Over 15 products in development (2 with conditional licenses)

Commercial introduction 

Lymphoma MAb

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Our Pipeline

Pilot Pivotal/ Commercial

Proof ofConcept

AT‐008Lymphoma

AT‐016Stem Cell in OA

AT‐003Post‐operative Pain

AT‐002Weight Gain

AT‐002Weight Gain

AT‐007Feline Immunodeficiency Virus

AT‐001Degenerative Joint Disease

AT‐006Feline Herpesvirus

AT‐004B‐cell Lymphoma

AT‐005T‐cell Lymphoma

AT‐001Osteoarthritis

AT‐002Appetite Stimulant

AT‐014Osteosarcoma

AT‐003Post‐operative Pain

AT‐018Atopic Dermatitis

AT‐012Feline Calicivirus

AT‐009Mast Cell Tumor

AT‐011Canine Parvovirus

AT‐010Atopic Dermatitis

OPTIONSeizures

AT‐015Lymphoma

AT‐017Lymphoma

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Source: APPA. 

Our Market

Large and growing– 2014E U.S. pet spend of > $50B

Insensitive to recent recessions 68% of U.S. households

– 96M cats– 83M dogs

Medicalization drives growth– Historically, limited innovation– Pet therapeutics underrepresented

U.S. Pet Owners Spend($Billions) 

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The Evolution of Pet Ownership

“Snoopy Generation” “Brian Generation”

Pets are family whose medical needs merit quality care

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A Favorable Comparison

Multiple Species Steps Direct to Species

~$1.3B ~$10M

~10 Years ~5 Years

Third Party Payer Private Pay

Generic Pressure Innovator Brand Loyalty

Difficult & Indirect Accessible & Direct

PetsPetsHumansHumans

Develop

men

tDevelop

men

tCo

mmercial

Commercial

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Building the Portfolio

Toxicology data are available Manufacturing is scaled‐up Effectiveness data are available

Key Attributes

Unmet medical need High incidence or prevalence Known mechanism of action Nuance in science “Early de‐risking”  

Early De‐Risking

Leveraging the investment in human therapeutics Pharmaceuticals Biologics US and OUS

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FDA and USDA TimelinesFDA Center for Veterinary Medicine

Proof of Concept

INADChemistry, Mfg. & Controls (CMC)Safety

Effectiveness

Labeling, FOI Summary, OtherAdministrative NADA

Year 5Year 1 Year 2 Year 3 Year 4

USDA ‐ Center for Veterinary Biologics

Proof of Concept

Manufacturing

File for Product License

Preclinical

Field Safety and Efficacy

Conditional Product License*

Extended Field Safety and Efficacy Study

Full Product License* Conditional  l i censes  granted under specia l  circumstances

Year 5Year 1 Year 2 Year 3 Year 4

Pilot  ‐‐‐>  Pivotal

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AT‐001 (Grapiprant) EP4 receptor antagonist for pain Multi‐site, 350 dose‐ranging 

study in dogs (4 groups, including placebo)

Clinical success rate 61.6% vs. 42.2% placebo (0<.05)

As well tolerated as placebo at single daily dose

300 dog pivotal field effectiveness study underway (protocol concurrence) now at once‐daily dose

AT‐002 (Capromorelin) Ghrelin agonist for appetite and 

weight gain Multi‐site, pilot field study in 

dogs (17 treated, 12 placebo) Appetite score on Day 6: 79 vs. 22 

placebo (p=0.025); Body weight 3.2% vs. ‐0.5% placebo (p=0.024)

200 hundred dog pivotal field effectiveness study now underway (protocol concurrence)

De-risking StrategiesDose-finding and pilot studies

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AT‐003 (ER Bupivacaine) Post‐operative pain Multi‐site, placebo‐controlled 

study in 46 dogs in an orthopedic indication

Better pain control for up to 72 hours based on pain score and time‐to‐rescue (p<0.05)

Proceed to discuss pivotal field effectiveness study with CVM

AT‐014 (Cancer Vaccine) Canine Osteosarcoma Impressive data from a 30 dog 

study at licensing (17 treated, 13 placebo) 

MST of <316 days in control group; MST in treatment group has not been reached with 80% of dogs (15) alive (p<0.001)

Submitted for product license to USDA in July 2014

De-risking StrategiesDose-finding and pilot studies

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AT‐004 Anti CD20 monoclonal antibody 

to aid in the treatment of canine B‐cell lymphoma

Prospective double‐blind randomized placebo controlled study demonstrated MAb‐treated dogs had statistically longer median PFS

Prospective open‐label, multi‐site pilot study demonstrated that antibody‐treated dogs had statistically longer median PFS

Product has received conditional license from the USDA, awaiting full license 

AT‐006 Feline Herpesvirus Positive pilot trial done in Leuven 

by Belgium team (prior to acquisition)

Positive pilot trial announced in November 2014

Improvement in total ocular score seen in treated cats versus placebo in both trials

Using both trials to plan design of pivotal trial

De-risking StrategiesDose-finding and pilot studies

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Drug DevelopmentMilestones and communication plan

Safety UpdatesCVM Concurrence With Pivotal Protocol ‐Initiation of Pivotal Study ‐Completion of Pivotal Study ‐Submission of TAS Technical Section ‐Technical Section Complete Letter Press Release

CMC UpdatesAPI:Final Process Defined QuarterlyInitiate VICH Stability ‐Manufacture of VICH Stability Batches Complete ‐1 Year Stability Completed ‐

Formulation:Final Formulation Defined QuarterlyFinal Packaging Defined ‐CTM Manufactured ‐Initiate VICH Stability ‐Manufacture of VICH Stability Batches Complete Quarterly1 Year Stability Completed QuarterlyTechnical Section Complete Letter Press Release

Effectiveness UpdatesFinal Dose Selection QuarterlyCVM Concurrence of Pivotal Field Study Protocol QuarterlyInitiation of a Pivotal Study Press ReleaseCompletion of Pivotal Field Study QuarterlyPivotal Study Top Line Results Press ReleaseSubmission of Efficacy Technical Section QuarterlyTechnical Section Complete Letter Press ReleaseNADA UpdatesSubmission of Administrative NADA QuarterlyNADA Press ReleaseEuropean Approval UpdatesSubmission of Dossier Press ReleaseApproval Press ReleaseOther UpdatesStopping a Development Program in Any Species Press Release

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Clinical StudiesProgram Study Type Study Title

AT‐001 Cat Pilot Field Pilot clinical study Degenerative Joint Disease

AT‐001 Dog Pivotal Field Pivotal field study osteoarthritis pain

Pivotal Lab Pivotal PK study

AT‐002 Cat Pilot Lab Pilot safety study

Pilot Field Pilot clinical study weight gain

AT‐002 Dog Pivotal Field Pivotal field study inappetence 

Pivotal Lab Pivotal PK study

AT‐003 Cat Pilot Lab Pilot clinical study post‐operative pain

AT‐003 Dog Pilot Field Pilot clinical study post‐operative pain

AT‐005 Dog Marketing Field study combination therapy T‐CHOMP

Marketing Field study combination therapy T‐LAB

AT‐006 Cat Pilot Field Field Study Feline Herpesvirus Infection

AT‐007 Cat Pilot Lab Pilot clinical study Feline Immunodeficiency Virus

AT‐Beta Pilot Field Proof of concept seizures in dogs

AT‐Gamma Pilot Lab Proof of concept skin allergy model in dogs

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The Industry

Total number of NADAs NADAs for dogs / cats Pet therapeutic NCEs*

2011 12 6 2

2012 11 6 0

2013 6 4 2

* NCE defined as new chemical entity not previously approved in humans or animals (excluding parasite drugs).

Non‐confidential materials(may not be comprehensive)

As of 9/1/2014

~15 ~2 ~1

~2 ~1

Active Products at Field Study Stage

Historic Productivity of the Animal Health Industry

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Annual Exams17%

Diagnostics17%

Surgery17%Non‐Invasive 

Procedures9%

Pet Food Sales4%

Heartworm Product Sales

6%

Flea‐Tick Product Sales

6%

Vaccinations15%

Source: DVM Newsmagazine’s State of the Profession Report 2012.

Innovation is valued and desired

Medicines are high margin to practice

Facing pressure from alternative channels

Other Pharma 9%

Practice Revenue Mix

Commercial EnvironmentAlignment with the Veterinarian

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Therapeutic ClustersOncology/Specialty Pain/Primary Care

AT‐016Allogeneic Stem Cell

AT‐003Post‐operative Pain

AT‐007Immunodeficiency Virus

AT‐001Osteoarthritis AT‐006

Herpesvirus

AT‐004B‐cell Lymphoma

AT‐005T‐cell Lymphoma

AT‐002Appetite Stimulant

AT‐014Osteosarcoma

AT‐018Atopic Dermatitis

AT‐012Feline Calicivirus

AT‐009Mast Cell Tumor AT‐008

Lymphoma

Melanoma

Hemangiosarcoma

AT‐015Cat Lymphoma

AT‐BetaEpilepsy

AT‐011Parvo Virus

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US Oncologists

Board Certified Veterinary Oncologists

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T-Cell Monoclonal Introduction

2Q14 3Q14 4Q14 1Q15 2Q15 4Q153Q15

MSLsVeterinary 

Cancer Society

T‐Cell MAb Full License

~Two DozenParticipating Hospitals byEnd of 3Q14

~Three DozenParticipatingHospitals

End of 4Q14

~50 Participating Hospitals by End of 2Q15

~75 Participating Hospitals by End of 4Q15

T‐CHOMP and T‐LAB Trials

Experience Program

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Our Financial Profile September 30, 2014 cash balance $108.3M Net Loss as of September 30, 2014 was ($28.6M) or ($1.01)/ share R&D investment will increase as a result of advancing pipeline Continue to identify non‐dilutive sources of capital

‒ Partnering opportunities globally‒ Out‐licensing of non‐core products‒ Debt instruments

Strong and supportive investor base

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Investment Highlights

Portfolio approach

Scalable and capital‐efficient

First mover, pure‐play

Large, growing market

De‐risked drug development

Private‐pay

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Product Detail

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AT-001 (grapiprant)For osteoarthritis pain

Medical Need Established market (U.S. sales $260M, mostly NSAIDs for dogs) Existing NSAID products have side effects and require monitoring Better tolerated product for pain and inflammation of osteoarthritis

Our Solution EP4 receptor antagonist (a novel mechanism)

‒ Potential for significantly improved safety profile vs. Coxibs  Pilot field study completed in 2013 Pivotal field studies were initiated in 2014, with FDA approval expected in 

2016

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AT-001 (grapiprant)EP4 receptor biology

EP4 Receptor• Pain and Inflammation

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AT-002 (capromorelin)For inappetence

Medical Need No currently approved product Effective appetite stimulus to avoid feeding tubes and euthanasia Seen in aging and chronic conditions

Our Solution Mimics ghrelin (hunger hormone) to turn on appetite Statistically significant results on increased appetite and weight gain in 

dog pilot study Pivotal field study began in late 2013, with FDA approval expected in 

2016

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AT-002 (capromorelin)Ghrelin biology

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AT-003 (ER bupivacaine)For post-operative pain

Medical Need Pain increasingly recognized and treated Need for long‐acting, non‐narcotic post‐operative pain relief

Our Solution Bupivacaine liposome injectable suspension Pacira launched product for human use in early 2012 Pilot studies began in 2013, with NADA expected in 2016

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AT-003 (ER bupivacaine)

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Pet AntibodiesA proprietary platform

Pet specific antibodies with 85%+ pet sequences

Pet Fc region Most effective IgG sequence Straightforward engineering 

with no shuffling IP position directed at 

platform

Mouse Pet Specific

Highly specific‒ Developed against pet targets

Non immunogenic‒ Compatible with pet immune 

system Highly potent

‒ Engages pet immune system Cost effective

‒ High yield production 

heavy chain

light chain

VHVL CH1

CH2

CH3

CL

Proprietary Platform Pet Specific Antibodies

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Oncology Is Target-RichChemotherapy Human Cancer Use Pet Cancer Use

Cyclophosphamide Lymphomas MM, solid tumorsDoxorubicin Lymphomas MM, solid tumorsVincristine Lymphomas MM, solid tumorsPrednisone Lymphomas MM, solid tumorsL‐asparaginase Leukemia, LymphomaCarboplatin Solid TumorsCis‐platinum Sarcoma, Carcinoma, LymphomaMitoxantrone Breast cancer, AML, LymphomasLomustine Brain/CNS, Lymphoma, Mast cellMethotrexate Lymphomas Osteosarcoma

Antibody Human Cancer Use Pet Cancer Use

Rituxan (CD20) Non‐Hodgkin's Lymphoma XAvastin (VEGF) Solid Tumors XErbitux (EGFR) Solid Tumors XHerceptin (HER2) Breast Cancer XCampath (CD52) Chronic Lymphocytic Leukemia XMylotarg (CD33) Acute Myeloid Leukemia XZevalin (CD20) Follicular Lymphoma XBexxar (CD20) Non‐Hodgkin's Lymphoma XVectibix (EGFR) Solid Tumors XTheraCIM (EGFR) Solid Tumors X

Human Chemo Market

Currently no protein market Immunogenicity Lack of efficacy

Human drugs migrate unchanged into veterinary practice

Human Cancer Antibody Market

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Canine LymphomaIdeal for first antibody therapy

A canine‐specific antibody therapy could achieve in dogs what Rituxan has done for human lymphoma

Lymphoma is most common blood cancer in dogs‐ 6% of total dog cancer

Lymphoma is the most treated cancer‐ Chemotherapy is the current “standard of care”‐ Approximately 300,000 dogs are diagnosed per year in 

the U.S.‐ Treatment cost ranges between $2,500 and $10,000

Clinical manifestations are similar to humans Lymphocyte targeting has proven efficacious in pets

HemangiosarcomaSarcoma

Lymphoma

Mast Cell

Skin

BoneOther

RITUXAN‐LIKE APPROACH FOR DOG LYMPHOMA

Incidence

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AT-004 and AT-005 Lymphoma monoclonal antibodies

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Medical Need Chemo achieves short remissions and has a very high relapse rate Chemo can be harsh on pets and burdensome on owners Need effective and safe therapy to maintain remission as long as possibleOur Solution First‐in‐class product Aid in the treatment of canine B‐cell lymphoma  USDA conditional license granted; expect full license in 2014Market Potential Approximately 228,000 dogs are diagnosed per year in the U.S. Canine lymphoma is treated with chemotherapy (like in humans) Cost to pet owners of lymphoma treatment: ~$5,000

AT-004Canine-specific antibody for B-cell lymphoma

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Medical Need 24% of all lymphoma is T cell lymphoma T‐cell lymphoma is more aggressive and less responsive to treatment  

Our Solution First‐in‐class product Aid in the treatment of canine T‐cell lymphoma  Submitted for USDA product license; conditional license received in 

January 2014 Initiated studies under field conditions in combination with chemotherapy

AT-005Canine-specific antibody for T-cell lymphoma

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AT-014Therapeutic vaccine for osteosarcoma

Medical Need Estimated 8,000 to 20,000 dogs in US are affected annually Standard of care is amputation and post‐operative chemotherapy Nine‐to‐twelve months median survival; only 25% of dogs survive two years Need for effective and safe therapy with longer survival time

Our Solution First‐in‐class product to aid in the treatment of osteosarcoma  Developed at University of Pennsylvania by Advaxis Statistically significant survival post amputation Filed for USDA approval conditional license

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AT-014Biology

Live Vector Accesses Antigen Presenting Cells

TAA‐Fusion Peptide Secreted

Triggers Innate and Adaptive Pathogen Immune Response 

Tumors Now “Seen” As Pathogen‐Infected and Targeted By T‐Cells

Lm-LLO Immunotherapy Infusion

MHC II

MHC I

CD4+ T Cell

CD8+ T Cell

LLO mediated escape

Activated Dendritic Cell

tLLO‐TAA Fusion Proteins

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Medical Need Incidence in dogs estimated at up to 10% with recent product launch peak sales 

estimated at $200M Chronic condition which often can onset at a young age (1‐3 years old) Owners can easily diagnose symptoms including itching, sneezing, hair loss, paw 

licking, stains on skin etc.

Our Solution CRTH2 mechanism treats underlying disease rather than symptoms Target has been validated in human medicine (asthma, allergic rhinitis and others)

AT-018Atopic Dermatitis

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AT-018Role of Th2 Cellular Immunity

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Other Pipeline ProductsProduct Species Indication Development Status

AT‐006 Cat Herpesvirus Pilot study

AT‐007 Cat Immunodeficiency virus Pilot study

AT‐008 Dog Lymphoma Field study

AT‐009 Dog Mast cell tumor Lead selection

AT‐010 Dog Atopic dermatitis Lead selection

AT‐011 Dog Parvovirus Lead selection

AT‐012 Cat Calicivirus Lead selection

AT‐015 Cat Lymphoma Proof of concept

AT‐016 Dog Allogeneic stem cell therapy in osteoarthritis Dose confirmation study

AT‐017 Dog Lymphoma immunotherapy Lead selection