Corporate Presentation January 2015 Sa fe Ha rbor Sta te me nt - - PowerPoint PPT Presentation

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Corporate Presentation January 2015 Sa fe Ha rbor Sta te me nt - - PowerPoint PPT Presentation

Corporate Presentation January 2015 Sa fe Ha rbor Sta te me nt Special Note Regarding Forward Looking Statements This presentation contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of


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Corporate Presentation

January 2015

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Special Note Regarding Forward‐Looking Statements This 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; the uncertainty of outcomes

  • f the development of pet therapeutics, which is a lengthy and expensive process; 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, and the Company’s Quarterly Report on Form 10‐Q filed with the SEC on November 12, 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

  • ur views as of any date subsequent to the date of this presentation.

Sa fe Ha rbor Sta te me nt

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Inve stme nt Hig hlig hts

  • Large, growing market
  • De‐risked drug development
  • Private‐pay
  • Portfolio approach
  • Scalable and capital‐efficient
  • First mover, pure‐play
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De fining Pe t T he ra pe utic s

2010 2013 2014 Founded Completed IPO (3 product candidates) Portfolio Expansion:

  • Option Deals
  • Vet Therapeutics
  • Okapi Sciences
  • Advaxis
  • Vet‐Stem
  • Atopix

Over 18 products in development (1 conditional and 1 full approval) Commercial introduction Lymphoma MAb

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Our Pipe line

Pilot Pivotal/ Commercial Proof of Concept

AT‐008

Lymphoma

AT‐016

Stem Cell in OA

AT‐003

Post‐operative Pain

AT‐002

Weight Gain

AT‐002

Weight Gain

AT‐007

Feline Immunodeficiency Virus

AT‐001

Degenerative Joint Disease

AT‐006

Feline Herpesvirus

AT‐004

B‐cell Lymphoma

AT‐005

T‐cell Lymphoma

AT‐001

Osteoarthritis

AT‐002

Appetite Stimulant

AT‐014

Osteosarcoma

AT‐003

Post‐operative Pain

AT‐018

Atopic Dermatitis

AT‐012

Feline Calicivirus

AT‐009

Mast Cell Tumor

AT‐011

Canine Parvovirus

AT‐010

Atopic Dermatitis

OPTION

Seizures

AT‐015

Lymphoma

AT‐017

Lymphoma

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Source: APPA.

Our Ma rke t

  • 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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T he E volution of Pe t Owne rship

“Snoopy Generation” “Brian Generation”

Pets are family whose medical needs merit quality care

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A F a vora ble Compa rison

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

Pets Pets Humans Humans

Development Development Commercial 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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F DA a nd USDA T ime line s

FDA Center for Veterinary Medicine

Proof of Concept INAD Chemistry, Mfg. & Controls (CMC) Safety Effectiveness Labeling, FOI Summary, Other Administrative NADA Year 5 Year 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 licenses granted under special circumstances

Year 5 Year 1 Year 2 Year 3 Year 4

Pilot ‐‐‐> Pivotal

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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)

  • Dog pivotal field effectiveness

study now underway (protocol concurrence)

De - risking Stra te g ie s

Dose - finding a nd pilot studie s

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)

  • Dog pivotal field effectiveness

study now underway (protocol concurrence)

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AT‐005

  • Monoclonal antibody to aid in the

treatment of canine T‐cell lymphoma

  • Medical science liaisons rather

than general sales strategy

  • Targeting specialist oncologists
  • T‐CHOMP, T‐LAB and T‐CEP

experience studies to better understand the market and how the product will be used

  • Anticipating full license from the

USDA in 2015

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%

  • f dogs (15) alive (p<0.001)
  • Submitted for product license to

USDA in July 2014

De - risking Stra te g ie s

Dose - finding a nd pilot studie s

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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 full license

from the USDA

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 studies

  • Using both studies to plan design
  • f pivotal study

De - risking Stra te g ie s

Pa rtne re d prog ra ms

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T he Industry

Total number of NADAs NADAs for dogs / cats Pet therapeutic NCEs* 2011 12 6 2 2012 11 6 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)

~15 ~2 ~1 ~2 ~1

Active Products at Field Study Stage Historic Productivity of the Animal Health Industry

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Annual Exams 17% Diagnostics 17% Surgery 17% Non‐Invasive Procedures 9% Pet Food Sales 4% Heartworm Product Sales 6% Flea‐Tick Product Sales 6% Vaccinations 15%

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

Comme rc ia l E nvironme nt

Alig nme nt with the Ve te rina ria n

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T he ra pe utic Cluste rs

Oncology/Specialty Pain/Primary Care

AT‐016

Allogeneic Stem Cell

AT‐003

Post‐operative Pain

AT‐007

Immunodeficiency Virus

AT‐001

Osteoarthritis

AT‐006

Herpesvirus

AT‐004

B‐cell Lymphoma

AT‐005

T‐cell Lymphoma

AT‐002

Appetite Stimulant

AT‐014

Osteosarcoma

AT‐018

Atopic Dermatitis

AT‐012

Feline Calicivirus

AT‐009

Mast Cell Tumor

AT‐008

Lymphoma

Melanoma Hemangiosarcoma

AT‐015

Cat Lymphoma

AT‐Beta

Epilepsy

AT‐011

Parvo Virus

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US Onc olog ists

Board Certified Veterinary Oncologists

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T

  • Ce ll Monoc lona l Introduc tion

2Q14 3Q14 4Q14 1Q15 2Q15 4Q15 3Q15 MSLs Veterinary Cancer Society T‐Cell MAb Full License ~Two Dozen Participating Hospitals by End of 3Q14 ~Three Dozen Participating Hospitals End of 4Q14 ~50 Participating Hospitals by End of 2Q15 ~75 Participating Hospitals by End of 4Q15 T‐CHOMP and T‐LAB Studies T‐CEP Experience Program

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Pa in Ma rke t

Multimoda l ma na g e me nt

Disease Progression

Osteoarthritis

  • Over the counter
  • Coxib NSAIDs
  • EP4
  • MAbs, Capsaicin
  • Regenerative /

Disease modifying

Pre / Post Surgical

  • Anesthesia
  • Fentanyl
  • Bupivacaine
  • Bupenorphrine

Cancer

  • Opioids
  • Intrathecal

Neuropathic and Other

  • Human drugs used
  • ff label
  • Acupuncture
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Our F ina nc ia l 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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Inve stme nt Hig hlig hts

  • 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 (g ra pipra nt)

F

  • r oste oa rthritis pa in

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 tolerability profile vs. Coxibs

  • Pilot field study completed in 2013
  • Pivotal field studies were initiated in 2014; FDA approval anticipated in 2016
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AT

  • 001 (g ra pipra nt)

E P4 re c e ptor biolog y

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AT

  • 002 (c a promore lin)

F

  • r ina ppe te nc e

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, FDA approval anticipated in 2016
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AT

  • 002 (c a promore lin)

Ghre lin biolog y

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AT

  • 003 (E

R bupiva c a ine )

F

  • r post- ope ra tive pa in

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
  • Announced positive results from pilot field study in 3Q 2014
  • Initiated pivotal field study in dogs in 4Q 2014, FDA approval anticipated

in 2016

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AT

  • 003 (E

R bupiva c a ine )

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Pe t Antibodie s

A proprie ta ry pla tform

  • Pet specific antibodies
  • 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 VH VL CH1 CH2 CH3 CL

Proprietary Platform Pet Specific Antibodies

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Onc olog y Is T a rg e t- Ric h

Chemotherapy Human Cancer Use Pet Cancer Use

Cyclophosphamide Lymphomas MM, solid tumors Doxorubicin Lymphomas MM, solid tumors Vincristine Lymphomas MM, solid tumors Prednisone Lymphomas MM, solid tumors L‐asparaginase Leukemia, Lymphoma Carboplatin Solid Tumors Cis‐platinum Sarcoma, Carcinoma, Lymphoma Mitoxantrone Breast cancer, AML, Lymphomas Lomustine Brain/CNS, Lymphoma, Mast cell Methotrexate Lymphomas Osteosarcoma

Antibody Human Cancer Use Pet Cancer Use

Rituxan (CD20) Non‐Hodgkin's Lymphoma AT‐004 Avastin (VEGF) Solid Tumors X Erbitux (EGFR) Solid Tumors X Herceptin (HER2) Breast Cancer X Campath (CD52) Chronic Lymphocytic Leukemia AT‐005 Mylotarg (CD33) Acute Myeloid Leukemia X Zevalin (CD20) Follicular Lymphoma X Bexxar (CD20) Non‐Hodgkin's Lymphoma X Vectibix (EGFR) Solid Tumors X TheraCIM (EGFR) Solid Tumors X

Human Chemo Market Human Cancer Antibody Market

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Ca nine L ymphoma

Ide a l for first a ntibody the ra py

  • A canine‐specific antibody therapy could achieve in

dogs what Rituxan has done for human lymphoma

  • Lymphoma is most common blood cancer in dogs

‐ 8% of total dog cancer

  • Lymphoma is the most treated cancer

‐ Chemotherapy is the current “standard of care” ‐ Treatment cost ranges between $2,500 and $10,000

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

Hemangiosarcoma Sarcoma Lymphoma Mast Cell Skin Bone Other

RITUXAN‐LIKE APPROACH

I n c i d e n c e

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AT

  • 004 a nd AT
  • 005

L ymphoma monoc lona l a ntibodie s

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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 possible

Our Solution

  • First‐in‐class product
  • Aid in the treatment of canine B‐cell lymphoma
  • USDA full license granted

Market Potential

  • Canine lymphoma is treated with chemotherapy (like in humans)
  • Cost to pet owners of lymphoma treatment ~$5,000

AT

  • 004

Ca nine - spe c ific a ntibody for B- c e ll 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 T‐CHOMP, T‐LAB and T‐CEP studies under field conditions in

combination with chemotherapy

AT

  • 005

Ca nine - spe c ific a ntibody for T

  • c e ll lymphoma
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AT

  • 014

T he ra pe utic va c c ine for oste osa rc oma

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

  • 014

Biolog y

  • 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

  • 018

Atopic De rma titis

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AT

  • 018

Role of T h2 Ce llula r Immunity

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Othe r Pipe line Produc ts

Product 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