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