Corporate Presentation - Jefferies 2015 Global Healthcare Conference
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Corporate Presentation Jefferies 2015 Global Healthcare Conference
Safe Harbor Statement
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 without limitation statements with respect to
expectations regarding the timing of discussions with the FDA and/or USDA and approval and licensure of products; development programs, clinical trials and studies,
including without limitation the timing of full enrollment in and the announcement of results of such trials and studies; commercialization and manufacturing of
products, including without limitation establishing larger manufacturing capacities for AT-004 and AT-005; the sufficiency of financial resources; expected future cash
balance and liquidity; licensing initiatives and collaborations; the Company’s plans and opportunities, including without limitation offering a unique portfolio of
innovative therapeutics; and the Company’s belief that its products and product candidates will result in improved outcomes for pets.
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 dependence on novel technologies and compliance with complex regulatory requirements; 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; our inability to realize all of the anticipated benefits
of our acquisitions of Vet Therapeutics and Okapi Sciences; uncertainties regarding the outcomes of studies regarding our products; the uncertainty of outcomes of
the development of pet therapeutics, which is a lengthy and expensive process; effects of competition; our inability to identify, license, develop and commercialize
additional product candidates; 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; unanticipated difficulties or challenges in the
relatively new field of biologics development and manufacturing; our ability to market our products only for the treatment of indications for which they are approved;
our small commercial organization; difficulties managing the growth of our organization; our significant costs of operating as a public company; risks related to the
restatement of our financial statements for the year ended December 31, 2013 and the identification of a material weakness in our internal control over financial
reporting; changes in distribution channels for pet therapeutics; consolidation of our customers; limitations on our ability to use our net operating carryforwards;
impact of generic products; 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; litigation resulting from the misuse of our confidential information; the
uncertainty of the regulatory approval process; our failure to comply with regulatory requirements or obtain foreign regulatory approvals; 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 filed with the Securities and Exchange Commission, or SEC, on March 16, 2015, 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.
2
Investment Highlights
Large, growing market Portfolio approach
De-risked drug development Scalable and capital-efficient
Private-pay First mover, pure-play
3
Defining Pet Therapeutics
Completed IPO
Over 18 products Regain Rights to
3 products in
in development AT-004
development
2010 2013 2014 2015 2016
Founded Portfolio Expansion:
Option Deals Introduction of
Vet Therapeutics Lymphoma MAb
Okapi Sciences
Advaxis
Vet-Stem
Atopix
4
Our Market
($Billions) U.S. Pet Owners Spend
Large and growing
– 2014 U.S. pet spend of $58B
Insensitive to recent recessions
68% of U.S. households
– 96M cats
– 83M dogs
Medicalization drives growth
– Historically, limited innovation
– Pet therapeutics underrepresented
Source: APPA.
5
The Evolution of Pet Ownership
“Snoopy Generation” “Brian Generation”
Pets are family whose medical needs merit quality care
6
A Favorable Comparison
Humans Pets
Development
Multiple Species Steps Direct to Species
~$1.3B ~$10M
~10 Years ~5 Years
Third Party Payer Private Pay
Commercial
Generic Pressure Innovator Brand Loyalty
Difficult & Indirect Accessible & Direct
7
Building the Portfolio
Key Attributes Early De-Risking
Unmet medical need Toxicology data are available
High incidence or prevalence Manufacturing is scaled-up
Known mechanism of action Effectiveness data are available
Nuance in science
“Early de-risking”
Leveraging the investment in human therapeutics
Pharmaceuticals
Biologics
US and OUS
8
FDA and USDA Timelines
FDA Center for Veterinary Medicine Year 1 Year 2 Year 3 Year 4 Year 5
Proof of Concept
INAD
Chemistry, Mfg. & Controls (CMC)
Safety
Effectiveness Pilot ---> Pivotal
Labeling, FOI Summary, Other
Administrative NADA
USDA - Center for Veterinary Biologics Year 1 Year 2 Year 3 Year 4 Year 5
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
* Condi tiona l l i cens es gra nted under s peci a l ci rcums tances
9
Our Pipeline
Proof of Pivotal/
Pilot
Concept Commercial
AT-001 AT-004
AT-010 AT-009 AT-006 (grapiprant)
Monoclonal Antibody
Atopic Dermatitis Feline Herpesvirus B-cell Lymphoma
Mast Cell Tumor Degenerative Joint Disease
AT-012 AT-011 AT-002 AT-007 AT-005
(capromorelin) Monoclonal Antibody
Feline Calicivirus Canine Parvovirus Weight Gain Feline Immunodeficiency Virus T-cell Lymphoma
AT-003 AT-001
AT-017 AT-015 (bupivacaine liposome AT-018 (grapiprant)
Lymphoma Lymphoma injectable suspension) Atopic Dermatitis
Post-operative Pain Osteoarthritis
AT-Beta AT-Iota AT-002 AT-016 AT-002
(capromorelin) (capromorelin)
Epilepsy Periodontal Weight Gain Allogeneic Stem Cell OA Appetite Stimulant
AT-003
AT-008 (bupivacaine liposome
Lymphoma injectable suspension)
Post-operative Pain
AT-014
Osteosarcoma
10Our Industry
Products at Field Study Stage in Dogs and Cats
~15 ~3 ~2
Non-confidential materials
~1 ~1 (may not be comprehensive)
Historic Productivity of the Animal Health Industry
Total number of NADAs NADAs for dogs / cats Pet therapeutic NCEs*
2011 12 6 2
2012 11 6 0
2013 6 4 2
2014 11 4 0
* NCE defined as new chemical entity not previously approved in humans or animals (excluding parasite drugs).
11Industry Recognition
12Commercial Environment
Alignment with the Veterinarian
Practice Revenue Mix
Other Pharma Annual
9% Exams
17% Innovation is valued and
Vaccinations desired
15%
Medicines are high
Diagnostics
Flea-Tick 17% margin to practice
Product Sales
6%
Heartworm Facing pressure from
Product Sales
6%
alternative channels
Pet Food Surgery
Sales Non-Invasive 17%
4% Procedures
9%
Source: DVM Newsmagazine’s State of the Profession Report 2012.
13Therapeutic Clusters
Oncology/Specialty Pain/Primary Care
AT-004
B-cell Lymphoma AT-018
AT-002 Atopic Dermatitis
AT-005 AT-017
Appetite Stimulant AT-Beta
Epilepsy
T-cell Lymphoma Lymphoma AT-003 AT-007
Post-operative Pain
Immunodeficiency Virus
AT-009 AT-014 AT-016 AT-010
Allogeneic Stem Cell Atopic Dermatitis
Mast Cell Tumor Osteosarcoma AT-006
AT-001 Herpesvirus
Osteoarthritis
AT-015 AT-Epsilon AT-011
Cat Lymphoma Melanoma AT-Eta AT-012 Parvo Virus
Anti HER-2 MAb Feline Calicivirus
AT-Zeta AT-Iota
Hemangiosarcoma
Periodontal
14Oncologists
Initial customer
Board Certified Veterinary Oncologists
15Oncology
Target-rich, known biology
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
Human Chemo
Carboplatin Solid Tumors
Market 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
Avastin (VEGF) Solid Tumors X
Erbitux (EGFR) Solid Tumors X
Herceptin (HER2) Breast Cancer X
Human Cancer Campath (CD52) Chronic Lymphocytic Leukemia
Antibody Market 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
16Pet Antibodies
A proprietary platform
heavy
chain
VH
VL CH1
light
CL
chain
CH2
CH3
Mouse Pet Specific
Proprietary Platform Pet Specific Antibody Ideal Profile
Pet specific antibodies Highly specific
Pet Fc region ‒ Developed against pet targets
Most effective IgG sequence Non immunogenic
‒ Compatible with immune system
Straightforward engineering
Highly potent
with no shuffling ‒ Engages immune system
IP position directed at Cost effective
platform ‒ High yield production
17Oncology Market
Specialty approach
Veterinary Veterinary T-CHOMP/
Cancer Society Cancer Society T-LAB Results
T-Cell MAb
Full License
4Q14 1H15 2H15 1H16 2H16
~ Three dozen ~75 Additional
Participating Participating Oncology
Practices Practices Practices
Scientific Studies
T-CHOMP and T-LAB Studies
T-CEP Experience Program
B-Cell Studies 18Pain Market
Multimodal management
Disease Progression
Over the counter Coxib NSAIDs Regenerative /
Osteoarthritis EP4 Disease modifying
MAbs, Capsaicin
Anesthesia Fentanyl
Pre / Post Surgical Bupivacaine
Bupenorphrine
Opioids Intrathecal
Cancer
Human drugs used Acupuncture
Neuropathic and off label
Other
19American College of Veterinary Internal Medicine
June 3-6 Schedule of Events
Cancer therapies
The Evolving Science of Immunotherapeutics in Veterinary Oncology
A Prospective, Open-Label Study Evaluating Treatment of Canine B-cell Lymphoma with L-Asparaginase,
Doxorubicin, and a Canine Anti-CD20 Monoclonal Antibody
Clinical Application of Immunotherapeutics in Veterinary Oncology
Anti-CD20 Monoclonal Antibody Canine Lymphoma Therapy: A Double-Blind, Randomized, Placebo-
Controlled Study
Combination Listeria-Based Immunotherapy Plus Palliative Radiation Delays Tumor Progression and
Prolongs Overall Survival in Canine Osteosarcoma
Inappetence
Safety of the Ghrelin Agonist, Capromorelin, Administered Daily to Beagle Dogs for One Year
Capromorelin, An Orally Active Ghrelin Agonist Caused Sustained Increases in IGF-1, Increased Food Intake
and Body Weight in Cats
Safety of the Ghrelin Agonist, Capromorelin Administered Daily to Cats for 91 Days at an Oral Dose of
6mg/kg
New Therapeutic Advances in Inappetence for Pets
Pain Management
Introduction to the Emerging Piprant Therapeutic Class of Prostanoid Receptor Antagonists
Safety and Toxicokinetic Profiles in Cats Administered Grapiprant, A Selective Prostaglandin-Receptor
Antagonist
20Anticipated Upcoming Events
2015 ACVIM Forum (multiple abstracts and scientific presentations)
Results of AT-002 Dog US pivotal field effectiveness study
Results of AT-003 Dog US pivotal field effectiveness study
Results of pilot studies (AT-016 Dog, AT-003 Cat, AT-002 Cat, AT-003 Cat)
Initiation of pilot studies (AT-017, AT-018)
Continued AT-004/AT-005 availability
Full USDA license for AT-005
21Our Financial Profile
March 31, 2015 cash balance $87.4M
Net Loss for 1st Quarter ending March 31, 2015 was ($8.8M) or
($0.26)/ 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
22Investment Highlights
Large, growing market Portfolio approach
De-risked drug development Scalable and capital-efficient
Private-pay First mover, pure-play
23Product Detail
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 Prostaglandin Receptor Antagonist
‒ Potential for significantly improved tolerability profile vs. Coxibs
Positive results from pivotal field effectiveness study in December 2014
Technical section complete for safety received; CMC submitted
FDA approval anticipated in 2016
25AT-001 (grapiprant)
EP4 receptor biology
26AT-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 results expected in late-June 2015
Technical section complete for safety received; CMC submitted
FDA approval anticipated in 2016
27AT-002 (capromorelin)
Ghrelin biology
28AT-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
Announced positive results from pilot field study in 3Q 2014
Pivotal field study results expected in July 2015
Technical section complete for safety received; CMC submitted
FDA approval anticipated in 2016
29AT-003 (ER bupivacaine)
30Canine Lymphoma
Ideal for first antibody therapy
RITUXAN-LIKE APPROACH
Hemangiosarcoma
A canine-specific antibody therapy could achieve in Sarcoma
dogs what Rituxan has done for human lymphoma I
Lymphoma is most common blood cancer in dogs Lymphoma n
c
- 8% of total dog cancer Mast Cell i
Lymphoma is the most treated cancer d
e
Skin
- Chemotherapy is the current “standard of care” n
c
- Treatment cost ranges between $2,500 and $10,000 Bone e
Clinical manifestations are similar to humans Other
Lymphocyte targeting has proven efficacious in pets
31AT-004 and AT-005
Lymphoma monoclonal antibodies
32AT-004
Canine-specific antibody for B-cell lymphoma
Medical Need
76% of all lymphoma is B-cell lymphoma
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
Planning additional scientific studies and clinical studies under field
conditions in combination with chemotherapy
Second generation product with increased specificity and ability to access
the OUS markets 33Human Experience
MAbs are now standard of care
34A-004 for B-Cell Lymphoma
Progression Free Survival for Phase 1 - Updated on 26Mar14
1.00
Free Survival
pAT-005
Canine-specific antibody for T-cell lymphoma
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
Additional scientific studies
36AT-014
Therapeutic 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
37AT-014
Biology
Live Vector Accesses
Lm-LLO Immunotherapy Infusion CD4+ T
Antigen Presenting Cells
Cell
TAA-Fusion Peptide
MHC Secreted
II
Triggers Innate and
Adaptive Pathogen
Activated Immune Response
Dendritic Cell
Tumors Now “Seen” As
LLO Pathogen-Infected and
mediated
escape Targeted By T-Cells
MHC
I
tLLO-TAA
Fusion
Proteins
CD8+ T
Cell
38AT-018
Atopic Dermatitis
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)
39AT-018
Role of Th2 Cellular Immunity
40De-risking Strategies
Dose-finding and pilot studies pivotal study
AT-001 (Grapiprant)
An oral, once-daily EP4 receptor antagonist
Pilot field study completed in 2013
Clinical success rates based on the validated CBPI at day 28 were 48.1%
for the once-daily dose of AT-001 vs. 31.3% for the placebo group which
represents a statistically significant difference (pDe-risking Strategies
Dose-finding and pilot studies pivotal study
AT-002 (Capromorelin) AT-003 (ER Bupivacaine)
Ghrelin agonist for appetite and Post-operative pain
weight gain Multi-site, placebo-controlled study
in 46 dogs in an orthopedic
Multi-site, pilot field study in dogs indication
(17 treated, 12 placebo) Better pain control for up to 72
Appetite score on Day 6: 79 vs. 22 hours based on pain score and
placebo (p=0.025); Body weight time-to-rescue (pDe-risking Strategies
Regulatory and post-marketing studies
AT-005 (T-cell Lymphoma) AT-014 (Cancer Vaccine)
Monoclonal antibody to aid in the Canine osteosarcoma
treatment of canine T-cell Study in 18 client-owned dogs
lymphoma
Medical science liaisons rather than MST not yet reached for treated
general sales strategy group; 80% of dogs surpassing the
Targeting specialist oncologists MST of the control group (pOther Pipeline Products
Product Species Indication Development Status
AT-006 Cat Herpesvirus Designing pivotal study with partner
AT-007 Cat Immunodeficiency virus Pilot studies
AT-008 Dog Lymphoma Planning for pivotal studies in Europe
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 Osteoarthritis Pilot studies
AT-017 Dog Lymphoma Lead selection
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