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 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 of 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 our views as of any date subsequent to the date of this presentation. 2

Inve stme nt Hig hlig hts   Large, growing market Portfolio approach   De ‐ risked drug development Scalable and capital ‐ efficient   Private ‐ pay First mover, pure ‐ play 3

De fining Pe t T he ra pe utic s Completed IPO Over 18 products in (3 product development (1 conditional candidates) and 1 full approval) 2010 2013 2014 Portfolio Expansion: Commercial Founded  Option Deals introduction  Vet Therapeutics Lymphoma MAb  Okapi Sciences  Advaxis  Vet ‐ Stem  Atopix 4

Our Pipe line Proof of Pivotal/ Pilot Concept Commercial AT ‐ 001 AT ‐ 003 AT ‐ 009 AT ‐ 006 AT ‐ 004 Degenerative Joint Disease Post ‐ operative Pain Mast Cell Tumor Feline Herpesvirus B ‐ cell Lymphoma AT ‐ 007 AT ‐ 010 AT ‐ 011 AT ‐ 002 AT ‐ 005 Atopic Dermatitis Canine Parvovirus Weight Gain Feline Immunodeficiency Virus T ‐ cell Lymphoma AT ‐ 012 AT ‐ 015 AT ‐ 002 AT ‐ 018 AT ‐ 001 Feline Calicivirus Lymphoma Weight Gain Osteoarthritis Atopic Dermatitis AT ‐ 017 AT ‐ 016 OPTION AT ‐ 008 AT ‐ 002 Lymphoma Stem Cell in OA Seizures Lymphoma Appetite Stimulant AT ‐ 003 Post ‐ operative Pain AT ‐ 014 Osteosarcoma 5

Our Ma rke t U.S. Pet Owners Spend ($Billions)  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 Source: APPA. 6

T he E volution of Pe t Owne rship “Snoopy Generation” “Brian Generation” Pets are family whose medical needs merit quality care 7

A F a vora ble Compa rison Humans Humans Pets Pets Development Development Multiple Species Steps Direct to Species ~$1.3B ~$10M ~10 Years ~5 Years Third Party Payer Private Pay Commercial Commercial Generic Pressure Innovator Brand Loyalty Difficult & Indirect Accessible & Direct 8

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 9

F DA a nd USDA T ime line s Year 1 Year 2 Year 3 Year 4 Year 5 FDA Center for Veterinary Medicine Proof of Concept INAD Chemistry, Mfg. & Controls (CMC) Safety Pilot ‐‐‐ > Pivotal Effectiveness Labeling, FOI Summary, Other Administrative NADA Year 1 Year 2 Year 3 Year 4 Year 5 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 10

De - risking Stra te g ie s Dose - finding a nd pilot studie s AT ‐ 002 (Capromorelin) AT ‐ 003 (ER Bupivacaine)   Ghrelin agonist for appetite and Post ‐ operative pain weight gain  Multi ‐ site, placebo ‐ controlled  Multi ‐ site, pilot field study in study in 46 dogs in an orthopedic dogs (17 treated, 12 placebo) indication  Appetite score on Day 6: 79 vs. 22  Better pain control for up to 72 placebo (p=0.025); Body weight hours based on pain score and 3.2% vs. ‐ 0.5% placebo (p=0.024) time ‐ to ‐ rescue (p<0.05)   Dog pivotal field effectiveness Dog pivotal field effectiveness study now underway (protocol study now underway (protocol concurrence) concurrence) 11

De - risking Stra te g ie s Dose - finding a nd pilot studie s AT ‐ 005 AT ‐ 014 (Cancer Vaccine)  Monoclonal antibody to aid in the  Canine Osteosarcoma treatment of canine T ‐ cell  Impressive data from a 30 dog lymphoma study at licensing (17 treated, 13  Medical science liaisons rather placebo) than general sales strategy  MST of <316 days in control  Targeting specialist oncologists group; MST in treatment group  T ‐ CHOMP, T ‐ LAB and T ‐ CEP has not been reached with 80% experience studies to better of dogs (15) alive (p<0.001) understand the market and how  the product will be used Submitted for product license to  USDA in July 2014 Anticipating full license from the USDA in 2015 12