Corporate Presentation
January 2015
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
January 2015
2
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
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
3
4
5
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
6
Source: APPA.
– 2014E U.S. pet spend of > $50B
– 96M cats – 83M dogs
– Historically, limited innovation – Pet therapeutics underrepresented
($Billions)
7
8
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
9
Key Attributes
Early De‐Risking
10
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
11
12
13
14
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
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.
Other Pharma 9%
16
Oncology/Specialty Pain/Primary Care
Allogeneic Stem Cell
Post‐operative Pain
Immunodeficiency Virus
Osteoarthritis
Herpesvirus
B‐cell Lymphoma
T‐cell Lymphoma
Appetite Stimulant
Osteosarcoma
Atopic Dermatitis
Feline Calicivirus
Mast Cell Tumor
Lymphoma
Melanoma Hemangiosarcoma
Cat Lymphoma
Epilepsy
Parvo Virus
17
18
19
Disease modifying
20
21
23
24
25
26
27
28
29
with no shuffling
platform Mouse Pet Specific
‒ Developed against pet targets
‒ Compatible with pet immune system
‒ Engages pet immune system
‒ High yield production
heavy chain light chain VH VL CH1 CH2 CH3 CL
Proprietary Platform Pet Specific Antibodies
30
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
31
Hemangiosarcoma Sarcoma Lymphoma Mast Cell Skin Bone Other
I n c i d e n c e
32
33
34
35
36
Antigen Presenting Cells
Secreted
Adaptive Pathogen Immune Response
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
37
38
39
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