Corporate Presentation
Fall 2015
Corporate Presentation Fall 2015 Safe Harbor Statement Special - - PowerPoint PPT Presentation
Corporate Presentation Fall 2015 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
Corporate Presentation
Fall 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 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
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;
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
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
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.
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Source: APPA.
– 2014 U.S. pet spend of $58B
– 96M cats – 83M dogs
– Historically, limited innovation – Pet therapeutics underrepresented
($Billions)
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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
Development Commercial
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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
7 AT-001 Osteoarthritis/Pain
Proof of Concept Safety & Effectiveness Chemistry, Mfg. & Control (CMC) Approval
AT-002 Inappetence AT-003 Post-Operative Pain
Proof of Concept Safety & Effectiveness Chemistry, Mfg. & Control (CMC) Approval
US US EU EU US US EU EU
2018
US US EU EU
2015 2016 2017 2014 2012 2013 Approval Chemistry, Mfg. & Control (CMC) Safety & Effectiveness Proof of Concept
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AT-004
Monoclonal Antibody B-cell Lymphoma
AT-005
Monoclonal Antibody T-cell Lymphoma
AT-001
Osteoarthritis
AT-002
Appetite Stimulant
AT-014
Osteosarcoma
AT-003
Post-operative Pain
AT-012
Feline Calicivirus
AT-009
Mast Cell Tumor
AT-011
Canine Parvovirus
AT-010
Atopic Dermatitis
AT-015
Lymphoma
AT-017
Lymphoma
AT-008
Lymphoma
AT-018
Atopic Dermatitis
AT-002
Weight Gain
AT-002
Weight Gain
AT-007
Immunodeficiency Virus
AT-001
DJD Pain
AT-006
Feline Herpesvirus
AT-016
Allogeneic Stem Cell OA
AT-003
Post-operative Pain
AT-Iota
Periodontal
* Current or next intended field study
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Total number of NADAs NADAs for dogs / cats Pet therapeutic NCEs* 2011 12 6 2 2012 11 6 2013 6 4 2 2014 11 4
* NCE defined as new chemical entity not previously approved in humans or animals (excluding parasite drugs)
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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.
Other Pharma 9%
Practice Revenue Mix
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Desire innovation
Prescribe and dispense medications
Partner mentality
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Less promotional regulations than human pharmaceuticals:
Ability to reach pet owners with advertising and public relations:
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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
Atopic Dermatitis
Melanoma
Hemangiosarcoma
Cat Lymphoma
Parvovirus
Lymphoma
Periodontal
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Osteoarthritis
Disease modifying
Pre / Post Surgical
Cancer
Neuropathic and Other
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Medical Need
Our Solution
‒ Potential for significantly improved tolerability profile vs. Coxibs ‒ No need for routine serum hematology and chemistry monitoring
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Phospholipids Arachidonic Acid Cyclooxygenase (COX)-2
PGE 2 (House keeping) TXA 2 PGI 2
NSAIDs
protection
aggregation
regulation EP2 EP3
Cyclooxygenase (COX)-1
EP1
PGE 2 (Inflammatory)
EP4 Receptor
Other EP Receptors
COXIBs Bs
AT-001 EP4 Receptor Antagonist
EP4 Receptor tor
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Design
Primary Endpoint: Canine Brief Pain Inventory – Success Rate on Day 28
Other Effectiveness Parameters Successes
Adverse Events
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Discrete chambers within a lipid matrix, each filled with bupivacaine liposome
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Design
Primary Endpoint: Improvements in Pain Evaluation
Other Effectiveness Parameters Successes
Adverse Events
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Medical Need
Our Solution
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1.5 million Doses
Drug Product Vet-Stem Single Fat Donation GMP Cell Expansion
Cryostorage and Distribution Harvest , Wash, Formulate and Freeze Initial isolation and expansion in GMP process Donor fat tissue Collection
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Brain
Pituitary gland
Stomach Intestine
Growth Hormone (GH)
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Design
Primary Endpoint: Owner Appetite Assessment – Success Rate on Day 4
Other Effectiveness Parameters Successes
Adverse Events
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Medical Need
peak sales estimated at $200M
licking, AND stains on skin Our Solution
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Figures adapted from: (Left) Townley, R. G. and S. Agrawal (2012). "CRTH2 antagonists in the treatment of allergic responses involving TH2 cells, basophils, and eosinophils. "Ann Allergy Asthma Immunol 109(6): 365-374. (Right) Arima, M. and T. Fukuda (2011). "Prostaglandin D(2) and T(H)2 inflammation in the pathogenesis of bronchial asthma.“ Korean J Intern Med 26(1): 8-18.
CRTH2 Signaling AT-018 inhibits PGD2 mediated activation and recruitment of basophils, eosinophils & TH2 lymphocytes.
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Board Certified Veterinary Oncologists
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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 Avastin (VEGF) Solid Tumors Erbitux (EGFR) Solid Tumors Herceptin (HER2) Breast Cancer Campath (CD52) Chronic Lymphocytic Leukemia Mylotarg (CD33) Acute Myeloid Leukemia Zevalin (CD20) Follicular Lymphoma Bexxar (CD20) Non-Hodgkin's Lymphoma Vectibix (EGFR) Solid Tumors TheraCIM (EGFR) Solid Tumors
Human Chemo Market Human Cancer Antibody Market
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with no shuffling
platform Mouse Pet Specific
‒ Developed against pet targets
‒ Compatible with immune system
‒ Engages immune system
‒ High yield production
heavy chain light chain VH VL CH1 CH2 CH3 CL
Proprietary Platform Pet Specific Antibody Ideal Profile
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Hemangiosarcoma Sarcoma Lymphoma Mast Cell Skin Bone Other
I n c i d e n c e
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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
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All dogs without gross metastatic disease at the time of first dosing
Median survival Control: 316 days Canine OSA Vaccine: 956 days
Diagnosis & Amputation Chemotherapy (Carboplatin 300mg/m2 q 21 days x 4) Screening visit 3 vaccinations given 3 weeks apart Re-staging visit 3 weeks after last vaccination Re-staging visits q2months
Boosters provided
every 4- 6 months n=18 p < 0.0001
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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-017 Dog Lymphoma Lead selection Other: AT-epsilon, AT-zeta, AT-iota, AT-eta, AT-theta
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‒ Debt instruments ‒ Partnering opportunities globally ‒ Monetize non-core products and operations
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