The Science The Business - CTL Business. The Problem We’re Solving: ... $35 Billion - Global...
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Bactana Animal Health Contact Information John Kallassy | Chief Executive Officer| 203-716-1230 | [email protected] OUR LEADERSHIP TEAM John A. Kallassy Chief Executive Officer Co-founder. Experienced entrepreneur and innovator having led early stage companies in the animal health and human medical device fields to exit or IPO. MBA, Cornell Johnson School Rodrigo Bicalho, Ph.D., DVM Chief Scientific Officer Co-founder. Professor, at Cornell’s College of Veterinary Medicine. One of the world’s leading experts on dairy cattle health. Ph.D. , DVM, College of Veterinary Medicine at Cornell University Reinaldo F. Cooke, Ph.D. Scientific Advisor Professor and beef cattle specialist at the Oregon State University. He is a trusted advisor to many of the most productive beef and cow calf operations in the world. Ph.D. Animal Sciences, University of Florida William F. Leimkuhler, JD General Counsel Former general counsel at New York investment banking firm Allen & Company LLC and corporate partner with Werbel & Carnelutti. MSc, MIT & JD, New York University The Science The Business The Problem We’re Solving: It is accepted among the scientific community that antibiotic use in livestock is a major contributor to human resistance, posing a significant public health risk. Large animal health co’s have a declining innovation pipeline and are seeking new technologies to fill the gap created by declining antibiotic (and hormone) use. Next Steps: - Use our FPS-4 platform to develop product Lifecycle Management Strategies for multiple livestock species and multiple formulations. Expand global IP platform. - Complete venture financing - Develop commercial scale manufacturing & formulation - Sign distribution and R&D collaborations— with partner(s) based on their strengths, product indication, species, and territory - Refine global regulatory strategy and pursue approvals (likely through partners). Expand clinical trials to include new species. Other Business Drivers: Strong IP Position, Cornell McGovern Center Client, in negotiations with Global Animal Health Distribution Partners. Historical Timeline: Large Addressable Markets: • $30 Billion - Global animal medicine & feed additives • $35 Billion - Global probiotic market • $1 Billion – US corporate spending on animal health R&D • Massive Potential Markets for Bactana: Cattle, Swine, Poultry, Aquaculture, Companion, and Human Diarrhea and Related Mortality Rate and Increased Weight Gain in Preweaned Dairy Heifers Carla Foditsch 1 , Richard Van Vleck Pereira 1 , Erika Korzune Ganda 1 , Marilia Souza Gomez 1 , Eduardo Carvalho Marques 2 , Thiago Santin 2 , Rodrigo Carvalho Bicalho 1 1 Department of Population Medicine and Diagnostic Sciences, College of Veterinary Medicine, Cornell University, Ithaca, New York, United States of America, 2 Department of Clinical Science, College of Veterinary Medicine and Animal Sciences, University of São Paulo, São Paulo—SP, Brazil Probiotics are a promising alternative to improve food animal productivity and health. However, scientific evidence that specific microbes can be used to benefit animal health and performance is limited. The objective of this study was to evaluate the effects of administering a live culture of Faecali bacterium prausnitzii to newborn dairy calves on subsequent growth, health, and fecal microbiome. A total of 554 Holstein heifers were assigned to one of two treatment groups: treated calves (FPTRT) and non treated calves (control). Treated calves received two oral doses of F. prausnitzii, one at treatment assignment (1st week) and another one week later. The FPTRT group presented significantly lower incidence of severe diarrhea (3.1%) compared with the control group (6.8%). Treated calves also had lower mortality rate associated with severe diarrhea (1.5%) compared to control calves (4.4%). Furthermore, FPTRT calves gained significantly more weight, 4.4 kg over the preweaning period, than controls calves. The relative abundance of F. prausnitzii in the fecal microbiota was significantly higher in the 3 rd and 5 th weeks of life of FPTRT calves than of the control calves, as revealed by sequencing of the 16S rRNA gene. Abstract: Published Trial Results 554 Holstein heifers were assigned to one of two treatment groups: treated calves and control New Clinical Findings— October 2016 Additional Opportunities for FPS-4™ Swine & Poultry Disease Prevention and Growth There are more than 120 million piglets and 8.54 billion broilers born each year in the U.S. alone. Multi-billion dollar markets exist for a low-cost natural product proven to increase weight gain, reduce disease, and improve gut health. Companion Animal Anti-diarrheal We estimate that 9 million dogs & cats are treated for diarrhea by veterinarians each year in the U.S. and many more pet owners treat their pets for diarrhea at home. Equine Anti-diarrheal There are over 9 million adult horses and foals in the U.S. Many succumb to diarrhea and there are no proven cost effective treatments. Human Pharmaceutical / Supplement There is evidence that FPS-4 based products may have benefits for human use: may aid malnourished global indigent populations. Annual U.S. Beef & Dairy Calf Market Enhancing the Microbiome to Reduce Hormone & Antibiotic Usage in the World’s Food Supply Our product development platform, FPS-4™, is based on a collection of bacteria isolates from Faecalibacterium spp., and licensed from Cornell’s Center for Technology Licensing (CTL). • Dr. Bicalho’s team at Cornell began DNA sequencing experiments to identify novel beneficial microbes from swine and cattle • Extensive lab testing performed on hundreds of bacteria isolates to identify product candidates. Patent applications developed 2014 2012 2013 2015 Q1: Developed business plan, established milestones, & performed mkt. research Q2: Signed exclusive global technology license with Cornell University (CTL) Q3: Signed LOI with Cornell for human market. Filed additional patents Q3-Q4: Created shelf stable formulation, process & filed provisional patent Q3-Q4: Entered partnership discussions w/six global animal health companies Q4: Launched angel investment round (convertible debt) • Breakthrough field trial results published in December 2015 • Strong Chinese patent granted • Dr. Bicalho’s research team continued advancing FPS-4 fermentation & lyophilization process • 238 isolates identified for further testing, resulting in four candidates (FPS-4) • Received grant to evaluate effect on ruminant microbiome, general health, and weight gain • Calf safety trial completed. Clinical field trial on 554 dairy calves initiated US Patent allowed and two new filings with the US patent office Closed angel financing round Scaling-up of manufacturing and formulation process Accepted into Cornell’s McGovern Incubation Center Initiated two additional trials 2016 2017 Q1-Q2 Sample Market Opportunity
Transcript of The Science The Business - CTL Business. The Problem We’re Solving: ... $35 Billion - Global...
Bactana Animal Health Contact InformationJohn Kallassy | Chief Executive Officer| 203-716-1230 | [email protected]
OUR LEADERSHIP TEAM
John A. KallassyChief Executive OfficerCo-founder. Experienced
entrepreneur and innovator having led early stage
companies in the animal health and human medical device fields to exit or IPO.
MBA, Cornell Johnson School
Rodrigo Bicalho, Ph.D., DVMChief Scientific Officer
Co-founder. Professor, at Cornell’s College of Veterinary Medicine. One of the world’s
leading experts on dairy cattle health. Ph.D. , DVM, College of Veterinary Medicine at Cornell
University
Reinaldo F. Cooke, Ph.D.Scientific Advisor
Professor and beef cattle specialist at the Oregon State
University. He is a trusted advisor to many of the most productive beef and cow calf
operations in the world.Ph.D. Animal Sciences,
University of Florida
William F. Leimkuhler, JD General Counsel
Former general counsel at New York investment banking firm Allen & Company LLC and
corporate partner with Werbel & Carnelutti.
MSc, MIT & JD, New York University
The Science The BusinessThe Problem We’re Solving: It is accepted among the scientific community that antibiotic use in livestock is a major contributor to human resistance, posing a significant public health risk. Large animal health co’s have a declining innovation pipeline and are seeking new technologies to fill the gap created by declining antibiotic (and hormone) use.
Next Steps: - Use our FPS-4 platform to develop product Lifecycle
Management Strategies for multiple livestock species and multiple formulations. Expand global IP platform.
- Complete venture financing- Develop commercial scale manufacturing & formulation- Sign distribution and R&D collaborations— with partner(s) based
on their strengths, product indication, species, and territory- Refine global regulatory strategy and pursue approvals (likely
through partners). Expand clinical trials to include new species.
Other Business Drivers: Strong IP Position, Cornell McGovern Center Client, in negotiations with Global Animal Health Distribution Partners.
Historical Timeline:
Large Addressable Markets:• $30 Billion - Global animal medicine & feed additives• $35 Billion - Global probiotic market• $1 Billion – US corporate spending on animal health
R&D• Massive Potential Markets for Bactana: Cattle, Swine,
Poultry, Aquaculture, Companion, and Human
Diarrhea and Related Mortality Rate and Increased Weight Gain in Preweaned Dairy HeifersCarla Foditsch1, Richard Van Vleck Pereira1, Erika Korzune Ganda1, Marilia Souza Gomez1, Eduardo Carvalho Marques2, Thiago Santin2, Rodrigo Carvalho Bicalho1
1 Department of Population Medicine and Diagnostic Sciences, College of Veterinary Medicine, Cornell University, Ithaca, New York, United States of America, 2 Department of Clinical Science, College of Veterinary Medicine and Animal Sciences, University of São Paulo, São Paulo—SP, Brazil
Probiotics are a promising alternative to improve food animal productivity and health. However, scientific evidence that specific microbes can be used to benefit animal health and performance is limited. The objective of this study was to evaluate the effects of administering a live culture of Faecali bacterium prausnitzii to newborn dairy calves on subsequent growth, health, and fecal microbiome. A total of 554 Holstein heifers were assigned to one of two treatment groups: treated calves (FPTRT) and non treated calves (control). Treated calves received two oral doses of F. prausnitzii, one at treatment assignment (1st week) and another one week later. The FPTRT group presented significantly lower incidence of severe diarrhea (3.1%) compared with the control group (6.8%). Treated calves also had lower mortality rate associated with severe diarrhea (1.5%) compared to control calves (4.4%). Furthermore, FPTRT calves gained significantly more weight, 4.4 kg over the preweaning period, than controls calves. The relative abundance of F. prausnitzii in the fecal microbiota was significantly higher in the 3rd and 5th weeks of life of FPTRT calves than of the control calves, as revealed by sequencing of the 16S rRNA gene.
Abstract: Published Trial Results
554 Holstein heifers were assigned to one of two treatment groups: treated calves and control
New Clinical Findings— October 2016Additional Opportunities for FPS-4™
Swine & Poultry Disease Prevention and Growth There are more than 120 million piglets and 8.54 billion broilers born each year in the U.S.
alone. Multi-billion dollar markets exist for a low-cost natural product proven to increase weight gain, reduce disease, and improve gut health.
Companion Animal Anti-diarrheal We estimate that 9 million dogs & cats are treated for diarrhea by veterinarians each year in
the U.S. and many more pet owners treat their pets for diarrhea at home.
Equine Anti-diarrheal There are over 9 million adult horses and foals in the U.S. Many succumb to diarrhea and
there are no proven cost effective treatments.
Human Pharmaceutical / Supplement There is evidence that FPS-4 based products may have benefits for human use: may aid
malnourished global indigent populations.
Annual U.S. Beef & Dairy Calf Market
Enhancing the Microbiome to Reduce Hormone & Antibiotic Usage in the World’s Food Supply
Our product development platform, FPS-4™, is based on a collection of bacteria isolates from Faecalibacterium spp., and licensed from
Cornell’s Center for Technology Licensing (CTL).
• Dr. Bicalho’s team at Cornell began DNA sequencing experiments to identify novel beneficial microbes from swine and cattle
• Extensive lab testing performed on hundreds of bacteria isolates to identify product candidates. Patent applications developed
2014
20122013
2015
Q1: Developed business plan, established milestones, & performed mkt. researchQ2: Signed exclusive global technology license with Cornell University (CTL)Q3: Signed LOI with Cornell for human market. Filed additional patentsQ3-Q4: Created shelf stable formulation, process & filed provisional patentQ3-Q4: Entered partnership discussions w/six global animal health companiesQ4: Launched angel investment round (convertible debt)
• Breakthrough field trial results published in December 2015• Strong Chinese patent granted• Dr. Bicalho’s research team continued advancing FPS-4 fermentation &
lyophilization process
• 238 isolates identified for further testing, resulting in four candidates (FPS-4)• Received grant to evaluate effect on ruminant microbiome, general health,
and weight gain• Calf safety trial completed. Clinical field trial on 554 dairy calves initiated
US Patent allowed and two new filings with the US patent officeClosed angel financing round Scaling-up of manufacturing and formulation processAccepted into Cornell’s McGovern Incubation CenterInitiated two additional trials
2016
2017Q1-Q2
Sample Market Opportunity
