Oragenics Inc. · AMEX:OGEN
Oragenics — Investor Presentation (January 2009)
32 slides from Oragenics's investor presentation, Jan 15, 2009
Slide 1: Corporate Overview January 2009
CORPORATE OVERVIEW JANUARY 2009 This presentation does not constitute an offering of any securities for sale or a solicitation of offers to purchase securities. The Company's securities may not be offered or sold absent registration under applicable securities laws or an exemption from registration.
Slide 2: Safe Harbor
Safe Harbor Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect ONI BioPharma's current views with respect to future events and financial performance. These forward-looking statements are based on management's beliefs and assumpti
Slide 3: ONI BioPharma is a multi-faceted biopharmaceutical company
ONI BioPharma is a multi-faceted biopharmaceutical company with operations in four divisions: Consumer Healthcare Diagnostics Replacement Therapy Antibiotics ONI is commercializing its first consumer products: - Probiora3 TM , the first full-care oral probiotic that promotes healthy teeth and gums a
Slide 4: Financial Highlights
Financial Highlights OTCBB: ORNI NYSE Alternext Paris: ALONI Industry: Biopharmaceutical Equity Cap: $13.03M (US) As of 1/2/09 Volume: 33,843 Shares Outstanding: 38.3M Float: 21.6M Long-term debt: 0 Founded: 1996
Slide 5: Four Product Divisions
Four Product Divisions Consumer Healthcare DPOLT/Antibiotics Platform Diagnostics Replacement Therapy ONI’s science has developed into four distinct categories. Technologies complement one another. ONI intends to use revenue generated by initial consumer products to support research and development
Slide 6: Technology Overview
Technology Overview
Slide 7: Probiora3
Mixture of 3 natural beneficial oral bacteria for Maintaining dental (tooth) health Maintaining periodontal (gum) health Whitening teeth Promoting fresh breath Probiora3™
Slide 8: Clinically Proven Probiotic Blend for Improving Oral Health
Glinically Proven Probiotic Blend for Improving Oral Health Modern Innovation, The Way Nature Intended ce gery win EverPan Peden one pose et at pee ‘tt ith ne (OM / AMER) Contact Us Today for moe nformation on Eve 456.0028» 727 456-0029 « sles@onbopharma.com .
Slide 9: LPT3-04: Weight Loss Agent
Safety and activity established in animals Novel MOA - selectively kills white fat cells Strong evidence for safety in humans Clinical trial in Q2 LPT3-04™ : Weight Loss Agent
Slide 10: DPOLT: Our lead antibiotic MU1140
Our lead antibiotic Novel mechanism of action Safe and very active in pilot studies MRSA Most other gram positive infections Mtb, both growing and dormant No evidence for development of resistance Hard to make by conventional fermentation methods DPOLT MU1140™ - A Focus Techno
Slide 11: Platform for organic synthesis of MU1140
Platform for organic synthesis of MU1140 Proof of principle completed Cost effective GMP production Can make analogues of MU1140 and the other 50 known lantibiotics ala abu pro gly ala ala dhb gly ala phe asn ala tyr ala S NH CH CH S gly ala phe asn ala tyr ala S NH CH CH S S S phe lys ala trp dha l
Slide 12: IVIAT / CMAT – A Focus
Fast, sensitive, superior method for identification of targets for new diagnostics, vaccines and drugs Human infections Plant infections Cancers Also applicable to various other problems such as bioscavenging and biofouling IVIAT / CMAT – A Focus
Slide 13: SMaRT
Genetically modified Streptococcus mutans One-time treatment for lifelong protection against most tooth decay SMaRT
Slide 14: Strategy and Forecasted Calendar of Development
Strategy and Forecasted Calendar of Development
Slide 15: Revenue Model
$ $ Revenue Model * Consumer Health revenue is expected to support the growth of other business units.
Slide 16: Projected Summary Timeline 2009-2013
Consumer Healthcare Diagnostic Replacement Therapy 15 projects completed Second Phase I clinical trial DPOLT/ Antibiotic Platform Pro Biora3™ LPT3-04™ Commercially Available: EvoraPet ™ , EvoraKids ™ , EvoraPLUS ™ 5 molecules made MU1140 IND filed Commercially Available Phase II/III clinical trial R
Slide 17: Consumer Healthcare
2009 2010 Consumer Healthcare Benefits/Characteristics: GRAS – Generally Recognized as Safe status (vs FDA approval) Significantly reduces regulatory costs Fast to market Faster generation of gross and net revenues Lower capital requirements Marketed in US and internationally (Mexico in early 2009)
Slide 18: Media and Distribution Strategy
Consumer Product Manufacturers Direct Selling Companies Dental Product Companies Contract Private Label Companies Natural Product Companies Pet Product Companies Mass Retail Internet Independent Health Food Stores Independent Pharmacies Dental Offices Direct Response Direct Mail Government Media and
Slide 19: EvoraPlus Activity
EvoraPlus Activity Existing Internet & Dental Meetings With 50+ Mass Retailers
Slide 20: Probiotics Market
Confidential Probiotics Market Probiotics: live microorganisms, which when administered in adequate amounts, confer a health benefit on the host. Generally associated with the gut health, though they have been promoted for urogenital health, irritable bowel syndrome, bladder cancer and to boost the
Slide 21: DPOLT/Antibiotics Platform
2009* 2010* 2011* 2012-2013* DPOLT/Antibiotics Platform Benefits/Characteristics: Overcomes 80+ years of previous failures Predicted to lead to new antibiotics with novel mechanisms of action Potential substantial antibiotic pipeline Replaces current antibiotic treatments that are failing MU1140 IND
Slide 22: Diagnostics
2009* 2010* 2011* 2012* 2013* Diagnostics 15 proj. completed 15 proj. completed Three 510(k)s filed 15 proj. completed Three 510(k)s filed 15 proj. completed Three 510(k)s filed 15 proj. completed Three 510(k)s filed PIVIAT™ - Rapid and sensitive identification of novel targets for use in diagnosis
Slide 23: Replacement Therapy
2009* 2010* 2012* Replacement Therapy Second Phase I clinical trial Phase II/III FDA clinical trials Market SMaRT™ Benefits/Characteristics: Efficiency Mexico trials = 50% cost savings (vs. US) Regulatory Speed ONI Mexico (subsidiary) should attain faster regulatory access within Mexican government
Slide 24: Timeline
Timeline Oragenics (ONI BioPharma) Founded by Jeffrey Hillman Completes Initial public offering (IPO) Obtains $9M financing Initiates Phase I studies for tooth decay-replacement therapy Seeks patent to treat obesity- LPT3-04™ Acquires iviGene Corporation and gene/biomarker assets Patent issued for M
Slide 25: Management
Corporate Structuring Science Legal/ Accounting Confidential Management Stanley B. Stein , Chief Executive Officer, President and Director 25 years in securities in biotech & healthcare industry Managing Director at Drexel Burnham Lambert, Inc. Founded SRS Capital - boutique investment firm; special
Slide 26: Outside Directors
Confidential Outside Directors – Expertise in: Management , International Business, Academic Science & Media Rick Welch , Chairman President of Welch Business Solutions and Consulting, LLC in Tampa, Florida Director and CFO for the following: Orthopedic Development Corporation, Albiorex, LLC, Medi-S
Slide 27: Global Expansion
Confidential Global Expansion Mexico Subsidiary (ONI Biotec, Mexico) launch - Q1 2009 France Alternext Paris Listing – Planned operations in European Union USA – Alachua, FL ONI Corporate Offices est. 1996
Slide 28: Why a Listing in Paris?
An anchor point for the commercial conquest of Europe Significant market : popularity of probiotics among European consumers Central location Strong scientific and industrial network Attractive political environment “Fast Path” to Listing Direct listing (use of SEC filings for Information Document)
Slide 29: . . Gp iiorarn
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Slide 30: Summary
Confidential Summary Sales & near-term revenue generated from consumer product, Probiora3™. Facilities & business relations in the United States, Mexico, South America and Europe. Multiple strategies for getting consumer and biotech products to market. Targeting global healthcare segments where ther
Slide 31: In the News
Confidential In the News Probiotics - Topic Overview What are Probiotics? Why Probiotics? Probiotics May Help People Taking Antibiotics What health benefits do they offer? What is important to know about Probiotics?
Slide 32: Investor Contacts
Confidential Investor Contacts Global Headquarters: Stanley B. Stein Chief Executive Officer ONI BioPharma, Inc. 13700 Progress Blvd Alachua, FL 32615 Ph: (386) 418-4018 sstein@onibiopharma.com www.onibiopharma.com Investor Contact: Axelle Vuillermet Pierre Laurent 8 place de la Madeleine 75008 Pari