Tenax Therapeutics, Inc. · NASDAQ:TENX
Tenax Therapeutics — Oxygen Biotherapeutics — FY2012 Earnings Presentation
15 slides from Tenax Therapeutics's earnings presentation, Jul 25, 2012
Slide 1: OXBT FY2012 Year End Financial Results Conference Call
OXBT FY2012 Year End Financial Results Conference Call July 25, 2012
Slide 2: Forward-looking statements
This discussion may contain forward-looking statements. These statements are subject to factors which may cause our plans to change or actual results to differ materially from those described in this presentation. Additional information regarding these factors is discussed in our Annual Report on ou
Slide 3: Topical Update, Cosmetic, Neurological, Financial, Milestones
Topical Update Cosmetic/DERMACTYE Update Neurological Update Financial Update Targeted Milestones 3
Slide 4: PFC creams for dermatologic conditions and wounds
Anecdotal data suggests potential to use our PFC creams for a number of dermatologic conditions and wounds Conduct proof-of-concept studies to identify the indications most likely to benefit from our topicals Collaborate with key consultants, researchers and CROs 4
Slide 5: Research contract with Hackensack University Medical Center
Research contract with Hackensack University Medical Center funded under a 2-year grant from the DoD. Initial study to evaluate healing properties of full-thickness excisional wounds completed Data analysis underway; anticipate report late-summer Current study Partial Thickness, Infected Bur
Slide 6: Dermacyte cosmetic program curtailed in FY2012
Program sharply curtailed in FY 2012 Spending reduced on marketing and sales effort eliminating national focus and regionalizing instead New packaging developed and will be out this summer; Concentrate now packaged in 15mL tubes New formulations approved, but determined best to delay commerc
Slide 7: Systemic: Development of Oxycyte for STOP-TBI
Systemic: Development of Oxycyte® for STOP-TBI Required for STOP-TBI Phase IIb trial restart: cGMP Clinical Drug Material Compendial method verification reports in review FtBu and Related Compounds Assay, and Limit Tests feasibility studies almost complete Method validation in progress Upd
Slide 8: Systemic: Development of Oxycyte for Multiple Indications
Systemic: Development of Oxycyte® for Multiple Indications Required for Comprehensive Safety Profile and FDA Approval Potential: Updated Chemistry, Manufacturing, and Controls document Draft revision complete Pending final process development/validation documentation from our API suppliers and
Slide 9: Bioanalytical, PK, platelet function and immunocompetence studies
Bioanalytical: Method validation for detection of FtBu in rat and mouse whole blood to be completed in 1st Quarter. Pharmacokinetics: Rat and Mouse PK studies underway. In Vitro Platelet Function: FDA approved plan April 4th. Normal volunteer studies underway. Immunocompetence: FDA approved
Slide 10: Army Funded Research Program
Army Funded Research Program June 30, 2011 June 30, 2012 July 2013 Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Bioanalytical Assay Development/Validation *PK Studies in Rat and Mouse *Immunocompetence Studies in Mice *Platelet Distribution Study in Baboons *Platelet Transfusion Study in Rat *In Vitro Platelet Function
Slide 11: DCS, Hemorrhagic Shock, Spinal Cord Injury in DCS
DCS: •Two studies underway to evaluate effect of hyperbaric oxygen therapy after treatment with Oxycyte Hemorrhagic Shock: •NAMRUSA – anticipate late-summer to begin study, “Oxygen Therapeutics Survey Study in Hemorrhagic Shock” Spinal Cord Injury in DCS: • Two GLP studies will be conducted. “Platel
Slide 12: Aurum Biosciences and Technical University of Munich studies
Aurum Biosciences Acute Ischemic Stroke (diagnostic and therapeutic applications) • In vitro ischemia-reperfusion studies in rat neuronal cells ongoing – expect data in 4-6 weeks. • Positive results from first set of MRI studies in rats. Technical University of Munich Vasospasm following aneu
Slide 13: Year ended April 30 financial results
Year Ended April 30, 2012 2011 Net revenue 363,781 103,167 Total operating expenses 8,583,978 10,665,844 Net loss 15,712,410 10,448,296 Net loss per share (0.61) (0.45) Weighted average number 25,928,263 23,346,496 of common shares outstanding, basic 13
Slide 14: Targeted milestones
Resume STOP-TBI clinical trials by year end Complete preclinical studies needed to answer FDA concerns by Q1FY14 Conduct proof-of-concept trials focused on dermatologic indications Continue cost controlling measures to ensure maximum efficiency 14
Slide 15: Thank you!
Thank you! www.oxybiomed.com www.DermacyteUS.com
Oxygen Biotherapeutics — FY2012 Earnings Presentation on 6ix