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NuvOx Pharma Saves Lives with Nanotechnology Oxygenation Evan Unger, MD, FACR

NuvOx Pharma Saves Lives with Nanotechnology Oxygenation Evan Unger, MD, FACR President and CEO NuvOx Pharma. Management. Team has developed 15 FDA approved drugs!. Evan Unger , MD, CEO 1st Company Sold 20x Return 2nd Company Went Public

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NuvOx Pharma Saves Lives with Nanotechnology Oxygenation Evan Unger, MD, FACR

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  1. NuvOxPharma Saves Lives with Nanotechnology Oxygenation Evan Unger, MD, FACR President and CEO NuvOx Pharma

  2. Management Team has developed 15 FDA approved drugs! • Evan Unger, MD, CEO • 1st Company Sold 20x Return • 2nd Company Went Public • >100 US Pharma Patents Issued • Betty Weaver,CFO • Financial expert • Assists Biotech company expansion • Rajan Ramaswami, PhD, COO • Chemistry, Manufacturing, and Controls • Gordon Brandt, MD • VP Regulatory Affairs • Experienced in US and Intl. drug product approval

  3. Board of Directors • Richard Carmona, MD – Trauma Surgeon , 17th Surgeon General of US • Jennifer Johnson, PhD – Co-Founder, Formulation Scientist, Inventor • Michael Sember– 40 years in Pharma, 100+ Licensing Transactions/Acquisitions • Marvin Slepian, MD – Inventor, founded 8 biotech start-ups • Jonathan Schilling – Schilling Robotics was acquired by FMC for $400M • Evan Unger, MD – Co-Founder

  4. Scientific Advisory Board & Collaborators • Paul August, PhD, 20 years + experience in drug development R&D • Minesh Mehta, MD, Deputy Director and Chief of Radiation Oncology, Miami Cancer Institute • Solomon Ofori-Acquah, PhD, Associate Professor of Medicine, Director, Center of Translational and International Hematology, University of Pittsburgh • William Culp, MD, Distinguished Chair of Stroke Research, University of Arkansas, PI of current stroke trial

  5. NuvOx Company • Employees • 4 PhDs, 2 MDs, 1 MS, 1 MBA, 3 BS Chem. • Clean room for clinical product manufacturing • Aseptic filling system • Manufacturing capacity to support Phase I and Phase II clinical trials. • 5 fully equipped laboratories • 5 active R&D programs

  6. NuvOx’s Oxygen Therapeutics Dodecafluoropentane emulsion (DDFPe) • Terminal half-life 90 minutes • Clears via exhalation • Used as an oxygen therapeutic • Carries > 100x more O2 than other fluorocarbons (FCs) • Required dose < 0.5% of other FCs 250 nm

  7. Competitive Advantages and Intellectual Property • Reduced Development Risk • $100 million spent by licensor developing DDFPe • Used safely in 2,200 patients • Approved in Europe as an ultrasound contrast agent • 5 patents issued, 12 pending

  8. Oxygen Therapeutic Pipeline

  9. NuvOx Solution for Brain Cancer

  10. DDFPe Delivers Oxygen to Hypoxic Tissue In-human BeforeInjection AfterInjection • These MRIs show the oxygen level of a patient with a hypoxic solid brain tumor. • Tumor oxygenation increases significantly (p=0.015) • Healthy brain tissue oxygenation does not change significantly (p=0.65)

  11. NuvOx Solution for Stroke

  12. Pre-Treatment with NVX-208 Diminishes Stroke in Animals Treated with tPA A = control, B = animal treated with t-PA at 9 hours, and C = animal pre-treated with NVX-208 prior to t-PA.

  13. NuvOx Solution for Hemorrhagic Shock

  14. DDFPe vs. Volume Expander Standard of care – Stop the bleeding and give 500 mL Volume Expander • DDFPe was tested at less than 1/10th the volume of volume expanders – lighter weight. • DDFPe could be carried in patent pending pre-loaded syringes for field use.

  15. DDFPe Protects Against Fatal Anemia Rats’ blood slowly replaced with Volume Expander, then given either DDFPe or Blank Vehicle • Control rats see 0% survival (n = 16) • DDFPe rats see 100% survival (n = 16) • DDFPe rats survive with about half the hemoglobin level that was fatal in controls

  16. Hemorrhagic Shock Model, Part 1 Pigs anesthetized, given fractured femur bone, and ~50% blood loss. • Controls had 30% survival (n=19) • Pigs given Volume Expander had 80% survival (n=10) • Pigs given DDFPe had 100% survival (n=6)

  17. Hemorrhagic Shock Model, Part 2 Pigs sedated and bled ~50% of their blood volume, then given treatment 1 hr later • Volume expander had 86% survival (n=7). • DDFPe had 100% survival (n=7) at 14 days. Pigs grow and act normally. • DDFPe pigs had increased arterial O2 (p<0.01).

  18. Conclusion • Researchers concluded: “DDFPe is a better resuscitation fluid than volume expander.”

  19. Going Forward • Technology Out-licensed for Peri-Operative Blood Loss and Hemorrhagic Shock in China. • Partner will fund clinical studies, NuvOx will supply the drug. NuvOx gets data and retains rights to all other countries. • Manufacturing not transferred until drug launched in China.

  20. NuvOx Solution for Traumatic Brain Injury

  21. DDFPe in Rat TBI Model Hypoxia is a Secondary Injury Mechanism • DDFPe significantly increases brain tissue oxygen tension (p < 0.05)

  22. DDFPe in Porcine TBI Model:Prevents Brain Damage in TBI.

  23. NuvOx is Seeking: • Collaborators for its programs to develop battle-field ready products to prevent combat death due to traumatic injury associated with hemorrhagic shock and TBI.

  24. Thank you • Clinical stage biotechnology company - substantially reduced risk • Actively seeking investors and corporate partners NuvOxPharma,1635E.18th St.,Tucson,AZ,85719,USAeunger@nuvoxpharma.com office:+1520-624-6688www.nuvoxpharma.com

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