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Invivo Investor Presentation


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  • 1. Symbol: NVIV Symbol: NVIV.OBInvestor Presentation 2012
  • 2. Safe Harbor Statement Symbol: NVIVThis presentation contains "forward-looking statements" as that term is defined in the PrivateSecurities Litigation Reform Act of 1995. These statements are based on managements currentexpectations and involve risks and uncertainties, which may cause results to differ materially fromthose set forth in the statements. The forward-looking statements may include statementsregarding product development, product potential or financial performance. No forward- lookingstatement can be guaranteed and actual results may differ materially from those projected.InVivo Therapeutics undertakes no obligation to publicly update any forward-looking statement,whether as a result of new information, future events, or otherwise. Forward-looking statementsin this presentation should be evaluated together with the many uncertainties that affect InVivosbusiness, particularly those mentioned in the risk factors and cautionary statements in theCompany’s filings with the Securities and Exchange Commission. Forward-looking statementsrepresent managements current expectations and are inherently uncertain. We do notundertake any obligation to update forward-looking statements made by us.
  • 3. Introduction Symbol: NVIVDeveloper of polymer-based • Founded in 2005 medical devices for the • Headquartered in Cambridge, MA repair of spinal cord tissue Platform technologies • Currently no successful treatment options for SCI patients represent groundbreaking • Developing first and only treatments to address the underlying approach to the treatment pathology of SCI of spinal cord injuries (SCI) 3 phase development • Pursuing near-term launch of human pilot study,strategy focused on speed to • Will create new paradigm of care, addressing both acute and market and expansion of chronic injury products and application • $10+ billion global market potential for acute SCI alone Key scientific and medical • Partnerships with M.I.T., Harvard Medical School, Children’s Hospital Boston, Geisinger Health System, New England Baptist community backing Hospital
  • 4. Defeating Secondary Injury Symbol: NVIV ~ 21 Day Process Primary Secondary Acute Bleeding Inflammation Scarring Injury Injury Loss of Motor Control & Sensory Function[An animation shows the [An animation shows theadvancement of secondary advancement of secondaryinjury in an open wound injury in a closed woundspinal cord injury from a spinal cord injury from apenetrating injury such as a contusion such as a carbullet wound. Results in scar accident. Results in scartissue formation.] tissue formation.] C6 - C7 Injury
  • 5. Leadership Team Symbol: NVIV George Nolen Todd Albert, MDFormer President and CEO Scientific Advisory Board of Siemens, Board of Directors, Lead DirectorRichard Roberts, PhD V. Reggie Edgerton, PhD 1993 Nobel Laureate Frank Reynolds Scientific Advisory Board Medicine & Physiology Chairman and CEO Board of Directors Co-FounderScientific Advisory Board David Feigal Christi Pedra Former Head of FDA Center for Sr. VP, Marketing Devices & Biologics Cardinal Health USA Business Advisory Board Board of Directors Dr. Robert Langer, ScD Co-Founder Scientific Advisory Board Adam Stern Rick Layer, PhD Sr. Managing Manager Director, Research & Spencer Trask Development Ventures. Eric Woodard, MD Ed Wirth, Ph.D., MD Jonathan Slotkin, MD Chief Medical Officer Chief Science Officer Medical Director Scientific Advisory Board Scientific Advisory Board Scientific Advisory Board
  • 6. Regulatory Submission Timeline Symbol: NVIV PLGA-PLL Acute SCI: July ‘11 Scaffold Injectable Hydrogel with drugs Peripheral Nerve Chronic Pain: Q2 ‘12 Injectable Hydrogel with drugs Acute SCI Q3 ‘12 Acute SCI PLGA-PLL Scaffold with cells Peripheral Nerve Injury Acute & Chronic SCI Injectable Hydrogel with cells Peripheral Nerve Injury PLGA-PLL Scaffold with cells and drugs Acute & Chronic SCI Acute & Chronic SCI Injectable Hydrogel with cells and drugs Peripheral Nerve Injury2011 2012 2013 2014 2015 Anticipated Submission Year
  • 7. Objective of Intervention Symbol: NVIVSupport neuroplasticity: Spare 10% of spinal cord tissue to allow patients to recover function → Intervene before secondary injury causes permanent paralysis (therapeutic window) [An animation shows the current [An animation shows the current standard of care for an open wound standard of care for a closed wound or injury to decompress and stabilize the contusion injury to decompress and spinal cord. No intervention to the spinal stabilize the spinal cord. No cord itself is performed and the spinal intervention to the spinal cord itself is cord tissue become scar tissue. performed and the spinal cord tissue Animation then shows InVivo’s become scar tissue. Animation then procedure to implant a scaffold into the shows InVivo’s procedure to implant a open wound to prevent the spinal cord scaffold using a Touhy needle injected tissue from dying.] into a closed wound to prevent the cord tissue from dying.]
  • 8. Device Customization Symbol: NVIV[Device customization and implantation is completedin one minute and four seconds. Video from pilot non-human primate study shows Dr. Eric Woodard, ChiefMedical Officer, customizing the scaffold in theoperating room with a scalpel. The scaffold is thenimplanted into the spinal cord of an African GreenMonkey (AGM). Approximately fifteen seconds afterimplantation the scaffold is shown absorbing the fluidinside the cord and changing color to match thesurrounding tissue. Demonstrates the ability of thedevice to absorb fluids in the spinal cord.]
  • 9. Injectable Surgical Intervention Symbol: NVIV[An animation shows the short procedure during whichInVivo’s injectable hydrogel is guided by x-ray to, and injectedinto, the injury site. This technology provides a minimallyinvasive alternative to the scaffold and will be well suited forpatients with additional injuries such as collapsed lungs orbrain injuries. The hydrogel has been designed to time-release drugs based on the advancement of inflammation tomitigate inflammatory response.]
  • 10. Implanting Scaffolds in Non-Human Primates Symbol: NVIV[Video shows Dr. Eric Woodard, ChiefMedical Officer, and Dr. Jonathan Slotkin,Medical Director, during surgicalimplantation of InVivo’s scaffold into thespinal cord of an AGM.][Figure (a) shows the scaffold design. Figure(b) shows stem cells attached to thescaffold under electron microscope. Figure(c) shows a higher magnification. Figure (d)shows the channels running through thescaffold allowing healthy tissue to bebridged. Figure (e) depicts the Brown-Sequard injury model resulting from theremoval of 50% of the cord.]
  • 11. Pilot Study: AGM Stem Cell Day 2 Symbol: NVIV Scaffold w hNSC Y430 [This technology intended for chronic SCI patients. Video shows AGM two days post injury and treatment. This animal received a scaffold implanted with human neural stem cells after 50% of tissue was removed from a section of the spinal cord. There is no evidence of functional recovery as the monkey moves around in an ambulation chamber.]
  • 12. Pilot Study: AGM Stem Cell Week 5 Symbol: NVIV Scaffold w hNSC Y430 [Video shows the same AGM five weeks after receiving a scaffold with human neural stem cells. The AGM is walking with its spinal column parallel to the floor. This study was the first successful non-human primate study for traumatic SCI. Five different treatment arms have shown a therapeutic effect including the scaffold no drugs or cells, the scaffold with growth factors, the scaffold with low dose human neural stem cells, the scaffold with high dose human neural stem cells, and an injectable hydrogel with steroids.]
  • 13. Pilot Study: AGM Scaffold Day 2 Symbol: NVIV Control Scaffold w No Drugs/Cells[Video shows AGM two days post injury [First product to market. Video showswhere the animal received no treatment AGM two days post injury where theafter 50% of the tissue from a section of animal received InVivo’s scaffoldthe spinal cord was removed. The animal without drugs or cells after 50% of thedemonstrates Brown-Sequard syndrome; tissue from a section of the spinal cordthe left leg has no function, and the right was removed. The animal alsoleg functions properly.] demonstrates Brown-Sequard syndrome. The two animals appear to function similarly.
  • 14. Pilot Study: AGM Scaffold Week 2 Symbol: NVIV Control Scaffold w No Drugs/Cells[Video shows AGM two weeks post [Video shows AGM two weeks postinjury where the animal received no injury where the animal receivedtreatment after 50% of the tissue InVivo’s scaffold without drugs or cells.from a section of the spinal cord was The animal runs and the previouslyremoved. The animal demonstrates paralyzed left leg has regainedBrown-Sequard syndrome; the left leg function.]has no function, and the right legfunctions properly.]
  • 15. 2nd Primate Study: AGM Week 12 Symbol: NVIV R123 Control R090 Scaffold[Video shows AGM twelve weeks post [Video shows AGM twelve weeks post injuryinjury (received no treatment after 50% (received the scaffold without drugs or cellsof the tissue from a section of the spinal after 50% of the tissue from a section of thecord was removed). The animal spinal cord was removed). Wireless EMG anddemonstrates Brown-Sequard syndrome; Kinematic technologies were added to thethe left leg has no function, and the right second study protocol to monitor electricalleg functions properly.] activity in the muscles in the legs of the animals. The animal runs on a treadmill demonstrating the left leg has regained function.]
  • 16. 2nd Primate Study: AGM Week 12 Symbol: NVIV R123 Control X957 Hydrogel[Video shows AGM 12 slides twelve [Video shows AGM twelve weeks postweeks post injury (received no injury (received the injectable hydrogeltreatment after 50% of the spinal cord technology after 50% of the tissue from awas removed). The animal demonstrates section of the spinal cord was removed).Brown-Sequard syndrome; the left leg Wireless EMG and Kinematic technologieshas no function, and the right leg were added to the second study protocol tofunctions properly.] monitor electrical activity in the muscles in the legs of the animals. The animal runs on a treadmill demonstrating the left leg has regained function.]
  • 17. EMG Analysis Symbol: NVIV[Split screen video shows AGM running on a treadmillon the left, and wireless EMG data being processed onthe right. The data is synchronized with the animalrunning. Dr. Gregorie Courtine of the University ofZurich is responsible for processing EMG andkinematic data for InVivo and will present it to the FDAon the company’s behalf. Dr. Courtine has published adefinitive paper in Nature on the value of non-humanprimate data in advancing rodent data to humans.]
  • 18. Glial Scarring and Astrogliosis Glial Fibrillary Acidic Protein (GFAP) Immunolabeling Symbol: NVIVGFAP (red) and neurofilament (green) immunoreactivity in cross-sections of Macaca Mulatta monkeyspinal cords near lesion center following hemi-section surgical injuries. Cell nuclei labeled with DAPI (blue).A) Extensive astrogliosis (red) throughout the tissue near the midline in a control primate. The central canal was preserved (blue).B) Central portion of the lesion in a scaffold-treated primate, showing reduced gliosis compared to controls restricted to lesion border.
  • 19. ‘09 Data Confirm ‘08 Pilot Primate Data Symbol: NVIV from Nature Neuroscience Individual Data Principal Component Analysis (PCA) Week 12 15 Average PCA Score 10 (n=4) 5 (n=3) 0 Control Scaffold Treatment Group Principal component analysis (PCA; see Courtine, G., et al., Nat Neurosci 12:1333-1342, 2009) was applied to 149 quantified kinematic,Typical representation of individual EMG and gait parameters. Resulting PCA scores were used to compare kinematic, EMG, and gait treatment groups. The dashed line represents the average pre-lesion parameters from a single primate. PCA scores. Higher PCA scores signify greater recovery.
  • 20. Replication by Academic Researchers Symbol: NVIV
  • 21. Anticipated FDA Clinical Study Symbol: NVIV• Human Pilot Study • 2nd Half of 2012 • Positive FDA Meeting held on April 12, 2012 • FDA Affirmed HDE regulatory pathway –will expedite approval • Acute SCI patients with contusion injuries • Open label study-will report on results as patients are treated • Clinical Sites: • Harvard Brigham & Women’s in Boston • Geisinger Health System in Pennsylvania • Rehabilitation: The Shepherd Center, Atlanta • One year follow-up• Human Pivotal Study • To be conducted if requested • 30 acute contusion SCI patients
  • 22. IP & Manufacturing Symbol: NVIVExclusive, world-wide license from Children’s Medical CenterCorporation and MIT • Covers the use of a wide range of biopolymers to treat SCI, and to promote the survival and proliferation of human stem cells in the spinal cord. • 11 issued and 4 pending US patents • 57 issued and 34 international pending patentsOpened new manufacturing and development facility to support firsthuman clinical trial • Raw materials for first device product readily available from FDA-cleared suppliers • Proprietary manufacturing processes will include 46 3D printing and batch processes to create the scaffolds.
  • 23. Go-To-Market Strategy Symbol: NVIV• Ease of market penetration – 80% of SCIs treated in only 75 Level I Trauma Centers in USA• No need to strategically license to reach our market• Forecasted price $60,000/unit – Could exceed $100,000+/unit• Direct sales force: ~20 for entire USA• Fast early adoption by spine surgeons• Complements current standard of care with one surgery• In-house manufacturing of FDA-approved materials• Results in gross margins ~85+%
  • 24. Market Stats Symbol: NVIVTrading Symbol NVIVStock Price* $2.20Exchange OTC. BBMarket Cap* $141.5 MPrimary Shares Outstanding 64.3MFully Diluted Shares 89.6MApprox. Float 42.0MAvg. Daily Trading Volume 265,000 sharesInside Ownership 37%52 Week Range $0.60-$3.23Cash on Hand at 3.31.12 $20.5MBurn Rate $855,000/month* Information as of June 6, 2012
  • 25. Market Stats Symbol: NVIV
  • 26. Cost Effective Business Model Symbol: NVIV $929 $900 $800Total Capital Raised (in millions) $700 $600 Geron $500 StemCells, Inc $400 NeuralStem,Inc $338 $300 InVivo Therapeutics $200 $100 $107 $36 $- 0 2 4 6 8 10 12 Time to Market in Years
  • 27. Milestones Symbol: NVIV Finalized Plan with FDA for Human Study in 2012 Raised $20 M in public offering with blue chip institutions 2011 Apple Award from American Spinal Injury Assoc. Expanded Patent to Peripheral Nerves, Prostate, Retina, and Brain• Determine regulatory pathway for hydrogel + steroidal drug: Q2 2012• File IDE for Peripheral Nerve Injection: Q3 2012• Complete Pre-Clinical Sloan Kettering Prostate Study Q3 2012• Begin Patient Enrollment for scaffold: 2nd Half 2012
  • 28. Summary Symbol: NVIVNear-Term Value Creating Milestones Will Drive Shareholder Value – Pilot human trial approval and human clinical data in late 2012 – Second Product based on our hydrogel to be filed with FDA in 2012 – Potential for revenue generation by end of 2013Acute SCI Represents a $10+ Billon Untapped Market Opportunity – No products today will effectively treat a spinal cord injuryEfficient Go-to -Market Strategy Generates High Profits for InVivo Shareholders – 80% of SCI patients are treated at the top 75 Level One Trauma Centers – Small sales force of ~20 will provide sales coverage for the US Market. – Gross margins approaching 85%InVivo Has a Robust Platform Technology and Product Pipeline – Exclusive Worldwide Patent Licensed from MIT and Harvard – Injectable hydrogel: time released drug delivery for back pain, prostate nerve, SCI – Biopolymer scaffoldings seeded with cellular therapies to treat chronic SCI“NVIV” with a $144 Million Market Cap has Significant Upside Potential – Acorda -$938 million market cap, VeraStem Pre-IND $210M
  • 29. Symbol: NVIVInVivo Therapeutics Holdings Corp.Stock Symbol: NVIV.OB