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Bach Pharma GVT Informational Deck

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Bach Pharma Inc. is developing GVT, a potential solution of neurodegenerative diseases for U.S. distribution. Find out about GVT and our current fundraising goals.

Publicado en: Salud y medicina
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Bach Pharma GVT Informational Deck

  1. 1. Help Us, Help Millions. Your company tagline Bach Pharma, Inc. 800 Turnpike Street North Andover, MA 01845 Tel 978.794.5510 www.bachpharma.com v072819
  2. 2. Overview ● Science & Development of GVT ● Development, Timelines & Budgeting ● Our Team and Partners ● The Future of GVT
  3. 3. Overview Bach Pharma is developing new therapeutics for the treatment of neurodegenerative diseases and other life-threatening redox regulation-related illnesses.
  4. 4. Neurodegenerative Disease & GVT 1 Neurodegenerative Disease A term that encompasses a variety of conditions which affect the neurons in the human brain. Diseases suppress the reproduction of neurons which damages the body and thus creates permanent damage. 2 GVT Our Lead asset is Monosodium Luminol - trade name GVT®. Since so many neurodegenerative diseases share inflammation and oxidative stress in common and GVT addresses these issues, GVT potentially will treat a wide range of clinical issues with no side effects
  5. 5. Lead Asset: GVT 1 Created to treat: Gulf War Illness (GWI) ALS (Amyotrophic Lateral Sclerosis) Lou Gehrig’s Disease Multiple Chemical Sensitivity Axtaxia-telangiectasia Parkinson’s Disease Additional Neurodegenerative Diseases 2 Development Status: $12+ Million Equity $18+ million in non-dilutive research grants First round of $25 Million fundraising
  6. 6. GVT is a Leading Candidate for the Treatment of GWI Gulf War Illness (GWI) is a chronic, multi symptom health problem with a high unmet need Involves brain dysfunction, typified by memory and mood dysfunction, depression and anxiety Characterized by reduced neurogenesis in the hippocampus Often becomes full blown ALS GWI Afflicts approximately 200,000 veterans who served in Persian Gulf War Caused by multiple chemical exposures
  7. 7. How it Works:
  8. 8. How GWI Evolves & How GVT Works Modes of Contraction GWI enters the body through the nose, the mouth and the skin Multiple chemical exposures causes oxidative stress and mitochondrial impairment: ● Anti nerve gas "vaccine" ● Clothing saturated with DEET ● Tents treated with Permethrin ● Pollution from burning oil fields DEET (An insect repellant) PB (designed for protection from nerve gasses) & overwhelming amounts of mental stress create Synergistic Interactions in the brain that lead to the common symptoms of GWI.
  9. 9. GVT has High Potential for the Treatment of ALS (Lou Gehrig’s Disease) Progressive motor neuron disease- death within 2-5 years, usually from respiratory failure due to diminished strength in breathing muscles.
  10. 10. GVT has High Potential for the Treatment of ALS (Lou Gehrig’s Disease) Currently only two drugs approved in the U.S and neither cure nor effectively treat ALS they only slow the progression while still causing many different side effects.
  11. 11. ALS (Lou Gehrig’s Disease) is an unmet medical need Daily >15 Newly diagnosed patients each day afflicted in the U.S Yearly 5,600 New cases diagnosed each year in the U.S Any Given TIme 30K People living with ALS in the U.S at anytime, 250K is the estimated worldwide number. Clinical Plans in Place Post GWI-IND
  12. 12. GVT Potentially Treats Additional Neurodegenerative Diseases Frontotemporal dementia Glaucoma Cancer Inflammation Multiple Chemical Sensitivity Ataxia-telangiectasia (A-T) Parkinson's Alzheimer's Huntington’s Multiple Sclerosis (MS) LATE -- Limbic-predominant age- related TDP-43 encephalopathy - Shares many symptoms with Alzheimer’s All share Oxidative Stress, Mitochondrial impairment, and Inflammation leading to neural cell death
  13. 13. Bottom Line Benefits 12+ Millions 1,000’s 0 Impacts multiple diseases Will help a very large number of patients Even children with Axtaxia- telangiectasia No side-effects
  14. 14. The Science and Development of GVT
  15. 15. Redox state out of bounds Too much reduction &/or oxidation reactions Stability STOPS neurodegeneration and revives redox suppressed cellular defenses Redox Reactions GVT as a Redox Buffer GVT GVT acts a buffer normalizing cell function
  16. 16. Development, Timelines & Budgeting
  17. 17. Bach Pharma is Well Positioned For Success Highly compelling preclinical data on GVT’s efficacy ● Leading candidate for GWI – no current approved drugs ● High potential for ALS – only two approved drugs with limited effectiveness and negative side effects. GVT significantly de- risked ● Well established safety profile in animals and humans ● Patented manufacturing processes ● Drug Master File (DMF) and Safety Gap Analysis completed Short timeline to IND* for Gulf War Illness ● After toxicology studies for oral delivery required by VA ● IND* Application after 9- 12 months ● Pre-clinical trials already in place *Investigational New Drug
  18. 18. Bach Pharma is Well Positioned For Success Funding for Phase I and Phase II Clinical Trials for GWI in place ● $8M available from Department of Defense Parallel focus on ALS ● Data from GWI Clinical trials will be leveraged for an ALS /IND ● Clinical Development Plan is in place
  19. 19. Gulf War Illness Research Plan: Current - $2.2 million; GWI IND followed by a $22.8 ALS Funding Plan
  20. 20. Usage of next Capital Raise What the upcoming $2.2 Million will do ● Allow Bach Pharma Inc. to complete our preclinical studies in animals for the VA’s specified oral route of administration ● Once completed, this qualifies Bach for an $8m commitment from Congress that will be used for Phase 1 & 2 clinical studies for GWI
  21. 21. Timeline Toxicology Research Chemical Manufacturing Component Funding Regulatory GWI IND Application $250K GWI IND Single Dose Toxicology 2 Species $150K Rat Bone Marrow Oral Administration $50K 13 Week Toxicology 2 Species $750K Animal Models $200K Formulations Drug Delivery Toxicology $400K $1.3 M Pre GWI IND $2.2M Days 90 180 270 365
  22. 22. This $2.2M is the most essential step in our goal to treat Neurodegenerative Diseases.
  23. 23. Bach Pharma’s Value Proposition ● Compelling data showing GVT’s effectiveness in the treatment of a wide range of neurodegenerative diseases such as Gulf War Illness and ALS ● 9-12 months to achieve an IND (Investigational New Drug) status with next round of funding ● Clinical plans in place for both Gulf War Illness and ALS Streamlined Focus Supported by the DoD
  24. 24. Funding Requirement ● Gulf War Illness Research – Raise $2.2M, conduct oral toxicology studies on VA specified oral method of delivery ○ Apply to FDA for an Investigational New Drug (IND) application ● ALS Research- Raise $22.8M, fund clinical studies for additional indications post GWI-IND $2.2 Million Required to Achieve IND Milestone
  25. 25. Our Team and Partners
  26. 26. The Management Team The Board of Advisors Mark O. Henry, CPA, MBA Chief Executive Officer Chief Financial Officer Dr. Steven L. Stroup, MD Chairman of the BOD Chief MEdical Officer and Director of US Medical Research Christopher G. LaFarge, MBA Chief Operating Officer Barbara A. Stima Vice President and Director of Administration Paul K.Y Wong, PhD Professor, Department of Molecular Carcinogenesis Ashok K. Shetty, PhD Professor, Department of Molecular and Cellular Medicine Gerard T. Berry, MD Director, Metabolism Program, Boston Children’s Hospital Tatiana Grishina, MD, PhD Head of the Chair of Clinical Immunology
  27. 27. GVT R&D Performed at Premier Institutions
  28. 28. Selective Non-Dilutive Funding Sources
  29. 29. MD Anderson Cancer Center-Efficacy and Toxicology studies and reports BioReliance-Genotox studies and reports Sigma Aldrich (SAFC Pharma)- API Manufacturing Cato Research Ltd. -Regulatory Affairs Select Corporate Partners/Affiliations
  30. 30. The Future of GVT 30
  31. 31. Reasons to Invest Financial ● Bach is offering $2,200,000 in capital stock to accredited investors for a limited time ● Minimum investment is $25,000, subscription rights are available ● Investing in Bach Pharma is a medium-term limited investment opportunity. ● The Company expects its value to grow two to three times upon issuance of product license
  32. 32. Reasons to Invest Shareholder Benefits ● Access to medical research and pre-publication reports, inside and outside the Company, at every stage of their development. ● The right to elect members of the Board of Directors and affect the long-term direction of the company ● Direct access to Bach’s team of researchers and medical Doctors throughout the world
  33. 33. Reasons to Invest Your Health ● Access to research supplies at 50% of the price paid by institutions and collaborators ● Access to formulations before they are offered to the general public ● The right to participate in clinical trials run by the Company
  34. 34. Reasons to Invest The Future ● Be a part of changing the treatment of neurodegenerative diseases ● Help millions of veterans, athletes, adults, and children who suffer from these diseases ● Participate in the launch of our amazing product, GVT.
  35. 35. HELP BACH PHARMA INC, HELP MILLIONS WHO ARE SUFFERING FROM NEURODEGENERATIVE DISEASE

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