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.
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Bach Pharma GVT Informational Deck
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. Overview
● Science & Development of GVT
● Development, Timelines & Budgeting
● Our Team and Partners
● The Future of GVT
3. Overview
Bach Pharma is developing new therapeutics for the treatment of
neurodegenerative diseases and other life-threatening redox
regulation-related illnesses.
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. 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. 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
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. 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. 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. 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. 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. 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
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
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. 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. Gulf War Illness Research Plan:
Current - $2.2 million; GWI IND followed
by a $22.8 ALS Funding Plan
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
22. This $2.2M is the most essential step
in our goal to treat
Neurodegenerative Diseases.
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. 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
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
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
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. 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. 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. 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. HELP BACH PHARMA INC, HELP MILLIONS WHO ARE
SUFFERING FROM NEURODEGENERATIVE DISEASE
Hinweis der Redaktion
Make clearer, one column all the way down
2.2 million fundraising campaign for toxicology study underway
Change picture to WAR plane not an air show
Combine two slides into 1
Check 45,000 world wide
Human trials only, so can't be used for preclinicals
