Ambra BioScience – Lovidia was formed to develop and commercialize products that deliver measurable improvement in health and wellness. Lovidia Hunger Control Formula, the first GSM-based commercial product has been shown to reduce hunger in a randomized, double-blind, placebo-controlled clinical study with 220 subjects. The Company’s flagship product, Lovidia hunger control and weight loss, is based on the Company’s patented science known as Gut Sensory Modulation or GSM. GSM involves delivering GRAS (General Recognized As Safe) dietary ingredients orally past the stomach to the lining of the gut. Lovidia’s proprietary blend of GRAS ingredients is non-stimulating, vegan, non-GMO, gluten-free and dairy-free. There are two forms of Lovidia: (1) Lovidia, which is a natural Hunger Control blend that releases over 1-3 hours in your gut and (2) Lovidia XR (Extended Release) which releases the natural blend over 3-6 hours in your gut.
2. Ambra BioScience
Why?
Medical Science has made huge progress dealing with life-threatening
diseases and traumatic medical events. At the same time Americans have
steadily become less healthy due to the rise in chronic conditions such as
obesity and diabetes. Today, more than half of America’s healthcare dollars
are spent on lifestyle diseases that can be “treated” with diet and exercise.
We want to make America healthy again & do it without drugs. Our mission
is to help people everywhere measurably improve their health.
Live healthier, live happier, live longer!
Read on to learn about our science and our products.
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3. Gut Sensory Modulation (GSM) and
Lovidia®
• GSM Technology Platform
• Science & Patents
• Clinical Testing
• Lovidia Value Proposition
• Products
• LOVIDIA Way
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4. GSM Technology Overview
• Learnings from gastric-bypass surgery
• Physiology of L-cell hormone release
• L-cell gastrointestinal distribution
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Based on:
5. Learnings from gastric-bypass surgery
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GI manipulations that result in rapid
delivery of food to the lower bowel where
L-cells are most abundant lead to:
Improved glucose control prior to weight loss
Frequent remission of diabetes
Elevated circulating concentrations of GLP-1,
PYY and other gut hormones
Roux-en-Y
GI sleeve
6. L-cells release gut hormones that
mediate appetite and glucose regulation
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Gut Wall
CR
L-cell
Bitter
Sweet
Umami
GLP-1
PYY
Oxyntomodulin
Excreted
Hormones Target Organs ActivityBlood
Chemosensory
Receptor
Islet
Βeta Cell
Satiety
Meal cessation
Glucose/insulin
Regulation
Leveraging gut hormonal responses observed during ingestion of food
7. L-cell density is highest in the lower gut
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fundusfundus
<1<1antrumantrum
<1<1
duodenumduodenum
5.7 ± 0.95.7 ± 0.9
jejunumjejunum
4.7 ± 1.04.7 ± 1.0
ileumileum
84 ± 884 ± 8
ascendingascending
coloncolon
82 ± 982 ± 9
coloncolon
sigmoidsigmoid
coloncolon
196 ± 34196 ± 34
rectumrectum
480 ± 66480 ± 66
Adrian et al.,Adrian et al., GastroenterologyGastroenterology 1985; 89:1070-71985; 89:1070-7
~80 fold gradient in L-cell density from duodenum to rectum *
* Distribution assessed by PYY content (pmol/g)
pH 5-5.5
pH 6-6.5
pH 7.0
8. GSM Mode of Action
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The Science of Gut Sensory Modulation
• Deliver GRAS food ingredients to the lower gut to enhance
secretion of gluco-regulatory and satiety hormones (e.g.,
GLP-1, PYY) from enteroendocrine cells
9. Science Summary
Gut Sensory Modulation - proven platform
•Modulated release of endogenous gut
hormones (GLP-1, PYY…)
•Potential to deliver multiple high value
products (dietary supplements, medical foods,
food ingredients) that affect hunger, satiety,
glucose regulation, inflammatory response
and mood
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10. GSM Patents
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CHEMOSENSORY RECEPTOR
LIGAND-BASED THERAPIES
COMPOSITIONS AND METHODS
FOR HUNGER CONTROL AND
WEIGHT MANAGEMENT
(First Patent Filed: 2009)
(First Patent Filed: 2018)
Issued Patents: 15 (US 4, OUS 11)
Patents Pending: 9
11. GSM Clinical Testing Overview
Elcelyx Therapeutics Inc. invented the GSM technology platform. Ambra BioScience acquired the
GSM patent portfolio and Lovidia development program in 2014.
Multiple, placebo-controlled, acute GSM clinical studies conducted by Elcelyx between 2010 -
2013 showed that various tastants (alone and in combination) could stimulate the release of L-cell
hormones. Elcelyx also demonstrated in a 16-week, placebo-controlled, study that these same
tastants could produce statistically significant, categorical weight loss.
Ambra conducted a 1-week, 220-subject, double-blind, placebo-controlled clinical study with the
Lovidia® Hunger Control Formula in late 2015. Reduced hunger was the endpoint and the results
were statistically significant with a p-value = .02.
In 2017, Ambra conducted a 13-week health outcomes study involving 52 healthy subjects using
Lovidia in combination with intermittent fasting. Subjects lost an average of 14 lbs. (7 % reduction
in body weight) and significantly improved metabolic and cardiovascular indicators including
reduced blood pressure, and improved lipids and glucose control.
In 2017, Ambra conducted a 7-day hunger control and weight loss study using the Lovidia Hunger
Control Bar. The Bar group lost an average of 4 lbs. compared to 0.5 lbs. without the bars.
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12. GSM Clinical Evidence
Enhanced Hormone Release
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• Placebo-controlled, crossover, acute hormone release study
• Increased release of GLP-1 and PYY observed in study participants
taking GSM test formulation (LC001) compared to placebo
Baseline-corrected GLP1 Active
(Glucose Challenge N=12)
Time (min)
GLP-1active(pM)
-60 0 60 120 180 240 300
-5
0
5
10
Baseline-corrected GLP1 Active
(Ensure Challenge N=12)
Time (min)
GLP-1active(pM) -60 0 60 120 180 240 300
-5
0
5
10
Baseline-corrected PYY Total
(Glucose Challenge N=12)
talPYY(pg/mL)
0
10
20
30
Baseline-corrected PYY Total
(Ensure Challenge N=12)
talPYY(pg/mL)
0
10
20
30
Placebo
Active
*AUC P= 0.151
*Cmax P= 0.077
AUC P= 0.204
Cmax P= 0.021
GLP1 Active
ge N=12)
n)
80 240 300
Baseline-corrected GLP1 Active
(Ensure Challenge N=12)
Time (min)
GLP-1active(pM)
-60 0 60 120 180 240 300
-5
0
5
10
ed PYY Total
nge N=12)
Baseline-corrected PYY Total
(Ensure Challenge N=12)
talPYY(pg/mL)
0
10
20
30
Placebo
Active
*AUC P= 0.151
*Cmax P= 0.077
C P= 0.204
max P= 0.021
* Reproduced in 4 separate studies, total n=58
Baseline-corrected GLP1 Active
(Glucose Challenge N=12)
Time (min)
GLP-1active(pM)
-60 0 60 120 180 240 300
-5
0
5
10
Baseline-co
(Ensure
T
GLP-1active(pM)
-60 0 60
-5
0
5
10
Baseline-corrected PYY Total
(Glucose Challenge N=12)
Time (min)
TotalPYY(pg/mL)
-60 0 60 120 180 240 300
-20
-10
0
10
20
30
Baseline-co
(Ensure
T
TotalPYY(pg/mL)
-60 0 60
-20
-10
0
10
20
30
*AUC P= 0.151
*Cmax P= 0.077
AUC P= 0.204
Cmax P= 0.021
LC001 LC001
Glucose LoadGlucose Load
14. Clinically-proven to reduce hunger
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The commercial Lovidia Hunger Control Formula was tested in
220 subjects in a randomized, double-blind, placebo-controlled
study designed to evaluate the effectiveness of Lovidia to
reduce hunger over 7-day period
Study Results:
• Lovidia significantly more
effective than placebo,
p=0.02
• No safety flags noted
15. 13-week “LOVIDIA Way” lifestyle study using Lovidia in
conjunction with alternate-day caloric restriction
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Baseline
BMI
Average BMI
Average BMI
Change, (%)
P value
25 - 29.9
(n = 9)
28.3 -1.6, (-5.6%) 0.0029
30 - 34.9
(n = 14)
32.4 -1.8, (-5.6%) < 0.0001
35 -39.9
(n = 7)
37.3 -2.9, (-7.9%) 0.0089
40
(n = 8)
43.9 -3.0, (-6.8%) 0.0003
Average Weight Loss: 14 lbs.
Weight Loss Range: 3 lbs. - 51 lbs.
16. The LOVIDIA WAY study also resulted in significant
improvements in A1c, Lipids, Blood Pressure
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Baseline
Total/HDL
Cholesterol
N
Average Total/HDL
Cholesterol
P value
Baseline
Change
at Week
13
All 38 4.13 -0.357 0.0012
<3.5 14 2.95 -0.129 0.0823
> 3.5 24 4.82 -0.492 0.0035
Triglycerides
(mg/dL)
N
Average Triglycerides
(mg/dL)
P value
Baseline
Change at
Week 13
All 38 143.5 -19.68 0.0418
<150 24 100.1 2.33 0.7481
150 - 199 6 175.3 -27.83 0.2662
>200 8 250.0 -79.63 0.0188
≥ 150 14 218.0 -57.43 0.0084
Systolic/Diastolic
blood pressure
All
Normal
< 120/80
mmHg
Elevated
≥ 120/80
mmHg
High
≥ 140/90
mmHg
Average
MAP(mmHg)
113.75 106.87 116.21 125.31
Average Change in
MAP (mmHg)
-3.87 1.77 -5.88 -9.42
P value 0.05 0.66 0.01 0.02
N 38 10 28 12
Blood Pressure Lowering
Improved Lipids
Baseline
HbA1c
Category
N
Average HbA1c (%)
P valueBaselin
e
Week
13
Change
All 38 5.69 5.38 -0.31
<
0.0001
Normal 20 5.395 5.14 -0.26
<
0.0001
Prediabetes 17 5.92 5.64 -0.28 0.003
Diabetes 1 7.6 5.8 -1.8 -
Improved Glucose Control
17. Lovidia Value Proposition
• Clinically proven Lovidia Hunger Control products work in your lower gut to help you feel full
faster and lose weight all while living a full and happy life!
• Natural GRAS (Generally Recognized as Safe) Ingredients.
• Patented formulas based on $20 million dollars and 6 years of research.
• 1000’s of lives improved and counting!
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18. The Lovidia Products
• Lovidia products are designed to work with your
natural digestive process to reduce hunger and
help prevent overeating.
• Lovidia products help:
• Reduce snacking
• Give you more control over the amount of
food you eat
• Lose weight without having to fight hunger
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19. Lovidia Products
• Lovidia 3-Product Sample Pack for $19.95 lets you determine which products work best for you!
• Lovidia: All-natural Hunger Control Blend. Releases the blend over 1-3 hours in your gut.
• Lovidia XR (Extended Release): All-natural Hunger Control Blend. Releases the blend over 3-6
hours in your gut.
• Lovidia Bar: Use in conjunction with the tablets for a supercharged hunger control boost*
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20. Lovidia Value
• The Lovidia 3-Product
Sample Pack lets you
decide which products
work best for you!
• $19.95 + Free Shipping!
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21. Lovidia Products
• Lovidia Hunger Control Formula 30-count tablets
starting at $29.95, sold in 1, 2, or 3 bottle increments.
• Flip the switch on hunger! Lovidia Hunger Control
Formula targets the #1 obstacle to weight loss…
overeating. By working with your body’s own natural
hunger-control process, Lovidia’s patented formula
helps you feel satisfied with fewer calories, so you can
lose weight without dangerous stimulants or
unpleasant side effects. Ϯ
• All-natural, proprietary hunger-control blend
• No stimulants, diuretics, or negative side effects
• Non-GMO, Vegan, Gluten-free, Dairy-free
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22. Lovidia Products
• Lovidia XR 60-count tablets starting at $49.95.
• The Lovidia XR is designed to release slower in
the gut and target the L-cells lower in the
digestive system. Our research has shown that
for some people, a slower release is more
effective for hunger control.
• All-natural, proprietary hunger-control blend
• No stimulants, No caffeine, No diuretics
• Non-GMO, Dairy-free
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23. Lovidia Products
• Lovidia Hunger Control Bars starting at $2.95.
• Mixed Nuts
• Oats and Nuts
• The Lovidia Hunger Control Bars are made with
our scientific hunger control blend of ingredients
that keep you full and help crush cravings. These
small but mighty bars are 100% natural and
clinically proven to help you lose weight.
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24. Lovidia Products
• The LOVIDIA Way – Monthly Subscription - $89.95
• 60 Lovidia Tablets
• 12 Hunger Control Bars
• 12 Crispy Heart Sachets
• 4 complementary coaching calls
Developed from our 13-week Clinical Study with 52
participants that not only lost on average 14 lbs.
each but saw meaningful cardiovascular and
metabolic improvements.
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25. Lovidia Success Stories
• https://youtu.be/6-xSh_Ac-Oo
• Katrina lost 22 lbs. with the help of Lovidia.
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26. Lovidia Success Stories
• Tristin is down 2 pants sizes by using Lovidia products.
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Our area of focus in metabolic diseases and peptide/protein science.
We’ve been in business for almost 24 years and were able to successfully launch our first two first in class products, Symlin and Byetta, within months of each other in 2005.
We’re headquartered here in San Diego and have ~1500 employees with ~300 sales reps in the field and ~300 in our manufacturing facility in West Chester, OH.
Our area of focus in metabolic diseases and peptide/protein science.
We’ve been in business for almost 24 years and were able to successfully launch our first two first in class products, Symlin and Byetta, within months of each other in 2005.
We’re headquartered here in San Diego and have ~1500 employees with ~300 sales reps in the field and ~300 in our manufacturing facility in West Chester, OH.
Our area of focus in metabolic diseases and peptide/protein science.
We’ve been in business for almost 24 years and were able to successfully launch our first two first in class products, Symlin and Byetta, within months of each other in 2005.
We’re headquartered here in San Diego and have ~1500 employees with ~300 sales reps in the field and ~300 in our manufacturing facility in West Chester, OH.