Application Of Norm-referenced Tests & Criterion –Referenced Tests 1.
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November 2017
Corporate Presentation
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All statements in this communication, other than those relating to historical facts, are "forward‐looking statements.” These forward‐lookingstatements may include, but are not limited to, statements relating to our objectives, plans, and strategies, the expected timing of trials,statements relating to the research, development, and use of our platform technologies, technologies, products and product candidates; and allstatements (other than statements of historical facts) that address activities, events, or developments that we intend, expect, project, believe, oranticipate will or may occur in the future. Forward‐looking statements are not guarantees of future performance and are subject to risks anduncertainties.
We have based these forward‐looking statements on assumptions and assessments made by our management in light of their experience andtheir perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate.
Important factors that could cause actual results, developments, and business decisions to differ materially from those anticipated in theseforward‐looking statements include, among other things: the uncertainties as to the future success of ongoing and planned clinical and pre-clinical trials; the unproven safety and efficacy of products under development or that may be developed in the future and the sufficiency of ourcash resources to conduct and complete clinical and pre-clinical trials; the overall global economic environment; the impact of competition andnew technologies; general market, political, and economic conditions in the countries in which we operate; projected capital expenditures andliquidity; changes in our strategy; government regulations and approvals; and litigation and regulatory proceedings. We caution you thatforward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity,and the development of the industry in which we operate may differ materially from the forward-looking statements contained in thispresentation as a result of, among other factors, the factors referenced in the “Risk Factors” section of our annual report on Form 20-F filed withthe Securities and Exchange Commission on May 1, 2017 (the “Annual Report”).
You should read carefully the factors described in the “Risk Factors” section of the Annual Report to better understand the risks anduncertainties inherent in our business and underlying any forward-looking statements.
These statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause ouror our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by theforward‐looking statements. You should not rely upon forward‐looking statements as predictions of future events. Although we believe that theexpectations reflected in the forward‐looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, orachievements. These forward‐looking statements speak only as of the date of this presentation, and we assume no obligation to update or revisethese forward‐looking statements for any reason.
Forward Looking Statements
Disclaimer
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Proven Science, Novel Approach
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
Therapix Overview
Compelling proprietary, technology based on cannabinoid-based science
Compelling valuation – discounted to comparable companies
World-class scientific leadership and proven management
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Potentially highly cost- and time-efficient with a de-risked regulatory pathway
Therapeutic programs address areas of high unmet medical need
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5
3
2
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Focused cannabinoid-based neurological pipeline with broad impact
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
Clinical-Stage Pipeline
THX-110
(i) Phase IIa Study at Yale University currently scheduled to complete recruitment by 4Q17 with top-line read-out anticipated in 1Q18.(ii) Phase IIb Study at Hannover Medical School currently scheduled to commence in 1H18 with top-line read-out anticipated in 2H19.(iii)PK Study currently scheduled to commence in 1Q18 with
anticipated data available in 1H18; concurrent pre-clinical TBI model currently scheduled to commence in 4Q17 and anticipated to complete in 1H18.
Phase IIbPhase IIaPhase IPreclinical Phase III
THX-130
THX-150
TS
OSA
TBI
A-B
Undisclosed Pain
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THX-110For the treatment of Tourette’s Syndrome
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Disease Overview & Clinical Features
Tourette’s Syndrome
Disease Overview Clinical Features
• Tourette syndrome (TS) is a movement and neurobehavioral disorder characterized by motor and vocal tics
• Tics may be associated with a premonitory sensation to perform the specific action, which may lead to “relief” once performed
• Tics, the clinical hallmark of TS, are sudden, brief, intermittent movements (motor tics) and utterances (phonic tics), and can be either:
- Simple: blinking, facial grimacing, head jerking, grunting, coughing
- Complex: coordinated movements, bizarre gait, kicking, jumping, coprolalia (obscene words), echolalia (repetition of words)
• Patients with TS often present with comorbidities, with the most frequent conditions being ADHD and OCD
“Tourette’s consists of chronic motor tics with onset before age 18. About half to two-thirds of the cases get much better during adolescence. In general, the adults you see will have had tics for a while and will generally be more severe.”
- Therapix SAB Member
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Patient reports of successful use of cannabis to treat Tics
Scientific Rationale: Treating TS with THC (1)
Source: Huron Primary Research (06/2017), Acta Psychiatr Scand.1998 Dec;98(6):502-6. PMID: 9879795, J Clin Psychiatry. 2003 Apr;64(4):459-65. PMID: 12716250
• Many TS patients have reported to their physicians that smoking marijuana helps reduce tic severity
• Anecdotal evidence suggests that cannabis addresses many comorbidities associated with TS, such as anxiety, OCD, and depression
“Tourette’s is certainly one of those disorders that crops up from time to time as medical marijuana has been beneficial for it and prescription THC has been helpful for it.”
– US Cannabinoid KOL
Clinical Rationale For Cannabis In TS
Articles Exploring Cannabinoid Potential In TS
“I can think of an adult who told me that he smoked marijuana every night for his tics. He brought his wife in and she said that she insisted he stop, but his tics got so much worse that she insisted he restart it.”
– US TS KOL
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• Biological evidence suggests that the brain endocannabinoid system may contribute to the pathophysiology of TS and other movement disorders as they play an important role in motor inhibition
• This hypothesis is supported by the fact that the highest density of central cannabinoid (CB1) receptors is located in the frontal cortex, basal ganglia, cerebellum, hypothalamus, hippocampus, and nucleus accumbens – areas of the brain that have been implicated to be involved in TS pathology
• In the brain, endogenous ligands (endocannabinoids) bind to CB1 receptors and affect the activity of monoamines (e.g., dopamine), excitatory (glutamate) and inhibitory (GABA, glycine) transmitters. There are several lines of evidence suggesting a complex interaction between the CB1 receptor and the dopaminergic systems
• Consistent with this hypothesis, in has demonstrated that treatment with dronabinolincreases intracortical inhibition (Hasan et al., 2010). Accordingly, researchers have suggested that dronabinol might counteract deficits of intracortical inhibition by modulating the release of several neurotransmitters including dopamine
Scientific Rationale: Treating TS with THC (2)
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• In the 1990s, TS patients reported a reduction or complete remission of their tics and an amelioration of premonitory urges, OCD, and ADHD after use of marijuana – without SAE (Müller-Vahl et al., 1998)
• In 2002, in a randomized double-blind placebo-controlled crossover single-dose trial 12 adult patients were treated with up to 10 mg dronabinol (Müller-Vahl et al., 2002b) demonstrated:
• A significant global tic improvement was found after dronabinol compared with placebo. In addition, a significant improvement in OCD was observed
• 10/12 patients experienced a global improvement after dronabinol (mean of +35% + 28.0, range, 20 – 90%), but only 3/12 after placebo (mean of +7% + 13.7, range, 10 – 40%)
• Including only those patients who had received 7.5 or 10.0 mg dronabinol (n=8) suggested that higher dosages were more effective
• No SAEs occurred
• In 2003, Professor Müller-Vahl et. al. conducted another randomized double-blind parallel group placebo-controlled study with dronabinol target dosage 10 mg/day over six-weeks, including 24 adult patients with TS:
• A significant difference was found between the dronabinol and placebo groups
• No SAEs occurred
• Conclusions:
• Dronabinol appears to improve not only tics, but also associated behavioral disorders such as ADHD, OCD, and depression in patients with GTS as well as patients’ quality of life (Sandyk and Awerbuch, 1988; Hemming and Yellowlees, 1993; Müller-Vahl et al., 1999; Hasan et al., 2010; Brunnauer et al., 2011)
• Immediate verbal memory span even improved during dronabinol treatment (Müller-Vahl et al., 2003b). These results clearly contradict the argument that tic improvement due to dronabinol is simply caused by general sedation or relaxation
Clinical evidence since the 1990s
The Treatment of TS with Cannabinoids
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
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Maximizing the therapeutic benefits of THC
Therapix’s Edge: “Entourage Effect”
Duration of Effect
THC
Eff
ect
Stre
ngt
hTHC
THC + PEA
THC and PEA, a Proprietary CombinationThe Entourage Effect
Oral formulation
✓Coined in 1998 by Therapix Scientific Advisor Dr. Raphael Mechoulam
✓Refers to apparent potentiation of drug effects by other similar, but inactive compounds
✓Combining PEA with THC dramatically increases the effectiveness of THC and its duration
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
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• Significant limitations to the currently only two antipsychotic agents FDA-approved medications available for TS treatments in terms of both efficacy and side-effects including a black box warning on their label due to their potential lethal effect In some cases, the adverse reactions are more disturbing than the TS symptoms for which they were prescribed
• In Germany, however, only haloperidol is licensed for TS, but due to clinically relevant adverse events no longer recommended
• A substantial number of patients are treatment resistant to all established drugs. Therefore, several patients are unsatisfied with available treatments either due to less efficacy or significant AEs and seek alternative medicine, including cannabinoids
• The major limitations of both cannabis and dronabinol use are the adverse psychoactive side effects that they induce in higher doses. Thus, in order to harness the therapeutic potential of THC for patients with Tourette's syndrome, there is a need to reduce the accompanied adverse effects
• We hope to use the entourage effect to deliver the therapeutic benefits of dronabinol in reducing tics with decreased psychoactive effects using Palmitoylethanolamide
TS is an Unmet Medical Need
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
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Antipsychotics are the most efficacious therapy available; use is limited given side effects
Drug Class ProductsIndicated
for TSReduction In
Tics*Safety Physician Perceptions
Alpha-2 adrenergic agonists
Guanfacine(Intuniv / Tenex)
Used off label
30%“The alpha-2 agonists are the first line of treatment, but those are not super effective for Tourette’s… there is a small to medium benefit in improving tics.”
Clonidine(Catapres)
Used off label
18%
Anti-psychotics
Haloperidol(Haldol)
Approved 65%“With the antipsychotics, there is a quite a significant risk of weight gain, metabolic syndrome, diabetes, which makes these medications quite problematic for a substantial proportion of patients with tics.”
Aripiprazole(Abilify)
Approved 50%
Pimozide(Orap)
Approved 16%
Risperidone(Risperdal)
Used off label
32%
Source: UpToDate (“Tourette Syndrome”, 2017), CDC (“Tourettes”), MedScape (“Pediatric Tourette Syndrome Treatment & Management”), Tourette Association Of America, Ther Adv Neurol Disord. 2011 Jan; 4(1): 25–45.
* Based on clinical studies and does not necessarily represent efficacy seen in clinical practice
Classes of Drugs Currently Used to Treat TS
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
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Abide is developing an MGLL inhibitor targeting cannabinoid pathway In Ph I
TS Has Limited Late-stage Pipeline Activity
Drug Class Products PhaseReduction
In TicsSafety Physician Perceptions
Cannabinoid
THX-110 (Therapix)
Ph II TBD TBD “The hottest thing right now is looking at
cannabinoids, and I think that’s worth
looking at. Anecdotally, there are patients
who report a subjective improvement.”ABX 1431
(Abide)Ph I TBD TBD
VMAT
inhibitors
Valbenazine(Neurocrine)
Ph II 31%“If you look at the studies, the side effect
profile is very impressive.” Deutetrabenazine(Teva)
Ph I 38%
GABA
modulators
CPP 115 (Catalyst)
Ph II TBD TBD “There’s evidence that there are
abnormalities of neurotransmitters in the
Tourette’s brain, particularly GABA.” SNC 102 (Synchroneuron)
Ph II TBD TBD
Other
Botulinum toxin A (Ipsen)
Ph II 39%*
Ecopipam(Psyadon)
Ph II 17%** “The side effect profile was interesting.”
* Reduction in tics seen per minute and agent used off-label today** Reduction seen in 2014 open-label study, though recent 2017 interim data from Ph IIb suggests statistically significant reduction
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
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Limited Late-stage Pipeline Activity in Tourette’s Syndrome (TS) Among Peers
1. http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/OrphanDrugAct/
2. Treatment of Tourette syndrome with cannabinoids, Muller-Vahl KR , Behavioural Neurology 27 (2013) 119–124
Clinical Competitive Landscape
Competitive Pipeline (Ph I – Pre-reg) Highlights
• ABX-1431 is an inhibitor of monoacylglycerol lipase (MGLL), which breaks down 2-AG and thus serves as a key control-point for endocannabinoid signaling
‒ Separately, Abide has established a collaboration with the Tourette Association of America
‒ Celgene has exercised its option to obtain ex-US rights to ABX-1431
• Pipeline includes two VMAT inhibitors, with Neurocrine and Teva, and two assets targeting GABA, with Catalyst and Synchroneuron
• Psyadon recently announced positive results from Ph IIb of Ecopipam for Tourette Syndrome in children
• Ipsen is cosponsoring a pilot Ph II for treatment of vocal tics in patients with Tourette Syndrome
Botulinum toxin A(Ipsen, Acetylcholine inhibitor)
Valbenazine(Neurocrine, VMAT2 inhibitor)
Ecopipam(Psyadon, D1 dopamine receptor antagonist)
SNC 102(Synchroneuron, GABA agonist)
CPP 115(Catalyst, GABA-AT inhibitor)
ABX 1431(Abide/Celgene, MGLL inhibitor)
Deutetrabenazine(Teva, VMAT2 inhibitor)
PI PIIIPII Pre-Reg
Targets cannabinoid pathway
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Commercial Opportunity and Presentation of Potential Upside Opportunities
Tourette’s Syndrome & Chronic Tic Disorder
+ Cronic Tic Disorder, $797m
+ Pediatric, $335m
+ Orphan Pricing, $127m
Base Case (Adults Only),
$293m
The TS and Chronic Tic Disorder Markets Potentially Represent a
$1.5 Billion Commercial Opportunity
Analysis based on a proprietary consulting engagement conducted by Huron Consulting (June 2017).
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
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Yale UniversityHannover Medical School
(Investigator-led study)
Number of Patients ~18 ~40
First Patient In (Date) 4Q 2016 1H 2018
Last Patient In (Expected Date)
4Q 2017 19 2019
Expected Data (Expected Date)
1Q 2018 2H 2019
Experimental Procedure Open-label, single center Randomized, double-blind, placebo controlled, 3-arm study, single center
Primary Endpoint Improvement in Tic Severity (measured by the Yale Global Tic Severity Scale on a Total Tic Score)
Improvement in Tic Severity (measured by the Yale Global Tic Severity Scale on a Total Tic Score)
Principal Investigator Dr. Michael Bloch Prof. Kirsten Mueller-Vahl
Dosing Regimen Once daily Up to twice daily
Ongoing Phase 2 Clinical Trials
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
THX-110
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THX-130For the treatment of Mild Cognitive Impairment (MCI)
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✓ In 2015, there were an estimated 46.8 million people with dementia worldwide, and that number is estimated to increase to 74.7 million by 20301
✓ The global societal economic impact of dementia in 2015 was estimated at $818 billion, a 35% increase from 20101
✓ The prevalence of MCI increases with age, with 10% of those in the 70-79 age bracket showing signs, incrasing to 25% in those aged 80-892
✓ There is no FDA approved treatment or therapy for MCI3
✓ TBI is the first indication
A Curse with no Cure
1. World Alzheimer Report 2015, https://www.alz.co.uk/research/WorldAlzheimerReport2015.pdf2. E-Health and Telemedicine: Concepts, Methodologies, Tools, and applications, https://books.google.co.il/books?isbn=14666875763. http://www.alz.org/professionals_and_researchers_13518.asp
Mild Cognitive Impairment
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~1.7M ER Visits Among Ages 14+ Annually for TBI (U.S.)
TBI Market Opportunity
US Estimated TBI Incidence (2017)*
1,020
250
440
30
900
20
0
500
1,000
1,500
2,000
2,500
EDVisit Only
Hospitali-zations
Incid
en
ce
(K
s)
0-14 yr
14-25 yr
25 yr +
Note: ED visits only tend to correlate with mild TBI & hospitalizations with moderate-severe TBI
Special Populations: Athletes & Military
Athletes:
• At least 300K sports-related TBIs of mild-moderate severity each year in the US
• Athletes are at risk for “second impact syndrome” – which can be catastrophic or fatal – if they return to play too soon**
Military:
• Active duty: ~300K TBIs between 2000-2016 (~10-30K/year), according to the DoD
- Of these, ~82% mild & ~9% moderate
• Veterans: may sustain TBIs throughout their lifespan, with the largest increase as the veterans enter into their 70s and 80s
- These injuries are often caused by falls and result in high levels of disability
*Excludes deaths (~55K). These figures also underestimate TBI incidence, as they do not account for those who: did not receive medical care, had outpatient or office-based visits, or received care at a federal facility (i.e., U.S. military, or Veterans Affairs hospital)**Repeated mild brain injuries occurring within a short period (i.e., hours, days, or weeks); repeat injuries over an extended period (i.e., months or years) can also result in cumulative neurologic and cognitive deficitsSource: please see notes
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~3.4M U.S. Adults Suffer From Cognitive Impairment Due to TBI
*Definitions of mild, moderate & severe & rates of cognitive impairment over time are not well defined; KOLs believe that rates of cognitive impairment should decrease over time as some cases resolve; **Defined as a TBI with loss of consciousness (LOC); ***Impairment is no longer detectable at the group level by 3 months after a mild TBI in most controlled studiesSource: New Therapeutics for Traumatic Brain Injury: Prevention of Secondary Brain Damage and Enhancement of Repair and Regeneration, 2017, Neuroepidemiology. 2013;40(3):154-9, Brain Inj. 2013;27(7-8):767-74, N Z Med J. 2008 Jan 25;121(1268):U2903, http://www.traumaticbraininjury.com
TBI Market Opportunity
US Estimated TBI Cognitive Deficit Prevalence (2017)*
TBI Prevalence, US Adults**~12% (~29M)
Moderate TBI~10-15%
Severe TBI~5-10%
Mild TBI~80%
Cognitive Impairment:
~50%
Cognitive Impairment:
~70-80%
Cognitive Impairment:
~10-15%
~2.9M ~1.8M ~1.6M
~3.4M US adults are cognitively impaired due to TBI overall
Caveats
• TBI prevalence & epidemiology of cognitive impairment are poorly characterized in the literature
• Data on the rate of memory impairment specifically is lacking
• KOLs caution that a better understanding of the natural history of cognitive impairment – as many cases resolve – will be helpful for clinical trial design
• There is significant debate among KOLs as to when relative to injury cognitive impairment can be confidently measured
Assumed to resolve***
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✓ Cannabis has been shown to cause long-term cognitive deficits in chronic users manifested as impairment in attention, memory, or executive functions
✓ Paradoxically, Ultra-Low Doses of THC have been shown to prevent and reverse cognitive decline in preclinical trials as demonstrated by Prof. Yosef Sarne at the Tel Aviv University
A Proven Connection
Ultralow doses of cannabinoid drugs protect the mouse brain from inflammation-induced cognitive damage, Fishbein-Kaminietsky M., et al. The Journal of Meuroscience Research, Volume 92, Issue 12, December 2014, Pages 1669–1677http://onlinelibrary.wiley.com/doi/10.1002/jnr.23452/full
Cannabis and Cognition
THX-130 Overview
• Mechanism of Action: ultra-low dose formulation of dronabinol (synthetic delta9-tetrahydrocannabinol, or THC)
• Route of Administration: sublingual
• Indication: cognitive impairment associated with traumatic brain injury (TBI) (adults)
• Safety: clean, due to the ultra low dose
Status & Cognition Results
• Development Status: preclinical (mice)
• Results: A single injection protects the brain from cognitive deficits when applied 1-7 days before or 1-3 days after an insult
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Leadership, Comparable Company Analysis & Upcoming Anticipated Milestones
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Tested and Proven Experience in the Sector
Management Team
Dr. Ascher ShmulewitzInterim Chief Executive Officer
- Chairman of Therapix since January 2014
- Prolific inventor and serial entrepreneur in biomedical technologies
- Has founded over two dozen life science companies and led multiple companies to successful exits
- Ph.D. from Tel Aviv University and M.D. from Israel Institute of Technology (Technion)
Josh BlacherChief Financial Officer
- >25 years of experience in a wide variety of managerial, operational, financial, and business development-related positions
- Vast experience managing equity investments in biotech, across wide range of development stage companies from pre-clinical through Ph.3 projects
- MBA from Columbia University
Dr. Adi Zuloff-ShaniChief Technology Officer
- >17 years of vast experience as an R&D executive
- Has served as VP of Development at Macrocure
- >Experienced in Clinical, Operations, QA/QC, Finance and RA.
- Ph.D. in Immunology and Human Biology from Bar-IlanUniversity, Ramat Gan, Israel
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
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Award winning, active scientists
Scientific Advisory Board
Prof. Raphael Mechoulam
- A Professor Emeritus of the School of Pharmacy at the Faculty of Medicine of the Hebrew University in Jerusalem
- A recipient of the Israel Prize
Prof. James Leckman
- A child Psychiatrist at Yale University
- Served as Director of the Child Study Center at Yale for over two decades
- A prominent international expert in the field of research and treatment of Tourette Syndrome
Prof. Kirsten Muller-Vahl
- Professor of Psychiatry the Hannover Medical School, Germany
- Recognized as the leading researcher in the field of cannabinoid use in treatment of Tourette Syndrome
- Served as a member of the scientific advisory board of the German Tourette Syndrome Association
Prof. Michael Davidson
- Professor of Psychiatry
- Served as Chief Psychiatrist at the Department of Psychiatry of the Sheba Medical Centre Tel-Hashomer
- Chairman of the StuckinskiCentre for Alzheimer's Disease Research in Ramat Gan
Dr. Michael Bloch
- Associate training director of the Child Study Center's Solnit Integrated Program, Yale School of Medicine
- Noted researcher on the study of Tourette Syndrome, obsessive-compulsive disorder and trichotillomania
Dr. Daniele Piomelli
- The Editor-in-Chief of Cannabis and Cannabinoid Research
- Serves as Louise Turner Arnold Chair in Neurosciences
- Professor of Anatomy and Neurobiology, Pharmacology, and Biological Chemistry at University of California, Irvine
Prof. Avi Weizman
- Professor of Psychiatry at the Sackler School of Medicine Tel Aviv University
- Head of the Laboratory of Biological Psychiatry at the Felsentein Medical Research Center
- Director and Head of GehaMental Health Center's Research Unit
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
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Comparable Company Analysis
(Figures in millions, unless otherwise noted) Current Share Price Appreciation (%):
Company Ticker Exchange Share Price
Market
Value
3 Month
Average
Volume (000s)
Since TRPX
IPO
(3/22/2017) 3Q17a QTD 4Q17
Trailing 30
Days
Trailing 5
Trading
Days
52-Week
High
52-Week
Low
GW Pharmaceuticals GWPH NASDAQ 111.44$ 2,820$ 339 -7% 1% 10% 2% -1% -17% 18%
Insys Therapeutics INSY NASDAQ 5.03$ 369$ 701 -51% -30% -43% -42% -1% -66% 1%
Corbus Pharmaceuticals CRBP-US NASDAQ 6.80$ 373$ 662 -25% 13% -5% -4% -1% -34% 19%
Zynerba Pharmaceuticals ZYNE NASDAQ 10.90$ 144$ 926 -42% -51% 30% 16% 6% -57% 90%
Therapix Biosciences TRPX-us NASDAQ 5.00$ 17.69 30 -17% -18% -13% -14% -3% -60% 0%
Average -31% -16% -2% -7% 0% -43% 32%
Median -34% -14% 2% -1% -1% -46% 19%
Market Weighted Median 3,706₹ -14% -3% 4%
NASDAQ Composite COMP-USA 6,789 17% 6% 5% 3% 0% 0% 30%
NASDAQ Health Care IXHC-USA 740 9% 7% -5% -6% -1% -7% 18%
NASDAQ Biotechnology NBI 3,276 8% 8% -6% -8% -1% -8% 18%
Russell 2000 Index RUT^ 3,682 10% 5% -1% -1% -1% 144% 199%
2017 share price appreciation for TRPX based on IPO price of $6.00 on 3/22/17.
Market data as of 11/08/17
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
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Recent News Flow
September 2017 October 2017 November 2017
September 27th
First-in-class therapy demonstrates reversal of age-related cognitive impairment in pre-clinical study under Professor Yosef Sarne at Tel Aviv University
October 6th
Signs formulation development and clinical manufacturing agreement with Catalent for THX-120
October 18th
Enters collaboration with Assuta medical center to initiate clinical trial in Obstructive Sleep Apnea
October 30th
Initiates non-clinical studies for antibacterial program in collaboration with the Weizmann Institute of Science and Tel Aviv Sourasky Medical Center
November 2nd
Board Chairman, Asher Shmulewitz, appointed as Interim Chief Executive Officer
November 7th
Entered into a product development agreement to develop cannabinoid-based product for sleep disorders
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Upcoming Anticipated Milestones and Catalysts
4Q17 1Q18 2Q18 3Q18
Top-Line Data:Phase IIa Study in TS at
Yale
IMPD Submission Phase IIb Study in TS at
Hannover
First Patient In, Phase IIb Study in TS at
Hannover
Top-Line Data:Phase I PK Study in MCI
First Patient In, Phase IIa Study in OSA at
Assuta
Top-Line Data:Phase IIa Study in OSA
at Assuta
Data: Preclinical Studies in A-B at Weizmann & Sourasky
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
27
Proven Science, Novel Approach
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially different than assessed and estimated previously.
Therapix Review
Compelling proprietary, technology based on cannabinoid-based science
Compelling valuation –discounted to comparable companies
World-class scientific leadership and proven management
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Potentially cost- and time-efficient with a de-risked regulatory pathway
Therapeutic programs address areas of high unmet medical need
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5
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Thank You!
450 Lexington Avenue4th Floor New York, NY, 10017+1-646-688-5535
4 Ariel Sharon StreetHashahar Tower, 16th Floor Givatayim, Israel, 5320047+972-3-616-7055