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Invest estor or Pre resentation sentation Ja Januar ary y 2016 :GLMD Forward ard Looking king St Stat atement ement This presentation contains forward-looking statements about our expectations, beliefs or intentions regarding, among
This presentation contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations
forward-looking statements may be included in, but are not limited to, this presentation, various filings made by us with the SEC, press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the factors summarized below. These factors include, but are not limited to, the following: FDA approval of, or other regulatory action with respect to AramcholTM; the commercial launch and future sales of aramchol or any other future products or product candidates; our ability to achieve favorable pricing for aramchol; our expectations regarding the commercial market of NASH in patients who also suffer from obesity and insulin resistance; third- party payor reimbursement for aramchol; our estimates regarding anticipated capital requirements and our needs for additional financing; patient market size and market adoption of aramchol by physicians and patients; the timing, cost or other aspects of the commercial launch
receiving favorable results of Phase IIb and Phase III trials for aramchol; the development and approval of the use of AramcholTM for additional indications or in combination therapy; and our expectations regarding licensing, acquisitions and strategic operations. These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our
looking statements. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf included in, but not limited to, this presentation speak only as
looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.
Forward ard Looking king St Stat atement ement
AramcholTM addresses a significant, and growing unmet need in the U.S., EU & RoW – Non-alcoholic steatohepatitis (NASH) and liver diseases
Focused Strategy, Broad Vision
First in a new class of drug candidates with proof-of- concept as demonstrated in Phase I & IIa clinical trials; no serious or drug-related adverse events observed
Novel Technology
Completed pre-clinical and 4 clinical trials (Phase Ia/Ib, PK Food effect & Phase IIa … on time and under budget)
Strong Track Record of Execution
~10% population in U.S. & EU-5 nations has NASH; prevalence expected to rise in parallel with obesity and
Significant Market Opportunity
January 2016
GLMD trades significantly below comparable companies. Exceptionally modest Enterprise Value
Compelling Valuation
1
Regulatory Pathway Clinical Trials Initiated Clinical Infrastructure Additional PoC Clinical Trials In Advanced Formation Share Price GLMD Professionals
X 12 0/0 $5.80 2 22 2 9/42 2 $7.61 Big Significant Huge Meaningful 31%
January 2016 2
Significant
January 2016 3
N A S H
“Nonalcoholic steatohepatitis is the most rapidly growing indication for liver transplantation.”1
“The most common cause of death in patients with NAFLD, NAFL and NASH is cardiovascular disease.”2
Liver Disease Metabolic Syndrome
TM Uni
January 2016 4
January 2016 5
Clinical Gastroenterology and Hepatology 2014: The Fatty Acid–Bile Acid Conjugate Aramchol Reduces Liver Fat Content in Patients With Nonalcoholic Fatty Liver Disease;
January 2016 6
Clinical Gastroenterology and Hepatology 2014: The Fatty Acid–Bile Acid Conjugate Aramchol Reduces Liver Fat Content in Patients With Nonalcoholic Fatty Liver Disease;
treatment period and subsequent recovery period
January 2016 7
St Study udy N Summ mmary y of Safety y Resul ults ts
Chronic Toxicology (non-clinical) No AEs and minimal toxicity following single doses (750 mg/kg); repeat dose studies in rats up to 6-months (1000 mg/kg) and in dogs up to 9-months (1500 mg/kg); reproductive studies in rats (1000 mg/kg) and rabbits (750 mg/kg). NOAEL determined at highest dose tested for all studies; didn’t reach MTD Phase I 41 Single doses of AramcholTM from 30 mg to 900 mg and repeated dose of 100 mg, 300 mg were found to be safe and well tolerated in healthy male subjects Phase IIa 57 No severe AEs during the 3-month treatment period. Mild AE in 6 patients were mild or moderate and transient, and did not differ between the placebo and treated groups PK / Food Effect 66 All doses of AramcholTM were safe and well tolerated. No serious AEs. Most of AEs were mild and unrelated to AramcholTM and all AEs were transient and gave no indication of target organ toxicity
January 2016 8
Source: Deutsche Bank by 2025
January 2016 9
Design:
study
Participants:
Doses:
Treatment Plan:
treatment (1H16). Top-line results in 3Q17
Number of Subjects (Est.):
Primary Endpoint:
Secondary Endpoints:
measured by biopsy
January 2016 10
January 2016 11
50 100 150 200 250 300 Patients Screened (Cumulative) Europe/Israel Latin America United States
Europe = France and Romania (Germany and Italy have recently received regulatory approval; Latin America = Mexico and Chile.
January 2016 12
Europe = France and Romania (Germany and Italy have recently received regulatory approval; Latin America = Mexico and Chile.
9 13 18 25 44 44 3 7 10 11 9 10 13 13 10 20 30 40 50 60 70 1Q15 2Q15 3Q15 4Q15 1Q16 2Q16 Activated Sites (Cumulative) Europe/Israel Latin America United States
January 2016
Phase IIb Ongoing
13
Phase III < PoC (noteworthy)
NASH
80% of Market
Fibrosis
20% of Market
(Cirrhosis; IV Formulation)
– HIV-associated lipodystrophy refers to abnormal, abdominal visceral fat accumulation – In patients with HIV, liver disease is among the leading causes of death – Nearly half of the HIV infected patients without viral hepatitis that undergo evaluation for unexplained liver test abnormalities are found to have NAFLD – The prevalence of NAFLD is higher in individuals with HIV infection than in the general population
– Like NASH, there are no therapies for the treatment of HIV-associated NAFLD and clinical trials in this area have been few – The first step in extrapolating additional commercial value with our existing assets – Signifies the beginning of our de-risking strategy through more potential applications and end markets for our product
January 2016 14
Design:
proof-of-concept Phase IIa clinical trial, which is an investigator-initiated study, conducted at the University of California San Diego by Professor Rohit Loomba
Participants:
fatty liver disease
Doses:
Treatment Plan:
Primary Endpoint:
Secondary Endpoints:
biochemistry
January 2016 15
January 2016
Phase II
16
>=Phase III <=Phase I
Biologic / Peptide Small Molecule
17 January 2016
(Figures in millions, unless otherwise noted)
Current Per Share (%): Share Price Appreciation: Company Ticker Share Price Market Value Enterprise Value Cash Franchise Value YTD 2016 Trailing 30 Days Actual 4Q15 2015 52-Week High 52-Week Low Conatus CNAT 2.87 $ 57 $ 15 $ 77% 23% 0%
15% Galectin GALT 1.76 $ 51 $ 37 $ 51% 49% 7%
17% Genfit PA GNFT-FR 34.45 $ 825 $ 700 $ 11% 89%
28% Intercept ICPT 151.44 $ 3,685 $ 2,989 $ 19% 81% 1%
10% Tobira TBRA 10.12 $ 190 $ 137 $ 37% 63% 1%
4% 22%
37% Average 39% 61% 1%
22% Median 37% 63% 1%
17% MC-Weighted 1%
Galmed GLMD 7.65 $ 85 $ 60 $ 30% 70% 1%
2% 31%
30% NASDAQ Composite COMP-USA 4,891
8% 6%
14% NASDAQ Health Care IXHC-USA 732
10% 7%
12% NASDAQ Biotechnology NBI 3,421
12% 11%
14% Russell 2000 Index RUT^ 1,110
3%
3% Market data as of: 1/05/2016
18 January 2016
$13.50
Additional Indications Aramchol+ Combination Therapy
Aramchol
More Shots on More Goals: Expand pipeline to include anti-fibrotic – late stage – NASH More Shots on Goal: AramcholTM for, ABC & DEF
19 October 2015
Solidify Base Expand Pipeline
1Q15
Begin enrollment in Europe Announce developments in combination therapy for advanced (fibrotic) NASH Initiation of Phase IIa ARRIVE Study ARREST Study interim results
for 6 months of treatment
20 January 2016
Unfold the Development of Non-Invasive Companion Diagnostic Program
2Q15 3Q15 4Q15 1Q16 2Q16
Initiate ARREST Study; begin enrollment in Israel; Expansion Clin.
Begin enrollment in US and LatAm Initiation of Phase IIa PoC clinical trial in new indication Business Development
21 January 2016
Economics (USD in MMs) Seller Buyer Asset Mechanism Transaction Structure Date Stage of Development Upfront Total Lumena Shire LUM002 (Phase I, NASH) ASBT Inhibitor Acquisition 5/12/14 Phase I (LUM002) 260 $ N/A Galecto BMS TD-139 Galectin-3 Inhibitor License 11/3/14 Phase I N/A 444 $ Phenex Gilead Px-102 FXR Agonist Asset Acquisition 1/6/15 Phase II N/A 470 $ NGM Merck NGM282 CYP7A1 Inhibitor License 2/23/15 Preclinical 200 $ 450 $ Regulus AstraZeneca RG-125 miR-103/107 Inhibitor License 4/7/15 Preclinical N/A 500 $ Pharmaxis Boehringer Ingelheim PXS478A SSAO/VAP-1 Inhibitor Asset Acquisition 5/18/15 Preclinical 31 $ 840 $
acquired/licensed by BigPharma – all at earlier stages of development than AramcholTM – for escalating deal values:
Bank Analyst Rating Price Target
SunTrust Edward Nash Buy $19 ROTH Elemer Piros, Ph.D. Buy $20 Maxim Jason Kolbert Buy $24 FBR Vernon T. Bernardino Buy $24 H.C. Wainwright Yi Chen, Ph.D. CFA Buy $21
22 January 2016
Please visit www.galmedpharma.com for more information
Josh Blacher her, , CFO 551 Fifth th Ave venue nue, , New ew York rk, NY 10 10176 6 T: +1.646.780 46.780.7 .7605 05 | | M: +972.52 .52.7 .770. 70.2655 2655 josh@gal galme medphar pharma ma.co com