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:GLMD Forward ard Looking king St Stat atement ement This - - PowerPoint PPT Presentation

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


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Invest estor

  • r Pre

resentation sentation

Ja Januar ary y 2016

:GLMD

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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

  • f these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These

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

  • f aramchol; the timing and cost of Phase IIb and Phase III trials for aramchol or whether such trials will be conducted at all; completion and

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

  • r our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-

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

  • f the date hereof and are expressly qualified in their entirety by the foregoing. We undertake no obligations to update or revise forward-

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

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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

  • diabetes. No approved drugs

Significant Market Opportunity

The Ga Galmed ed St Story y in a Nu Nutshell shell

January 2016

GLMD trades significantly below comparable companies. Exceptionally modest Enterprise Value

Compelling Valuation

1

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2015 15: : A Year r of

  • f Certaint

ainty, , Executi cution

  • n & G

Gro rowth wth A Year Ago Today Δ

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

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SLIDE 5

That Was Then

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NA NASH: H: The he Dou

  • ubl

ble-Edge Edged d Swor

  • rd

January 2016 3

N A S H

“Nonalcoholic steatohepatitis is the most rapidly growing indication for liver transplantation.”1

  • 1. Wong RJ, Cheung R, Ahmed A. Hepatology. 2014 Jun;59(6):2188-95. doi: 10.1002/hep.26986. Epub 2014 Apr 25
  • 2. Chalasani N. et al. Hepatology 2012

“The most common cause of death in patients with NAFLD, NAFL and NASH is cardiovascular disease.”2

Liver Disease Metabolic Syndrome

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Ho How i w is Aramc ramcho holTM

TM Uni

nique? que?

1.No serious or drug-related adverse

events observed to date

2.Target the underlying CAUSE of the

disease – excess fat in the liver

3.Addresses both the hepatic and

metabolic parameters of NASH

January 2016 4

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Pha hase IIa : : St Statistically istically Signif nificant icant Redu duction tion in Li n Liver ver Fat Content nt

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;

  • Drs. Tuvia Gilat, Maya Halpern, Ran Oren, et. al.; 58 patients completed the study.
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Pha hase IIa: Enh nhanc nced d Adi Adipo ponec nectin tin Le Level vels

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;

  • Drs. Tuvia Gilat, Maya Halpern, Ran Oren, et. al.; 58 patients completed the study.
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Pha hase IIa: Safe fety ty Profile rofile

  • No significant changes in LDL and total cholesterol levels
  • No severe drug-related adverse events (AEs) during 3-month

treatment period and subsequent recovery period

January 2016 7

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Summar ary y of

  • f Safe

fety ty Data

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

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“Yesterday’s the past, tomorrow’s the future, but today is a gift. That’s why it’s call the present”

  • Bil Keane”
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Add Addre ressable sable Market et (U (US + EU-5)

Adult Population (441m) NAFLD (167m) NASH (45m) Diagnosed (5.5m) Treated (1.6m)

Source: Deutsche Bank by 2025

January 2016 9

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ARREST EST St Study dy

Design:

  • Multicenter, randomized, double-blind, placebo-controlled, dose ranging

study

Participants:

  • Biopsy-diagnosed NASH patients with obesity and insulin resistance

Doses:

  • Placebo (62 patients)
  • 400 mg (89 patients)
  • 600 mg (89 patients)

Treatment Plan:

  • 12 months treatment (once-daily tablet) and 3 months of follow-up
  • Interim analysis planned on first 120 patients completing 6 months of

treatment (1H16). Top-line results in 3Q17

Number of Subjects (Est.):

  • 240 patients
  • ~70 sites in U.S., Europe, Latin America and Israel

Primary Endpoint:

  • Statistically significant reduction in liver fat content measured by MRS

Secondary Endpoints:

  • Resolution of NASH (ballooning); no worsening of fibrosis – both as

measured by biopsy

  • Improvement of liver and metabolic markers

January 2016 10

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ARREST EST St Status tus Upda pdate: : Patie Patients nts Scree reened ned

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.

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ARREST EST St Status tus Upda pdate: : Clinical nical Sites Ac Activ ivat ated

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

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NA NASH: H: Com

  • mpetitiv

petitive La Land ndscape scape

January 2016

Phase IIb Ongoing

13

Phase III < PoC (noteworthy)

NASH

80% of Market

Fibrosis

20% of Market

(Cirrhosis; IV Formulation)

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St Strat rategic gic & Sc Scientif ntific ic Rationale ionale

  • Scientific rationale:

– 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

  • Strategic rationale:

– 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

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ARRIVE IVE St Study dy

Design:

  • Randomized, double-blinded, allocation-concealed, placebo-controlled,

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:

  • Up to 50 patients with HIV-associated lipodystrophy and nonalcoholic

fatty liver disease

Doses:

  • Placebo (up to 25 patients)
  • 600 mg (up to 25 patients)

Treatment Plan:

  • 12 weeks treatment (once-daily tablet) and 1 months of follow-up
  • Top-line results in 2H17

Primary Endpoint:

  • Improvement in hepatic steatosis as measured by MRI

Secondary Endpoints:

  • An improvement in total body fat, metabolic profile, and liver

biochemistry

January 2016 15

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HI HIV-Asso Associat ciated d LD LD: Com

  • mpet

petitiv itive La Land ndscape scape

January 2016

Phase II

16

>=Phase III <=Phase I

Biologic / Peptide Small Molecule

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St Strong rong Cash h Pos

  • siti

tion;

  • n; Clean

n Balance ance She heet et

17 January 2016

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(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%

  • 6%
  • 35%
  • 59%
  • 74%

15% Galectin GALT 1.76 $ 51 $ 37 $ 51% 49% 7%

  • 8%
  • 30%
  • 53%
  • 61%

17% Genfit PA GNFT-FR 34.45 $ 825 $ 700 $ 11% 89%

  • 3%
  • 12%
  • 7%
  • 22%
  • 57%

28% Intercept ICPT 151.44 $ 3,685 $ 2,989 $ 19% 81% 1%

  • 2%
  • 10%
  • 4%
  • 52%

10% Tobira TBRA 10.12 $ 190 $ 137 $ 37% 63% 1%

  • 12%

4% 22%

  • 58%

37% Average 39% 61% 1%

  • 8%
  • 16%
  • 23%
  • 60%

22% Median 37% 63% 1%

  • 8%
  • 10%
  • 22%
  • 58%

17% MC-Weighted 1%

  • 5%
  • 9%
  • 7%

Galmed GLMD 7.65 $ 85 $ 60 $ 30% 70% 1%

  • 7%

2% 31%

  • 43%

30% NASDAQ Composite COMP-USA 4,891

  • 2%
  • 5%

8% 6%

  • 7%

14% NASDAQ Health Care IXHC-USA 732

  • 3%
  • 2%

10% 7%

  • 16%

12% NASDAQ Biotechnology NBI 3,421

  • 3%
  • 1%

12% 11%

  • 18%

14% Russell 2000 Index RUT^ 1,110

  • 2%
  • 6%

3%

  • 6%
  • 14%

3% Market data as of: 1/05/2016

Com

  • mpa

parab rable le Com

  • mpa

pany y Ana naly lysis sis

18 January 2016

$13.50

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SLIDE 23

“Do your duty and a little more and the future will take care of itself”

  • Andrew Carnegie -
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Value ue Cre reation tion Map

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

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Execution ution Foc

  • cused;

d; Upc pcom

  • ming

ng Ne Near- and nd Mid-Term rm Milest stones nes

1Q15

Begin enrollment in Europe Announce developments in combination therapy for advanced (fibrotic) NASH Initiation of Phase IIa ARRIVE Study ARREST Study interim results

  • n 120 patients

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.

  • Ops. in the US

Begin enrollment in US and LatAm Initiation of Phase IIa PoC clinical trial in new indication Business Development

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Mergers & Acquisitions … Gaining Steam

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 $

  • Over the last year+, there have been six NASH assets

acquired/licensed by BigPharma – all at earlier stages of development than AramcholTM – for escalating deal values:

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Curr rrent nt Ana nalyst lyst Recom

  • mme

mendatio ndations ns

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

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Please visit www.galmedpharma.com for more information

Thank ank you!

  • u!

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