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Investor Presentation March 2016

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Page 1: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Investor PresentationMarch 2016

Page 2: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

This presentation contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our productdevelopment efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we or ourrepresentatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use offorward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of thesewords or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-lookingstatements may be included in, but are not limited to, this presentation, various filings made by us with the SEC, press releases or oral statementsmade 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, thesestatements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed orimplied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and resultsanticipated 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 commerciallaunch and future sales of aramchol or any other future products or product candidates; our ability to achieve favorable pricing for aramchol; ourexpectations regarding the commercial market of NASH in patients who also suffer from obesity and insulin resistance; third-party payorreimbursement for aramchol; our estimates regarding anticipated capital requirements and our needs for additional financing; patient market size andmarket adoption of aramchol by physicians and patients; the timing, cost or other aspects of the commercial launch of aramchol; the timing and costof 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 andPhase III trials for aramchol; the development and approval of the use of AramcholTM for additional indications or in combination therapy; and ourexpectations 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 or ourindustry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-lookingstatements. 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 of thedate hereof and are expressly qualified in their entirety by the foregoing. We undertake no obligations to update or revise forward-looking statementsto reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-lookingstatements, you should consider these risks and uncertainties.

Forward Looking Statement

Page 3: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

AramcholTM addresses a significant, and growing unmet need in the U.S., EU & RoW – Non-alcoholic steatohepatitis (NASH) and other liver-related 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; adding incremental, significant shots-on-goal

Significant Market Opportunity

The Galmed Story

1

GLMD trades significantly below comparable companies. Exceptionally modest Enterprise Value

Compelling Valuation

Page 4: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

2015: A Year of Execution & Clinical Progress

A Year Ago Today

Regulatory Pathway

Clinical Trials Initiated

Clinical Infrastructure (Countries / Sites)

Additional PoC Clinical Trials In Advanced Formation

Share Price

X

0

0/0

0

$9.29

2

2

10/~55

3

$5.18

22

Macro Environment:

Galmed:

Screened Subjects for ARREST Study

0 >400

Page 5: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

AramcholTM

First-in-Class

Potentially disease modifying

Novel; Strong Intellectual Property portfolio

Synthetic conjugate of ARAchidic acid (fatty), and CHOLic acid (bile)

No serious or drug-related adverse events observed to date

Orally administered

3

Page 6: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

How is AramcholTM Unique?

1. Target the underlying CAUSE of the disease – excess fat in the liver

2. Addresses both the hepatic and metabolic parameters of NASH

3. No serious or drug-related adverse events observed to date

4

Page 7: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

A Visible Reduction in Lipid Deposits & Ballooning (In-Vivo)

Gilat et. al., HEPATOLOGY, Vol. 38, No. 2, 2003

Fatty Liver

Fatty Liver Treated with AramcholTM

Rodents in this study were treated with AramcholTM for ten weeks

5

Page 8: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

AramcholTM: Results-to-date in, and Future Objectives of Clinical Trials

Reduction in liver fat

Resolution of NASH (hepatocyte

ballooning)

Effect on metabolic syndrome

Safety profile

ArmacholTM

(TPP)Phase I Phase II Phase IIb Phase III

Not evaluated (goal of Phase I study is safety screening)

Demonstratedability to significantly reduce liver fat content

Confirmation of effect on reducing liver fat content

Efficacy and safety to be confirmed in pivotal Phase III trials

• Prevent progression of NASH to life-threatening liver disease through resolution of NASH as measured by disappearance of ballooning (biopsy)

• Treat the underlyingcondition, metabolic syndrome, by improving insulin resistance and other parameters of the metabolic syndrome

• High safety profile for chronic (1X daily) dosing

Trend of improvement in adiponectin, ALT HOMA and other liver-function parameters

Resolution of NASH as measured by disappearance of ballooning(biopsy)

Metabolicindices, showed trends of improvement

Significantimprovement in metabolic syndrome

No notable changes in safety parameters

No severe drug-related adverse events observed

Confirmation of clean safety profile

6

Page 9: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Phase IIa : Statistically Significant Reduction in Liver Fat Content

7

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.

Page 10: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Phase IIa: Enhanced Adiponectin Levels

8

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.

Page 11: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Phase IIa: Improvement in Endothelial Function

9

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.

Page 12: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

10

Phase IIa: Marked Improvement in Liver Function (ALT)

-12.0

-10.0

-8.0

-6.0

-4.0

-2.0

0.0

Visit 2 Visit 3 Visit 4 Visit 5 Visit 630 days post

treatment

ALT

(U

/L)

Placebo (n=19)

Aramchol 100 mg/d (n = 18)

Aramchol 300 mg/d (n = 20)

Immediate relapse in ALT Improvement following conclusion

of treatment

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.

Page 13: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Summary of Safety Data

11

Study N Summary of Safety Results

ChronicToxicology

(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

Page 14: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

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 expected in 2H17

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

ARREST Study

12

Page 15: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

NASH: Addressable Market (US + EU-5)

Adult Population (441m)

NAFLD (167m)

NASH (45m)

Diagnosed (5.5m)

Treated (1.6m)

13

Source: Deutsche Bank by 2025

Page 16: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

NASH: Competitive Landscape

14

Phase IIbOngoing

Phase III< PoC(noteworthy)

NA

SH8

0%

of

Ma

rket

Fib

rosi

s2

0%

of

Ma

rket

(Cirrhosis; IV Formulation)

Page 17: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

ARREST Status Update: Patients Screened

15

-

50

100

150

200

250

300

350

400

450

Europe/Israel United States Latin America

Page 18: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Selecting Additional Pipeline Indications

16

Strong Scientific Foundation

Moderate Competition

and Clear TPP Advantage

>$1.0B+ Commercial

Potential

Page 19: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

ARRIVE Study

17

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 month 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

Page 20: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Strategic & Scientific Rationale

Scientific rationale:HIV-associated lipodystrophy refers to abnormal, abdominal visceral fat accumulationIn patients with HIV, liver disease is among the leading causes of deathNearly half of the HIV infected patients without viral hepatitis that undergo evaluation for unexplained liver test abnormalities are found to have NAFLDThe 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 fewThe first step in extrapolating additional commercial value with our existing assetsSignifies the beginning of our de-risking strategy through more potential applications and end markets for our product

18

Page 21: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

HIV-Lipo & NAFLD: Addressable Market

HIV Population US + EU-5a,b,c (2.0m)

… With Lipodystrophyd (785k)

… Who Require Treatmentd (471k)

AramcholTM Market Sharee – 40% (188k)

Projected Peak Annual Salese (~$1.0B)

19

Sources: (a) CDC, (b) WHO, (c)Global Markets Direct (Lipodystrophy – Pipeline Review, H2 2015), (d) Epocrates, and (e)GLMD estimates.

Page 22: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

HIV-Associated LD: Competitive Landscape

Phase II >=Phase III<=Phase I

Bio

log

ic /

Pep

tid

eSm

all

Mo

lecu

le

20

Page 23: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Maximize Commercial Potential of Existing Assets

21

NASH

HIV-Associated Lipodystrophy & NAFLD

Cardiovascular TBA – Phase IIa

Juvenile NAFLD/NASH – Phase I/II

Fibrotic NASH (Combination) – Phase IIa

On

go

ing

In Su

bm

ission

or <

6 M

on

ths

• IND/IIT•Funded•PoC Trials

Page 24: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Strong Cash Position; Clean Balance Sheet

22

Page 25: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

(Figures in millions, unless otherwise noted) Current Share Price Appreciation:

Company Ticker Share Price

Market

Value

Enterprise

Value YTD 2016

Trailing 30

Days 2015

52-Week

High

52-Week

Low

Conatus CNAT 2.24$ 45$ 2$ -22% 22% -59% -74% 60%

Galectin GALT 1.52$ 44$ 30$ -7% 30% -53% -63% 41%

Genfit PA GNFT-FR 32.95$ 868$ 721$ -7% 11% -22% -48% 46%

Intercept ICPT 128.45$ 3,135$ 2,439$ -14% 30% -4% -59% 43%

Tobira TBRA 7.70$ 145$ 98$ -23% 12% 22% -68% 27%

Average -15% 21% -23% -62% 43%

Median -14% 22% -22% -63% 43%

MC-Weighted -13% 26% -8%

Galmed GLMD 5.18$ 57$ 32$ -32% -15% 31% -62% 22%

NASDAQ Composite COMP-USA 4,708 -6% 8% 6% -10% 12%

NASDAQ Health Care IXHC-USA 631 -16% 6% 7% -27% 11%

NASDAQ Biotechnology NBI 2,821 -20% 5% 11% -33% 12%

Russell 2000 Index RUT^ 1,094 -4% 11% -6% -16% 16%

Market data as of 3/7/2016.

Comparable Company Analysis

23

$13.50

Page 26: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Execution Focused; Upcoming Near- and Mid-Term Milestones

24

1Q15

Begin enrollment in Europe

First-Patient-In Phase IIa ARRIVE

Study

ARREST Study interim results on 120 patients for 6

months of treatment

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

Announce developments in

combination therapy for

advanced (fibrotic) NASH

Page 27: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Mergers & Acquisitions

Over the two years, there have been five NASH assets acquired/licensed by BigPharma – all at earlier stages of development than AramcholTM –for escalating deal values:

25

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$ 600$

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$

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$

Page 28: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Current Analyst Recommendations

26

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

Page 29: Investor Presentationgalmedpharma.investorroom.com/...+March+2016+... · 2015: A Year of Execution & Clinical Progress A Year Ago Today Regulatory Pathway Clinical Trials Initiated

Please visit www.galmedpharma.comfor more information

Thank you!

Josh Blacher, CFO 16 Tiomkin Street, Tel Aviv 6578317 Israel

T: +1.646.780.7605 | M: +972.52.770.2655 [email protected]