Investor Presentation March 2016
Forward Looking Statement 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 of 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 Aramchol TM ; 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 of 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 Aramchol TM 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 or 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 of 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.
The Galmed Story Aramchol TM addresses a significant, and growing unmet need Focused Strategy, in the U.S., EU & RoW – N on- a lcoholic s teato h epatitis (NASH) Broad Vision and other liver-related diseases First in a new class of drug candidates with proof-of-concept Novel Technology as demonstrated in Phase I & IIa clinical trials; no serious or drug-related adverse events observed ~10% population in U.S. & EU-5 nations has NASH; prevalence Significant Market expected to rise in parallel with obesity and diabetes. No Opportunity approved drugs; adding incremental, significant shots-on-goal Strong Track Record Completed pre-clinical and 4 clinical trials (Phase Ia/Ib, PK of Execution Food effect & Phase IIa … on time and under budget ) Compelling GLMD trades significantly below comparable companies. Valuation Exceptionally modest Enterprise Value 1
2015: A Year of Execution & Clinical Progress A Year Ago Today Macro Environment: X 2 Regulatory Pathway Galmed: Clinical Infrastructure 0/0 10/~55 (Countries / Sites) 0 2 Clinical Trials Initiated Screened Subjects for ARREST 0 >400 Study Additional PoC Clinical Trials In 0 3 Advanced Formation $9.29 $5.18 Share Price 2 2
Aramchol TM First-in-Class Potentially disease modifying Novel; Strong Intellectual Property portfolio Synthetic conjugate of ARA chidic acid (fatty), and CHOL ic acid (bile) No serious or drug-related adverse events observed to date Orally administered 3
How is Aramchol TM 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
A Visible Reduction in Lipid Deposits & Ballooning ( In-Vivo ) Fatty Liver Treated with Aramchol TM Fatty Liver Gilat et. al., HEPATOLOGY, Vol. 38, No. 2, 2003 Rodents in this study were treated with Aramchol TM for ten weeks 5
Aramchol TM : Results-to-date in, and Future Objectives of Clinical Trials Armachol TM Phase I Phase II Phase IIb Phase III (TPP) Demonstrated Confirmation of • Prevent progression Reduction in ability to effect on liver fat of NASH to life- significantly reducing liver threatening liver reduce liver fat fat content disease through content resolution of NASH as measured by Trend of Resolution of Resolution of Not evaluated improvement in NASH as disappearance of NASH (hepatocyte (goal of Phase I adiponectin, ALT measured by ballooning (biopsy) ballooning) study is safety HOMA and other disappearance Efficacy and screening) liver-function of ballooning safety to be • Treat the underlying parameters (biopsy) confirmed in condition , metabolic pivotal Phase syndrome, by Effect on Metabolic Significant III trials metabolic improving insulin indices, showed improvement syndrome trends of in metabolic resistance and other improvement syndrome parameters of the metabolic syndrome No notable No severe drug- Confirmation of • High safety profile for Safety changes in related adverse clean safety chronic (1X daily) profile safety events observed profile dosing parameters 6
Phase IIa : Statistically Significant Reduction in Liver Fat Content 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. 7
Phase IIa: Enhanced Adiponectin Levels 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. 8
Phase IIa: Improvement in Endothelial Function 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. 9
Phase IIa: Marked Improvement in Liver Function (ALT) 30 days post Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 treatment 0.0 Placebo (n=19) -2.0 Aramchol 100 mg/d (n = 18) Aramchol 300 mg/d (n = 20) -4.0 ALT (U/L) -6.0 -8.0 -10.0 Immediate relapse in ALT Improvement following conclusion -12.0 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. 10
Summary of Safety Data Study N Summary of Safety Results 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 Chronic dogs up to 9-months (1500 mg/kg); reproductive studies in rats Toxicology (1000 mg/kg) and rabbits (750 mg/kg). NOAEL determined at (non-clinical) highest dose tested for all studies; didn ’ t reach MTD Single doses of Aramchol TM from 30 mg to 900 mg and repeated dose of 100 mg, 300 mg were found to be safe and Phase I 41 well tolerated in healthy male subjects No severe AEs during the 3-month treatment period. Mild AE in 6 patients were mild or moderate and transient, and did not Phase IIa 57 differ between the placebo and treated groups All doses of Aramchol TM were safe and well tolerated. No serious AEs. Most of AEs were mild and unrelated to PK / 66 Aramchol TM and all AEs were transient and gave no indication Food Effect of target organ toxicity 11
Recommend
More recommend
