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 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 Ga Galmed ed St Story y in a Nu Nutshell shell Aramchol TM addresses a significant, and growing unmet Focused need in the U.S., EU & RoW – N on- a lcoholic Strategy, Broad Vision s teato h epatitis (NASH) and liver diseases First in a new class of drug candidates with proof-of- Novel concept as demonstrated in Phase I & IIa clinical trials; Technology no serious or drug-related adverse events observed Significant ~10% population in U.S. & EU-5 nations has NASH; Market prevalence expected to rise in parallel with obesity and Opportunity diabetes. No approved drugs Strong Track Completed pre-clinical and 4 clinical trials (Phase Ia/Ib, PK Food effect & Phase IIa … on time and under Record of Execution budget ) Compelling GLMD trades significantly below comparable companies. Valuation Exceptionally modest Enterprise Value January 2016 1
2015 15: : A Year r of of Certaint ainty, , Executi cution on & G Gro rowth wth A Year Ago Today Δ X 2 Significant Regulatory Pathway 12 22 Big GLMD Professionals 0 2 Significant Clinical Trials Initiated 0/0 9/42 Huge Clinical Infrastructure Additional PoC Clinical Trials 0 2 Meaningful In Advanced Formation $5.80 $7.61 31% Share Price January 2016 2
That Was Then
NASH: NA H: The he Dou oubl ble-Edge Edged d Swor ord Liver Disease “Nonalcoholic steatohepatitis is the most rapidly growing indication for liver transplantation.” 1 Metabolic Syndrome “ The most common cause of death in patients with NAFLD, NAFL and NASH N is cardiovascular A disease .” 2 S H 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 January 2016 3
TM Uni Ho How i w is Aramc ramcho hol TM 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
Pha hase IIa : : St Statistically istically Signif nificant icant Redu duction tion in Li n Liver ver Fat Content nt 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. January 2016 5
Pha hase IIa: Enh nhanc nced d Adi Adipo ponec nectin tin Le Level vels 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. January 2016 6
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
Summar ary y of of Safe fety ty Data St Study udy N Summ mmary y of Safety y Resul ults ts 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 Phase I 41 dose of 100 mg, 300 mg were found to be safe and 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 differ Phase IIa 57 between the placebo and treated groups All doses of Aramchol TM were safe and well tolerated. PK / No serious AEs. Most of AEs were mild and unrelated to 66 Aramchol TM and all AEs were transient and gave no indication of Food Effect target organ toxicity January 2016 8
“Yesterday’s the past, tomorrow’s the future, but today is a gift. That’s why it’s call the present ” - Bil Keane”
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
ARREST EST St Study dy • Multicenter, randomized, double-blind, placebo-controlled, dose ranging Design: study • Biopsy-diagnosed NASH patients with obesity and insulin resistance Participants: • Placebo (62 patients) • 400 mg (89 patients) Doses: • 600 mg (89 patients) • 12 months treatment (once-daily tablet) and 3 months of follow-up Treatment • Interim analysis planned on first 120 patients completing 6 months of Plan: treatment (1H16). Top-line results in 3Q17 • 240 patients Number of • ~70 sites in U.S., Europe, Latin America and Israel Subjects (Est.) : Primary • Statistically significant reduction in liver fat content measured by MRS Endpoint: • Resolution of NASH (ballooning); no worsening of fibrosis – both as Secondary measured by biopsy Endpoints: • Improvement of liver and metabolic markers January 2016 10
ARREST EST St Status tus Upda pdate: : Patie Patients nts Scree reened ned 300 Patients Screened (Cumulative) 250 200 150 100 50 0 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 11
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