| --- | --- | --- | --- | |---------------------------------------------|-------|-------|-------| | | | | | | Clinical antifibrotic effect of Aramchol™: | | | | Prof. Vlad Ratziu, Professor of Hepatology, Sorbonne Université, ARMOR study coprincipal investigator November 2021 1 Safe Harbor and Disclaimer Statement This presentation contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, r ...

Financial Data and Key Metrics Changes - For Q3 2021, the company reported a net loss of $7.7 million or $0.31 per share, compared to a net loss of $6.9 million or $0.32 per share in Q3 2020 [61] - Research and development expenses remained at $6.5 million for Q3 2021, consistent with the same quarter in 2020 [61] - General and administrative expenses increased to $1.3 million from $1.1 million in the corresponding period in 2020 [61] - Cash balance as of September 30, 2021, totaled $42 million, down from $51 million on December 31, 2020 [61] Business Line Data and Key Metrics Changes - The ARMOR study's open-label part demonstrated a 60% response rate in fibrosis improvement among patients treated with Aramchol, significantly higher than historical placebo response rates [21][14] - The study included a rigorous pathology reading process involving three independent pathologists to ensure accuracy in assessing fibrosis [10] Market Data and Key Metrics Changes - The company is focusing on the NASH (Non-Alcoholic Steatohepatitis) market, which has seen limited successful treatments for fibrosis, positioning Aramchol as a potential leader in this space [44] - The Phase 3 ARMOR study is expected to provide further insights into the efficacy of Aramchol, with discussions ongoing with the FDA regarding potential conditional marketing authorization [21][59] Company Strategy and Development Direction - The company aims to optimize its NASH program by focusing on fibrosis improvement as the primary endpoint and increasing the effect size through higher dosing of Aramchol [58] - Plans to initiate the double-blind portion of the ARMOR study in the second half of 2022, with expectations for a shorter trial duration based on recent data [64] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the results from the ARMOR study, viewing them as a potential game changer for the treatment of liver fibrosis [57] - The company acknowledges skepticism in the NASH space but remains committed to demonstrating the efficacy of Aramchol through robust clinical data [57] Other Important Information - The preliminary results from the ARMOR study have been accepted for presentation at the American Association for the Study of Liver Diseases meeting [11] - The company is preparing for a bioequivalence study of a new Aramchol formulation, which is crucial for the upcoming double-blind study [65] Q&A Session Summary Question: Are any patients receiving other therapies? - Patients are allowed to be on other medications if they have been on them for an extended period before the initial biopsy [25] Question: When should we expect the next set of biopsy data from the ARCON cohort? - The next data update is expected when the first 50 patients reach the end-of-treatment biopsy, likely around the EASL conference next year [29] Question: How do you view the results on fibrosis improvement compared to other data sets? - The results show a higher level of response compared to historical placebo rates, positioning Aramchol favorably against other treatments in the NASH space [44] Question: What is the expected timeline for the double-blind portion of the ARMOR study? - Enrollment for the double-blind portion is planned to reinitiate in the second half of 2022 [64] Question: Is there any weight loss induced by the drug? - Currently, there is no clear effect on weight loss; the drug appears to be weight neutral [52]

| --- | --- | --- | --- | |---------------------------------------------|-------|-------|-------| | | | | | | Clinical antifibrotic effect of Aramchol™: | | | | Prof. Vlad Ratziu, Professor of Hepatology, Sorbonne Université, ARMOR study coprincipal investigator November 2021 1 Safe Harbor and Disclaimer Statement This presentation contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, r ...

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q2 2021 Results Earnings Conference Call August 5, 2021 8:30 AM ET Company Participants Allen Baharaff - President, Chief Executive Officer Yohai Stenzler - Chief Financial Officer Liat Hayardeny - Chief Scientific Officer Conference Call Participants Edward Nash - Canaccord Genuity Kristen Kluska - Cantor Fitzgerald Timur Ivannikov - Raymond James Operator Good day and welcome to Galmed conference call to discuss financial results for the second quarter 2021. Today ...

Financial Data and Key Metrics Changes - For Q1 2021, the company reported a net loss of $8.9 million or $0.38 per share, compared to a net loss of $6.1 million or $0.29 per share for Q1 2020, indicating a deterioration in financial performance [15] - Research and development expenses increased to $7.4 million in Q1 2021 from $5.6 million in Q1 2020, primarily due to higher drug development costs associated with Aramchol meglumine [15] - General and administrative expenses rose to $1.7 million in Q1 2021 from $0.9 million in Q1 2020 [16] - The cash balance as of March 31, 2021, was $58.9 million, up from $51 million on December 31, 2020, reflecting a positive cash flow from a public offering [16] Business Line Data and Key Metrics Changes - The ARMOR study for Aramchol is progressing, with results from approximately one-third of the study population expected in Q4 2021 [7] - The IND approval for Aramchol in China is seen as a significant milestone, potentially accelerating patient randomization in the ARMOR study [8] - Amilo-5MER has completed its first-in-human Phase 1 trial, with topline data expected in the second half of 2021 [12] Market Data and Key Metrics Changes - The company is focusing on the U.S. and China markets for the ARMOR study, with plans to initiate enrollment in China as soon as practical [9] - The company is also exploring additional indications for Amilo-5MER, targeting chronic inflammatory diseases beyond ulcerative colitis [14] Company Strategy and Development Direction - The company aims to position Aramchol as a leading therapeutic candidate for NASH and fibrosis, particularly in emerging markets like China [8] - The development of Amilo-5MER is being pursued in two formulations to target different patient populations and indications [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to gather comprehensive data for the first 50 patients in the ARMOR study despite challenges posed by the COVID-19 pandemic [32] - The company anticipates reinitiating the double-blind part of the ARMOR study by Q1 2022, focusing on areas less affected by COVID-19 [34] Other Important Information - The company is awaiting written feedback from the FDA regarding the Aramchol meglumine development plan, with expectations for a response in June 2021 [22] Q&A Session Summary Question: Insights on the single ascending dose study for Amilo-5MER - Management clarified that the decision to double the highest dose was based on pharmacokinetics and safety data [20] Question: Clarification on FDA interactions regarding Aramchol meglumine - Management confirmed they are awaiting written feedback from the FDA and have submitted the necessary documentation [22] Question: Details on histology data from patients in the ARMOR study - Management indicated that the majority of patients will be F2, H3, with approximately 25 patients expected to undergo 48 and 72 weeks of treatment [24] Question: Plans for the new Aramchol meglumine formulation in China - Management stated that the existing protocol for the ARMOR study has been approved, and they are working on amendments for the new formulation [26] Question: Confidence in data collection amid the pandemic - Management reassured that they have selected U.S. sites less affected by COVID-19 for patient recruitment [32] Question: Target patient populations for Amilo-5MER - Management emphasized the focus on mild to moderate ulcerative colitis patients, highlighting the safety and efficacy profile of Amilo-5MER [36]

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q4 2020 Earnings Conference Call March 18, 2021 8:30 AM ET Company Participants Allen Baharaff - President & Chief Executive Officer Yohai Stenzler - Chief Financial Officer Conference Call Participants Ed Arce - H.C. Wainwright Steve Seedhouse - Raymond James Kristen Kluska - Cantor Fitzgerald Operator Good day. Welcome to the Galmed Conference Call to discuss Financial Results for the Fourth Quarter and Year Ended 2020. Today's conference is being recorded. Before ...

Financial Data and Key Metrics Changes - For Q3 2020, the company reported a net loss of $6.9 million or $0.32 per share, compared to a net loss of $4.5 million or $0.21 per share in Q3 2019 [12] - Research and Development expenses increased to $6.5 million in Q3 2020 from $4.1 million in Q3 2019, primarily due to higher clinical trial expenses related to ongoing ARMOR trials [12] - General and Administrative expenses rose to $1.5 million in Q3 2020 from $1 million in the same period in 2019, mainly due to increased D&O insurance policy premiums [13] - The cash balance as of September 30, 2020, was $58.7 million, down from $75.6 million as of December 31, 2019 [14] Business Line Data and Key Metrics Changes - The company is focusing on the Aramchol meglumine program, with expectations to report first-in-human PK data next month [5] - A collaboration with Gannex Pharma was announced to develop a combination therapy that includes ASC41 and Aramchol, aimed at improving liver fat reduction and blood lipid profiles [5][6] - The ARMOR Phase 3 study has opened sites in 10 additional countries, but recruitment has been hampered by the COVID-19 pandemic [8][9] Market Data and Key Metrics Changes - The company is assessing recruitment plans due to the impact of COVID-19, which has slowed down patient enrollment in key markets like the US and Europe [22][44] - Brazil is expected to start recruiting patients as early as January, which could help meet enrollment targets [24] Company Strategy and Development Direction - The company aims to maximize the clinical efficacy of Aramchol through collaborations and product optimizations, including a focus on microbiome-based therapies [6][31] - The strategy includes enhancing the response rates to Aramchol and exploring the microbiome as a potential biomarker for treatment efficacy [31][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress of the Pfizer vaccine and its potential impact on business operations [5] - The ongoing COVID-19 pandemic presents significant uncertainty, affecting recruitment timelines and operational activities [2][9] - The company plans to provide updates on recruitment and clinical data by mid-December [9][44] Other Important Information - The first virtual Analyst Day is scheduled for January 26, where clinical data from the ARMOR meglumine and Amilo-5MER programs will be presented [10][54] - The company is collecting microbiome samples from various patient groups to enhance the understanding of treatment responses [34][35] Q&A Session Summary Question: Details on Gannex TR beta licensed - Management refrained from disclosing specific information about ongoing studies but highlighted the specificity and potency of the licensed molecule [17][18] Question: Geographic distribution of ARMOR study enrollment - Management indicated it is too early to determine if the anticipated geographic distribution of enrollment will change due to the pandemic [21][22] Question: Collaboration with MyBiotics and microbiome role in NASH - Management discussed the potential of microbiome changes to enhance Aramchol efficacy and the role of precision medicine in identifying responders [28][31][37] Question: Update on recruitment plan and timelines - Management acknowledged the need for a new recruitment plan and indicated that updates would be provided in December [41][44] Question: Bioequivalence and dosing for Aramchol meglumine - Management confirmed that data on single and multiple dosing will be presented in December, which is crucial for regulatory discussions [45][48]

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q2 2020 Results Conference Call August 6, 2020 8:30 AM ET Company Participants Allen Baharaff - President and CEO Dr. Tali Gorfine - CMO Yohai Stenzler - CFO Dr. Liat Hayardeny - CSO Conference Call Participants Steve Seedhouse - Raymond James Ed Arce - H.C. Wainwright Kristen Kluska - Cantor Fitzgerald Operator Good day, and welcome to the Galmed conference call to discuss Financial Results for the Second Quarter of 2020. TodayÂ's conference is being recorded. Befo ...

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q1 2020 Earnings Conference Call May 14, 2020 8:30 AM ET Company Participants Allen Baharaff - Chairman, CEO & President Yohai Stenzler - CFO & Controller Liat Hayardeny - Chief Scientific Officer Tali Gorfine - Chief Medical Officer Conference Call Participants Steve Seedhouse - Raymond James Adam Walsh - Stifel Kristen Kluska - Cantor Fitzgerald Ed Arce - H.C. Wainwright Mayank Mamtani - B. Riley FBR, Inc. Operator Good day. Welcome to GalmedÂ's Conference Call to ...

Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) Q4 2019 Earnings Conference Call March 12, 2020 8:30 AM ET Company Participants Allen Baharaff - Chairman, CEO & President Yohai Stenzler - CFO & Controller Liat Hayardeny - Chief Scientific Officer Conference Call Participants Yasmeen Rahimi - ROTH Capital Partners Steven Seedhouse - Raymond James Antonio Arce - H.C. Wainwright & Co. Kristen Kluska - Cantor Fitzgerald Jason McCarthy - Maxim Group Operator Good day, and welcome to Galmed’s Fourth Quarter and Full Yea ...