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 ...

Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) Q3 2019 Earnings Conference Call November 6, 2019 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 Steven Seedhouse - Raymond James & Associates Antonio Arce - H.C. Wainwright & Co. Adam Walsh - Stifel, Nicolaus & Company Paul O'Brien - Roth Capital Mayank Mamtani - B. Riley FBR, Inc. Kristen Kluska - ...

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q2 2019 Earnings Conference Call August 5, 2019 8:30 AM ET Company Participants Allen Baharaff - President and Chief Executive Officer Yohai Stenzler - Chief Financial Officer Tali Gorfine - Chief Medical Officer Liat Hayardeny - Chief Scientific Officer Conference Call Participants Yasmeen Rahimi - Roth Capital Partners Adam Walsh - Stifel Steve Seedhouse - Raymond James Ed Arce - H.C. Wainwright Mayank Mamtani - B. Riley FBR Operator Good day, and welcome to the G ...

Financial Data and Key Metrics Changes - For Q1 2019, the company reported a net loss of $3.5 million or $0.17 per share, compared to a net loss of $2.5 million or $0.17 per share in Q1 2018 [19] - Research and development expenses increased to $3.3 million in Q1 2019 from $1.9 million in Q1 2018, primarily due to manufacturing costs for Aramchol in preparation for the ARMOR study [19] - General and administrative expenses decreased to $0.8 million in Q1 2019 from $0.9 million in Q1 2018 [20] - Financial income rose to $0.5 million in Q1 2019 from $0.1 million in Q1 2018, attributed to interest income from financial instruments [21] - Cash balance as of March 31, 2019, was $86.6 million, down from $90.2 million on December 31, 2018 [21] Business Line Data and Key Metrics Changes - The ARMOR study is a Phase 3/4 multinational clinical trial aimed at evaluating the efficacy, safety, and tolerability of Aramchol in patients with NASH and fibrosis [8][10] - The study will involve approximately 2,000 patients, with a dosage of twice daily 300 mg compared to placebo in a 2:1 randomization [10] Market Data and Key Metrics Changes - The ARMOR study is designed to be a global study, including participants from the U.S., Europe, Latin America, and Asia, which is expected to facilitate faster registration across continents [15] Company Strategy and Development Direction - The company aims to submit the ARMOR study protocol to the FDA during the current quarter, with study commencement expected in Q3 2019 [8] - The focus is on completing preparations for the ARMOR study and ensuring efficient randomization within 18 months of commencement [17] - The company is also exploring combination studies with other treatments, which are considered a top priority [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ARMOR study's design and its alignment with FDA recommendations, anticipating positive results that could lead to accelerated conditional approval [12][17] - The company is committed to maintaining a robust safety profile for Aramchol while increasing exposure to enhance efficacy [46] Other Important Information - The estimated budget for the ARMOR study is around $65 million, with a total projected cost of approximately $110 million for the entire program [26][61] - The company plans to report results from the first part of the ARMOR study in Q4 2022 [17] Q&A Session Summary Question: Reasons for enrolling 1,200 patients in the interim Aramchol study - Management stated that the larger enrollment is to ensure robust data for both endpoints, with the study powered to meet both [25] Question: Cost of Phase 3 study - The estimated budget remains around $65 million, accounting for both high-cost and low-cost recruiting countries [26] Question: Per-patient costs for NASH trials in the U.S. versus ex-U.S. - Costs in the U.S. range from $25,000 to $50,000 per patient, while costs in Europe are about $12,000 to $15,000, and in Latin America, less than $10,000 [35] Question: Timeline for turning on Phase 3 sites - The U.S. is expected to have the first sites open, with the study anticipated to start in Q3 2019 [37] Question: Safety considerations for increased exposure in Phase 3 - Management indicated that splitting the dose reduces side effects while maintaining efficacy, with extensive monitoring planned for the ARMOR study [44][47] Question: Interim efficacy or safety analysis before top line readout - There will be no interim efficacy analysis, but routine safety reviews will be conducted [57][59] Question: Cost estimate for the entire ARMOR program - The total cost for the ARMOR program is estimated at approximately $110 million, with the first part budgeted for $65 million [61]