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]

Financial Performance - Revenue for the year ended December 31, 2020, was $0, while revenue for 2019 was $2,038,000, reflecting a significant decline[26] - Net loss for the year ended December 31, 2020, was $28,771,000, compared to a net loss of $20,461,000 in 2019, indicating a 40.5% increase in losses[26] - Total assets decreased from $77,139,000 in 2019 to $52,381,000 in 2020, a decline of 32.0%[29] - Total liabilities increased from $7,286,000 in 2019 to $8,228,000 in 2020, marking a 12.9% rise[29] - The accumulated deficit as of December 31, 2020, was $135.7 million, reflecting ongoing financial challenges[41] Research and Development - Research and development expenses increased from $18,180,000 in 2019 to $26,082,000 in 2020, representing a 43.7% increase[26] - The company expects a significant increase in research and development expenses related to the ARMOR Study and other clinical trials, leading to continued significant operating losses in the foreseeable future[47] - The clinical trial process for the lead product candidate, Aramchol, is complex and expensive, with potential delays due to various factors, including the COVID-19 pandemic[33] - The ARMOR Study has experienced material delays primarily due to slower than expected recruitment and regulatory authorization processes[75] - Positive results from previous clinical studies do not guarantee similar outcomes in future trials, and negative or inconclusive results may require additional studies or termination of the development program[76] Regulatory and Approval Challenges - The company has not yet commercialized any products and faces uncertainty regarding the timing and success of obtaining regulatory approvals for Aramchol or any other product candidate[51] - The regulatory approval process for Aramchol is expected to be lengthy and costly, with no approved therapies for NASH currently available[80] - The FDA may require additional bioequivalence data for the transition to Aramchol meglumine, potentially delaying timelines for the ARMOR Study[83] - The marketing approval process varies by jurisdiction and may involve additional studies, potentially delaying the approval timeline significantly[88] - Regulatory authorities may impose additional requirements or restrictions on Aramchol, which could negatively impact market acceptance and increase costs[116] Market and Competitive Landscape - The market is highly competitive, with potential competitors including larger pharmaceutical companies that may have superior products, which could render the company's offerings non-competitive[162] - The acceptance of Aramchol by the medical community and third-party payors is uncertain, which could affect market acceptance and profitability[52] - The company anticipates challenges in enrolling sufficient U.S. NASH patients for clinical trials, which could delay development timelines[114] - The healthcare industry is expected to impose increased limitations on reimbursement, which could adversely affect the coverage of Aramchol by third-party payors[134] - Legislative changes and increased scrutiny on pharmaceutical pricing may adversely impact the company's revenue and market acceptance of its products[144] Financial and Operational Risks - Future capital requirements are expected to be substantial, influenced by factors such as clinical trial results, regulatory approvals, and the need for additional research and development[59] - The company may incur substantial costs in pursuing future capital financing, which could adversely impact its financial condition and results of operations[57] - The company may need to raise additional capital to fund operations and development, with potential dilution of current shareholders' ownership interests[56] - The company relies on third-party manufacturers for production, which poses additional risks to its operations[36] - The company must navigate complex regulatory environments across different jurisdictions, which may complicate compliance efforts and increase operational costs[156] Intellectual Property and Legal Considerations - The company must maintain a strong intellectual property position to compete effectively, but uncertainties in patent protection could impact its competitive edge[193] - The company relies on a combination of patent, copyright, trademark, and trade secret laws to protect its intellectual property, which is crucial for commercial success[217] - The company may face litigation regarding patent rights, which could lead to substantial costs and distract management[214] - There is a risk of third-party patents preventing commercialization of product candidates, potentially requiring significant licensing fees[198] - The company may struggle to enforce non-competition agreements, which could allow competitors to benefit from the expertise of former employees[220] Compliance and Regulatory Environment - The company is subject to extensive environmental, health, and safety regulations, which could result in substantial costs and liabilities[132] - The company must comply with the Sarbanes-Oxley Act and related regulations, and any failure to establish effective internal controls could result in material misstatements in financial reports[174] - Compliance with the GDPR could result in fines up to €20 million or 4% of total worldwide annual turnover, whichever is greater, impacting the company's financial condition[157] - The company is subject to federal and state healthcare laws, including the Anti-Kickback Statute and the False Claims Act, which impose significant compliance risks and potential penalties[150] - The company may face significant penalties, including administrative, civil, and criminal penalties, if found in violation of healthcare laws, which could adversely affect financial results[154]

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]

Financial Data and Key Metrics Changes - For Q2 2020, the company reported a net loss of $5.5 million or $0.26 per share, compared to a net loss of $4.2 million or $0.20 per share in Q2 2019 [20] - Research and development expenses increased to $5 million in Q2 2020 from $3.5 million in Q2 2019, primarily due to increased CMC and formulation expenses related to Aramchol [20] - General and administrative expenses decreased to $0.8 million in Q2 2020 from $1.2 million in Q2 2019, attributed to lower professional services and investor relations expenses [21] - Cash balance as of June 30, 2020, was $63.5 million, down from $75.6 million as of December 31, 2019 [23] Business Line Data and Key Metrics Changes - The ARMOR Phase III study for Aramchol faced recruitment delays due to COVID-19 but began to see positive signs in patient screening starting in June 2020 [9][10] - The company is developing Aramchol meglumine, which aims to provide long-term patent protection and improved efficacy compared to Aramchol free acid [11] - Amilo-5MER, a new clinical program, is ready for Phase I trials, targeting chronic inflammation and potentially severe COVID-19 cases [16][15] Market Data and Key Metrics Changes - The ARMOR study is currently active in multiple countries including the USA, Canada, and several European and Asian nations, with plans to expand to additional countries [9][53] - The company is preparing to submit a full IND in China based on a pre-IND meeting, with expectations to start activities there in early 2021 [53] Company Strategy and Development Direction - The company is focused on advancing its clinical programs while navigating the challenges posed by the COVID-19 pandemic [6][10] - There is an emphasis on collaboration and potential licensing opportunities to expand the reach of its products without straining financial resources [42] - The company plans to conduct a bioequivalence study for Aramchol meglumine in Q3 2020, with a full regulatory study planned for Q2 2021 [12][29] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the recruitment pace for the ARMOR study, maintaining guidance for completion of recruitment in Q4 2021 and top-line results in the second half of 2023 [10] - The ongoing impact of COVID-19 remains a significant uncertainty, affecting timelines and operational capacity [3][10] - Management highlighted the importance of Serum Amyloid A as a biomarker for various inflammatory diseases, including IBD and COVID-19, indicating a strategic focus on these areas [40][56] Other Important Information - The company plans to attend several investor conferences and hold a virtual Analyst Day to provide updates on its clinical programs [16][18] - Amilo-5MER has shown promise in reducing chronic inflammation in animal models and is being investigated for its effects on COVID-19 patients [15][14] Q&A Session Summary Question: Discussion on the bioequivalence study for Aramchol meglumine - The study will start with healthy volunteers and will test both once-daily and twice-daily doses, with a full regulatory bioequivalence study planned for Q2 2021 [26][29] Question: Discovery of Amilo-5MER peptide - The peptide was isolated from joint inflammatory cells, identifying a specific sequence in human CD44 variant responsible for higher inflammation [32][34] Question: Potential for Amilo-5MER in IBD and other indications - The company is starting with IBD due to clear biomarkers and is open to exploring other indications as the compound advances [40][42] Question: Half-life and dosing considerations for Amilo-5MER - The anticipated half-life is approximately 1.5 hours, with subcutaneous administration planned for the Phase I study [36][45] Question: Timeline for utilizing the salt formulation in the ARMOR study - The salt formulation will be ready for use in the ARMOR study after the bioequivalence study, expected to begin in Q2 2021 [61][66]

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 ...

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 20-F ¨ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ¨ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring t ...

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 ...