Galmed Pharmaceuticals(GLMD)
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Galmed Pharmaceuticals(GLMD) - 2022 Q4 - Annual Report
2023-03-29 20:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 20-F GALMED PHARMACEUTICALS LTD. ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ 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 EXCH ...
Galmed Pharmaceuticals(GLMD) - 2022 Q3 - Quarterly Report
2022-11-16 22:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 Under the Securities Exchange Act of 1934 For the Month of November 2022 001-36345 (Commission File Number) GALMED PHARMACEUTICALS LTD. (Exact name of Registrant as specified in its charter) 16 Tiomkin St. Tel Aviv 6578317, Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover ...
Galmed Pharmaceuticals(GLMD) - 2022 Q2 - Quarterly Report
2022-08-04 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 Under the Securities Exchange Act of 1934 For the Month of August 2022 001-36345 (Commission File Number) GALMED PHARMACEUTICALS LTD. (Exact name of Registrant as specified in its charter) 16 Tiomkin St. Tel Aviv 6578317, Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Fo ...
Galmed Pharmaceuticals(GLMD) - 2021 Q4 - Earnings Call Transcript
2022-05-02 17:56
Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q4 2021 Earnings Conference Call May 2, 2022 8:30 AM ET Company Participants Allen Baharaff - President and CEO Yohai Stenzler - Chief Accounting Officer Conference Call Participants Steven Seedhouse - Raymond James Kristen Kluska - Cantor Fitzgerald Naz Rahman - Maxim Group Operator Good day and welcome to the Galmed Conference Call to discuss Financial Results for the Fourth Quarter and Year-end 2021. Today’s conference is being recorded. Before we begin, please ...
Galmed Pharmaceuticals(GLMD) - 2021 Q4 - Annual Report
2022-05-02 13:11
UNITED STATES 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 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 ☐ 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 eve ...
Galmed Pharmaceuticals(GLMD) - 2022 Q1 - Quarterly Report
2022-05-02 11:07
Financial Performance - The net loss for the twelve months ended December 31, 2021, was $32.5 million, or $1.32 per share, compared to a net loss of $28.8 million, or $1.35 per share, for the same period in 2020[5]. - Net loss for the year 2021 was $32,467 thousand, an increase of 13.9% compared to a net loss of $28,771 thousand in 2020[14]. - The total operating loss for the twelve months ended December 31, 2021, was $32.9 million, compared to $30.2 million for the same period in 2020[13]. Cash and Cash Equivalents - Cash and cash equivalents, restricted cash, short-term deposits, and marketable debt securities totaled $34.9 million as of December 31, 2021, down from $51.0 million as of December 31, 2020[10]. - Cash and cash equivalents at the end of 2021 decreased to $2,998 thousand from $7,060 thousand at the end of 2020, representing a decline of 57.5%[14]. - Total cash received from interest in 2021 was $562 thousand, down from $1,192 thousand in 2020, indicating a decline of 52.8%[14]. Research and Development - For the three months ended December 31, 2021, research and development expenses totaled $6.3 million, a decrease from $9.0 million for the same period in 2020[4]. - Research and development expenses for the twelve months ended December 31, 2021, were $27.2 million, compared to $26.1 million for the same period in 2020[5]. - The company is currently in a Phase 3 registrational study for its lead compound, Aramchol, targeting NASH and fibrosis[8]. General and Administrative Expenses - General and administrative expenses for the twelve months ended December 31, 2021, were $5.7 million, an increase from $4.1 million for the same period in 2020[4]. Financial Activities - Net cash used in operating activities for 2021 was $32,892 thousand, up from $26,287 thousand in 2020, reflecting a 25.2% increase[14]. - Net cash provided by investing activities in 2021 was $11,462 thousand, a decrease from $16,536 thousand in 2020[14]. - The company raised $8,147 thousand from the issuance of ordinary shares in an at-the-market offering in 2021[14]. - Proceeds from the sale of securities available for sale in 2021 amounted to $21,243 thousand, compared to $47,198 thousand in 2020, a decrease of 55.0%[14]. Other Financial Metrics - Financial income, net for the twelve months ended December 31, 2021, amounted to $0.4 million, down from $1.4 million for the same period in 2020[10]. - The company reported a depreciation and amortization expense of $42 thousand in 2021, slightly up from $39 thousand in 2020[14]. - Stock-based compensation expense for 2021 was $1,886 thousand, a decrease from $2,066 thousand in 2020[14]. - The company experienced a decrease in trade payables by $2,175 thousand in 2021, contrasting with an increase of $1,047 thousand in 2020[14]. Assets - Total assets decreased to $36.6 million as of December 31, 2021, from $52.4 million as of December 31, 2020[12].
Galmed Pharmaceuticals (GLMD) Investor presentation - Slideshow
2021-11-19 19:10
| --- | --- | --- | --- | |---------------------------------------------|-------|-------|-------| | | | | | | 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(GLMD) - 2021 Q3 - Earnings Call Transcript
2021-11-08 20:24
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]
Galmed Pharmaceuticals(GLMD) - 2021 Q3 - Earnings Call Presentation
2021-11-08 19:42
| --- | --- | --- | --- | |---------------------------------------------|-------|-------|-------| | | | | | | 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(GLMD) - 2021 Q2 - Earnings Call Transcript
2021-08-09 15:00
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 ...