Galmed Pharmaceuticals Ltd.

and welcome to the GALMED conference call to discuss financial results for the first quarter 2021. Today's conference is being recorded. Before we begin, please note that we will be making certain forward-looking statements on today's call, including those regarding financial results, statements, and forecasts regarding anticipated timelines and expectations with respect to our regulatory and clinical development programs. as well as other statements that relate to future events. These statements are based on the beliefs and expectations of management as of today, and actual results, trends, timelines, and projections relating to our financial position and projected development programs and pipeline could differ materially. We urge all investors to read carefully the risks and uncertainties disclosed in our filings with the SEC, including, without limitation, the risks under the heading Risk Factors described in our most recent annual report on Form 20-F, filed with the SEC. SALMED assumes no obligation to update any forward-looking statements or information, which speaks as of to their respective dates only. I will now turn the call over to Alan Vajaroff, President and Chief Executive Officer. Alan, please go ahead.

Thank you, Donna. Good morning, and thank you for joining us on today's conference call. I'm pleased to be here today with our Chief Scientific Officer, Dr. Liata Yardeni, our Chief Financial Officer, Zohaish Chancellor, to provide you with an update on our clinical development programs, as well as report to you on our financial results for the first quarter of 2021. As always, we will be happy to take any questions you may have at the conclusion of our prepared remarks. As we have held our investors' year-end poll only a few weeks ago, my report to you this time will be very short. Starting with our global phase three registrational RMO study, and as previously reported, the addition of the open label part was approved in the U.S., Canada, Australia, the U.K., France, Belgium, Spain, Israel, Chile, and Turkey. and is expected to be approved in the coming weeks in Korea and Mexico. Based on our plans and the rapid regulatory approvals, I can reconfirm that results from approximately one-third of the study population, i.e., about 50 subjects, that have completed the post-baseline labor biopsy are expected to be available in Q4 2021 head plans. That being said, In Q4, we expect to have results on the efficacy of Aramcol with higher exposure on fibrosis and liver fat confirmed by liver biopsy. Also reported earlier this month, Aramcol received an IND approval in China. We view the approval of the Aramcol study in China as a significant milestone in the development of Aramcol for national fibrosis, which may accelerate the pace of randomization of patients with the double-blind part of the ARMO study, and also position Aramcol as one of the foremost therapeutic candidates for national fibrosis in this large and emerging market. We look forward to rapidly initiating enrollment in China as soon as practical. As previously reported, ARMO's double-blind placebo-controlled registrational part is expected to initiate by the end of Q1 2022, and is expected to be based on aramcol megalamine, which is a salt form of aramcol-free acid with an improved target product profile. Earlier this month, we submitted to the FDA the results of aramcol megalamine Phase I study with specific product development plan that would enable Dalmed to replace aramcol acid BID with aramcol salt QD with the same exposure. Gambit is expecting, during Q3, to receive guidance from the FDA to allow us to introduce Aramcol Megalamine into the double-blind, placebo-controlled, registrational part of the Aramol Phase 3 study. Now, shifting gear to our partner compound, Amilophagmer. As a brief reminder, amylo-5-MER is a highly potent inhibitor of chronic inflammation currently under development for IDD with a targeted and a specific mechanism of action. Amylo-5-MER does regulate multiple pro-inflammatory cytokine secretion. In previous clinical studies, amylo-5-MER demonstrated interference with serum amyloid A polymerization and aggregation, which is the active form of serum amyloid A. Aggregated serum amyloid A is the main cause and the biomarker of chronic inflammation. Amylo-5-MER treatment resulted in significant reduction of clinical symptoms and pathological characteristics of disease in multiple animal models. Amylo-5-MER has a unique mode of action upstream to all pro-inflammatory cytokine production, which are currently being used in the clinical trials and in the clinical use. Earlier this quarter, we announced the first dosing of a first-in-human phase one clinical trial of Amilop5MER for single and multiple dosing. I'm happy to report today that we completed all single-administrated doses starting from 10 milligrams up to 180 milligrams. Following excellent safety and proportional we decided to go one dose even higher, and at 360 milligrams, it's currently being dosed. Topline data is expected in the second half of 2021. Phase 1, the proof-of-concept study, is planned for Q4 2021 and will include biomarkers for efficacy, such as reducing serum amyloidase in the serum of patients and other inflammatory biomarkers, such as CRP, et cetera. In this Phase 1b study, amil-O5MER will be administrated subcutaneously and orally for four weeks with additional four-week safety follow-up period. We are currently developing amil-O5MER as an oral treatment for mild to moderate ulcerative colitis. However, if its mechanism of action is relevant to other chronic inflammatory diseases, we are also looking at additional indications and plan to develop targeted formulations accordingly. Now let me transfer the call to our CFO, Yochai Stentzler. Yochai?

Yochai Stentzler Thank you, Alan. Good morning and thanks for joining us for today. This morning I will be providing you with our financial results for the first quarter and March 31st, 2021. For more information please refer to our report on Form 6K filed earlier today with the SEC, which among other things provides a summary of such financial results. For the first quarter of 2021, our net loss totaled $8.9 million, or $0.38 per share, compared with a net loss of $6.1 million, or $0.29 per share, for the corresponding quarter in 2020. Research and development expenses totaled $7.4 million for the first quarter of 2021, compared with $5.6 million for the first quarter in 2020. Increased results were found from an increase in drug development expenses in connection with the manufacturing of Aramco Megalomide. Turning now to G&A, our general and administrative expenses for the quarter totaled $1.7 million compared with $0.9 million for the corresponding period in 2020. During the quarter, we raised a total of approximately $17.4 million of net proceeds in under-recent public offerings and from our ATM equity facility. As a result of the fund raise and our net loss, Our cash balance as of March 31st, 2021, which includes cash, cash equivalents, restricted cash, short-term deposits, and marketable securities, was at $58.9 million, if compared with $51 million on December 31st, 2020. With that said, operator, please provide instructions for the Q&A portion of our call.