Galmed Pharmaceuticals Ltd.

Good day and welcome to GalMed conference call to discuss financial results for the second 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 the expectations of the management of today and actual results, trends, timelines and projections relating to our financial position and projected development programme and pipeline could differ materially. We urge all investors to read carefully the risks and uncertainties disclosed in our filings with the SCEC, including without limitations the risks under the heading risk factors described in our annual report on form 20F filed with the SEC and the risks and uncertainties included in the form 6K filed with the SEC earlier today. GALMED assumes no obligation to update any forward-looking statements or information which speak as of the respective dates only. I would now like to turn the conference over to Alan Beharif, President and Chief Executive Officer. Alan, please go ahead.

Thank you, Emma. 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. Liat Hayardeni, and our Chief Financial Officer, Bokhai Stensler, to provide you with an update on our clinical development programs, as well to report to you on our financial results for the second quarter of 2021. As always, we'll be happy to take any questions you may have at the conclusion of our prepared remarks. Let me start with the news we reported earlier this week announcing FDA agreement with our plan to use aramcol megalomines in the randomized double-blind placebo-controlled part of the Phase III R-MO study. In essence, the FDA agreed that we can proceed with our proposed clinical studies with aramcol megalomines in use of aramcol-free acid without the need to repeat any non-clinical or clinical studies. As you may recall, Administration of Aramcol megalomine doubled the systemic exposure of Aramcol compared with that after dosing Aramcol-free acid. Thus, once daily QB 383 mg Aramcol megalomine oral dosage correspond to that obtained with existing twice daily BID 300 mg Aramcol-free acid form, which is currently being evaluated in the Phase III RMO study. As a reminder, in addition to its longer IP protection until December 2034, the transition to Aramcol Megalomine will benefit our patients in two meaningful ways. First, achieving the required exposure with 50% less API means that we can move back to one's daily regimen with a potential improvement in convenience and adherence in our Phase III registration report. The second benefit is that we can potentially significantly reduce our target marketing price once Aramco is approved via potential saving of approximately 50% of cost of goods. We consider the FDA agreement a significant validation of our consistent efforts to maximize the potential of Aramco in developing enough treatment. The transition to Aramco Megamind is the final step in our drug product optimization which included dose optimization, higher exposure, treatment duration optimization, 24, 48, and 72 weeks, and compound optimization, i.e., salt form, which can be given QB and allows longer patent protection. Now, let me update you on the open-label part of our HOMO Phase III study. As you may recall, the open label part will provide us highly valuable data on the optimization of treatment duration and potential non-invasive test needs associated with NASH and fibrosis. This is aimed at de-risking our clinical development plan while increasing the probability of success of Aramco's ARMO registration report of the ARMO study. Results from approximately one-third of the study population, about 50 subjects, The open-label part of our RMO phase 3 study that has completed the post-baseline liver biopsy are expected to be available in Q4 2021 as planned. Now, shifting here to our pipeline compound, amyloprimer. As a brief reminder, amyloprimer is a highly potent inhibitor of chronic inflammation currently under development for IVD with targeted and specific mechanism of action. Amil-O5MER done regulates multiple pro-inflammatory cytokine secretion. In preclinical studies, Amil-O5MER demonstrated interference with serum amyloid A polymerization and aggregation, which is essential for the activity of serum amyloid A. Aggregated serum amyloid A is the main cause and a biomarker of chronic inflammation. Amil-O5MER has a unique mode of action upstream to all pro-inflammatory cytokine production, which are currently being used in clinical trials and in clinical use. Earlier in Q2, we announced the first dosing of the first in-human Phase I clinical trial of amyloprimer for single and multiple dosing. I'm happy to report to you today that we completed Phase I dosing, and top-line data is expected later this quarter. We are currently developing Amido 5 Mer as an oral treatment for mild to moderate ulcerative colitis. Since this mechanism of action is relevant to other chronic inflammatory diseases, we are also looking at additional indications and are currently developing formulations accordingly. Before I conclude, I would like to note that we are planning to virtually attend three investors' conferences in the coming quarter. The first is Canicode Annual Growth Conference, to be held next week on August 10th to 12th, 2021. The second is the H.C. Wenright Annual Global Investment Conference to be held on September 13th to 15th, 2021. And lastly, the Kantor Global Healthcare Conference to be held on September 27th to 30th, 2021. We will be happy to schedule one-on-one meetings during these events. Now let me transfer the call to our CFO, Lohar Stensler.

Thank you, Alan. Good morning, and thanks for joining our call today. This morning, I will be providing you with our financial results for the second quarter and in June 30th, 2021. For more information, please refer to our report on Form 6-K, signed earlier today with the SEC, which, among other things, provides a summary of such financial results. For the second quarter of 2021, our net loss totaled 8.4 million, or 33 cents per share, compared with a net loss of $5.8 million, or $0.26 per share, for the first money quarter in 2020. Research and development expenses totaled $7 million for the second quarter of 2021. This compares with $5 million for the second quarter in 2020. Increase resulted primarily from an increase in clinical trial expenses in connection with the R-MODE trial. Turning now to GNA, our general and administrative expenses for the quarter totaled $1.4 million, compared with 0.8 million for the corresponding period in 2020. Increased results primarily from an increase in the cost of our DNO insurance policy premium, as well from an increase in salaries and benefits. Our cash balance as of June 30th, 2021, which includes cash, cash equivalents, restricted cash, short-term deposits, and marketable securities, was at 51.2 million, compared with 51 million on December 31st, 2020. With that said, operator, please provide instructions for the Q&A portion of our call.