Gamida Cell Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the Gameta Sales Conference call for the first quarter 2023 financial results. My name is Catherine, and I'll be your operator for today's call. Please be advised that this call is being recorded at Gameta Sales request. I would like to introduce your host for today's conference, Mike Koskowski of Gameta Sales Corporate Communications. Mike, please go ahead.

Thank you, Catherine, and good evening, everyone. Welcome to today's call, during which we will provide an update on the company and review our financial results for the first quarter of 2023. Earlier today, we issued a press release summarizing our financial results and providing a business update, which is available on our website at www.gamitacel.com. Here with me on our call today are Abby Jenkins, President and Chief Executive Officer, Michelle Corfin, Chief Operating Officer and Chief Commercial Officer, Ronit Samantabh, Chief Medical Officer and Scientific Officer, and Shai Lankre, Chief Financial Officer. Today's call will follow a slightly different format than we have recently, as we just had our ArmaSurge approval call on April 17th. Abby and Shai will share brief updates. Michelle and Ronit will be available for the Q&A. Before I begin, I want to remind everyone that during the call, we may make forward-looking statements about our future expectations and plans, including with respect to the timing of and initiation and progress of and data reported from preclinical and clinical trials of our products and product candidates, regulatory filings, commercialization planning efforts, the potentially lifesaving or curative therapeutic and commercial potential of GametaCell's product, Omisurge, and product candidate, GDA201, and our expectations regarding our projected cash, cash equivalents, and investments to be used for operating activities. Our actual results may differ materially from what we project today due to a number of important factors, the scope, progress, and expansion of our clinical trials, impacts to the cost thereof, clinical, scientific, regulatory, and technical developments, those inherent in the process of developing and commercializing product candidates that are stated as human therapeutics, and in the endeavor of building a business around such product candidates, as well as those considerations described in the risk factor sections of our most recent annual report on Form 10-K, and other filings that we may make with the SEC from time to time. These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information or future events, except as required by applicable law. Now, let me turn the call over to our President and CEO, Abby Jenkins.

Thank you, Mike, and welcome to our call, everyone. Today, we're providing a brief corporate update I know many are interested in hearing more details on how the launch is going. We will be hosting an investor day at the end of June to share more details and offer external perspectives on what OmniSurge means to the transplant community. Look for an announcement on the date and time of that event in the next week or two. In terms of our update, I want to pull through the thread of the last seven weeks because there have been a lot of changes and we want to make sure that the picture we're conveying is crystal clear. At the end of March, we took several actions to strategically restructure the company's operations to focus on the approval and launch of OmniSurge. These actions, as you will recall, have the net effect of reducing our expenses, slowing the anticipated ramp of our launch, and extending our cash runway through the third quarter. We further communicated that we would be executing a two-pronged corporate strategy going forward with these two objectives. One, to successfully execute our commercial plan for a targeted AmiSurg launch in the U.S. aiming to onboard 10 to 15 transplant centers by year end 2023, and two, to pursue strategic partnerships with biopharmaceutical companies to expand transplant center onboarding to accelerate patient access to AmiSurg. I'm pleased to share that we are making positive progress on both fronts. In terms of the launch, Our team was launch ready on April 15, so when the FDA approved OmniSurg on April 17, two weeks before its due date, we were able to move swiftly to initiate onboarding of transplant centers and secure payer coverage in order to make OmniSurg available to appropriate patients in need of a stem cell transplant. As of today, we are on track to complete the goal of onboarding 10 to 15 of the top 70 transplant centers in 2023. Additionally, I'm excited to report that we have confirmed coverage with payers that cover more than 65% of commercial lives and discussions are ongoing with other commercial payers and CMS. We are absolutely thrilled at the progress we've made with payers. We believed coverage would come quickly based on our market access team's engagement with payers over the last 18 months. But these results exceeded our expectations of what could be possible within just the first month post-approval. This level of access reinforces the important role that AmiSearch can play in Allo HSVT. It is also a credit to our experienced and exceptional cell therapy market access and medical affairs team who built relationships and prowess introducing other novel cell therapies to the market in recent years. In terms of the onboarding of transplant centers, this, as you know, is the single most important rate-limiting step for getting Omni-Surg to appropriate patients. Our targeted plan of transplant center engagement and onboarding is going well. The team has reported interest from both centers that participated in our clinical studies as well as those that did not. This, again, suggests the important role Omni-Surg can play in allo-HSVT. No other enhanced and expanded cell therapy has been approved for use in alloHSCT, and nothing similar is on the horizon in other companies' pipelines. We have said that we believe AmiSurg has the potential to both increase access and improve outcomes. It is gratifying to see this belief translated into interest from the transplant community. I also want to acknowledge, though, that this momentum signals a significant opportunity. And it's the area where if we had more resources or it could secure additional investment or a strategic partnership, we could be doing more. We could drive more education. We could onboard more transplant centers and do so much more quickly. We know from pre- and post-approval market research that this is an educationally sensitive market. The more resources we can apply to capturing the interest in the market, the more successful the launch of OmniSurge will ultimately be. I also want to note some additional progress stabilizing the company's financial position. In our press release, we noted that we recently received $22.8 million in gross proceeds from a public offering of securities. This funding enables us to jumpstart the launch of Omnisurge while extending our cash runway into early 2024. We also reduced our debt obligations through a combination of share redemptions by Highbridge Capital Management and our installment payments on Hybridge's December 2022 Senior Secured Convertible Term Loan. Through these actions, the outstanding principal balance of this loan has been cut in half from $25 million to $12.5 million as of May 12th. In terms of the second element of our two-pronged corporate strategy, we are also actively pursuing discussions with strategic partners, including potential U.S. and global partnerships with biotech and pharmaceutical companies that can help resource our commercial efforts more robustly. We're making progress here as well with the help of banking partner, Molison Company LLC, who are supporting the process. We've had active and ongoing conversations, and there has been significant interest post-approval. So to summarize, we believe we've made the right move, tightening our belt on expenses, raising equity, reducing debt, and extending our cash runway into 2024. We promised that we would be a more streamlined and focused company, and we are. We are launching OmniSurge and seeing support from payers through their coverage and great interest from transplant centers. And we're confident that with a strategic partnership, we can capitalize on the interest we're seeing more quickly to maximize access for patients and value for shareholders. I will now turn the call over to Shai to review our Q123 financial results. Shai, over to you.