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8/8/2023
a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Louis Wilkie, Vice President of Investor Relations and Corporate Communications. Please go ahead.
Thank you. Good afternoon. I'm Louise Wilkie, Sangamo's Vice President of Investor Relations and Corporate Communications. Thank you for joining us on the call today. On this call are several members of the Sangamo Executive Leadership Team, including Sandy McRae, Chief Executive Officer, Mark McClung, Chief Operating Officer, Patricia Durrababu, Chief Financial Officer, Jason Fontenot, Chief Scientific Officer, Natalie Dubois-Stringfellow, Chief Development Officer and Lisa Roy Care, Chief Medical Officer. Slides from our corporate presentation can be found at our website sangamo.com under the investors and media section of the events and presentations page. This call includes forward-looking statements regarding Sangamo's current expectations. These statements include, but are not limited to, statements relating to the therapeutic and commercial potential of our product candidates. the anticipated plans and timelines of Sangamo and our collaborators for regulatory submissions, initiating and conducting clinical trials, screening and dosing patients, and presenting clinical data, advancement of our product candidates, anticipated feedback from and interactions with regulatory agencies, advancement of preclinical programs to the clinic, our strategic reprioritization and the anticipated benefits thereof, the sufficiency of our resources, cash runway, and plans to seek additional capital, our estimated financial guidance for 2023 and estimates of 2024 operating expenses, upcoming catalysts and milestones, and other statements that are not historical facts. Actual results may differ materially from what we discussed today. These statements are subject to certain risks and uncertainties that are discussed in our filings of the SEC, specifically on our annual report on Form 10K for the fiscal year ended December 31, 2022, as supplemented by our quarterly report on Form 10Q for the quarter ended June 30, 2023, filed with the SEC. The forward-looking statements stated today are made as of this date, and we undertake no duty to update such information except as required by law. On this call, we discuss our non-GAAP operating expenses. Reconciliation of this measure to our GAAP operating expenses can be found on our press release, which is available on our website. Now, I'd like to turn the call over to our CEO, Sandy McRae.
Thank you, Louise, and good afternoon to everyone joining the call. The second quarter has been a busy one for Sangamo, and I'm pleased to share some exciting clinical and preclinical progress as we advance our mission to translate groundbreaking science into genomic medicines that transform the lives of patients afflicted with serious genetic diseases. Our visionary culture has been a key driver in our success to date, alongside our innovative approach to genomic medicines, both which I believe will continue to drive Sangamo forwards towards the future. Starting with our clinical programs, we continue to make good progress in our Phase 1-2 STAR study for Fabry disease, having now dosed a total of 22 patients. Importantly, we recently received productive written feedback from the FDA on our proposed Phase 3 trial strategy. While we're seeking some specific clarifications, as it stands today, we feel we have a regulatory path forward to a potential Phase 3 trial. I'm enormously proud of the team for the work to get us to this point. We're refining our trial strategy and expect to submit a proposed phase three protocol to the FDA as early as the end of 2023. Needless to say, our operations team is driving forward with the logistics of these studies in parallel. We have also made good progress advancing our wholly owned clinical asset, TX200, our CAR Treg cell therapy candidate, for renal transplant rejection. Based on the encouraging safety data to date, we received endorsement from the Safety Monitoring Committee to progress to the next dose cohort. We are encouraged by the rate of patient enrollment we are seeing in this study and are pleased to be receiving initial approvals from European regulators for an updated study protocol that we believe will enable us to accelerate more quickly through the dose escalation phase. The underlying value of Sangmo is our zinc finger platform, which we believe is at the cutting edge of genomic medicine. Jason will share more context on the importance of our science and our neurology pipeline shortly, along with some of the exciting scientific advancements we present this quarter on our two lead neurology programs, our AAV capsids and our platforms. These scientific advancements are at the heart of the three business development deals that we recently signed and that Mark will elaborate on shortly, all of which underscore the important role SAGMA plays in helping to progress the broader cell and gene therapy industry forward. We are proud to be part of the important collaboration that is necessary within the field in order to best serve patients and are happy that our genome editing and payload delivery technology is being recognized by the broader industry. Lastly, I'd like to take a moment to welcome Dr. Lisa Roycair as our new Chief Medical Officer. Lisa joins us with strong experience as a physician and a drug developer. I'm delighted to have her as a strategic member of the leadership team focused on advancing our clinical and preclinical programs, and I am confident she will continue to bring great value to Sango as we progress our potential medicines closer to patients. We are proud of the strong progress we have made this quarter. Nevertheless, we recognise the importance of bringing in additional funding, as well as further reducing our operating expenses. This is a top priority for me and the rest of the leadership team and remains at the forefront of decision makings each and every day. While we stay committed to execution and our prioritised clinical and preclinical activities, we look forward to providing updates in these areas at the appropriate time. I'd now like to turn the call over to our Chief Development Officer, Natalie, who will share more on our clinical programs. Natalie?
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