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11/3/2022
Good day, and thank you for standing by. Welcome to the Sangamo Therapeutics third quarter earnings call. At this time, all participants are in 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 11 on your telephone. You will then hear an automated message advising that your hand is raised. Please be advised that this call is being recorded. I will now turn it over to Louise Wilkie, Head of Corporate Communications and Investor Relations. Please go ahead.
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 Sangamo Executive Leadership Team, including Sandy McRae, Chief Executive Officer, Mark McClung, Chief Operating Officer, Pratyusha Dhirubhavu, Chief Financial Officer, Jason Fontenot, Chief Scientific Officer, Natalie Dubois-Stringfellow, Chief Development Officer, and Bettina Cockcroft, Chief Medical Officer. Slides from our corporate presentation can be found at our website, sangamo.com, under the Investors and Media section on 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 initiating and conducting clinical trials, dosing and screening patients, and presenting clinical data, advancement of our product candidates, advances of preclinical programs to the clinics, our investment focus and the sufficiency of our resources, our 2022 financial guidance, upcoming catalysts, 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 with the FDC, specifically in our annual report on Form 10K for the fiscal year ended December 31, 2021, as supplemented by our quarterly report on Form 10Q for the fiscal quarter into September 30, 2022. 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 gap operating expenses can be found in today's 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 on the call. Sanger will continue to pursue scientific innovation and development excellence in the third quarter as we've progressed our mission of turning groundbreaking science into potentially transformative genomic medicines for patients. I am pleased with the momentum we are achieving across our programs, with our clinical data continuing to demonstrate the strength of our pipeline. Regarding our wholly-owned Fabry Disease Program, we were excited to present additional preliminary data from our Phase 1-2 STAR study at three separate medical conferences since the last call. We continue to be encouraged by the promising data generated to date showing sustained and elevated alpha-galli activity along with a favorable safety profile as of the last data cut in July. These data demonstrate the potential of this therapy to replace the current standard of care and provide the potential for a one-time dosing alternative rather than a lifetime of ERT infusions. I'm also pleased to share that the study has moved into the dose expansion phase and we've begun dosing patients, including the first female patients in the study. We continue to make progress in our wholly owned sickle cell program this quarter, dosing the sixth patient in the Phase 1-2 precision study. This is the second patient to be dosed with our product candidate manufactured using improved methods. In addition, the FDA has granted Regenerative Medicine Advanced Therapy, or RMAT, designation to our sickle cell product candidate. Momentum continues behind our Phase 1-2 steadfast study of TX200 in HLA-A2 mismatched kidney transplantation. I am pleased to announce that the second patient was successfully dosed in late September, while the first patient has reached eight months post-infusion. Lastly, We jointly announced with Pfizer on September 22nd that the phase three affine trial in haemophilia A had reopened recruitment. Trial sites resumed enrollment in September and those they expected to resume shortly. The resumption of this study is an important milestone as it takes us with our partner Pfizer one step closer to getting this potential treatment to patients in an area of significant unmet medical need. I'm proud of the team for the advancements we continue to make. staying true to our strategic focus on our research and development capabilities. Each incremental update brings us closer to our goal of creating transformative medicines for patients while creating long-term value for shareholders. I'd like to turn the call over to our head of development, Natalie, who will discuss the data from our clinical programs in more detail. Natalie?
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