On Thursday, Sangamo Therapeutics (NASDAQ:SGMO) discussed first-quarter financial results during its earnings call. The full transcript is provided below.

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Summary

Sangamo Therapeutics is advancing its BLA submission for ST920, an investigational gene therapy for Fabry disease, with two modules already submitted.

The company has transitioned to the OTCQB Venture market following a NASDAQ delisting determination and plans to appeal the decision.

Sangamo is actively pursuing strategic opportunities to secure additional funding and maximize asset value, supported by a global investment bank.

Progress in the neurology pipeline includes six clinical sites activated for the ST503 study and ongoing preclinical activity for ST506.

Management remains optimistic about the regulatory pathway for ST920, with recent FDA affirmations on data submission criteria.

Full Transcript

OPERATOR

Good afternoon and welcome to Zagnamo Therapeutics first quarter 2026 teleconference call. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker today, Louise Wilke, Head of Investor Relations and Corporate Communications, . Please go ahead.

Louise Wilke (Head of Investor Relations and Corporate Communications)

Thank you. Good afternoon everyone. Thank you for joining us on the call today. On this call are several members of the Sangamo Executive leadership team including Sandy McCrae, Chief Executive Officer, Natalie Dubrar, Stringfellow, Chief Development Officer and Nukund Jain, Interim Chief Financial Officer. Slides from our corporate presentation can be found on our website, sangamo.com, and under the presentations page of the Investors and Media section. This call includes forward looking statements regarding Sangamo's current expectations. These statements include, but are not limited to, statements relating to Sangamo's cash Runway, Sangamo's plans to obtain additional capital and its ability to continue to operate as a going concern, the therapeutic and commercial potential and value of Sangamo's product candidates and technologies, Sangamo's ability to establish and maintain collaborations and strategic partnerships including for its Fabry Disease programme, the anticipated plans of Sangamo and its collaborators for clinical trials, regulatory submissions and regulatory approvals and other statements that are not historical fact. Actual results may differ materially from what we discuss today. These statements are subject to certain risks and uncertainties that are discussed in our filings with the SEC, specifically in our Annual Report on Form 10K for the fiscal year ended December 31, 2025 and the Quarterly Report on Form 10Q for the fiscal quarter ended March 31, 2026 and subsequent filings and reports that Sangamo makes from time to time with the sec. The forward looking statements stated today are made as of today and we undertake no duty to update such information except as required. Please note that all forward looking statements about our future plans and expectations are subject to our ability to secure adequate additional funding. Now I'll turn the call over to our CEO Sandy MacRae.

Sandy MacRae

Thank you Louise and good afternoon to everyone joining the call today. In the short time since our fourth quarter earnings call, we have continued to advance the rolling submission of the BLA for ST920 and Fabry disease and made progress across our differentiated neurology pipeline. Natalie will provide a detailed update on our development pipeline shortly. This quarter, Sangamo's common stock transitioned to trading on the OTCQB Venture market following the receipt of a delisting determination from NASDAQ Capital Markets due to non compliance with NASDAQ's minimum bid requirements. We intend to appeal the determination at a hearing before Nasdaq in June. Our stock began trading on the OTCQB Venture Market earlier this month under the same ticker symbol SGMO. While we are disappointed by the Nasdaq delisting determination, the transition to the OTC QB market will allow Sangamo to maintain access to the public markets. While we seek to advance our promising development pipeline, we remain focused on pursuing a number of opportunities to raise additional capital, including evaluating all strategic options to maximize the value of Sangamo's assets. Throughout this process, we have been and continue to be supported by a global investment bank. We continue to engage in business development discussions for a potential Fabry commercialization agreement and will share more information as appropriate. Before I hand over to Natalie, I'd like to share an update from Boston, where I've just returned where we had three abstracts accepted this year's American Society of Gene and Cell Therapy Annual Meeting. ASGCT is an important forum for showcasing innovation in gene and cell therapy and I was proud to see our talented scientists present our most recent advances in zinc finger epigenetic regulation specifically for NAV 1.7 and prion disease, alongside a platform presentation on our modular integrase technology. We have now achieved impressive levels of targeted integration in a variety of different cell types, moving us one step closer to our aspiration of achieving large scale genome engineering to integrate large sequences of DNA into the genome. I'd like now to hand over to Natalie Natalie, thank you.

Natalie Dubrar

Thank you Sandy. First, I am pleased to share updates from our registrational phase 12 STAR study evaluating isaragalcer gene therapy or ST920, our investigational gene therapy for the treatment of adults with Fabry disease as outlined during our recent fourth quarter earnings call. The rolling submission of a BLA to the US FDA seeking approval of ST920 under an accelerated approval pathway is in progress with the first two modules submitted. The team is actively advancing the activity required for the CMC module and we anticipate completing the BLA submission as early as this summer, subject to our ability to secure adequate additional funding. As a reminder, SD920 has a clear pathway to accelerate approval. Agreed with the FDA using mean annualized eGFR slope at 52 weeks across all 32 dose patients in the study. The FDA also affirmed to us in a very recent interaction that an additional confirmatory study will not be required and that we may submit 104 week data across all dose patients when seeking traditional approval in February. We also presented detailed clinical data via four platform and poster presentation at the 22nd Annual WORLD Symposium that took place in San Diego, California. We continue to believe that the data support the potential of ST920 as a one time well tolerated and durable treatment to provide meaningful multi organ clinical benefit that could fundamentally shift the Fabry treatment paradigm. All four presentations are available on the Sangamo website. Moving to our neurology pipeline, we have six clinical sites activated for the phase 12 STAN study evaluating ST5.03, our investigational epigenetic regulator for patients with intractable pain due to small fiber neuropathy or sfn. These sites are working to identify patients this quarter. We were also pleased to have a manuscript published in Science Translational Medicine detailing the preclinical safety and pharmacology of ST503 in human neurons, mice and non human primates. Finally moving to ST506, our epigenetic regulator for the treatment of prion disease. This quarter we continue to advance clinical trial application or CTA enabling activities. The Good Laboratory Practice or GLP Toxicology study has been completed and analysis is ongoing. In addition, we held a further productive interaction with the UK's Medicine and Healthcare Products Regulatory Agency or MHRA, including alignment on diagnostic testing, analytical validation and non clinical safety matters. I would like now to hand back to Sandy for closing remarks.

Sandy MacRae

Sandy thank you Natalie. In closing, we've made good progress this quarter. The rolling BLA submission for ST920 remains in progress with the first two modules submitted and with real clarity on the regulatory pathway reaffirmed very recently by the FDA. Six sites have been activated in the Phase 12 stand study evaluating ST503 for patients with chronic neuropathic pain. We held a productive meeting with the MHRA including further alignment on key matters for the Prion program and we showcased continual progress across our pipeline and platforms at ASGCT, including a platform presentation showing impressive advances in our Mint integrase technology. This remains an important period for Sangamo as we continue to advance our pipeline while actively pursuing strategic opportunities to strengthen our financial position and maximize the value of our assets. We will continue to provide relevant updates when we are able to Operator, Please open the line for questions.

OPERATOR

Thank you. To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. One moment for our first question. Our first question comes from the line of Murray Raycroft with Jefferies. Your line is open. Please go ahead.

James Onframori

Hi, this is James Onframori. Thanks for taking our question. Congrats on getting the reaffirmation from the FDA on the 104 weekend point. Given that the last patient reached the two year time point around April, can you walk us through the gating factors for analyzing that data set and disclosing the data set? Would you wait to present the 104 week data at a medical conference such as World Next Year or could it be disclosed earlier after you file the bla?

Sandy MacRae

So as you know, we're I'm going to say three-fifths of the way through the rolling submission and the clinical module with the one year data is already submitted. We have a series of cleaning processes to gather the full two year data and we'll work out once we have that when the best place to submit it. But we can reassure you, Natalie, that we're now seeing patients out to five years worth of experience and it's looking very stable.

Natalie Dubrar

Yes, we absolutely show durability in the benefit for the patient at five years and beyond. We have now four patients that are beyond five years and with supraphysiological level of alpha-Gal and you know, safety of the product also remains remarkable. And the 17 patients that are off enzyme replacement therapy (ERT), some of them are over three years off enzyme replacement therapy (ERT) now. Yes, absolutely.

James Onframori

Great. Thank you for taking my question. I'll hop back in the queue.

OPERATOR

Thank you. And one moment for our next question. Our next question comes from the line of Yan and Zhu with Wells Fargo. Your line is open. Please go ahead.

Kwanang

Hi, thanks for taking our question. This is Kwanang for yana. So with FDA's recent affirmation that two year EGFR data can serve as a confirmatory evidence, can you talk about how that would affect your business development (BD) discussions and any updates on the business development (BD) discussion around the Fabry program that you can share with us? Thank you. I hope you can understand that we can't talk about those conversations. I am certain that the people who have been looking at this asset are pleased by the recent affirmation from the agency. Most importantly is to get accelerated approval as quickly as possible and that's with the one year data. Equally important is agency signaling that a second study will not be necessary because that would be expensive and delay the process. And as we now gather the two year data, not just for the EGFR but for all the other benefits to the patients. We will plan when we can submit it and I can assure you that the data is looking good, it's showing durability and we look forward to sharing this at the appropriate time. That's helpful, thank you.

OPERATOR

Thank you. And I would now like to hand the conference back over to Louise Wilke for closing remarks.

Louise Wilke (Head of Investor Relations and Corporate Communications)

Thank you once again for joining us today and for your questions. As a reminder, you can access our presentation on the investor relations section of the Sangamo website. We look forward to keeping you updated on our future developments.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.