Sangamo Q3 2025 Earnings Call Summary and Q&A Highlights: Advancing Clinical Pipeline and Regulatory Progress
Earnings Call
Nov 07
[Management View] Sangamo Therapeutics reported positive clinical data for ST-920 in Fabry disease, with a mean annualized eGFR slope of nearly 2.0 observed at 52 weeks in all 32 patients. The company plans to submit a BLA for ST-920 under the accelerated pathway as early as Q1 2026. Patient enrollment for ST-503 in chronic neuropathic pain has begun, and updated preclinical findings for ST-506 in prion disease show promising results.
[Outlook] Sangamo expects to submit the BLA for ST-920 in Q1 2026 and continues to advance its neurology pipeline, including ST-503 and ST-506. The company is actively seeking a commercialization partner for its Fabry asset and aims to secure additional funding to support its operations into 2026.
[Financial Performance] Sangamo received $6 million from Pfizer's buyout option in October 2025 and continues business development discussions for Fabry and other pipeline assets. Cash and cash equivalents are expected to fund operations into 2026.
[Q&A Highlights] Question 1: On Fabry disease, could you share with us what's the latest progress in your partnership deal negotiation? Also, on the regulatory front, you shared your progress with FDA. But, in light of recent news from Unicure, is there any read-through to your Fabry disease drug program? Answer: We can't comment on Unicure's discussions, but our interactions with the FDA confirm our ability to use eGFR data for accelerated approval. The FDA has endorsed the use of eGFR at one year for accelerated approval, which is helpful for our business development discussions.
Question 2: Are you planning to have any additional meetings with FDA prior to a pre-BLA meeting? Do you need to have a pre-BLA meeting? And what additional clarification do you need from FDA at this point? Answer: We are pleased with the clarity on the clinical and safety package required for the BLA submission. We are exploring if there are further topics that require a pre-BLA meeting, but we have had many interactions with the FDA this year, providing good clarity on our questions.
Question 3: In your engagement with FDA, has the topic of a priority review voucher ever been mentioned? And do you think that could affect your BD discussions? Answer: We have not discussed a priority review voucher specifically, but we are looking into it. We have shared the essence of the FDA meeting minutes with our potential partners, and they always get to see all regulatory correspondence as part of any business development deal.
Question 4: Regarding the STAND study and the dosing that you said is going to start in the coming months, are there any additional challenges that we should consider recruiting this patient population and looking ahead into the readout in about a year? What would be a clear win for getting the study going? Answer: We are optimistic about dosing the first patient in the coming months and have broadened the population to SFN, not just idiopathic small fiber neuropathy. Success will be measured by safety, tolerability, and pain reduction from baseline using the PI-NRS scale.
Question 5: Can you discuss any ongoing partner interests in the STAK BBB capsid? Any additional deals that could extend your runway? Also, with your MINT platform progressing, are there any updates? Answer: We are always talking to new people about the capsid, and our relationships with Genentech, Astellas, and Lilly are going well. The MINT platform is advancing with minimal spend, and we continue business development negotiations for potential partnerships.
[Sentiment Analysis] Analysts and management expressed optimism about the regulatory progress and clinical data for ST-920. The tone was positive regarding the potential for partnerships and the advancement of the neurology pipeline.
[Risks and Concerns] - The ability to secure adequate additional funding remains a concern. - Regulatory approval processes and timelines could impact commercialization plans. - Recruitment challenges for clinical trials in neuropathic pain.
[Final Takeaway] Sangamo Therapeutics is making significant progress in advancing its clinical pipeline, particularly with ST-920 for Fabry disease and ST-503 for chronic neuropathic pain. The company's regulatory interactions with the FDA have reaffirmed the accelerated approval pathway for ST-920, which is expected to enhance partnership negotiations. Financial discipline and strategic business development are key focuses as Sangamo seeks to secure additional funding to support its operations into 2026.
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