Earnings Call Transcript - SGMO Q3 2020

Operator, Operator

Ladies and gentlemen, thank you for standing by and welcome to Sangamo Therapeutics Q3 2020 Webcast. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. I would now like to hand the conference over to your host, Head of Corporate Communications, Aron Feingold. Madam, please go ahead.

Aron Feingold, Head of Corporate Communications

Good afternoon and thank you for joining us today. With me this afternoon on this call are several members of the Sangamo executive leadership team, including Sandy Macrae, Chief Executive Officer; Sung Lee, Chief Financial Officer; Mark McClung, Chief Business Officer; Jason Fontenot, Interim Head of Research; and Bettina Cockroft, Chief Medical Officer. Slides from our corporate presentation can be found at our website, sangamo.com, under the Investors and Media section in 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 our R&D pipeline; our ability to develop, obtain regulatory approvals for and commercialize therapies to treat certain diseases and the timing, availability and cost of such therapies; plans and timelines for Sangamo and our collaborators to conduct clinical trials and share clinical data and the potential for these data to demonstrate clinical benefits to patients; the potential to use certain technologies to develop our therapies, our collaboration strategy and the potential to earn milestone payments and royalties from our collaborations and the timing of receiving such payments and royalties; plans and timelines for building and opening manufacturing facilities, the effects of the evolving COVID-19 pandemic; our expectations regarding our financial performance and resources and other statements that are not historical facts. Actual results may differ substantially from what we discuss today. In addition, these statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in documents that we file with the Securities and Exchange Commission, specifically in our quarterly report on Form 10-Q for the quarter ended September 30, 2020. The forward-looking statements stated today are made as of this date and we undertake no duty to update such information, except as required under applicable law. On this call, we discuss a non-GAAP financial measure. We believe this measure is helpful in understanding our past financial performance and our potential future results. This is not meant to be considered in isolation or as a substitute for the comparable GAAP measure. The comparable GAAP measure and reconciliations of GAAP to the non-GAAP measure discussed on this call are included in today’s press release, which is available on our website. Now, I would like to turn over the call to our CEO, Sandy Macrae.

Sandy Macrae, CEO

Thank you and good afternoon to everyone on the call. This quarter, we advanced our R&D activities as we continue to adapt to the conditions brought on by the evolving COVID-19 pandemic. We are moving forward in clinical execution and we are optimistic about our plans to continue to dose patients and initiate new trials. We also completed our research activities associated with our ALS collaboration with Pfizer and are continuing to move our research projects with Biogen and Novartis forward, and are progressing our work with other partners. Pfizer has dosed the first participant in the Phase 3 AFFINE study of giroctocogene fitelparvovec or SB-525, our investigational gene therapy for hemophilia A patients. This event triggered a $13 million milestone achievement for Sangamo, which we expect to receive in the current quarter, further strengthening our cash position. Pfizer previously communicated that they expect pivotal data readout from the AFFINE study in 2022. During the mid-September Investor Day, Pfizer provided an update from the Phase 1/2 Alta study showing encouraging data regarding tolerability, clinically meaningful factor levels, bleeding rates, and factor use in the highest dose cohort up to 85 weeks in the longest treated patients. Pfizer and Sangamo believe that these data support the potentially differentiated hemophilia A gene therapy product candidate. In August and September, in close collaboration with principal investigators, monitoring safe conditions for patients within the context of COVID-19, Sangamo dosed the first two patients in the Phase 1/2 STAR study evaluating ST-920 gene therapy in Fabry disease. The first cohort of this study is now complete. Enrollment is ongoing for cohort 2. We expect to share data on this study by the end of next year. During the quarter, we received additional regulatory approvals for the first-in-human Phase 1/2 clinical study evaluating CAR regulatory T cell or CAR-T reg candidate, TX200 in kidney transplantation. We believe we are on track to initiate the study next year. Initiating this study may allow us to be the first company to explore the potential of CAR-T reg cells in humans. We are hopeful that this will provide broader proof-of-concept for genetically engineered cell therapy using T regs. Beyond transplantation, we intend to further evaluate CAR-T regs, including zinc finger nuclease edited allergenic T-reg therapies in autoimmune diseases with high unmet medical need. Also this quarter, we completed our research activities associated with our ongoing Pfizer collaboration to develop gene regulation therapy using our zinc finger technology for the treatment of C9orf72 related ALS. In this program, our zinc finger proteins are designed to selectively target disease allele repeats, a remarkable demonstration of yet another way our versatile technology may be able to have a disease-modifying impact on challenging CNS diseases. We recently earned a $5 million milestone payment from Pfizer associated with this program, which we expect to receive later this quarter. It is a testament to our R&D momentum. We look forward to continuing to work closely with Pfizer to support their research and development in this program. With that, I will turn the call over to our Chief Medical Officer, Bettina Cockroft, who will provide additional details on our clinical accomplishments.

Bettina Cockroft, Chief Medical Officer

Good afternoon. As Sandy mentioned, our clinical operations have adapted to the challenges of the evolving COVID-19 pandemic. And we are pleased with our progress in executing on our partnered and wholly-owned programs. Pfizer dosed the first patient in the AFFINE study of giroctocogene fitelparvovec or SB-525, our first asset in a registrational trial. AFFINE is a global Phase 3 open-label multi-center single arm study evaluating the efficacy and safety of SB-525 in patients with moderately severe to severe hemophilia A. The primary endpoint is annualized bleeding rates, or ABR, to 12 months following treatment. This will be compared to ABR while in Factor VIII replacement Therapy, collected in the Phase 3 bleeding study, which will provide a baseline for Phase 3 study participants. The secondary endpoints include Factor VIII activity level after the onset of steady state over 12 months. Participants will be analyzed throughout the 5-year study period following the single infusion to further assess durability of efficacy and safety. Pfizer shared updated Phase 1/2 data at a Pfizer investor event in September, which demonstrated that SB-525 was generally well tolerated. Each of the 5 patients in the high dose cohort sustained a clinically meaningful level of Factor VIII activity without leads or the need for prophylactic factor for up to 85 weeks for the longest treated patient. Both companies are encouraged by these results and plan to present further follow-up data from the ALTA study in the next few months, when all 5 patients in the 3e13 vector genomes per kilogram dose cohort have been followed for at least 1 year. We have dosed the first two patients comprising the first cohort in the Phase 1/2 STAR study evaluating ST-920 in Fabry disease. The goal of this gene therapy candidate is to provide a predictable and durable expression of the α-Gal A enzyme, which is deficient in Fabry disease due to mutations in the GLA gene, resulting in the accumulation of the substrates Gb3 and its soluble derivative lyso-Gb3. This includes challenging symptoms and morbidities, including impaired renal and cardiac function, pain and gastrointestinal symptoms. The STAR trial is a multi-center open label dose ranging study evaluating the safety and tolerability of ST-920 in classical Fabry patients 18 years and older. Study participants will receive a single intravenous infusion of ST-920, followed by 1 year of observation and monitoring of clinical endpoints, such as α-Gal A activity and assessment of Gb3 and lyso-Gb3 levels. A long-term follow-up study will allow patients to be monitored for an additional 4 years. We expect that data will be shared towards the end of 2021 after we have identified the optimal dose for cohort expansion. We believe that ST-920 offers a potentially differentiated treatment for Fabry disease, with the potential to deliver efficacy with preserved renal function and reduced cardiac morbidity and neuropathy. Preclinical studies evaluating ST-920 demonstrated strong expression of α-Gal A and Gb3 substrate reduction across tissue types. As the liver-directed gene therapy, ST-920 is delivered by a one-time intravenous infusion that does not require any preconditioning regimen for patients. We are also working closely with our oncology collaborator, KITE, a Gilead Company, as it advances KITE-037, an allogeneic anti-CD19 CAR-T therapy into a clinical trial. KITE expects to submit an investigational new drug application by the end of 2020 and to initiate a clinical trial evaluating KITE-037 in 2021. Throughout the third quarter, we have continued to receive additional regulatory approvals that support the Phase 1/2 STEADFAST clinical study evaluating the first-in-human CAR-T reg cell therapy, TX200 in HLA-A2 mismatched renal transplantation. We expect to initiate the study next year. The goal for the study is the prevention of transplant rejection through the engineering of T regs to express an HLA-A2 chimeric antigen receptor, or CAR, allowing them to localize to the renal graft and activate upon recognition of the HLA-A2 antigen. The CAR-T regs may prevent immune-mediated rejection through the inhibition and modulation of inflammatory immune cells and the release of anti-inflammatory cytokines to induce a tolerogenic environment within the graft. Preclinical data supporting the STEADFAST study presented last month showed that the TX200 HLA-A2 CAR-T reg efficiently prevented rejection in both graft-versus-host disease and skin transplantation models. They are also shown to be safe and well-tolerated in our in vivo studies. Similar to other genetically engineered cell therapy approaches, patients will undergo a leukapheresis procedure from which their T reg cells will be isolated and engineered then cryopreserved. The HLA-A2 negative patients will subsequently undergo transplantation surgery and following a recovery period will receive their personalized TX200 drug candidate. As a result of this detailed process, we expect dosing of patients will occur several months after their enrollment. Recent publications show that the regulatory cell therapy space is gaining momentum and excitement in the scientific community. In particular, one study, a large international clinical study gathering 7 investigator-led trials across 5 countries, showed that immune regulatory cell therapy as a whole was safe and that immune cell therapy is a potentially useful therapeutic approach in renal transplant recipients, allowing immune cell composition restoration to normal healthy levels and minimizing the burden of general immunosuppression. This is very promising and supports our plan to evaluate CAR-T regs in renal transplant patient populations. I will now turn the call over to Sung for an overview of the financial results.

Sung Lee, CFO

Thank you, Bettina, and good afternoon everyone. We are pleased to share our financial results for the third quarter of 2020. We reported a net loss of $1.6 million or $0.01 per share compared to a net loss of $27.3 million or $0.24 per share for the same period in 2019. Total revenues were $57.8 million compared to $22 million for the same period in 2019. The increase was primarily attributable to a $30 million milestone achieved for SB-525, our hemophilia A candidate partnered with Pfizer, and a $5 million milestone achieved for our C9orf72 collaboration with Pfizer. Turning to expenses, non-GAAP operating expenses, which exclude stock-based compensation expense, were $54.8 million compared to $46.5 million for the same period in 2019. The increase in operating expense reflects our headcount growth and facilities expansion to support the advancement of our therapeutic pipeline and manufacturing capabilities. These increases were partially offset by a decrease in clinical and manufacturing supply expenses. Moving to the balance sheet, we ended the quarter with $695 million in cash, cash equivalents and marketable securities. This balance includes the $75 million upfront license fee payment received from Novartis. Additionally, in the current quarter, we expect to receive the $35 million milestone payments from Pfizer mentioned earlier. We believe our balance sheet remains strong and will allow us to reach several important R&D milestones, including the potential filing of the BLA for SB-525 for Hemophilia A. Turning to 2020 full year guidance, we are updating our financial guidance for non-GAAP operating expenses, which exclude estimated stock compensation expense of $25 million from an estimated range of $210 million to $225 million, to now be in the estimated range of $210 million to $220 million.

Sandy Macrae, CEO

Thank you, Sung. We are focused on clinical execution and building momentum as we adapt to the conditions of COVID-19 and head towards the end of the year. We are pleased with our progress in clinical operations and with our partner programs. Our strong balance sheet enables us to advance our R&D pipeline. We believe these accomplishments have put Sangamo in a strong position to achieve several important milestones and catalysts heading into next year. We believe we remain on track for the AAV manufacturing facility in Brisbane to be operational at the end of this year, and for cell therapy facilities in Brisbane and Velban to be operational by year end 2021. We anticipate continued enrollment in Pfizer’s Phase 3 AFFINE study with a pivotal data readout expected by Pfizer in 2022 and we also expect 1-year and 2-year Phase 1/2 data presentations over the next year and a half. We expect continued enrollment in the Phase 1/2 STAR study and the data readout towards the end of 2021. Sanofi has guided that the first data readout from the Phase 1/2 sickle cell disease study is expected next year. We anticipate presenting follow-up ST-400 beta-thalassemia data at the same time. Lastly, we expect that clinical trial initiations of the Phase 1/2 first-in-human CAR-T reg study will occur in 2021. KITE expects that its study of the allogeneic anti-CD19 CAR-T product candidate, KITE-037, will also commence in 2021. We look forward to delivering on these milestones in the coming year. Operator, please open the line for questions.

Operator, Operator

Certainly. And our first question comes from the line of Geoff Meacham with Bank of America.

Geoff Meacham, Analyst

Hey, guys. Thanks for the question and congrats on all the pipeline progress. I had a couple on the first one is on the hemophilia A study just with the 12 month analyze bleed rate endpoint, I want to get your feedback on what FDA is looking for just relative to the feedback that BioMarin received. And that’s obviously subject a lot of investor conversations of late. And then the second question is just a broader one on the strategy for the CAR-T regs just wanted to maybe give us a little bit more context for how you see that differentiating and maybe what successes you see what the best probability of success you see, and for example, solid tumors versus the liquid tumor cells? Thank you.

Sandy Macrae, CEO

Thank you for your questions. On the first one around hemophilia-A, we are limited in what we can see, because this is known Pfizer sounds, we are so pleased with their progress into Phase 3, with their enthusiasm for the program, and that all the way up and down their organization right up to their CEO, how valuable they see this asset for them. You can be assured that they will be having regular conversations with the regulatory authorities. And I’m certain that Pfizer will know how to navigate that landscape. As regards to CAR-T regs, I’m going to pass over to Jason who is a real expert in this area. And Jason, can you talk to us about how you see your CAR-T regs strategy?

Jason Fontenot, Interim Head of Research

Thanks, Sandy. And thanks for the question. So first, I’ll start off by pointing out that our programs and regulatory T-cells, engineered regulatory T-cells are directed in the autoimmune and inflammatory disease space; these are drugs for cancer. So we’re really excited about our engineered regulatory T-cell platform and the programs that we’re bringing forward. We’re excited about the progress and regulatory approvals we’ve received so far and about our first-in-human CAR-T regs study, TX200. We’re leaders in this field. And we’re developing and refining our understanding of CAR-T regs biology and rapidly advancing our ability to engineer and manufacture that T-cell. Our TX200 study will be the first-in-human test of engineered regulatory T-cells of CAR-T regs, and this will be further demonstration of our leadership. The goal with that study is the prevention of renal transplant rejection in the setting of an MHC mismatch transplant. So this is a setting where an HLA-A2 negative patient will receive an HLA-A2 positive kidney transplant. Our therapy is comprised of T regs that are engineered to recognize A2 antigen through a chimeric antigen receptor and that CAR that will drive the accumulation and activation of the T regs in the renal graft and suppress the rejection of the graft by the patient’s immune system. What’s important about that study is that as I mentioned, this is going to be the first test of this therapeutic hypothesis around CAR-T regs. This study will be important for us to understand the safety and efficacy in the therapeutic potential of CAR-T regs. And we’ll be informing programs that we’re actively pursuing in larger autoimmune and inflammatory indications such as multiple sclerosis and Crohn’s disease.

Geoff Meacham, Analyst

Okay, great. Thank you.

Operator, Operator

Thank you. Our next question comes from the line of Maury Raycroft with Jefferies.

Maury Raycroft, Analyst

Hi, everyone. Thanks for taking my questions. I had one on the T reg program as well. So I guess for getting that study started. Can you talk more about what factors have led to pushing the study start to 2021? Is it due to COVID or the autologous cell manufacturing process or anything else that you can comment on? And can you talk more about what else needs to be completed before starting the study?

Sandy Macrae, CEO

Maury, thank you very much for your question. We are very pleased with the progress of the T reg for HLA-A2 mismatch. We’re very pleased with the approval from the regulatory authorities, but COVID is having an impact on hospitals, laboratories, and manufacturing. So there’s a general COVID impact, but we are confident that we’ll be able to move forward with this program.

Jason Fontenot, Interim Head of Research

One of the reasons that we acquired TxCell in 2018 was their understanding of how to look after T regs, which is different from how people look after T-cells. And so we’re very pleased with the progress that they’ve made.

Maury Raycroft, Analyst

Got it. Okay. And then the other question I had was just on the Prion program that you guys have, which is sort of under the radar, I’m just wondering if you can provide a status update on that program, any timeline update on that program, and then maybe talk about the strategic importance of that one as well.

Sandy Macrae, CEO

Jason, can you talk about Prions and what we think of them?

Jason Fontenot, Interim Head of Research

Sure, Sandy, thank you. The Prion program is in preclinical development. I think we’ll be looking forward to sharing updates at the appropriate time. There is a great opportunity there to demonstrate the power of our platform, similar to the approaches that we’re taking with our partners in CNS, both Biogen and Novartis. These partnerships are driven by what our partners see in our platform. The Prion program is yet another example of that, and we’ll be excited to talk about it as we move forward. We have done some of the initial work with the Broad Institute in Boston. They have a real deep expertise in this area, and we are working with a group that has matching biological expertise to our technological expertise.

Maury Raycroft, Analyst

Got it. Thank you for the perspective. Thanks for taking the questions.

Jason Fontenot, Interim Head of Research

Thank you, Maury.

Operator, Operator

Thank you. And our next question comes from the line of Jim Burchinal with Wells Fargo.

Yanan Zhu, Analyst

Hi, thanks for taking my question. This is Yanan on for Jim, some perhaps a question on the T reg program as well. Could you confirm whether this is a gene additive product? Because I think it’s autologous. So, obviously the HLA-A2 is put in with a gene audition approach. So if you can comment on whether it’s a gene edited product, and then for your future product, the allogeneic regulatory CAR T-cells. How do you see the issue of persistence? I guess it’s for this program, TX200, as well. How do you see the issue of persistence? For renal transplant, would you require long-term persistence? Would you explore repeated dosing for your allogeneic programs? Thanks.

Jason Fontenot, Interim Head of Research

Thank you for your question. They are very sensible scientific questions. Let me try and lay out the path that we have chosen, which is to start with autologous so we can understand the effectiveness of T regs. One of the advantages of renal transplant is that the transplanted kidney can be biopsied because it’s implanted close to the surface. We can look at things like persistence, which is an important feature that would be required of any good treatment. We will gradually switch to allogeneic and we can either develop allogeneic T regs by editing down from healthy donor volunteers or through studying IPSCs and other forms of stem cells to develop them up to be T regs. This is really at the very cutting edge of regulatory cellular science and we are lucky to have as many options as possible to take us into those areas.

Yanan Zhu, Analyst

Got it. And a quick follow-up in TX200, is there a gene editing component?

Sandy Macrae, CEO

TX200 is an autologous form and therefore it doesn’t have a gene editing component. Jason, am I correct on that?

Jason Fontenot, Interim Head of Research

Yes, that’s correct. TX200, we introduced the CAR with a lentivirus for that first program, but obviously, our platform, one of the assets we have at Sangamo is our platform’s ability to do genomic engineering for T regs for our future products.

Sandy Macrae, CEO

And that was why the merge of Sangamo and TxCell was so sensible. They brought the T reg experience, and we brought editing that was needed to take the platform forward.

Yanan Zhu, Analyst

Got it. Then maybe a question on zinc finger transcription factors, just wondering about the origin of the transcription factor, whether it is fully human, or is there any synthetic component in those transcription factors? And how do you think – how should we think about immunogenicity? Thanks.

Sandy Macrae, CEO

Jason, do you want to have a go on that please?

Jason Fontenot, Interim Head of Research

Sure. The base components of the zinc finger transcription factors are all human. Obviously, in order to direct those transcription factors to a desired sequence, we have to design a synthetic protein that is specific for a specific sequence in the genome, and due to the fact that they are fully human we expect that the immunogenicity should be inherently lower. We haven’t made any observations to date to suggest that immunogenicity could be a problem.

Yanan Zhu, Analyst

Great. Thank you so much for taking the questions and congrats on our progress.

Sandy Macrae, CEO

Thank you very much.

Operator, Operator

Thank you. And our next question comes from the line of Gena Wang with Barclays.

Gena Wang, Analyst

Thank you for taking my questions. I have three questions. Now, first is regarding hemophilia A, just wondering, certainly I know this is already tech transferred to Pfizer given the feedback from Phase 1/2 data did not – or Phase 3 data did not have quite difference from the Phase 1/2. Any thoughts you can share with us regarding your Phase 1/2 data and regarding also the Phase 3 data and one hypothesis was the manufacturing part. In essence, dose manufacturing Phase 1/2 is from your side and now we will transfer to the Pfizer; any thoughts you have to help us understand in terms of our potential predictability from Phase 1/2 data to Phase 3? The second question is regarding Pfizer's partner program for ALS, zinc finger protein transcription gene regulation program. Wondering if you can share any color regarding the efficiency from this initial R&D study? The last question is regarding the Fabry program, you already enrolled the second cohort and what will be the determination that you think you will reach the optimal cohort that you can extend the cohort regarding biomarker data like plasma lyso-Gb3 as a reference, Avro showed 30% to 40% further reduction versus the baseline ERT; any thoughts you have regarding what is your thought in order to determine the optimal dose?

Sandy Macrae, CEO

Gena, I am afraid I may disappoint you in my answers. The Pfizer – the Phase 2 of the Alta study and progression of this with Pfizer is really in their hands to talk about and they will announce or the abstracts for ASH were announced today. So they will be talking about that at ASH and so I would guide you to wait for those results. The convertibility between Phase 2 and Phase 3, really we mustn’t see anything until we see the Phase 3 results. As regards the C9orf, all I can tell you is Pfizer is very pleased with the product that we produce for them. They have transferred to their research organization and paid the necessary milestone. As regards Fabry, I am going to pass on to Bettina. Bettina, can you talk about Fabry? And what we are looking for and what this study will measure?

Bettina Cockroft, Chief Medical Officer

Absolutely. Yes, thank you for the question. As I mentioned earlier, we dose the first cohort of two patients, and enrollment is ongoing. The study goal really is to provide a predictable and durable expression of the α-Gal A enzyme, which is the enzyme deficient in Fabry disease due to mutations in the GLA gene. We are going to be measuring this parameter as one of the more important parameters. But as you point out, we are also looking at substrates, Gb3 and lyso-Gb3, these are the basis of some of the challenges in terms of morbidity in patients with Fabry. We are going to be monitoring all of this data along with other data. Remember, this is first and foremost, the safety and tolerability study to start off with and we have a safety monitoring committee that will be involved in the decisions as we move on to escalate doses to the optimal dose. Think of this as with the totality of the data and the data that we are monitoring from other studies with other products, of course as well, that we will be making our ultimate decisions on the dose that we bring forward in our cohort expansion.

Gena Wang, Analyst

Okay, thank you.

Sandy Macrae, CEO

Thank you very much for your question.

Operator, Operator

Thank you. Our next question comes from the line of Eric Joseph with JPMorgan.

Eric Joseph, Analyst

Hi, thanks for taking the question. Maybe just perhaps a strategic one, I am curious to get a sense of whether there are – well, how we should be thinking about the potential for additional, largely wholly owned programs coming forward to the clinic over the next 12 to 18 months, relative to I guess what we have seen over the past year, a fair amount of leveraging up the platform through partnering activities? Thanks.

Jason Fontenot, Interim Head of Research

Thank you for your question, Eric. Mark, this feels like one for you, please.

Mark McClung, Chief Business Officer

Hi, Eric. Thanks for the question. So if you take a look at the deals that we have done, including those most recently, really the driver of that is twofold. In some cases, they come to us with candidates that we had progressing towards the end, but they came to us with an expanding number of candidates that we weren’t otherwise considering. So we looked at that as being really an extension of our potential pipeline. The second way we looked at partnerships is whether they are bringing a specific expertise and the resources necessary to accelerate the products assuming they are successful to patients. In that particular case as well as the Novartis case, both of those really fit those criteria. We fully intend to become a genomics medicine company and we are continually looking to advance wholly owned assets, which we would take into the clinic. A good example of that is what you have heard in terms of TX200 as well as the follow-on programs we are intending to take forward into the clinic for our CAR-T reg programs.

Eric Joseph, Analyst

Got it. I guess in addition to T reg, are there certain disease states or targets that you have essentially walled off and are prioritizing for internal development?

Mark McClung, Chief Business Officer

We have not disclosed that. I mean, we have got interest in the autoimmune space as we have talked about, with our CAR-T reg programs and Jason touched on earlier. Naturally, we’re working heavily within the CNS area with our partners in Biogen and our partnership with Novartis. There may be targets that we choose in that particular space, but we have not made any decisions on that as yet. We don’t believe you can really speak here and then go after it; we need to let the science drive us toward things that we believe are important to develop for patients.

Eric Joseph, Analyst

Got it. That’s helpful. Thanks for taking the question.

Mark McClung, Chief Business Officer

Sure. Pleasure.

Operator, Operator

Thank you. And our next question comes from the line of Ritu Baral with Cowen.

Unidentified Analyst, Analyst

Hi, guys. Thank you for taking the question. This is Laila on for Ritu. Just two quick questions from me. First, on the STAR Fabry study, are you still seeing impacts from COVID on enrollment? I know you have completed the first cohort, but are all the sites up and running? Then as a quick follow-up regarding the Pfizer collaboration with the ALS program, what are the next steps for the program? Specifically, what’s the next opportunity for a milestone to reach? Is that contingent on them initiating a clinical trial? Any color on this would be helpful. Thank you.

Sandy Macrae, CEO

Thank you for your question. We haven’t – we or Pfizer haven’t commented on the ALS program and when the milestones will come. I would say again, I would reiterate what I said in the call script; it’s a remarkable piece of science to be able to suppress the transcription of one allele and leave the other one untouched is why Pfizer came to us, and we have achieved what they requested of us, and it’s moved forward to them. So let’s hope because it’s such a dreadful disease, let’s hope it gets to patients as soon as possible. For the Fabry disease, I’m going to refer you to Bettina who will answer that question.

Bettina Cockroft, Chief Medical Officer

Yes, and thank you for that question. So on the clinical operations side, I have to say, we have an excellent clinical operations team working very hard on maintaining the relationship with all the sites. During the pandemic, we have also been able to initiate sites, and qualify other sites as we expand our footprint for the study. Of course, COVID has had an impact worldwide, some regions more than others. We are confident that we can keep going with following the enrollment and dosing of the first two patients to keep going with our enrollment despite the pandemic at this stage, where the things we have put in place from an operational perspective with home visits and virtual assistance have really helped us make sure that we, together with the sites, manage to guide the patients through the enrollment and screening procedures to ultimately get us to dosing and then follow-up.

Unidentified Analyst, Analyst

Got it. Okay, thank you for the color.

Sandy Macrae, CEO

I am very pleased with the way that our clinical team has navigated. We feel we have a responsibility to do this well to ensure that the patient comes first, whether they are being treated for COVID, in which case we should not be taking up doctors’ time. However, we have been ready to dose as soon as the window was open. Bettina and her team have done a remarkable job to get us there.

Unidentified Analyst, Analyst

Got it. Thank you for the color.

Operator, Operator

Thank you. And our next question comes from the line of Nicole Germino with Truist.

Nicole Germino, Analyst

Good evening, everyone. Hi, thanks for taking my question. On Fabry, given the competition in the space, what is it more specifically about Sangamo’s AAV tested or the promoter that may get differentiated and better than your peers? How have you made that determination? And then does – how does ST-920 impact the renal and cardiac tissue?

Jason Fontenot, Interim Head of Research

Let me take that one. We are encouraged by the data we have seen from AAV6 in hemophilia A. However, until we dose patients with Fabry disease, we really can’t and shouldn’t comment on what it’s going to look like. The animal data looks very encouraging. We achieved supramaximal dosing and supramaximal effect. In the animal dosing that we recently published, we are able to show benefit to both the heart and the kidney. I am just prudent in telling people to wait and let’s see what the clinical results are. We are guiding that we will show the clinical results towards the end of next year when the dose escalation phase is completed.

Nicole Germino, Analyst

Okay, great. Thank you so much.

Operator, Operator

Thank you. And our next question comes from the line of Evan Wang with Guggenheim Securities.

Evan Wang, Analyst

Hi, guys. Thanks for taking my question. I had two; one on hemophilia A and the other on the allo CAR-T program. On hemophilia A, what’s the plan going forward to share data on the Phase 1/2? I know you will have the update at ASH, but are there any specific time points prior to completing the picture of the data? Do all patients require crossing that time point? On the allo CAR-T program, we have seen some early data from other allo programs from Allogene and CRISPR. Any thoughts on the initial data generated so far and any kind of learnings you can take, especially given some of the deaths we have seen in those trials?

Sandy Macrae, CEO

Let me do the hemophilia A and then pass this to Jason to comment on allo. I’m going to say again that the decision to present data on hemophilia A is in Pfizer’s control. There is an abstract that’s been accepted for ASH and they will use for a conference schedule in the future to continue to demonstrate the benefit to patients of reduced absent bleeding events and no requirement for factor. Jason, can you talk about the allogeneic question, please?

Jason Fontenot, Interim Head of Research

Sure. I believe that you are referring to allo CAR-T programs in oncology, and we have our partnership as you know with KITE Gilead to support their allogeneic CAR-T programs. KITE has guided that we are expecting to begin the studies on their allogeneic CD-19 targeted CAR-T therapy next year. We believe that the data that we have seen so far from others are consistent with these therapies having real therapeutic potential and we are excited about it and we are excited to see KITE get the therapies into patients.

Evan Wang, Analyst

Okay, thank you.

Operator, Operator

I will now turn the call back over to Head of Corporate Communications, Aron Feingold for any further remarks.

Aron Feingold, Head of Corporate Communications

Thank you once again for joining us today and for your questions. We look forward to keeping you updated on our future developments.

Operator, Operator

Ladies and gentlemen, this concludes today’s conference call. Thank you for participating and you may now disconnect.