Editas Medicine, Inc. (NASDAQ:EDIT) Q1 2024 Earnings Call Transcript

Editas Medicine, Inc. (NASDAQ:EDIT) Q1 2024 Earnings Call Transcript May 8, 2024

Editas Medicine, Inc. misses on earnings expectations. Reported EPS is $-0.76 EPS, expectations were $-0.63. Editas Medicine, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good morning, and welcome to the Editas Medicine’s First Quarter 2024 Conference Call. All participants are now in a listen-only mode. There will be a question-and-answer session at the end of this call. Please be advised that this call is being recorded at the company’s request. I would now like to turn the call over to Cristi Barnett, Corporate Communications and Investor Relations at Editas Medicine.

Cristi Barnett: Thank you. Good morning, everyone, and welcome to our first quarter 2024 conference call. Earlier this morning, we issued a press release providing our financial results and recent corporate updates. A replay of today’s call will be available in the Investors section of our website approximately two hours after its completion. After our prepared remarks, we will open the call for Q&A. As a reminder, various remarks that we make during this call about the company’s future expectations, plans and prospects constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent Annual Report on Form 10-K, which is on file with the SEC as updated by our subsequent filings.

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. Except as required by law, we specifically disclaim any obligation to update or revise any forward-looking statements, even if our views change. Now, I will turn the call over to our CEO, Gilmore O’Neill.

Gilmore O’Neill: Thanks, Cristi, and good morning, everyone. Thank you for joining us today on Editas’s first quarter 2024 earnings call. With me today are four members of the Editas executive team, our Chief Medical Officer, Baisong Mei; our Chief Scientific Officer, Linda Burkly; our Chief Financial Officer, Erick Lucera; and our Chief Commercial and Strategy Officer, Caren Deardorf. We are pleased with Editas’ momentum and progress in the first quarter of 2024. Editas’ goal is to deliver life-changing medicines to patients with previously untreatable or undertreated genetically determined diseases. And our vision and focus strategy is to position Editas as a leader in in vivo programmable gene editing. Three pillars underpin our strategy.

The first of those pillars is to drive reni-cel, an edited cell therapy for hemoglobinopathies, and formerly known as EDIT-301, toward BLA and commercialization. The second is to build an in vivo editing pipeline. And the third is to increase business development activities with a particular focus on monetizing our very strong intellectual property. At the start of 2024, we announced the following 2024 objectives. For reni-cel, we will provide a clinical update from the RUBY trial for severe sickle cell disease and the EdiTHAL trial for transfusion-dependent beta thalassemia in mid-2024 and by year-end 2024. We will complete adult cohort enrollment and initiate the adolescent cohort in RUBY and continue enrollment in EdiTHAL. For our in vivo pipeline, we will establish in vivo preclinical proof-of-concept for an undisclosed indication.

And for BD, we will leverage our robust IP portfolio and business developed to drive value and complement core gene editing technology capabilities. So how are we executed against this strategy and these objectives in the first quarter? Let us start with reni-cel. First, on enrollment. We’ve been very pleased with the growing patient and healthcare provider interest in reni-cel. Indeed, we are delighted to share that we have completed enrollment in the adult cohort of the RUBY clinical trial. Additionally, we have enrolled multiple patients and have more in screening in the adolescent cohort of a RUBY study, which was launched at the beginning of this year. And we continue to enroll beta thalassemia patients in our EdiTHAL study. Dosing continues in both the RUBY and EdiTHAL studies.

Second, on clinical data. We remain on track to present a substantive clinical data set of at least 18 sickle cell patients with 2 to 21 months of clinical follow up in the RUBY study in the middle of 2024. And we will share a further update by year-end. We are also on track to present clinical data from the EdiTHAL study of reni-cel in transfusion dependent beta thalassemia in the middle of 2024 and again by year end. Baisong Mei will share more reni-cel detail later on in this call. On the manufacturing front, I am pleased to share that we have promoted Greg Whitehead to the role of Chief Technology and Quality Officer, leading our technical development, technical operations and quality departments. Greg has more than 25 years of experience in the biotech industry and extensive cell and gene therapy clinical and commercial development expertise.

Now, let’s turn to in vivo and our pipeline development, where we continue to strengthen our in vivo discovery capabilities and continue lead discovery work on in vivo therapeutic targets in hematopoietic stem cells and other tissues. Importantly, we remain on track to establish in vivo preclinical proof-of-concept for an undisclosed indication by the end of the year. Our internal development efforts are differentiated by leveraging the indel CRISPR technology we already use to upregulate gamma globin expression through direct editing of the HBG12 promoter site in our ex vivo reni-cel program. Our in vivo approach is aimed at functional upregulation of gene expression in genetically defined diseases with a preliminary focus on rare and orphan patient populations.

In the medium to long term, we intend to expand to more common genetically determined diseases. Linda Burkly, our CSO, will share more details on our in vivo strategy and progress towards building an in vivo pipeline later on in the call. Finally, what is happening in business development? In March, we signed a two year extension to the collaboration with Bristol-Myers Squibb to research, develop and commercialize autologous and allogeneic alpha beta T cell medicines for the treatment of cancer and autoimmune diseases. We also have options to extend that collaboration for an additional two years. To date, Bristol-Myers Squibb has opted into 13 different programs across 11 gene targets to date. Two programs are currently in IND enabling studies and four programs are in late stage discovery.

And in intellectual property, yesterday, oral arguments were held before the U.S. Court of Appeals for the Federal Circuit regarding an appeal of the Patent, Trial and Appeal Boards, or PTABs, previous decision favoring Broad Institute of the US Patent Interference involving specific patents for CRISPR-Cas9 Editing in human cells between the University of California, University of Siena and Emmanuelle Charpentier, or CDC, and the Broad. We expect a decision on the case in the second half of 2024. Eric will share more BD and IP details later on in the call. We are energized by our progress and execution this quarter. With our sharpened strategic focus, our world-class scientists and employees, our keen drive and execution and strong balance sheets, we continue to build momentum to progress our strategy to deliver differentiated editing medicines to patients with serious genetic disease.

Now, I will turn the call over to Baisong, our Chief Medical Officer.

Baisong Mei: Thank you, Gilmore. Good morning, everyone. Let’s talk about reni-cel, which is on the clinical development for severe sickle cell disease and transfusion-dependent beta thalassemia. As Gilmore shared, we are pleased that we have completed enrollment in the adult cohort of the Phase 1, 2, 3 RUBY trial and the dosing continues. In the adolescent cohort of the RUBY study, we have enrolled multiple patients and several more patients in screening. The interest and demand are high. I’m very pleased about how quickly we have moved in screening and enrollment of the adolescent cohort. I’d like to thank colleagues and editors and our clinical trial partners for the collaboration and hard work. And more importantly, I would like to thank patients, their families, investigators, and the study side staff for their trust and support.

In the EdiTHAL trial for transfusion-dependent beta thalassemia, we continue to move forward with enrollment and dosing. We look forward to sharing clinical data in the middle of this year and also at the year-end. As I have shared, I visited and continue to visit our RUBY’s EdiTHAL clinical trial site and speak with the investigators. I appreciate the enthusiasm and support from the investigators and study sites. I’m pleased with the momentum of reni-cel in patient recruitment, apheresis and dosing in both studies. I’m excited to hear from the investigators that patients those who use reni-cel have already seen positive changes in their lives. As we shared in our February earning call, we aligned with FDA that RUBY clinical trial is now considered a Phase 1, 2, 3 trial for BLA filing.

We also have alignment with the FDA on the study design, endpoints, and sample size. We look forward to future discussions with the FDA and continue the collaboration. Turning to clinical data, as Gilmore mentioned, we are on track to present a substantive clinical data set of sickle cell patients with considerable clinical follow-up in the RUBY study in the middle of 2024 and a further update by year-end 2024. What we will show, the RUBY data set will include clinical data from at least 18 sickle cell patients with a 2 to 21 month of follow-up. And the EdiTHAL data set will include clinical data from seven patients with 4 to 12 month follow-up. We will present efficacy data including total hemoglobin, fetal hemoglobin, and the vessel occlusive event or VOE for sickle cell patients in RUBY study.

And the red blood cell transfusion or transfusion-dependent beta thalassemia patients in EdiTHAL study. And safety data including neutrophil and platelet engraftment for both studies. As a reminder, in December 2023, we shared safety and efficacy data from 11 RUBY patients and six EdiTHAL patients. Once again, the data confirmed the observation from our prior clinical readouts, including reni-cel drove early robust correction of anemia to a normal physiological range of total hemoglobin in sickle cell patients. Reni-cel drove robust and sustained increase in fetal hemoglobin level in excess of 40%. All RUBY sickle cell patients remained free of vessel occlusive events following Reni-cel treatment. Reni-cel treated sickle cell patients and transfusion dependent beta thalassemia patients have shown successful engraftment, have stopped red blood cell transfusion.

And the safety profile of reni-cel observed today is consistent with myeloablative busulfan conditioning and autologous hemopoietic stem cell transplant. This data reinforce our belief that we have a competitive product and a product potentially differentiated from other treatments with a rapid correction of anemia. Thanks to the deliberate choice of our discovery group have made early in the program. The choice of CRISPR enzyme and the target to edit for increased fetal hemoglobin expression matters. Reni-cel uses our proprietary AsCas12a enzyme to upregulate HBG12 promoter. Based on the clinical data thus far, we believe that sustained normal levels of total hemoglobin could be a potential point of differentiation for reni-cel. Now I’ll turn the call over to Linda, our Chief Scientific Officer.

Linda Burkly: Thanks, Baisong. And good morning, everyone. I’m happy to be talking to you this morning to share more details about our in vivo strategy and our progress towards building an in vivo pipeline. I would like to take a moment to remind you why we believe in vivo medicines will be a disruptive transformative development in medical history with the potential to address genetically determined diseases with durable and curative outcomes for patients. First, in vivo medicines may reduce the administration burden of delivering editing medicines to patients in need, which will provide for broader access to patients all around the world. Second, off the shelf administration may allow for scalable manufacturing and lower costs to produce.

Based on these two principles, we believe that in vivo gene editing will provide accessible cures for genetic diseases and therefore may be the most disruptive development in medical history. So how will Editas position itself? There are many monogenic diseases that can potentially be cured with gene editing approach. We have said that we will at first target the development of treatments that are clearly differentiated from current standard of care and that will leverage the aspects of CRISPR editing that give it a unique advantage over other therapeutic modalities. Our internal development efforts are differentiated by leveraging the indel CRISPR technology we use to upregulate gamma globin expression through direct editing of the HBG12 promoter site in our ex vivo reni-cel program.

Our in vivo approach is aimed at functional upregulation of gene expression in genetic diseases in rare and orphaned patient populations from which we intend to expand to more common diseases. I’m also pleased to share several progress updates as we advance our in vivo capabilities towards our long-term vision of being a leader in in vivo programmable gene editing. First and most importantly, as Gilmore mentioned, we remain on track to establish in vivo pre-clinical proof-of-concept for an undisclosed indication by the end of the year. Editas is well positioned with established capabilities in the four main components of in vivo gene editing medicine. One, guide RNA, two, editing enzyme, three, messenger RNA, and four, delivery technology. And we are currently evaluating lipid nanoparticles for delivery of gene editing cargo into multiple tissue types with multiple companies.

Additionally, we’re evaluating next generation delivery technology. Second, our in vivo capabilities with the potential to be used in developing transformative in vivo gene editing medicines are demonstrated by the preclinical data we are presenting at the American Society of Gene and Cell Therapy or ASGCT Annual Meeting in three presentations taking place on Thursday and Friday of this week. On Friday, in an oral presentation, we will share in vivo preclinical data from mouse studies using lipid nanoparticle mediated delivery of an optimized guide RNA and engineered ASCAS12a messenger RNA. In post-presentations on Thursday and Friday, we will share preclinical data demonstrating ASCAS12a guide RNA modifications that enable high potency gene editing in multiple cell types, including in the liver, and improve gene editing outcomes in vivo, enabling the development of in vivo gene editing medicines.

And research on identifying potent large serine recombinases, LSRs, as a foundation to develop novel in vivo gene editing technologies for whole gene knock-in, expanding potential in vivo gene editing targets for developing medicine. Third, Editas CRISPR-based in vivo gene editing capability has been clinically validated. Notably, in 2020, Editas was the first company ever to treat a human with an in vivo delivered CRISPR-based gene editing medicine, EDIT-101. In fact, earlier this week, the New England Journal of Medicine published a manuscript entitled, Gene Editing for CEP290-Associated Retinal Degeneration, detailing our former lead development candidate, EDIT101, for the treatment of Leber’s congenital amaurosis type 10, or LCA10. Editas established clear in vivo human proof-of-concept in 2022, and we are pleased that the results from this groundbreaking clinical trial were published by the New England Journal of Medicine.

These progress updates demonstrate Editas’ execution on our in vivo strategy and our proven in vivo gene editing capabilities. And I look forward to sharing more details about our in vivo development strategy and our progress towards building an in vivo pipeline later this year. Now, I will turn the call over to Erick, our Chief Financial Officer.

Erick Lucera: Thank you, Linda, and good morning, everyone. I’m happy to be speaking to you, and I’m excited to provide updates on our business development achievements, intellectual property, and financial results for the first quarter of 2024. First, in regard to business development, as Gilmore mentioned, in March, we announced a two-year extension to the collaboration with Bristol-Myers Squibb to research, develop, and commercialize autologous and allogeneic alpha beta T cell medicines for the treatment of cancer and autoimmune diseases. We also have options to extend the collaboration for an additional two years. To date, Bristol-Myers Squibb has opted into 13 different programs across 11 gene targets to-date. Two programs are currently in IND enabling studies, and four programs are in late stage discovery.

As a reminder, for each new experimental medicine that Bristol-Myers Squibb develops and commercializes using opted-into genome editing tools, Bristol-Myers Squibb will pay Editas Medicine potential future milestone payments. Following the approval of any products resulting from the collaboration, Editas Medicine is also eligible to receive tiered royalties on net sales. We are pleased that our Bristol-Myers collaboration has proved to be a productive partnership, and we are committed to future collaborations and partnerships that will allow for the continued access and advancement of gene editing. And in IP, as Gilmore mentioned, yesterday the oral arguments were held before the U.S. Court of Appeals for the Federal Circuit regarding the CBC’s appeal of the PTAB’s decision involving patents for CRISPR-Cas9 editing in human cells.

As you know, the Broad Institute has previously prevailed three times against the CBC, twice with the PTAB, and once at the Federal Circuit. The Federal Circuit’s review will determine whether the PTAB correctly applied the law. It is important to remember the Court will not hear new evidence. An appellate court decision in the Broad’s favor would reaffirm Editas’ position as the exclusive licensor of the patents covering Cas9 use in human medicines in the U.S. It is also important to remember that only a small fraction of the IP we licensed from the Broad are involved in the ongoing USPTO interference proceedings. We expect a decision on the case in the second half of 2024. We remain confident that the Broad will once again prevail. Our IP portfolio of foundational U.S. and international patents covering Cas9 and Cas12 use in human medicines are a source of meaningful value as we believe that globally there are more than 100 Cas9, Cas12a programs in development worldwide, with the majority of the programs being developed by 10 companies.

We believe these potential deals represent a potential material source of non-dilutive capital, as evidenced by our deal in the fourth quarter of 2023 that extended our cash runway by two quarters. We look forward to future discussions. And now I’d like to refer you to our press release issued earlier today for a summary of our financial results for the first quarter of 2024. I’ll take this opportunity to briefly review a few items for the quarter. Our cash, cash equivalents, and marketable securities as of March 31, $377 million compared to $427 million as of December 31, 2023. We expect our existing cash, cash equivalents, and marketable securities, together with the near-term annual license fees and contingent upfront payment payable under our license agreement with Vertex, to fund our operating expenses and capital expenditures into 2026.

Revenue for the first quarter of 2024 was $1.1 million compared to $9.9 million for the same period in 2023. The decrease relates to the January 2023 one-time sale of the company’s wholly owned oncology assets and related licenses. R&D expenses this quarter increased by $11 million to $49 million in the first quarter of 2023. This increase relates to additional clinical and manufacturing costs that support the continued progression of the company’s reni-cel program. The increase is also attributable to one-time payments related to sub-license and license obligations. Editas will continue to incur these types of payments, as we and our collaboration partners advance certain license programs in the gene editing space. G&A expenses for the first quarter of 2024 were $19 million, which decreased from $23 million in the first quarter of 2023.

The decrease in expense is primarily attributable, to one-time professional service expenses related to the 2023 strategic initiatives, and business development activities, as well as reduced legal and patent costs. With our BD and IP activity and a cash runway into 2026, Editas remains in a strong financial position. We have ample resources to continue the advancement of our reni-cel program, support the progression of our in vivo capabilities to develop our pipeline, and leverage our strong IP position for additional business development and licensing opportunities. With that, I’ll hand the call back to Gilmore.

Gilmore O’Neill: Thank you, Erick. We are proud of our progress in the first quarter of 2024, and we look forward to continue to accelerate the momentum in 2024. As we continue to evolve from a development stage technology platform company into a commercial stage gene editing company, we look forward to continuing our transformation and sharing our progress with you. As a reminder of our 2024 strategic objectives, for reni-cel, we will provide a clinical update from the reni-cel RUBY trial for severe sickle cell disease and the EdiTHAL trial for transfusion-dependent β-thalassemia in mid-2024 and year-end 2024. We have now completed the adult cohort enrollment, and have started enrolling patients in the adolescent cohort in RUBY.

We will also continue enrollment in EdiTHAL and dosing in both trials. For our in vivo pipeline, we will establish in vivo preclinical proof-of-concept for an undisclosed indication, and for BD, we will leverage our robust IP portfolio and business development capabilities to drive value and complement core gene editing technology capabilities. As we share today, we are making significant progress in all three pillars of our strategy this quarter, including reni-cel, in vivo, and business development, including intellectual property. We enter 2024 with great momentum, and I am proud of the Editas team’s significant progress towards becoming a commercial-stage company, and on developing clinically differentiated transformational medicines for people living with serious previously untreatable diseases.

As always, we could not achieve our objectives without the support of our patients, caregivers, investigators, employees, corporate partners, and you. Thanks very much for your interest in Editas. And we’re happy to answer questions. Thank you.

Operator: Thank you. [Operator Instructions] Our first question comes from Samantha Semenkow from Citi. Please proceed.

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Q&A Session

Samantha Semenkow: Hi. Good morning, and thanks very much for taking my question. I’m wondering about your in vivo pipeline and the proof-of-concept that you’re expecting, by the end of this year. And what would be the bar for success that you’re looking for in this program? Thank you.

Gilmore O’Neill: Thanks very much, Samantha. I’m going to ask Linda to address that.

Linda Burkly: Thank you, Sam. Thank you for the question. We are looking for proof-of-concept for high efficiency delivery and editing for our target of interest in vivo in this preclinical POC. That will give us confidence in our ability, to target the target of interest. We are going to be sharing more information on this at a future date. Thank you for the question.

Operator: Our next question comes from Joon Lee from Truist Securities. Please proceed.

Joon Lee: Hi. Congrats on the progress, and thanks for taking our question. An interesting update on your disclosure, is the plan to identify large serine recombinases, which implies sort of a newer approach to many of your – that many of your peers are also developing, you know, some call it gene mating, some call it pasting. Does the size of the recombinase-mediated insertion allow for, you know, inserting a coding sequence for dystrophin, for example? And are you able to comment on whether DMD is out of the question regarding your in vivo aspirations? Thank you.

Gilmore O’Neill: Thanks very much, Joon. I’m going to have Linda take that.

Linda Burkly: Yes. Thank you for commenting. We’re excited about the LSR technology that we’re disclosing here. We are identifying many different novel LSRs. We’re not disclosing at the moment the size of the integrations that can be accommodated by these large serum recombinases, but we have quite a few novel LSRs that we’ve identified and we’re further characterizing them. Thank you for the question.

Operator: Our next question comes from Mary Kate Davis from Bank of America. Please proceed.

Mary Kate Davis: Good morning. Thanks for taking my question. Looking at the reni-cel program here, how are you guys looking at the mid-year reni-cel update, compared to the year-end update here? As follow-up time progresses, what should we look for from treated patients in terms of safety and efficacy moving forward? Thank you.

Gilmore O’Neill: Thanks, Mary Kate. Baisong is going to take that one.

Baisong Mei: Yes. Thanks, Mary. In this middle-year release, we expect to have at least 18 patient data for RUBY study. Within the 18 patients, and four of them will have 12 or longer, 12 to 21 months of exposure, and seven will have five months to 12 months exposure, and another seven with two to five months exposure. With that, we feel this data is very meaningful to see the direction, not only the increase of total hemoglobin normalization of total hemoglobin and increase of fetal hemoglobin, but also the durability of the study and the impact from efficacy perspective, for example, the free of vessel occlusive events. For the EdiTHAL study, we will have patients from at least seven of those patients with four to 12 months of exposure, which also will be very meaningful. That is compared to the December release. We’ll have 11 RUBY patients and six EdiTHAL patients. That substantial more data will help us to understand RUBY much better. Thank you.

Operator: Our next question comes from Jack Allen from Baird. Please proceed.

Jack Allen: Hi. Congratulations to the team on the progress, and thanks for taking the question. I’m going to stick with the reni-cel program. I was hoping you could provide some color on dosing of the pivotal cohort. I know you’ve commented on the adult cohort being fully enrolled, but have all of those patients received therapy? Any other comments you can provide, as it relates to the size of the cohort that you’ve agreed to, with regulators would be very helpful? Thanks so much.

Gilmore O’Neill: Thanks very much, Jack. I’ll answer the first part and then pass it to Baisong to provide maybe give it a little more color to regulatory interactions. We have obviously completed the adult enrollment, which we’re actually very excited about, not least because that is in the context of two approved therapies. So it really is a very concrete reflection of the enthusiasm that Baisong has found and described, indeed, increasing enthusiasm about our program with his visits to sites and conversations with investigators, healthcare providers, and indeed with patient efficacy groups. We have scheduled many of those patients already for dosing, and we’ll give you further updates on the progress of dosing at a later date. And with regard to the regulatory color, I think, Baisong, you might want to maybe just share a little more of that.

Baisong Mei: Yes. For regulatory, as we shared, we have alignment with FDA that the RUBY study is a Phase 1, 2, 3 study for BLA filing. And we also have alignment on the sample size, duration, and study design of that. So we continue to have a collaboration with FDA, on the further discussion about this program.

Jack Allen: Great. Thank you.

Operator: Our next question comes from Gena Wang from Barclays. Please proceed.

Gena Wang: Thank you. If I may, very quick two questions. First, should we read into your ASGCT presentation for in vivo indication, such as glaucoma? And second, I know you mentioned also a little bit, but when we look at the current approved genomic therapy for sickle cell, we still have a 10% patient relapse with VOE events. What do you think is the key factors that we should look into for the potential differential durability with hopefully 100% control rate?

Gilmore O’Neill: Thanks very much, Gena. I’m going to ask Linda to handle the first part of your question around the ASGCT and then Baisong can talk about durability, what we’re seeing today?

Linda Burkly: Yes, thank you very much, Gena. Primary open-angle glaucoma is obviously an area of very high inmate need, and while we conducted those studies, because of that, we are not currently pursuing that indication, but we were able through those studies to really demonstrate impressive preclinical POC and showcase our in vivo capabilities with respect to three components. Our ability to deliver lipid nanoparticles in vivo, with our gene editing cargo, our proven capability of our proprietary enzyme, AsCas12a, to edit in vivo and our guide modifications, to enhance a gene editing potency. So these capabilities really position us well for delivering in vivo gene editing medicines, and we’re really pleased with the ASGCT disclosures. Thank you.

Baisong Mei: Yes, I can now take up on the question about the VOE relapse for sickle cell patients. First, I would like to say, I want to congratulate the entire field for the effort in treating sickle cell disease, including the recent approval of the two molecules. And so, I think what we see is that with the continued effort of all of us, we will continue to improve and transform the treatment for sickle cell disease patients. Within reni-cel, and we are still continuing to collect the clinical data, as I mentioned, we expect that this is, not only a competitive, but differentiated molecule. And with the normalization of the total hemoglobin correction of anemia. So, we’re looking forward to see our own data on the VOE. As we reported so far, we have seen all those patients, those with reni-cel, is free of VOE event.

Gena Wang: Thank you.

Operator: Our next question comes from Mani Foroohar from Leerink Partners. Please proceed.

Unidentified Analyst: Hi, good morning. This is [CJ] for Mani. Thanks for taking our question. I was just following the agreement with Vertex last year. Just how are you thinking about future IP monetization opportunities?

Gilmore O’Neill: Thanks very much. I’m going to ask Erick to address that question.

Erick Lucera: Yes, thanks for the question. Obviously, as we said in the transcript, we view the future potential royalty monetization and licensing activities as an integral, and very important source of non-dilutive capital. As you know, these are foundational IP patents which are applied to just about everybody’s projects in Cas9, Cas12. And we expect to have conversations with those folks as soon as we can.

Unidentified Analyst: Thank you.

Operator: Our next question comes from Brian Cheng from JPMorgan. Please proceed.

Brian Cheng: Hi, guys. Thanks for taking our question this morning. Can you just remind us, what’s your latest thinking around the timing of holding a discussion with regulators on sickle cell? And just given the data that you’re going to present mid-year, any updates and color on the timing of holding a productive conversation with regulators would be appreciated? Thank you.

Gilmore O’Neill: Thanks very much, Brian. I’m going to ask Baisong to talk about that sort of – I think your two questions, really which is about what the data are in the middle of year and how they integrate with our discussions with regulators?

Baisong Mei: Yes. So, Brian, as I mentioned, we are very pleased with the data we’re going to release in the middle of the year, and which is substantive, and also give us good direction how much we will get and to have, for example, a data set to have equivalent to the CASGEVY BLA filing, for example. So, that’s kind of one part of that. We’re very happy to see the amount of data and the patient outcome from the data. And then the other thing, is about the regulatory engagement. As I mentioned, we already have a line of this Phase 3 study to support the BLA, and we have continued engagement with FDA. We have not disclosed all those details of the interaction yet, but as a reminder, we have RMAT designation, and which allows us to have frequent interaction with agency.