EDIT - NASDAQ

Good morning and welcome to Editas Medicine’s Fourth Quarter and Full-year 2022 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 Ron Moldaver, Investor Relations for Editas Medicine.

Thank you, Gilmore. Good morning, everyone. As Gilmore mentioned, last December, we presented initial data from the RUBY trial of EDIT-301. For the first two patients with a severe sickle cell disease, that data for the first patient who had a five-months of follow-up showed clinically significant improvement across all hematological parameters. These preliminary data suggests that Editas has a product candidate that can potentially give robust clinical benefit to patients with severe sickle cell disease, and has the potential for clinical differentiation in the long-term. Specifically, that patient has increased fetal hemoglobin infraction of 45.4%, five-months of EBIT-301 infusion. Above the 30% fetal hemoglobin threshold where sickle cell patient may have no symptoms. We were also pleased to see that the patient’s total hemoglobin increase by more than four gram per deciliter to 16.4 gram per deciliter well into the normal range of male patients. And finally, the distribution of fetal hemoglobin was highly pan cellular with 96% F-cells and the Mean Corpuscular fetal hemoglobin or the fetal hemoglobin concentration per red blood cells increased to 13.8 pg gram per red cells, exceeding 10 pg gram threshold considered clinically meaningful as empirical evidence indicates those level will prevent that red blood cell from sickle. As we have previously highlighted, EDIT-301 utilize a unique mechanism of action that edit the promoted sequence of the gamma-globin genes to disrupt binding of BCL11A suppressor, mimicking the nature mechanism of hereditary persistence of fetal hemoglobin. The editing is done by a high fidelity, highly specific engineered AsCas12a enzyme. In turn, this provides a high sustained level of fetal hemoglobin in a manner that can be independent of every through periodic stress, residing in reduced, sickle, and the vessel occlusive events in sickle cell patients, and resolving anemia and transfusion dependence in beta thalassemia patients. Since launching the initial data, we have completed our safety review of sentinel patients from the RUBY trial for sickle cell disease. We are pleased to share that we continue to see a favorable safety profile. After completing sequential dosing of the first two patients, we have commenced parallel patient dosing, means that we can now dosing multiple patients simultaneously and we remain on track to dose 22 sickle cell patients by year-end. Our initial clinical data were very encouraging, consistent with preclinical data. We are confident we will see replication of similar results in subsequent patients. We have said before that sickle cell disease is categorized by more than just vessel occlusive events. It can result in other severe symptoms such as anemia, fatigue, hemolysis, stroke and other organ damage. As we continue to monitor patients over time, we see potential for differentiation via longer term improvement in symptoms and more durable treatment. Since joining Editas last year, I and the rest of management team has been focused on sharpening our clinical execution. We are very pleased with the momentum of EDIT-301 in both the RUBY and EDITHAL studies. Look forward to updating you as those trials progress. Now I will turn the call over to Michelle, our Chief Financial Officer, to review our financials.

[Operator Instructions] Our first question comes from Joon Lee with Truist Securities. Please proceed.

Thank you very much.

Our next question is from Samantha Semenkow with Citi. Please proceed.

Okay. Thank you very much.

Our next question is from Dae Gon Ha with Stifel. Please proceed.

Great. Thanks for the updates.

Our next question is from Phil Nadeau with Cowen & Company. Please proceed.

Thank you. Thank you, Phil for your question. Regarding your first question in the middle year of data release, we will not share the number patient this time, but what we can share is that we will share the longer term data for the two patient dose last year and the additional data from multiple patient dosed this year. And we have been not only dosed the sequential dosing the sentinel patient, but also started dosing the parallel dosing for the additional patients. And in addition to that, we have enrolled multiple patients and some of them already been - CD34 cell is being edited and others be in the process of recess. So we are very confident and pleased with the progress of the RUBY trial progress. For your second question, can you repeat again?

Yes, sorry. In terms of 301 and thalassemia is the design the same as the RUBY trial and that the first two patients will be dosed sequentially before you can move on to parallel dosing?

Yes. So we will have sentinel patients and we will share more details when we have more of the data.

Our next question is from Rick Bienkowski with Cantor Fitzgerald. Please proceed.

Great, thank you.

Our next question is from Joel Beatty with Baird. Please proceed.

Our next question is from Jay Olson with Oppenheimer. Please proceed.

Great. Hi, Jay. So with the refocus strategy, we were able to extend our cash runway into 2025. We don’t give out guidance on expenses, but obviously you can back into that. Given that our cash balance was 437 million at the end of the year, and we will continue to invest in EDIT-301, both of the clinical trials continue to invest in CMC, and then obviously in our advanced technology and further in-vivo platform.

Great, thank you very much. Thanks very much Michelle. Thanks.

Our next question is from Brian Cheng with JP Morgan. Please proceed.

Thank you Gilmore.

Our next question is from Luca Issi with RBC Capital Markets. Please proceed.

Great. Thanks so much for taking my question. Congrats on all the progress. I have two quick ones. Maybe circling back on a prior question based on if I may, I think you’ve spoken in the past about the RUBY trial potentially becoming registrational. Obviously you are now flagging that you’ll have 20 patients by year-end. How many patients and what is the minimum follow-up that you think is required to actually have a registrational package? Again, any color there will be much appreciated. And then maybe Gilmore for you on LCA-10 and IRD more broadly, can you just give us an update on what is a strategic option that you are exploring in the moment? What will be an ideal partner and ideal deal there? Thanks so much.

Got you. Thanks so much.

Our next question is from Greg Harrison with Bank of America. Please proceed.

Great, that is helpful. thanks for taking the questions.

Our next question is Yanan

Great. Thanks for the color.

Our next question is from Gena Wang with Barclays. Please proceed.

Okay. Have you already received the payment or you were received after the transaction close regarding the show?

The payment was received in 2023.

I see. So the cash reported already incorporate that.

The cash reported at the end of the year did not yet include that.

Okay. The guidance that will -.

That will be in our reforecast of our cash runway.

Yes, thanks Gena for the question. Yes, we will plan to have two data released for RUBY study. One is the middle of the year, and one is the end of the year. In terms of specific forum, we will share when we have more information. And we have not shared the number patient this point, but I just mentioned earlier we really have a strong momentum for the RUBY study as well as EDITHAL study. And we expect to have multiple patient data for the data release.

Our next question is from Rich Law with Credit Suisse. Please proceed.

Okay. Great. Thank you.

Our next question is from Madhu Kumar with Goldman Sachs. Please proceed.

Our next question is from Matthew Harrison with Morgan Stanley. Please proceed.

Thank you very much.

Our final question is from Liisa Bayko with Evercore ISI. Please proceed.