Q1 2020 Earnings Call
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Operator: Good morning. Welcome to Editas Medicine's first quarter 2020 conference call. All participant lines are 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 Mark Mulliken, Vice President of Finance and Investor Relations at Editas Medicine.
Good morning, welcome to advertise medicines first quarter 2020 conference call.
Ill participant lines are in a listen only mode.
There will be a question answer session at the end of this call. Please be advised that this call is being recorded at the company's requests.
I'd now like to turn the call over to Mark Milliken.
President of finance and Investor Relations at Times Medicine.
Thank you operator, good morning, everyone and welcome to our first quarter 2020 conference call.
Earlier. This morning, we issued a press release, providing our financial results and corporate updates for the first quarter of 2020.
A replay of today's call will be available on the investors and media section of our web site.
Proximately two hours after completion.
After our prepared remarks, we will open the call for Tonight.
As a reminder, various remarks that we make during the call about the company's future expectations plans and prospects constitute forward looking statements for part of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.
Mark Mulliken: Thank you, operator. Good morning, everyone, and welcome to our first quarter 2020 conference call. Earlier this morning, we issued a press release providing our financial results and corporate updates for the first quarter of 2020. A replay of today's call will be available on the investors and media section of our website approximately two hours after its completion.
Actual results may differ materially from those and those indicated by these forward looking statements as result of various important factors, including those discussed in the risk factor section of our most recent annual report on form 10-K, which is on file with the FCC.
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 Chief Executive Officer, Cindy Collins.
Thank you Mark good morning, and thank you everyone for joining us for our corporate update how competitive first quarter of 2020.
In addition to Mark I am joined by Charlie Albright, Our Chief Scientific Officer, and Michelle Robert Sanders, Our Chief Financial Officer.
Mark Mulliken: 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 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 FCC. 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. Although required by law, we specifically disclaim any obligation to update or revise any forward-looking statements, even if our views change. Now.
This year has started out quite unlike any other for the world and for our company that covers 19 outbreak is a challenge unprecedented and modern time.
The safety of our employees patients and partners is always our first priority and I want to thank them for their resilience in the face of adverse today.
We have taken measures consistent with public health policy and guidance to keep them say, while minimizing business disruption.
This includes implementing a work from home policy for office based employees, while we're directing onsite activities, two essential lab and manufacturing employees.
We are successfully conducting much of our business virtually and our executive team needs frequently to ensure that we continue to advance our business objectives.
We have been able to keep our program is largely on track, although the uncertainty does increase the risks to timeline, which will be discuss further on this call.
The situation is unfolding rapidly and we will provide further updates as we gain additional clarity on potential impacts.
Now I will turn to a review of our business.
Since we last spoke in February we achieved a historic milestone with our lead program at at 101, the first Nvvault, Chris for Medicine was administered to a patient in the beryllium clinical trial for the treatment of LCH Tan.
This is a landmark event for cyan from Madison, and most importantly for people living with this ocular disease.
And it is a significant step or or delivering on the promise and potential of Christopher medicine.
To transform the life for patients with devastating genetic diseases.
Charlie will provide additional color on the trial in a few moments.
Unknown Executive: Thank you, Mark. Good morning, and thank you everyone for joining us for our corporate update call for the first quarter of 2020. In addition to Mark, I am joined by Charlie Albright, our Chief Scientific Officer, and Michelle Robertson, our Chief Financial Officer. This year has started out quite unlike any other for the world and for our company.
Thrilled as we are to pioneer the first ever Nvvault, Chris for Medicine, we are equally excited about pioneering differentiated engineered cell medicine for cancer and Hemoglobinopathies.
We recently initiated I envy, enabling studies for oncology candidate at it to a one and allogeneic healthy donor NK cell medicine for the treatment of solid tumors.
Advancing novel treatments for solid tumor cancers, which represent approximately 90% of cases is a key priority for our company.
We expect edit tool one to be the first transformative oncology medicine to emerge from our efforts.
For Hemoglobinopathies, we are conducting I envy, enabling toxicology studies for editorial one for the treatment of sickle cell disease.
Unknown Executive: The COVID-19 outbreak is a challenge unprecedented in modern times, and the safety of our employees, patients, and partners is always our first priority, and I want to thank them for their resilience in the face of adversity. We have taken measures consistent with public health policy and guidance to keep them safe while minimizing business disruption. This includes implementing a work-from-home policy for office-based employees while restricting on-site activities to essential lab and
We remain on track to file and I, Andy or a potentially best in class medicine.
By the end of this year.
Finally, before I turn the call over I'm pleased to welcome Claire Carmichael to at a time as Chief Human Resources Officer, Claire joined US in April she brings deep experience in building biotech organization and will be instrumental as we continue to grow at a time as the leader in.
Genomic medicine.
Now, let me turn the call over to our Chief Scientific Officer, Charlie Albrecht to discuss our pipeline.
Thanks, Andy It's my pleasure to join all of you on the call today, we'll start with Invivo editing medicines first pillar of our therapeutic strategy.
In early March along with our partner allergy and we announced the treatment of the first patients in the brilliance clinical trials at one on one to treat LCD town.
As a reminder of the primary endpoint or brilliance assesses the safety and Tolerability of added one on one secondary endpoints measuring efficacy.
Unknown Executive: We are successfully conducting much of our business virtually, and our executive team meets frequently to ensure that we continue to advance our business objectives. We have been able to keep our programs largely on track. Although uncertainty does increase the risk to the timeline, which will be discussed further on this call, the situation is unfolding rapidly, and we will provide further updates as we gain additional clarity on potential impact. Now I will turn to a review of our business. Since we last spoke in February, we achieved a historic milestone with our lead program, EDIT 101, the first in vivo CRISPR medicine to be administered to a patient in the brilliance clinical trial for the treatment of LCA10. This is a landmark event for science, for medicine, and, most importantly, for people living with this ocular disease. And it is a significant step forward, delivering on the promise and potential of Christopher to transform the lives of patients with devastating genetic diseases. Charlie will provide additional color on the trial in a few moments.
We're pleased to report that based on a review of the first six weeks of safety data from the first patients. The study has been clearly continue.
We plan to complete dosing of the adult low dose cohort into dose at least one patients in the adult mid dose cohort by entities of this year.
We will keep you up to date on our progress, including any potential impact of cobot 19 on our enrollment activity.
Form at at 101, our next Vblocks or program that at one or two for the treatment of Usher syndrome to it.
Analytical studies support the advancement of at one of the two into R&D, enabling studies.
As part of our strategic alliances Allegan, we've delivered a data package at one or two for potential licensing and development.
We expect our games decision by the third quarter, after which I'd, enabling studies may begin.
On our third our dealer program addresses autism will dominate retinitis pigmentosa four or RP for a significant unmet medical need.
Well, we've made substantial progress on this medicine, we will delay the declaration of a development candidate to next year due to the need to Reprioritize staffing caused by cobot 90.
We remain eager to advance this program will make every effort to declare a candidate as soon as practical.
We also continue to advance our neurology program in collaboration with asked by we'll have more to say about our in vivo editing programs later this year.
Switching now to engineered cell medicines, the other strategic pillar of our therapeutic strategy.
The Sidney mentioned at a 301 or potentially best in class Medicine for Hemoglobinopathies remains on track for 90 finally for sickle cell disease. This year.
Preparatory activities supporting the I'd are underway site selection will begin shortly and we are planning for an investigator meeting in the fourth quarter.
As a three to one directly at its the beta globin locus, where the mutation that causes sickle cell disease is located.
We believe that editing, it's a beta global oak is de risk by human genetic so some sickle cell patients with elevated fetal hemoglobin contain mutations in the beta globin locus.
In contrast, mutations that elevated fetal hemoglobin in humans are not found that other genetic sites.
Unknown Executive: As thrilled as we are to pioneer the first ever in vivo CRISPR medicine, we are equally excited about pioneering differentiated engineered cell medicine for cancer and hemoglobin apathies. We recently initiated IND-enabling studies for oncology candidate EDIT-201, an allogeneic healthy donor in K-cell medicine for the treatment of solid tumors. Advancing novel treatments for solid tumor cancers, which represent approximately 90% of cases, is a key priority for our company. We expect EDIT 201 to be the first transformative oncology medicine to emerge from our efforts. For hemoglobinophyses, we are conducting IND-enabling toxicology studies for EDIT-301 for the treatment of sickle cell disease.
In addition, preclinical data shows that added three a one induces superior levels of fetal hemoglobin and recall institutes, all blood lineages, including Red blood cell crude precursors for these reasons, we remain enthusiastic about advancing editorial wants into the clinic to treat sickle cell disease patients.
Finally, moving to an oncology and area significantly growing investment for our company, we recently initiated I'd.
R&D, enabling studies were added to a one and allogeneic intesa medicine treating solid tumors.
We believe that we can apply gene editing NK cell to develop off the shelf medicines for cancer patients that have no effective therapeutic options available to them today.
The two one is the first of these medicines that we hope will extend to dramatically improve the laws. These patients.
We're continuing to make excellent progress on our program to produce NK cells with multiple genetic changes from induced pluripotent stem cells.
We'll have more to say about these efforts later in the year.
Now I will turn the call over to our Chief Financial Officer, Michelle Robertson.
Thanks, Charlie.
I'm pleased to join you on the call today to present, the company's latest financial results.
Our cash cash equivalents in marketable securities decreased $42 million to $450 million as of March 30, Onest 2020 from $457 million as of December 30, Onest 2019.
Our uses of cash in the quarter totaled $58 million cash operating expenses of $56 million exclude stock based compensation and depreciation and include changes in working capital.
Unknown Executive: We remain on track to file an IND for a potentially best-in-class medicine by the end of this year. Finally, before I turn the call over, I am pleased to welcome Claire Carmichael to Editas as chief human resources officer. Claire joined us in April. She brings deep experience in building biotech organizations and will be instrumental as we continue to grow Editas as the leader in genomic medicine. Now, I will turn the call over to our Chief Scientific Officer, Charlie Albrecht, to discuss our pipeline.
After adjusting for non recurring cash payments in Q1, our cash operating expenses were approximately $40 million.
Capital expenditures in the quarter totaled $2 million.
We grew the size of our organization by approximately 10% increasing to 213 fulltime employees and 195 employees at the end of 2019.
Hi, just houses in a strong financial position with more than 24 months of runway to from the business.
Further we remain committed to diligently managing our expenses in order to grow the company, while maintaining the strength of our balance sheet.
And with that I will hand it back.
Thank you Michel.
The beginning of this year brought an unprecedented global crisis that has changed the way EDITDA and every other company operates we're confident that our strong leadership dedicated employees and trusted partnerships will persevere during these difficult time.
Charlie Albright: Thanks Cindy. It's my pleasure to join all of you on the call today. Let's start with in vivo editing medicines, the first pillar of our therapeutic strategy. In early March, along with our partner Allergan, we announced the treatment of the first patients in the BRILLIANT Clinical Trial, Edit 101, to treat LCA-10. As a reminder, the primary endpoint of brilliance assesses the safety and tolerability of edit 101, while the secondary endpoints measure efficacy. We're pleased to report that based on a review of the first six weeks of safety data from the first patient, the study has been clear to continue. We plan to complete dosing in the adult low-dose cohort and to dose at least one patient in the adult mid-dose cohort by the end of this year. We will keep you up-to-date on our progress, including any potential impact of COVID-19 on our enrollment activities for EDIT101.
The health care and biotechnology community has always emphasized progress and development under strenuous circumstances, and I am confident that together, we will overcome the global pandemic.
As a company we remain incredibly excited about the times ahead editas programs have the potential to revolutionize the treatment of genetic blindness cancer sickle cell disease and neurological condition.
Earlier this year, we treated the first patient ever within Nvvault, Christopher Gene editing medicine, but our work is only getting started.
We are working to further extend the reach of gene editing as we tackle new indication explore new targets and expand our platform to deliver on the promise of Chris for technology.
We look forward to continuing to forge this Jerry in partnership with the broader community a patients clinicians employees and investors. We thank all of you for your continued interest and support.
With that we will open up the call for today operator.
Okay.
Thank you.
And I wanted to ask a question you need to press star one on your telephone.
To address your question press the pound key please standby only composite can a roster.
Unknown Executive: Editing by David Walsh
And I'm not showing any questions at this time.
Charlie Albright: Our next in vivoOcular program is edit 102 for the treatment of Usher syndrome 2A. Preclinical Study, Support the Advancement of N102 into IND Enabling Studies. As part of our strategic alliance with Allergan, we've delivered a data package for EDIT 102 for potential licensing and development. We expect Allergan's decision by the third quarter, after which IND-enabled studies may begin. Our third ocular program addresses Autosomal Dominant Retinitis Pigmentosa 4, or RP4, a significant medical need. While we've made substantial progress on this medicine, we will delay the declaration of a development candidate to next year due to the need to reprioritize staffing caused by COVID-19. We remain eager to advance this program and will make every effort to declare a candidate as soon as possible.
Great. So with that we thank you also participating in today's call and for your support as we work to bring transformative new medicines to patients take care NBC.
Ladies and gentlemen, this concludes todays presentation. Thank you once again for your participation you may now disconnect.
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Charlie Albright: We also continue to advance our neurology program in collaboration with ASPI, and we'll have more to say about our in vivo editing programs later this year. Now, switching to engineered cell medicines, the other strategic pillar of our therapeutic strategy. As Cindy mentioned, EDIT 301, our potentially best-in-class medicine for hemoglobinopathies, remains on track for an IND filing for sickle cell disease this year. Preparatory activities supporting the IND are underway. Site selection will begin shortly, and we are planning for an investigator meeting in the fourth quarter.
Charlie Albright: And the 301 directly edits the beta-globin locus, where the mutation that causes sickle cell disease is located. We believe that editing at the beta-globin locus is de-risked by human genetics, since some sickle cell patients with elevated fetal hemoglobin contain mutations in the beta-globin locus. In contrast, mutations that elevate fetal hemoglobin in humans are not found at other genetic sites.
Michelle Robertson: In addition, preclinical data shows that EDIT301 induces superior levels of fetal hemoglobin and reconstitutes all blood lineages, including red blood cell precursors. For these reasons, we remain enthusiastic about advancing ETA-301 into the clinic to treat sickle cell disease patients. Finally, moving to oncology, an area of significant and growing investment for our company, we recently initiated IND Enabling Studies for Edit 201, an allogeneic NK cell medicine treating solid tumors. We believe that we can apply gene editing to NK cells to develop off-the-shelf medicines for cancer patients that have no effective therapeutic options available to them today. Etatulon is the first of these medicines that we hope will extend and dramatically improve the lives of these patients. We're continuing to make excellent progress on our program to produce NK cells with multiple genetic changes from induced pluripotent stem cells. We'll have more to say about these efforts later in the year. Now, I will turn the call over to our Chief Financial Officer, Michelle Robertson.
Michelle Robertson: Thanks, Charlie. I'm pleased to join you on the call today to present the company's latest financial results. Our cash, cash equivalents, and marketable securities decreased $42 million to $450 million as of March 31, 2020 from $457 million as of December 31, 2019. Our uses of cash in the quarter totaled $58 million. Cash operating expenses of $56 million exclude stock-based compensation and depreciation and include changes in working capital. After adjusting for non-recurring cash payments in Q1, our cash operating expenses were approximately $40 million. Capital expenditures in the quarter totaled $2 million. Additionally, we grew the size of our organization by approximately 10 percent, increasing to 213 full-time employees from 195 employees at the end of 2019. Editas is in a strong financial position with more than 24 months of runway to fund the business. Furthermore, we remain committed to diligently managing our expenses in order to grow the company while maintaining the strength of our balance. And with that, I will hand it back to Cindy.
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Unknown Executive: Thank you, Michelle. The beginning of this year brought an unprecedented global crisis that has changed the way Editas and every other company operates. We are confident that our strong leadership, dedicated employees, and trusted partnerships will persevere during these difficult times. The healthcare and biotechnology community has always emphasized progress and development under strenuous circumstances, and I am confident that together we will overcome this global pandemic. As a company, we remain incredibly excited about the times ahead.
Unknown Executive: Editas programs have the potential to revolutionize the treatments for genetic blindness, cancer, sickle cell disease, and neurological conditions. Earlier this year, we treated the first patient ever with an in vivo CRISPR gene editing medicine, but our work is only getting started. We are working to further extend the reach of gene editing as we tackle new indications, explore new targets, and expand our platform to deliver on the promise of CRISPR technology. We look forward to continuing this journey in partnership with the broader community of patients, clinicians, employees, and investors. We thank all of you for your continued interest and support. With that, we will open up the call for Q&A. Operator.
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Operator: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. And I'm not showing any questions at this time.
Unknown Executive: Great. So, with that, we thank you all for participating in today's call and for your support as we work to bring transformative new medicines to patients. Take care, and be safe.
Operator: Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect.
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