Q1 2020 Earnings Call
[music].
Welcome to the meter.
Conference call for the first quarter 2020 resource.
My name is Chris and I'll be your operator for today's call.
At this time, all participants' lines are in listen only mode.
I think he speaks presentation, there will be a question and answer session.
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Now I'd like to introduce your host for today's conference Ms., Germany, Vice President Investor Relations and corporate Communications. Please go ahead.
Thank you, Chris and good morning, everyone. Welcome to today's call will provide an update on the company and review our financial results for the first quarter of 2020.
This morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website www dot comedic gosh sell dotcom you can find the press release related to say call here with me on our call today, it's really not <unk> Chief Executive Officer.
Let me talk Chief Medical Officer, and shy likely Chief Financial Officer, following our prepared remarks, well open the call situation.
During this call we may make forward looking statements about our future expectations on plans, including clinical development and commercial objectives, the therapeutic potential of our product candidates.
Operational plans and strategies and projected operating expenses in cash runway.
Our actual results may differ materially and what we project today due to a number of important factors, including the considerations described in the risk factor section of our form 20-F.
Other filings that to me the Soulmates at the FCC from time to time.
Forward looking statements represent our views only as of today, Let me caution you that we may not take them in the future. What are the result of the automation future events or otherwise.
I would like to turn the call over to Julian Adams.
Thank you John and thanks, everyone for joining us this morning.
Give me to sell we're committed to finding cures for patients with blood cancers, and rare serious sumit allergic diseases.
Developing next generation cell therapies.
Last week, we were thrilled to announce that the global randomized phase three studies do we sell our most advanced product candidate met its primary endpoint with a high degree of statistical significance.
We're also making strong progress with GDP to one our investigational expanded natural killer or NK cell therapy.
Potential for both hematologic malignancies in solid tumors.
Additionally, we announced a $16 million follow on earlier this week, which is expected to close today.
As we experienced minimal impact you to covert 19 today.
So we have made significant progress so far this year as we advance our programs.
Starting first with on the do Michelle last week, we reported positive highly soon.
At least significant topline data from our global randomized phase three clinical study apama due to sell in patients with high risk Haematological malignancies in need of a bone marrow transplant.
The data demonstrated that almond do the cell resulted in a significant reduction in time to neutrophil engraftment, a key milestones and transplant recovery.
These data exceeded our expectations and were very consistent with our results from our phase one two clinical study.
These data underscore the potential for Omid do the cells to create a new standard of care.
Based on the results of the Phase three study we are confident that on would do the self serve as a graph for any patients in need of a bone marrow transplant.
By providing a steadily it readily available.
Bone marrow transplant graph, we can reduce the time patients currently spend waiting for a donor match.
We can also help relieve patients and their families of the anxiety. They currently field.
During the search process.
Additionally, all Medusa can make transplant accessible to the 40% of patients who today are eligible for translarna, but unable to find a matched donor.
With these data in hand, we are focused on working towards initiating a b L. A submission on a rolling basis in the fourth quarter, this year, which will position us for a potential launch in the second half of 2021.
We are also advancing key activities to bring overdo the sell to patients following potential FTC approval.
Okay, I'm going to build out our manufacturing infrastructure both at Lonza.
And at our own facility to help ensure sufficient and reliable commercial supply.
We're also working to develop comprehensive hospital services and patient assistance programs.
Designed to seamlessly bring on the do braselton patients.
Moving now to GDH worldwide.
We are continuing to advance phase one clinical study.
And are working hard to initiate a multicenter phase one two study in patients with lymphoma next year.
We have previously reported striking early signs of efficacy multiple complete responses in patients with advanced lymphoma.
We expect to present updated phase one data at a medical meeting in the second half of the year.
We are quite fortunate that the impact of covert 19 on our business has been minimal.
And our Hearts go out to all the families who have been affected by this tragic pandemic.
Give me to sell we have taken undertaken important steps help ensure safety of employees and their families and to reduce the spread of cold at 90.
In early March give me to sell established a work from home policy for all employees other than those performing course supporting business critical laboratory experiments and manufacturing related activities.
For those employees. The company has implemented stringent safety measures designed to comply with applicable government guidelines instituted in response to the covert 19 pandemic.
Today, we believe our guidance with respect to clinical development and regulatory milestones are unchanged. We will continue to closely monitor any possible impact from covert 19 and will provide updates on any changes that occur.
I'll now turn the call over to relieve some of our Chief Medical officer to provide further update and almond dermacell and GBA two or one oneq.
Thank you Julie and good morning, everyone.
Julien noted last week, we recorded positive topline data from our phase three study only himself.
We are very proud.
Well executed trial and we truly appreciate.
The support of the translate community, including the investigators and her team that patients and their families partnered with us to help move to feel solid.
This phase three study was designed to evaluate safety and efficacy on would you be self compared to standard umbilical cord blood allogeneic bone marrow transplant in patients with hybrid hematologic malignancies.
Demographics and baseline characteristics were well balanced across the two study group.
The primary endpoint without represent any tend to treat analysis of all 125 randomized patients.
The primary endpoint would tighten neutrophil engraftment.
The key milestones in recoveries from bone marrow transplant.
Signifying how quickly the stem cells the patient Missy became established and began to make hoping you sell.
We are strictly defined grasping at the cheating absolute neutrophil count of greater than or equal to 500 cells or Mike what leader on three consecutive measurement on different date, we subsequent donor primaries.
Neutrophils aren't section fighting white blood cells, and kindred genetic evidence that the donor cells had a graph that.
And you said to treat it out.
The meeting continue just on grapple with 12 days and patients randomized on it yourself compared to 22 days for patients compared with randomized to stand the cord blood transplant.
The P value was less than 0.001.
Fortunately this was a clinically significant difference because faster when grafman associated with few exceptions and shorter hospitalization.
Meaningful for patient physician and hospital.
These data were consistent with our phase one two study what do we reported a median time to grasp of 11.5 days for patients were treated over due to sell compared to 21 days for historical cohort of 146 patients treated with Canaccord like.
These data also compared favorably to the tacky neutrophil Engraftment has previously been recorded in other study for other translate modalities well, we've seen data ranging from 16 to 21 day.
We remain blinded to individual patient outcomes and data on additional endpoint continues to be collected as they mature.
I think every endpoints include time lately and graph me infections and hospitalization and additional endpoints include graft versus host immune reconstitution survival.
We expect the presented data at a medical meeting at the ended the year.
We're also diving into the sell an investigator sponsored phase one two study in patients with severe plastic anemia.
Okay and life threatening blood disorder Oh.
Last year, we completed the first quarter. This study, which showed that all three patients successfully underwent a bone marrow transplant.
Insisting on mid yourself, what the Haploidentical sense so Brad.
Currently patients are being enrolled into the second cohort, which is designed to evaluate.
As a standalone graph.
We expect to report additional data from this study in the second half of this year.
In addition to only due to sell we're also advancing our second cell therapy program GDH, you, all one and natural killer based therapy.
Ongoing study in patients with non Hodgkin lymphoma, and multiple myeloma is designed to assess the safety of GE into a one in combination with monoclonal antibodies and to determine the recommended phase two dose.
We have already achieved a sneak one objective and as additional patients aren't roles. We continued to be very encouraged by the safety of activity is there.
In February and abstract was published in conjunction with the European Society for blood and marrow transplantation or empty annual meeting, which was to take place in March but was subsequently postponed due to cold it 90.
These data included 11 patients were non Hodgkin lymphoma, 14 patients with myeloma.
Briefly review the data in lymphoma.
Among the 11 patients with non Hodgkin lymphoma, seven achieved a complete response and one patients achieved a partial response.
This is a small they set from a single site. The activity is there any heavily pretreated patients, including those with diffuse large b cell lymphoma compare favorably with response there are other studies, including early study parties there.
We also continue to be impressed with the safety profile Gvhd were one.
25 patients.
No dose limiting toxicity and no gvhd and importantly, no neurotoxicity observe.
With the primary objectives at the study complete we have an opportunity to evaluate the duration of response and to ask additional question to inform future development plan.
For example, we successfully re treated patients with GE to a one outlet for completion.
In multiple myeloma, we are evaluating additional Tom lit up to the regimen, which may provide better activity, which isn't that with GE to a one alone.
In summary, we are very excited about potential TV to a one we expect to report additional data in the second half its 2020, and we are investing activities required to enable the initiation of a multicenter phase one two study in patients with lymphoma next year.
With that I will turn call over to shy to review our financial results.
Thank you very neat and good morning, everyone.
Have you learned mentioned we are pleased to close every $60 million full don't operate today, which importantly strength sorry, one maybe you could differ economics 2021, now I will review, our 2021st quarter financial Google.
At March 31st 2020, total cash cash equivalent and they'll be for social security $40.3 billion compared to $55.4 billion at December 31st wouldn't even be.
$40.3 million exclude approximately $60 million worst proceed tend to follow on offering which we expect to close today.
Richard We don't have expected for the first quarter for $7.9 million compared to $7.3 billion for the same period 2019.
The increase was primarily due to political activity related to be advancing could you didn't do a one off the big grants received from these really innovation ability.
Commercial expenses were 1.5 million bad for the quarter compared to $1 million for the same period.
The increase was mainly attributed to want me to be filled commercial readiness activities.
General and administrative expenses retrieving ended the quarter compared to 2.8 million dollar for the same period in 2019 decrease was mainly due to expenses associated with being a publicly traded company.
Net finance income of 1.7 billion dollar for the quarter brick net finance expense of $4.4 million for the same period, you 20 banking.
The increase is primarily due to non cash expenses, resulting from within the Asian exploring.
Net loss before for the first quarter was $10.6 million compared to net loss of 50 point $500.
Same period between 19.
At the beginning of the year, we provided guidance for the first six months of 2020.
Okay, a big or guidance reflect who your expectation.
We expect gets you for I'm going to break even activity this year to range from $60 million to $70 million. We anticipate the recurring took a cash position will support our ongoing to Britain acute with you into the second up 21.
These kish wondered guidance based on our current operational blend and excludes any additional funding, but maybe recede well because it doesn't have activity. The CD undertaken we did I will turn the call back over to Julien.
Thanks shot.
2020 has proven to be a transformation.
Here for the quarter for the company.
Phase three data further de risk almond, dermacell and provide us with it opportunity.
An important opportunity to bring on.
Potential cure to patients in need of a bone marrow transplant.
We look forward to reporting to data from the phase three study, including secondary endpoints in the second half of the year.
At the same time, we're focused on critical activities, including filing our belief and ensuring commercial readiness as we look for toward the potential launch of I mean do sell in 2021.
The Judy eight two or one we have a highly active clinical development candidate in an area of science that is increasingly recognize is holding potential to further transform how certain cancers are treated.
We have a strong team in place.
Committed to delivering the next generation of cell therapies to patients.
And look forward to further updating you.
And our progress.
Now we will open the call for questions.
Operator.
Thank you.
That's Vermont addressing your question. Please press star one of your telephone.
Well George your question. Please press the pound Keith.
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No first question comes from a lot of Gregory wins with RBC capital markets. Your line is now open.
Good morning, he doesn't equal to one for Greg. Thank you for taking my questions and congrats on the progress.
Thank you.
I was wondering if you could share some feedback on the topline data now that relieved in terms of what could tell all denting busters be latching onto and also what our to push backs and how's that shaping your focus for the awareness. So I meant that you need to build as you go forward with the regulatory and also to it.
Publish the value proposition increased visibility in the market and therapeutic space. Thank you.
Right.
Sure.
Oh I'll give you the impression that we have had from the transplant community the physicians and investigators who participated in the study.
Our very very excited to see these data they are really.
Really behind us in terms of developing on the do the cell and a very very gratified to see that the results of the study, where so convincing and so clinically meaningful for their patients.
They.
Really see neutrophil engraftment and being critically important in the recovery of patient for transplant and so they believe that we we really have the opportunity to be disruptive to the transplant community. So we were having had the primary endpoint the complete and successful.
We will and had breakthrough therapy designation with.
The FDA.
Until this time, we discussed the clinical development throughout the program with the FDA, we expect to take these data and submit them out in a B.L.A. by the end Didier.
And I will add to that.
We're going to build out a medical affairs and medical education.
Platform.
Gauge kao else.
And really a broadly.
Okay.
The transplant community.
As to the potential for on the do bustle.
And this will be done in conjunction with both the clinical department.
And the commercial.
Group.
To prepare the market for on the do the self lunch potential launch next year.
Great. Thanks, that's very helpful and maybe just on another on the GDH Your one program.
How are you balancing the focus on that program and is that an increasing focus now and what it makes sense to accelerate the program on would that be a possibility and how will we think about strategy there. Thanks.
So did he told one is a very exciting program for us it based on the platform that brought us the only do the cell program and a lot of experience knowledge and relationships that we've made are ones that we're leveraging for development of GDP to a one.
We continue to develop that program with.
Development of a cryopreserved product in our laboratories, and we will intend to bring that to a clinical study of company sponsored multicenter study for patients.
Next year, so that that program is quite important to us on the heels them on the due to sell and we will continue to focus on that.
Great. Thank you very much.
Thank you.
Next question comes from the line of Chad Messer with Needham and company. Your line is now.
Great. Thanks. Good morning, Good you know, but again congrats on on all the all the progress maybe more on G.H. one.
With the data update during the second half.
Just wondering if you can maybe set expectations in particular on.
What do we can expect to see more data on reduced.
Absolutely. So we incorporated resulting into the protocol last year at the end of last year in order to give patients the opportunity to have a second dose and then second dose is done without lymphodepletion. So that gives us a lot of experience on eliminating lymphodepletion from the patient regimen.
So additional data that will be presented by the end of the year will include.
At a multiple dosing in patients including.
Including the lack of or the elimination of the lymphodepletion for those dosing.
Right right very exciting and maybe just expand a little bit on it from on a prior question do you think there's a faster market strategy. It NHL and then.
Any further thoughts are we talking about this in the past on other indications besides NHL in multiple myeloma.
Absolutely so in in non Hodgkin lymphoma in both patients with diffuse large sell need as well silicon, but we've seen very impressive responses, including a high percentage of complete responses and we really feel that this is a population where patients had been treated with multiple therapies have.
Been refractory to standard of care and there's a need for further therapies and patience is making a real clinical difference in the patients who've been treated on this study and so we do feel that there is a potential fast to market strategy with response rates at the level that we've already observed them in our phase one study.
We believe that that.
I study that will be designed to look at response rates in a population of patients like that's one.
Potentially lead to.
A strike.
Our approval.
This patient population so absolutely in terms of other indication. So we believe that the non that's the natural killer cells.
Program, it's really a platform that can be used in conjunction with monoclonal antibodies to generate ADCC antibody dependent cellular cytotoxicity potentially for other tumors and so we had in the laboratory have generated some data using other.
Antibody, including in solid tumors, and we hope to be able to bring that to patients at some point in the future to explore the capabilities and other tumors.
All right great. Your hobbies, obviously excited for for omni, but.
Looking forward to hearing more about this program as well thank you.
Thank you.
Thank you Chad.
Thank you.
As a reminder, ladies and gentlemen, just one question per store, one or you touched on telephone cuts or move your question. Please press the pound key.
Your next question comes from a lot of Jason Butler with JMP Securities. Your line is now open.
Hi, Thanks for taking the questions I had to just the first on.
Joe in your comments about getting the medical affairs effort.
And discussing the only do we sell data can you just talked to where you are in that process rose from a.
Medical Affairs leadership perspective, or when you think you'll be able to be out there talking about the topline data versus later in the year having the.
The secondary endpoints and then on to a one can you just talked about the progress you've made toward.
I'm getting a manufacturing process applicable to a multi site center I study and if you're working or plan to work with a a manufacturing partner at some point on that program also thanks.
Yeah. So we are actively.
Recruiting for medical Affairs talent.
And our you know.
The pen.
It was dependent on the successful financing so that we would have the wherewithal to continue to build out.
All of the infrastructure, both for medical affairs commercial and manufacturing so.
This triggers our ability to go out and these data trigger our ability to go out and for begin a real education process.
And to your second question on manufacturing, we are undertaking to manufacture.
P and K.
GDH were one product.
Our own facilities and.
The key.
Event. It is too now that we've learned how to cryopreserved.
Recover NK cell activity.
As to turn that into a GMP process. So there's still some process development going on.
We're quite confident that we will achieve our milestone.
Great very helpful. Thanks, and congrats on all the progressing.
Phase three results last week.
Thank you.
Thank you.
This does conclude today's question and answer session our knowledge on the call back to Julian Adams for any further in March.
Thank you everyone for joining us on todays call.
We're excited about the opportunities that lie ahead and look forward to sharing updates on our progress throughout the year Chris.
Thank you. This concludes today's call you may now disconnect.
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