Q1 2020 Earnings Call

[music].

Good morning, and welcome to de she liked about Sanchez first quarter Twentytwenty Your financial results Conference call.

At this time, all participants are in listen only mode.

This call is being lies on the.

Webcast live on the investors and media section of select us website that.

W.W. dot select bio dot com.

And it is being recorded.

For opening remarks, I'd like to introduce alone not Cogan General counsel up Selectone.

Please go ahead.

Thank you and good morning, everyone welcome to our first quarter.

20 financial results incorporate update conference call.

A press release reporting our financial results is available in the Investor and media section of our web site.

I believe W. W Dot select a bio dot com.

And our quarterly report on form 10-Q.

Quarter ended March 31st 2020, well be filed later today with the FCC.

Joining me today, its crushed and Brian our President and Chief Executive Officer.

Brad Dom our Chief Financial Officer.

In addition, K Kishimoto, our chief scientific officer will be available for the Q when a portion of the call.

As a reminder, during todays call, we will be making certain forward looking statements, including without limitation.

And then about the potential.

Safety efficacy.

And regulatory and clinical progress of our product candidates.

All patients had reached three months of treatment.

We're also pleased to announce that our preparations for the commencement Oscar pastry program of F.D.L. to 12 remain on schedule and we plan to initiate this study in the second half off 2020, a barn any unforeseen impact due to cope with 19.

You have also taken several measures from manufacturing perspective to ensure we have enough supply of F.D.L. to 12 to complete the plans say three then it could program.

Oh, a gene therapy program remains he priority for select them.

Encode collaboration with a partner asked by.

We are jointly developing a broad portfolio of next generation A.B. gene therapies.

This partnership with leverage the unique proprietary technology platforms of both companies with a human proof of concept trial to validate this portfolio of products and their potential score reducing in patients, which could represent significant advancement in the gene therapy see it.

Select on asked bio intend to enter the clinic with this program by the end of 2020.

Additionally, we plan to provide further details off the initial proof of concept study in the second half of the year.

Finally select the continues to advance impropriety program in or anything <unk> couple of my lace efficiency.

We're also excited to announced the appointment of stuff that you're on I'm due to a board of directors.

I'm Gonna brings a wealth of experience and his approval almost certainly executive when a track record of execution in both the product development and commercialization.

It's a portable further in April the advancement up into her and we're excited for him to be part of the journey.

And also like to think I mean, a shot which took the under its replacing for as long term support.

It was just select the from the beginning and you're saying came for helping put select where we are today.

Oh, you know turn the called over to our Chief Financial Officer Radcoms Rat.

Thank you Carson.

Detail financials are laid out on our earnings <unk> with your father Smarting won't be further outlined in our 10 q. So I'll just highlight a few key items here.

We ended the quarter with 74.3 million and cash cash equivalent some restricted cash.

Metcalf using operating activities was 11.7 million as compared to 20.2 million for the same period of 2019.

Cashews and operating activities for the quarter includes a 5 million dollar receivable from asked by our relating to the license agreement, we signed with them and December 2019 for their potatoes. He's program 2 million of the 7 million was a season 2019, and the remainder was or C.H. in January.

As a reminder, select those eligible to receive up to 237 million and development commercial milestones plus royalties on that sales.

Leave our current cash position will provide us runway into the first quarter of 2021 and it's got it includes the commencement of our phase three clinical program the vessel to 12.

R. and D. expenses for the first quarter or 14.7 million, which compares with 7.4 million for the same period and 2019 [noise].

Quarterly increase reflects additional costs incurred specific to our head to head compare clinical trial, that's the L.C. 12 and for our gene therapy program in collaboration with asked bio.

G.N.A. expenses for the first quarter or 4.1 million, which compares with 4.5 million for the same period and 2019.

The reduction in costs was the result of reduced salaries consulting and professional fees, partially offset by increased dot com expense.

For the first quarter report, a net loss of 19.6 million or 21 cents per share, which compares with a net loss of 12.1 million for 31 cents per share for the for the same period and 2019.

Oh, no hand to call back over to Carson for closing remarks Carson.

I think you bread.

<unk>, the first quarter post unexpected and I'm president challenges for us as he did for most companies.

I'm proud of her team and then grateful for that flexibility dedication and unwavering commitments to insurance or clinical trials ended up in programs continued to progress.

Through the police that as a result of their efforts as of today, we are on schedule for a key milestones this year.

The announcement of top line data from to compare trial in Q3.

Initiation off the face tree study of S.L. to 12 in the second half of the year.

And the entry arching second program into the clinic by two four.

Oh commitments to pursuing new breakthroughs in treating diseases. They can benefit from reducing of gene therapy remain strong and moved forward. Degenerating addition value from our into a platform.

I'd like to conclude by reiterating our gratitude to than many people who've been supportive along the way, including or patients and their families are investigators, helping us with compare no great team at select them with that we're happy to take questions.

Thank you very much.

Where's the now begin the question and answer the question to ask a question you <unk> you know telephone keypad.

If you're using a speaker phone please pick up your hands before pressing the keys.

Do we enjoy your questions <unk>.

The small inflatable paused momentarily to assemble that roster.

We have the first question from the line up <unk> leap from <unk>.

[laughter] I've tried taking question just in terms of <unk>. Okay. Honey can you get it was just a little bit more color I, you know what proportion of.

Oh, how can you tell any television only that <unk>.

A little bit more color in terms that you know anything you saw incomes doesn't it sounds so far if at all.

Contingency planning I guess, if there weren't <unk> can your mind out from my perspective sort of how you would treat that and you know potential kind of <unk>, if they work and they eat attraction in terms of the data collection and arm that does that.

And then my final question. It's just on this will there be fine as he doesn't moving twice that clinic you know potentially you know don't think teach and can you talk a little bit about what what constituted a proof of concept from our perspective in terms on m. and training the ability to <unk> you'd think mucking for.

<unk> I guess, you know and you're not going there for the and and you started antibody tires name.

Great. Great question early thank you. So in terms of quote in fact, I think what's important and I think we we mentioned this in in previous discussion. We had is that it's important to know that you know they drugs are administered in a dedicated fusion centers are part of the matelski practices.

They also at Ministry life saving drugs. So you know all December so basically the main open throughout the cool the crisis, we had a a number off sites went off line.

For for two weeks at a time due to a either annotation not necessary from our trial or <unk> healthcare provider you know.

No. It's it's cool that but we have not this doesn't have an impact on to study patients got redirected to alternative sites and all this size actually are up and running so so I think that's important to nodes inch himself. The the infusions overall boasts the p. eyes and patients are extra.

<unk> motivated is obviously shows how sylvia to diseases.

So so today, we have not seen material impact actually.

Our safety measures that are taken by the sites and you're close you work with the sides a lot of the consultations are done by a tele medicine. They reduce the number of patients actually come to the in fusion centers Act infusion all the infusion suites are sterilize before the next patient disinfectant.

So I think all all those are you know changeable Corp perspective, but so far we we didn't have material impact.

In terms of contingency plan to get to your second question. So we're pleased that we have half of the patients completed the study and all patients completed three months right, So and I would kind of.

Call that the data set up pretty cool. It's we're obviously working on a potentially potentially they plan to make potentially changes to D.S.A.P. two account for pretend school dropouts and there's various approaches we could take and I mean.

In the worst case scenario, but you could do is you could do a page and analysis and from checked out you know missing data for those patients between three and six and have not completed the study. So we're working with stood up and we'll keep you updated around us.

In terms of gene therapy anything that's that's a great question as well and I think what we're really trying to do here with with into our engine therapy. He has to prevent the formation of replacing antibodies and in terms of proof of concept, we believe that.

It's it's fairly simple measure that we would administered a gene therapy together within tour and we would check for the <unk> off new Disney antibodies within a certain time frame you know 30 to 60 days <unk> and you know would obviously look forward to prevention off.

Formation antibodies, which is a good indicator that were able to retreat and and give a second dos.

I don't think so much for the time.

Thank you.

Thank you we have next question something I know 'cause onto croissants from William blend. Please go ahead.

Thanks, taking the question I just was curious to know in the pivotal trial.

Oh do you intend on or could you enroll kind of kidney transplantation as well as crystex experience patients or would likely be a naive uncontrolled outpatients and then I have a couple talks.

Hey, rochat good questions. So yeah, I mean, we would exclude to patients with a kidney transplants and we would also exclude patients have been treated with Chris sex or prior so we're looking to a recruiting the east patients to the pivotal study.

[noise] Grand then thinking about the covenant, whom situation from a a different angle have you spoke with Rheumatologists that would that have said anything regarding you know the benefits of obviously increase durability or a increased frequency of of dosing.

Very anecdotal information you're hearing.

In regards to S.L. to 12, specifically or.

Yes.

Yeah, I think I mean.

Obviously, you know one of the advantages off F.D.L.D.S.L. to 12 potentially he is that we are only ghost once a month you know which is is.

<unk> when you have to come in for wanting fusion per month I didn't get important pieces that are <unk> are you know still very dedicated to treat patients with quantum hectic out.

You know if they would be taken off <unk> off decompensation, which means they could have senior <unk>, which would often times you know leave them to go to the emergency room, which is probably not the best place to be at the moment give them coded 19, and the other consideration as often times skyscrapers are treaty.

<unk> you know, what's your immune suppression, which is also something that you know from tall, just try to avoid at the moment as well.

Great and then on the gene therapy platform.

There's only a couple of presentations at S.T.C.T. is there anything that you were kind of learning from the the increase data sets as far as a treatment paradigm into holiday V. and then look like from the abstract Indy and they may presentation that you saw.

Maternal utilizing antibodies were.

Didn't matter in in pretty juvenile mice anything you can only for the color that you can provide their or will there be submitted calling the poster on that.

Yeah, we'll provide additional color with the poster, but <unk> questions two k. to to get a bit more color at this point.

Hi, Yeah. So.

It was actually a very interesting observation. So we were looking at the pups porn to mice that had.

The existing antibodies to to.

The <unk> transgene and what we observed for what is when we get it tore together with the A.V. factor.

We had much better survival, even in the presence of those maternal a transfer down and body and this allows for read those saying and eventually we were able to rescue all those mines. So it. It's a very interesting study and encourage you to to kinda tune into that.

They think sober questions and government program.

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<unk>. We have next question from the line up your enjoyment from Jenny. Please go ahead.

Hi, So a full question on the corporate <unk>, it's good to know that that <unk> <unk> <unk> impact, but I wonder how much flexibility you had in terms of but <unk>. It's a patient is not available to go to the patient centered on specific <unk> is that is it acceptable.

You go if you're in an alternative and how much you have <unk>.

Yeah. That's that's a great question, yes, you do have indeed, some flexibilities around a dose saying.

It's it's kind of plus minus five days. So in case you do Miss <unk>, you are able to be rescheduled or you know we had this previously which I mentioned, if a size wants to shut down there. It's obviously the opportunity to go to an alternative site to get the infusion say, yes. There is.

Identity around the dosing I think the other piece you know that it's important lacrosse and I think there that the protocol also allows for flexibility. The patients don't have to go back to their initial site that can go to alternative sites or alternative laps closer to their home.

We will see explored potential home nursing a basis for black draws so we also dan providing flexibility insurance lacrosse as well.

Okay, and then <unk> wanted to confront that <unk> program to enter the clinic, it's gonna be the M.M.A. and go to your main objective you're looking at <unk> or a dose impatient that have <unk> everybody. We're both and for the O.T.C. program are we going to wait for new show proof of concept.

Data from M.M.A. program to start.

The O.T.C. proof to move to L.T.V. program into the clinic.

Yeah. So.

We have a discussion the past so and it's a was our program that we put into the partnership with asked bio.

We haven't guided which program will be the first to grow into the clinic. So you know as mentioned earlier will guide.

Throughout the year, you know, which the first indication will be but enemy is part of the collaboration with asks bio.

In terms of O.T.C., we're still working through the plans, but you know we we planned to continue with our efforts around Oh T.C.

And just kind of go back to the initial question you know what we're trying to demonstrate obviously ultimately we want to demonstrate that we are able to successfully read goes in M.A., but the initial you know early read we believe which we did quite impactful if we can show after the.

Cristo's, we can prevent formation off because an animal bodies I mean, that's you know would enable the the second goal was basically.

Okay, great. Thank you very much particular questions.

Function.

Thank you <unk>.

<unk> by one on their touched on the phone now.

We have next question from the nine John Human from kind of court. Please go ahead.

I guess good morning. Thanks for taking my question, then congrats and all the process C.D. progress given coding so.

My question is you gave us an interesting data.

At the end of 2019 regarding the initial dropout rate for the two different groups of the study it appeared that the active control group Dropouts number was higher.

Just wondering what's your opinion is on what we might expect.

During the Kobe crisis, given that the active control arm is still is twice a week.

Is it feasible to expect that they would be more patience potentially [noise] dropping out are missing infusions, because they have to go into the center.

Often then youre drug which is given monthly thank you.

Yeah. That's a good question, John and I, you know I don't want to speculate on on the data I think it is sad to say, but the patients and the P.I.S. are motivated in the study in both arms.

But but I think there's definitely a benefit you know with or without Coolidge to only have to come in once once a month, but I I don't expect any actual data, but we definitely feel very strongly as a key differentiator Oh actually out to 12 is the the monthly.

Regimen.

Okay, Great if I may I ask one more question.

You know in the earlier data that have been presented for 212 <unk>.

<unk> have been quite low.

I'm just curious as to.

How you plan to analyze the golf players and when you compare study just curious as to what types of analyses in general that you'll look to do between the two arms next.

Yeah, and lots of great question, and and as you know John EM Eh gout <unk>, it's a secondary and point in this study. So we'll have been looking at the the number all scouts now so that's that's built in G.D. analysis, but I think there's also other analysis, we can do as well for example, we can look.

The news off stick them coming use of steroids for example throughout the study which is good indicator as well in terms of you know the patients experience scouts garrison obsolete as a as a clear trends in a treatment. According to affect your guy out we're positions tried to reduce the the use of steroids and I think it's even more.

Now with the Coby crises were <unk> quite you know nervous around mainstream height, though so it's <unk>.

Great. Thank you.

Thank you Joe.

Hi, <unk>, we have next question from the line of defense again from.

Do hosts each allergies gets caught.

Hi, I'm to mine and things like cooking My class Chair [laughter], how Paul which we expect a permanent C.M. ought to be ball like a boy <unk> 212.

Yeah. That's that's a good question display we we're very pleased to have Peter <unk>, our acting Simo, Peter Brandish, a lot of experience, both from academic medicine, and and big pharma and biotech.

And you know we we.

Might potentially start a search box and now you know Peter is overseen to compare trial and and also the preparation for phase three so and what's important to known as well and we have a very strong team be no Peter but.

<unk> program manager has been on S.L. to 12 since the beginning so we have a very experienced team be loaded as well.

Couldn't feel <unk> kill program, Oh, Oh, <unk>, <unk>, <unk>, <unk>, <unk> <unk>, a little going <unk>.

Level off eight to follow.

And well to help us <unk> change.

<unk> 40, <unk>, just a week hopefully won't be fun are close to me though.

Yeah.

Yeah. So we we actually changed the inclusion criteria.

Pretty early on to help with the speed off Recruitments, you know, obviously by definition that patients with and she levels above 6.8 or consider its you know chronic the factory. They have previously failed on C.M.U. you're in luring Ah.

Compounds like on a core no for example, and to have at least one two of our present. So it is still a very severe patient population. So we don't think there's a.

The difference here the key drive a boss here speed off recruitment.

In terms of physical plan I think we you know we we have discussed previously we have not guidance to that in detail, but you know important to know that the study is powered to show statistical C.P.R.T. in terms of control.

Thank you.

Thanks to thing.

Thank you again to ask questions participants, but trust stop followed by work Yeah next question plus the line up <unk>.

She wins like just go ahead.

Hi, This is <unk>. Thanks for taking my question. So how about if the I'll go until I mean.

<unk> sometime in tiny tiny how long would you <unk> <unk> <unk>, it's the one item.

What time 0.0, then are you planning to run one day, one k. pre trial because they didn't have the airports truculent to thank you.

Yeah. Thanks, nice to meet you in and thinks a crush round face three so asked me if guided previously we plan to do to run to say three studies. They are two six months plus <unk> studies with them.

One study, having a six months safety extension. So that one study obviously will be the key driver into himself timing.

We plan to start to face tree in the second half off this year and we feel we're still on track for that we have one guy that too speed off recruitment, but you know once we complete recouping. It's basically we'll have a read out off the six months study and then we'll have a another readout after.

12 months.

[noise]. Thank you and that's the next question you see that you direct competitors in her eyes, it's a clothing additional discovery programs in the Gulf state to maintain that leadership. So do you have any similar <unk> fine type.

Yeah. That's a great question I mean at this at this point were strongly focused on S.C.O. 212, and a you know bring it into phase three and the second half Oh this year.

And it's you know I think that's that's our our key focus at the moment.

Oh.

Okay and that could be my final question. So.

I I understand that feeling three and three instead of two parts slated to enter into the cleaning. The fear maybe if you can talk about you know, especially I would <unk> collaboration.

Remaining dating I tends to be complete that you know from the U.R. and and brought out the items that <unk> in order to facilitate the entry.

Yeah. That's a good question. So I think first of all we we have thought guided to the specific indication, but you know what's important that we we bring.

Both you and an eight coping when the collaboration and <unk>. We are responsible for the manufacturing off of <unk> and asked biased response me for the manufacturing off off the A.V. caps, it and and the Connelly focused on those on those things and be that join to decide on.

Indications are we going to move forward with.

Oh.

Okay. Thank you so that's a crummy.

Thank you.

Thank you.

Last questions Express Tar one.

Thank you. This concludes the questionnaire nonsense works you know the call.

Oh, well now back to turn back over to select a scene you constantly <unk> <unk> <unk> a constant [noise].

Yeah. Thank you operator, and and thank you to everyone who joined up this morning were extremely excited about the upcoming milestones in 2020, and the continued growth for a company and our platform. We look forward to sharing further updates about that brought potential off the into platform throughout the year that concludes today's call.

Thank you.

Thank you very much.

That concludes this conference call. Thank you put training with that sounds human out disconnect you lines.

Yeah.

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