Q1 2020 Earnings Call

Good morning, ladies and gentlemen, and welcome to the Junos. Your first quarter 2020, <unk> conference call. At this time all participants are in a listen only mode. Later, we'll conduct a question and answer session.

And instructions will follow at that time.

If anyone is your require assistance during the conference. Please press Star then zebra on your Touchtone telephone as a reminder, this conference call is being recorded I would now like to turn the conference over to your host Das area of lifestyle advisors.

Thank you operator, and good morning, everyone.

Earlier today, we issued a press release that outlines the topics we plan to discuss today.

This release is available and should know should dot com under the investors tab.

During the call today Chip Clark President and CEO will provide a brief corporate update and the company's chief Financial Officer.

Sure Dan for Duvall will review the financial results.

After their prepared remarks, we will open up the call for Q1 day and chip Diantha.

Tom Davis General shows Chief Medical Officer, and Jessica Lakner Judicious Chief Scientific Officer.

I will then be available answer your questions.

Before we begin I would like to remind everyone that statements made during this conference call.

Relating to Jewish as expected future performance feature business prospects or future events or plans.

May include forward looking statements as defined under the private Securities Litigation Reform Act of 1995, all such forward looking statements are intended to be set.

Object to the Safe Harbor protection provided by the Reform Act.

Actual outcomes and results could differ materially from those forecast due to the impact of many factors beyond the control Junisha.

Junisha expressively disclaims any duty to provide updates to its forward looking statements, whether as a result of new information future events or otherwise.

Participants are directed to the risk factors set forth engine Osha's 2019 annual report on form 10-K, and other periodic reports filed with the Securities and Exchange Commission.

It's now my pleasure to pass call over to chip.

Thanks, Dan and thank you offered.

Today.

I'm pleased to record nurture remains on track with our two.

Currency aided clinical stage program Gen nine our new oriented.

And gentlemen, our neoantigens cell therapy.

Let me first speak more about Gen nine.

Throughout the quarter, we have continued part b of our phase one two a clinical trial, which test.

Jim nine in combination with standard of care checkpoint inhibitor therapy in patients with certain checkpoint sensitive tumors.

We believe we have attained sufficient enrollment to reach a preliminary conclusion about clinical efficacy.

Therefore, we have Paul.

As expected in the first half of 2021.

We believe gentle Evan is a potential best in class adopt.

T cell therapy.

Targeting an unprecedented breadth of relevant neoantigen.

Avoiding unwanted expansion of deleterious T cell.

And employing peripheral blood in a rapidly scale.

Global manufacturing process to treat large cancer patient populations.

On May 12, we will host a.

T cell therapy symposium with Dr., Eric Tran.

Who generated transformational data showing the potential of til therapy.

As a national Cancer Institute fellow working with Dr. Stephen Rosenberg.

Dr trend will provide a brief overview of the current T cell therapy landscape.

Including the evolution of adoptive cell therapy.

Okay and lots of life caused by the pandemic.

Like many companies covered 19 more directly affect our way.

Doing business too.

All but select employees performing central lab based functions have been working from.

Home since mid March.

As a consequence, we have had the scale back our critical research activities.

I am proud of our team because despite these challenges we continue to make significant headway on our objectives and look forward to continuing our progress.

Im now going to pass the call over to Diantha to summarize our funding.

Cancels from this quarter.

Before opening the call up to questions.

Okay.

Thanks, Chad and good luck.

Good morning, everyone.

We ended the quarter with 26.5 million dollar you cash cash equivalents.

Our operating results.

And our net loss was $12.9 million compared to $15.6 million.

Same period in 2019.

We reaffirm our guidance at our existing cash resources will be sufficient to support our operation into the first quarter of Twentytwenty one.

We are optimistic that our clinical progress Gen nine and gentlemen, really meaningful catalent, however, decoded nine related market volatility and the global economic slowdown.

It had a significant adverse impact on market reaction to our catalyst and our potential ability to raise additional capital.

We continually evaluate market dynamic and our business needs. During these challenging time as we look to continue to progress our preclinical and clinical program.

With that let's now open up the.

Paul for questions operator.

Ladies and gentlemen, if you have a question at this time. Please press the star and then the number one key on your Touchstone telephone. If your question has been answered or you wish to remove yourself from thank you. Please press the pound Keith.

Your first question is from Ben Bernanke with Stifel.

Hey, thanks, so much.

I guess, just just a quick question on Gen. None.

We are looking for adequate numbers of patients.

With all of that would allow us.

To assess that preliminary activity readout.

So it's a small population that were initially looking at and of course in order to have adequate information about the in act of the vaccine of Gen. Nine in each patient will have at least three months follow up on all of those patients.

Okay Thats fantastic.

And if I could just ask one follow up question on on the Gen 11 program.

Do you I guess now this is sort of approaching the clinic view at this point have.

Do you anticipate having to lend politically patients and or administer aisle too I mean this is something that's done in a lot of till programs. I was just curious how youre thinking about this with regards to June 11.

Yes. These are really important questions. The field is debating who is not just us as you can imagine, but I'll have Tom Hi answer our thinking on this question.

Well.

Yes, they did a great question.

As you noted.

Both limited lesion and aisle to are thought to be important for specifically til therapy.

And most of the research have focused on the use of those in this particular technology. However is not entirely clear whats necessary.

For the field in general during the trial to is not used for car T.

I think the question has not been answered.

So our clinical trial for general Evan will start out with a dose escalation.

And at the low dose, we will not be deploying lymphodepletion.

And and aisle to therapy, I will essentially be seeing what the gentleman cells can do in vivo.

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And then.

Sure leader.

That's very interesting great. Thanks, so much guys appreciate it.

Thank you Ben.

Your next question is from Dana Grey bars with SVB Leerink.

Hi, Thank you very much I had two question as you called enrollment and the general nine study can you give us a sense.

The patient indication is that you've enrolled which generally types, whether you had any the enrolled that were.

Hi, grasp on their check point before adding genuine and then I'll I'll wait so you're answering for my second question.

Sure David Thanks for the question and once again, I'll hand back to Tom to answer.

Yes.

So as the basket study as you know we have five tumor types that can't.

And enrolled and we have had patients from each of those five tumor types put onto the study.

At the end of the day, we'll be looking across the spec.

Some of tumors, some of which are very responsive to checkpoint inhibition.

Others, which are not.

We would expect to have data from at least one of each tumor type and more of some.

As you might imagine the tumor types that are less responsive to standard of care in this setting.

We'll contains on patients who have progressed as you ask.

And where possible we do plan to continue to.

We do also have patients who are.

Controlled well by checkpoint inhibitors, they may be less of the challenge and we're certainly going to be collecting data there as well.

Great.

And my second question is more of that scientific theoretical one for Gen 11, I heard more investors asking about that.

Thank you systems, Fedex dendritic cells, and making polyclonal T cell populations birth is patients Ellen dendritic cell and I Wonder if you could talk about what Youve Explorative, Jenny 11, and why you've made that the JCB made going forward.

So so Dana your question, specifically as well if we have use the patients own.

Dendritic cells versus synthetic and why we made that choice is up the question.

Yes, and wet and will ultimately, we're taking Florida, ingenue 11, and I realize you might address the up a lot more in the opinion at scale data as well.

You're absolutely right that we'll have a ton of information and Mikael data, but I think Jeff can still speak.

Second our CFO can still speak to what we what we have done and why so Jeff.

Hi, Dana Thanks to the question.

Yes, that's synthetic APC, they're very interesting because it's one more facet that you can control and your manufacturing process.

But they have limitations Joel incur.

Well that we derive from their peripheral blood in our manufacturing process.

Okay. Thank you.

Thanks, Dana for the questions.

Your next question is from the line of Mike goals with Baird.

Hey, guys. Thanks for taking the question just had one on Gen 10 nine.

You're guiding to.

Like preliminary part B data in the third quarter are you thinking more of a topline release are you targeting in particular medical meeting.

Yes.

And then just secondly, a follow up on some of the earlier questions in terms of what to expect with that data link.

You can you characterize the number of patients a small but I wonder if you can maybe give us a little more clarity on what you mean by that.

Yes, Mike Thanks, Uzi, Thanks for the questions I'll have Tom take.

Good morning being.

And we'll see what patients can play through the process by the time, we want to present data to answer your question.

So we're expecting to have.

Yes.

Where between.

10, and 20 patients.

You enough patients at least to be able to see some activity in this setting and of course as you know our specific focus here is going to be looking.

Or specific changes in tumor bulk after initiation of vaccination. So each of those patients will be serving as their own control.

Could be applied but of course is timing is such that it's more appropriate for us to presented.

Separate from an academic meaning we could do that doesn't stands right now we're not giving specific guidance as to where we would be sharing the data with you.

Certainly we're on track is just today and expecting to be able.

The shared with you in Q3.

Great. Thank you.

Thanks, Mike.

Your next question is from the line of Gil Glum with Needham and company.

Hi, guys. Thanks for taking my quick.

During the pandemic, but I will say that generally speaking what we have found from the Gen nine clinical trial experiences that.

Cancer care continues to be products.

Prioritized first of all and second of all that our team has done just a terrific job of.

Sweating, the details and ensuring that our.

Supply chain holds together.

Able to provide more concrete guidance.

And granularity on the Watson wins for.

Patient data there.

Thank you.

Sure.

And just as another one I mean, considering uncertainties around the financial market you guys looking at partners. These days.

Oh of course, we we were looking at partners before the the current.

Uncertainty in May and the capital markets and so we continue to evaluate.

But.

Okay product specific partnership opportunities you meeting gentlemen.

Women are genzyme.

As well as the possibility that our Atlas platform maybe.

Yes.

Okay.

We use to potential partners for their own programs, presumably not competitive with Genzyme and gem 11, and so as we think about capital strategy that is.

Vital.

Way in which we can advance with story alongside things like issuing new capital.

Excellent. Thank you for taking my questions and good luck.

Thank you.

Your next question is from the line of Joel that get us with H.C. Wainwright.

Hi, good morning, everyone.

Impact by coded.

On may making the decision to pause enrollment because even though cancer studies continue the earlier studies have been impacted.

Joe Thanks for the sentiment of course and also thank you for the question.

Tom I'll, let you handle that question.

Sure. Thanks, Joe.

So this is a pre planned.

Interim although not a formal analysis.

We have accrued quite well I think it's wonderful both 50 patients of course, our interest in participating.

Yes, and the sites have been actively capturing patients and we've accrued at a very good number.

Drummond as well as the side of lots that are going to be the core of our data reading out so I think into big picture.

Sure we're right on plan with the trial were not shortening things because of coated and we will be able to compensate for any compromises that do come along the way because of the current vanda.

Got it I appreciate that.

Thanks for that and then on 11.

Yeah.

Touched on it very briefly during these talk.

Here and I'm sure, we'll hear more on May 12, but just want to talk about manufacturing a second and Jeff touched touched on this as well.

When you look at the evolution of till therapies, whether its Io vans is either evolve from ends.

Yes, I or beyond.

A key Investor question has always been do you have come from commercial manufacturing ready to go sort of.

The fact that Youre getting these from peripheral blood is an important steps it Jeff I believe you mentioned that you have an industrialized process. So I guess what are some of the outstanding steps.

To be able to have a commercial manufacturing process.

In hand.

For upon approval and.

How should we look at it overall.

Yes, Joe so thanks for the question is your highlighted.

Acquiring we believe substantial process innovation, if we wanted to go from.

Lost their scale of the proposed clinical trial to something that would be.

Obviously, if it works commercializable.

Okay.

Immediately we think that process itself could work and so will speak in a couple of weeks to the specific elements of the process and why.

This is the case.

Got it very helpful. Thank you.

Thank you.

And at this time there no further questions.

So with that then I will say, thank you operator, and thank you to everyone for joining us today.

Ladies and gentlemen. This concludes today's conference call. Thank you for your participation have a wonderful day you may all disconnect.

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