Q1 2020 Earnings Call

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Greetings and welcome to the auction Therapeutics incorporated first quarter financial results Conference call.

At this time all participants are listen only mode. Great question, and that's just will follow the formal presentation.

What should require operator system during the conference. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.

It is now my pleasure to introduce your host Mr. Rich Vincent Chief Financial Officer. Please go ahead Mr. gets it.

Thank you operator.

Good afternoon, everyone and thank you for joining us.

I'd like to walk you need to our business update and 2021st quarter financial results Conference call.

Joining me on the call this afternoon, or our president and CEO Dr., James Bright Meyer and our Chief Medical Officer Dr. Frank shoe.

Today's call includes a business update and discussion of our 2021st quarter results, which will be followed by Q1 day.

Please note that today's press releases available on the Investor Relations section of alternatives website.

Earlier today, we filed our 10-Q for the first quarter 2020.

A replay of today's earnings call will be available on the Investor section of our website for at least the next 30 days.

Please note that certain information discussed on the call today, it's covered under the Safe Harbor Harbor provisions of the private Securities Litigation Reform Act.

We will be making forward looking statements. During this call about future events, such as our business and product development strategies and future financial and operating performance.

Our actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with our business.

These forward looking statements should be considered in conjunction with and our qualified by the cautionary statements contained in todays press release, and our SEC filings, including our form 10-Q for the quarter ended March 31 2020.

This conference call contains contains time sensitive information that is accurate only as of the date of Thislife broadcast may 7th 2020, we undertake no obligation to revise or update any forward looking statements to reflect events or circumstances occurring after the date of this.

Conference call.

With that it's my pleasure to introduce our CEO, Jim Bright Meyer.

Thank you rich.

And good afternoon, everyone.

I'd like turn all we're committed to developing novel treatments for patients with cancer, who have critical unmet medical needs.

We are advancing a robust product pipeline with clinical and preclinical product candidates that target several such cancer indications.

Our development efforts focus on untapped biological pathways implicated in cancer, Genesis and or progression.

In the first shorter quarter, a 2020, we've made steady progress on all four of the cancer indications, we are studying [laughter] without clinical product candidates.

And this includes the clinical trial studying teekay to 16 for Ewing's sarcoma and the clinical trial studying certain choose a map for mantle cell lymphoma or M.C.L.

Well, its breast cancer, and chronic lymphocytic leukemia or CLL.

We are particularly enthusiastic about the 50% complete response rate, we recently reported for patients with the mcl treated with the combination of so choose a map and a burden.

And the 28.5% response rate, we recently reported for patients with relapsed Refractory York sarcoma treated the PK twosixty.

Everybody is thinking about Kobin 19, and its effect on the biotechnology industry.

Oh Boy I can report that I turtles programs continue to move forward and her employees are doing a wonderful job of managing the challenges related to the pen Dan.

I'm turtles first priority during this unprecedented public health emergency has been protecting the safety of the patients on our clinical trials along with the safety of the staff the clinical sites and out of our own employees, while ensuring regulatory compliance in data integrity.

Enrollment of new patients into our studies have slowed as reported by most other drug developers, but we'll continue to enroll additional relapsed refractory patients into the Ewing's sarcoma study in the last few weeks. Despite cobot 19 related constraints highlighting the excitement that our recent deep clinical responses.

Teekay Twosixty have engendered among investigators and the patient community.

We believe we have adequate supplies of Teekay to 16 in certain choose a map clinical trial material through at least the end of 2021.

Well, she our interbody manufacturer in China is back to full operations.

Preclinical studies of Teekay to 16, and certain choosing member continuing but many of the laboratories of our academic collaborators are in partial locked down. So we do expect some delays in preclinical results concerning potential new indications.

Overall I'm happy to report their nocturnal remains on track to meet our previously disclosed clinical data milestones for 2020.

And I will review them for you shortly.

I will now called turn the call over to our Chief Medical Officer, Dr. freight shoe, who will provide more detail on the clinical programs.

Oh, Thank you Jim I'll spend the next few minutes updating you on the progress of or clinical programs and taking you through more end caps I look at a diverse product candidates.

In April 2020, we announce in interim clinical data update for Teekay to 16, which is a novel investigational small molecule inhibitor.

Targets, the 26 transformation specific where you too yes.

Family possible proteins.

In our ongoing multi center phase one clinical trial weve been investigating the effect.

I'll just agent in patients with relapsed or refractory ewing's sarcoma, which is a relatively rare and it really difficult to treat malignancy.

As of the data cutoff date of March 26.

2027 patients have been treated at the recommended phase two dose for the Arctic too deep.

Two Kate at Teekay to 16, which is.

200 milligrams per meter squared per day for 14 days with or without been Kristen.

Patients where valuable for clinical responses.

To the seven patients 28, and a half a percent had cheat the partial response.

Two had stable disease and three had progressive disease two additional patients had rapidly progressive. These early in the first treatment cycle and accidents trial before being evaluated for toxicity. Your African CN per protocol will replace with two new patients.

Both responding PR patients I remain on treatment on are doing well.

One of these patients receiving a single nation Teekay to 16 had a complete regression ball metastatic lung lesions, except one.

After maintaining a sustained PR on T.K. to 16, and then to Teekay to 16 plus Christian.

The last residual long lesion was surgically removed and so the patients achieved a surgical complete remission.

The second responding patients.

Achieved 90% reduction.

Target lesions and resolution of non target lesions following two cycles, a PK to 16 combinations and Christian.

Overall safety events associated with Teekay to 16 happened manageable.

For instance related events such as Neutropenia have responded quickly did you see itself.

No I'm going to switch the discussion over towards serve choosing that program.

In March 2020, we announced an interim clinical data update for CIRM treason map, which is a ror one targeted monoclonal antibody.

In combination with the burden of <unk> in patients with relapsed refractory mantle cell lymphoma enrolled in our ongoing phase one two clinical trial.

The new data indicate that six or 12 of valuable patients or 50%.

Achieved a complete response by Chessen criteria.

One is the six had a complete that bulk responses churn by pet scans.

Overall, a best objective response, a CR or PR response rate of 83% was observed.

We believe these results compare well to reported outcomes from rudeness or other BTK inhibitors and similar mcl populations.

Not the same time to seal a portion of our ongoing clinical study.

Continues to enroll and treat patients.

34 patients were enrolled into the dose escalation expansion portions of the study.

As expected that all active patients in this move will reach actually one year of therapy by the second half of 2020.

We are playing to update both be mcl and COO data from this trial add enough coming medical meeting.

Now regarding breast cancer, which is an ice tea study, we expect additional clinical data to be available from the phase one.

That scares sponsored study.

CIRM plus taxol inpatients with her to negative breast cancer in the second half with 2020.

Now a final program is to develop and over Ror one car T cell therapy in February 2020, we presented ror one car T preclinical data at the Ascos sits C.

Critical immunology symposium.

For one car T cell therapy demonstrated expansion.

Persistence and anti tumor activity in an animal model of human keep me.

This research is being conducted by our collaborators at the University of California, San Diego, where you see San Diego under Grant from the California Institute Regenerative medicine, otherwise known as CIRM.

Now this work continues through a partnership with Shanghai pharma.

The timing of the program has been delayed due to cope with 19.

Pandemic events in China.

And our goal is now to initiate a first in human study in 2021.

Finally before.

Performing clinical trials has been a challenge during.

During the cold at 19 pandemic.

On Colonel has been fortunate to remain active and be able to run or clinical studies.

He has continued to roll new patients. Although it is a slower pace and have worked with or investigators and their sites to maximize continued visits and treatment over existing patients when possible.

In addition, we have worked to provide self administered medications directly to our patients to help or just travel.

And we had been working to develop a broader network from sub investigator sites to help administer ivy drugs closer to home.

These efforts and combined with the dedicated dedicated patience and tremendous investigators for whom we are very thankful have allowed us to continue to treat her patients in our studies and trials.

Now I'd like to turn it over back over to Richard Johnson, Our Chief Financial Officer.

Review financial results.

Thank you Frank.

In October 2017 sermon awarded an $18.3 million grant to the researchers at the you'll see San Diego School of Medicine to advance our phase one two clinical trial evaluating some to some abbott in combination with ibrutinib for the treatment of patients with B cell lymphoma malignancies, including.

Mcl and CLL.

We are conducting that study in collaboration with you see San Diego and expect to receive 14 million and development milestones on a research sub awards throughout the award period.

In conjunction with this award our grant revenue was point 6 million for the first quarter ended March 31 2020.

Our total operating expenses for the quarter ended March 31, 2020 were 5.3 million.

Research and development expenses totaled 2.7 million in general and administrative expenses totaled 2.6 million.

Net loss for the fourth quarter was 4.7 million for a loss of 31 cents per share basic and diluted.

As of March 31, 2020, we had 16 million in cash and cash equivalents.

We believe these funds will be sufficient to fund our operations into the fourth quarter of 2020.

As of March 31020, we had approximately 15.4 million shares of common stock outstanding.

Now I will turn the call back to our CEO, Jim Bright Meyer.

Thank you rich for that summary of our financial results and Frank for the clinical summary.

I would now like to highlight the upcoming milestones that we expect to reach over the next several months.

Despite the disruptions related to the covered 19 pandemic, we remain on track to achieve the same key clinical data read outs portion, which is a map and T.K. to 16 that we had planned for this year.

Specifically.

We expect to present clinical data from seven to 12 patients with relapsed refractory ewing's sarcoma would've been treated with Teekay to 16, plus vincristine and the expansion cohort of the study in the second half of 2020.

We expect to present, a clinical data update for patients with mcl treated with certain twos amount plus a brutal lib.

Moving data from 15 patients in the dose finding an expansion cohorts of the phase one two study.

In mid 2020.

We expect to present, a clinical data update for patients with CLL treated with certain twos amount plus ibrutinib, including up to 12 months a follow up for 34 patients in the dose finding an expansion cohorts of the phase one two study in mid 2020.

We expect a clinical data update to be available from the phase one be investigator sponsored study of some twos amount plus paclitaxel in patients with Hertwo negative breast cancer in the second half I'm pointing toward.

We expect to treat the first patient with our ror one targeted car T. In the first half with 2021.

Collaboration with Shanghai Pharma limited.

In closing we have a well defined work plan ahead of us with multiple potential catalyst in 2020, and a clear priority of deploying our financial and operating resources to advance our product candidates in multiple clinical indications to benefit patients.

With cancer.

We look forward to updating you during the remainder of 2020.

With that I'll turn things back to the operator for the Q and a portion of this afternoons call.

Thank you well now be conducting a question and answer session, if you'd like to ask a question.

Yes, so our one on your telephone keypad a confirmation total indicate that your line is in the question Q. You May proceed start to if you'd like to remove your question from the Q.

For participants using steeper equipment, it may be necessary to pick up your headset before pressing the star keys, but.

One moment, please while we pull for questions.

First question is some hard Taj, saying Oppenheimer. Please go ahead Sir.

Oh, great. Thank you for my question and Jim should add one Oh, that's great that you're continuing on the work or is this a pretty he's pandemic. So thank you for that I'm, just a couple of questions and yeah. Thanks for the you know the upcoming milestones that those are very clear there's lot of data from over the next thanks.

Nine months Oh My question, specifically on regulatory interactions. So if you could just maybe just walk who you are starting to some Abbott MTL in CLL and then do you get to on six once you presented data what are the key regulatory interactions you expect after that and then the second question. That's a follow up to that would be it.

Each of these three you know would you expect to sort of go into that next range of clinical trials and would any one of the treaty that trial that would be something accelerated approval.

So like trial and ideally 2021 that I got a quick follow.

Thank you Hartaj, that's a that's quite a compound question. So so I'll start out a and this is Jim I'll start out and and then turn it over to break so from the <unk> from a regulatory perspective.

We have always believed that.

Let's start with Teekay Twosixty, we've always believed that a the evidence of objective responses in a relatively small number of patients would be sufficient to.

Go and discuss the Teekay to 16 program for Ewing's sarcoma with the FDA because the treatment landscape for Ewing's sarcoma is so a dismal with only a single combination regimen is as frontline standard.

To the care and no standard separately.

So as you can imagine we're encouraged by having had to a substantial clinical responses out of the first seven patients would the phase two regimen and we believe that up.

With a little bit more data that we would be ready to go to the FDA and talk about a.

Pathway to an excel the salary that approval that would be based on objective response rate.

Our T.K. to 16 in Ewing's sarcoma.

In mantle cell lymphoma.

We believe that a 50% complete response rate with the combination of Ibrutinib plus CIRM twos amount is notable compared to Ibrutinib alone.

Particularly considering a an interesting.

Safety profile that appears to be a toe to have fewer adverse events. Then other E group NIM combinations that have been presented recently, so we we think that.

We are quite close to having enough information in mantle cell lymphoma to have a discussion with the FDA about a potential accelerated approval.

For CLL with the data that you've seen so far and that we discussed today, we think that we needed a little bit more time for the day them to mature.

To see if we would go to talk to the FDA about a complete response and point or a progression free survival and poorly.

And and so we'll know more about that after our next data update.

With that let me turn it over to freight show.

And let him discussed with you what potential.

Registrational studies might look like for Ewing's sarcoma and mcl as the next step up.

Thank you Jim.

This is obviously something which is very much.

Much on any discussion that are.

Within our group about how best to proceed.

As Jim has pointed out we have some exciting data both in Teekay to 16 answered.

Particularly with the math to self program that weve been highlighting.

Right now as Jim mentioned, we have some exciting Dave with Teekay to 16, which shows that.

We have activity.

We would like to expand on that and then discuss with the FDA potential registration pathways that might.

As bill alluded to be something which we hope could be a negotiated to limit.

On an accelerated program, but that's all within it did negotiations course.

The other main program is a mantle cell program as Jim mentioned.

We believe our results, which although a small group of patients a cold, but they hold up indicate that we have a very.

Active combination right now when compared to historical data.

And that is something which.

In negotiations with the FDA, there several pass and which one could imagine and accelerated trials assist us being set up for it but that is very very much something which we.

I'll have.

I have to have an ongoing discussion with the FDA. So it does nothing like that comment on about that until we get further guidance on that.

Great. Thank you thanks of the commentary and that's actually very very helpful. Yeah. The question I have is that you know you indicated that you've got enough drug supply drug mature it looks like to get through the rest of the year, you've got cash on hand through the end of year. How are you thinking I mean, if let's say you know your regulatory discussions.

Hi, good, especially after you present, the state and middle part of year sort of keyed up right.

Either.

You can start Kumar with Teekay 206, or NPL the term to demand to go into an accelerated approval kind of trial I know this properties are historically tend to be low it all depends on the data, but just how are you thinking about you know manufacturing and sort of from a cash in financial perspective, and how to get ready.

He or 2021 and again, thank you called the question.

Our does this is Jim. Thank thank you heard that question really around manufacturing strategy with a with a potential fast track clinical program. So we have we've reviewed alternatives and end up.

And we have we do have plans in place to continue to improve our manufacturing processes.

We're already happy with the way that we put that we're manufacturing both teekay to 16 in certain twos, a man and with some.

Some modest additional work we believe that.

We can produce a potentially.

Commercial grade material that and we do have a we do have a plan that.

That we think the CMC side of things can keep up with the clinical side of things even under a a best case fast track a regulatory pathway.

Of course, it's quite a juggling act with finances, and so we are very carefully gating spending on the CMC side.

To be.

Related to a clinical or clinical results. So that we're not getting out over our skis on C.C.M.C. spending.

Great. Thank you Jim. Thank you everyone. We appreciate all the questions.

Thank you for your questions hard time.

The next question is from Carl Burns Northland Securities. Please go ahead Sir.

Thanks for the question first congratulations on your progress and the impressive results. Today I was just wondering if there were any abstracts and presentation publications that you anticipate from the studies near term. Thanks.

Thank you Karl this is Jim and that's yes, that's easy we we you will see an abstract from us at <unk> at the ask go when the abstracts are disclosed in about a week.

Great. So that that's what they're just goes on May 13 for the 29 switches 30, Onest ask a virtual yes.

Perfect Okay.

Thank you huh.

We have a question from Robert burdens H.C. Wainwright. Please go ahead Sir.

Hi, Thanks for taking my questions and congrats on the quarter guys. Two questions for me if I'm right. So I wanted it first one I want to get your thoughts around the positive topline results. We saw from the phase three unity CLL trial.

And the fact that it was stopped early due to superior African say I you know I was wondering how you're viewing not just you know from a competitive landscape development and weather changes your calculus, a within development of C for serum Chisholm AD for CLL and then my second question. So I was looking at the end the investigator sponsored.

A trial in breast cancer for Serums isn't <unk> and I noted that no there including Bose.

HR positive urge you not going as well as triple negative breast cancer, but they exclude specifically through patients who had prior exposure to a taxane.

Now given the I am Pashtunwali 30 regimens that's in front line CNBC and you know the use of a other taxanes.

As single agent within the frontline I was curious how you're thinking about that you know, it's how you're thinking about the development of conservatism and that indication.

If the data is positive would you specifically exclude TNBC moving forward just considering how much of it is actually administered in the heartland setting. Thank you.

Oh, thank thank you Rob So let me I'll handle the breast cancer related question first and so so at when when this investigator sponsored study.

Was it.

Initiated.

The the triple negative results, including Taxanes.

Had not been presented and we didnt have any preclinical data.

ER and.

And on on prior Taxane exposure and response to subsequent Taxanes and term to them out and so where where we were the highest he is designed to get a.

Clean resolved.

With the with patients that are seeing a tax change for the first time. So so we will consider very carefully.

Evolving landscape.

And we we are a we're also doing we're we're developing some preclinical models to see yeah. Prior taxane exposure is an important factor for the.

For the.

Subsequent response to Taxanes, plus CIRM twos amount. So so basically I'm, saying, it's an open question.

So then.

Let me.

Turning over to freight shoe to discuss our results in the context of the CLL landscape.

Well as you pointed out the sealed all landscape has been changing.

Quickly and dramatically.

I'll begin to tease study, which you talked about.

Was stopped on the base a PFS so about a data hasn't.

Been released as far as I could find or know about except that it supposedly it is superior at this point.

So we'll need to gauge or make an assessment of that once the data has been fully.

To that but and released at the public but at the moment, we're still relatively early we do not know our overall effects on PFS. The PFS can take a bit of time with seal dollars, you're aware to mature and so.

I think that we are still showing some very interesting results.

That we've reported in the past so we have.

An active agent. The question will remain is whether or not we will impact PFS long term and you don't we don't have enough long term follow up with enough patients yet.

No the answer to that.

So there was that a weapon.

Im sorry go ahead, Rob go ahead, I thought I don't think Frank's comments real quick.

And for the update that's going to becoming a in mid.

2020 would there be any PFS data associated with that update because I know it for.

Phase one to mid twenties, when the update is they're gonna be any PFS data associated with it.

Right go ahead.

He on where we haven't released any of that data yet I'm I'm not sure how how much were embargoed, but as much data as we can will be presented at that meeting.

Okay. Thank you.

Yes.

And Rob you'll recall that we when we last disclose CLL data in March I take that the that we had not seen a single event. That's CLL disease progression. So on PFS was sitting at 100.

Uh huh.

And so we're certainly crossing our fingers that it is are there that that kind of can continuing a day to something near that might show up again, but of course, we don't know at this point.

Awesome. Thanks for taking my question.

No no further questions at this time.

Well it taking a call back over to Mr. rich Vincent for closing remarks. Please go ahead Sir.

Thank you operator and on behalf of all internal thank you all again for joining us today.

Every one stay safe and healthy and we look forward to future updates.

This concludes todays teleconference. You may disconnect your lines at this time. Thank you for your participation.

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