Q1 2020 Earnings Call

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I guess I'm all participants' lines are in listen only mode.

I think the speakers presentation that will be a question answer session.

The question Joint session. Please press star one your telephone.

Hi, Nicole.

Great. Thanks.

I like to head to conference over to your speaker today.

Our hair. Please Sir go ahead.

Welcome everyone and thank you for joining US with me today are Dayton misspelled interim CEO Junior box here, So easy P. research and development data review recent corporate events.

He will provide more details on a pipeline that people will provide a brief financial overview of the first quarter of 2020, well then open the call for questions for which we will all be available.

Before we begin let me remind you that todays conference call, we will be making forward looking statements that represent the companys intentions expectations or beliefs concerning future events. These forward looking statements requalified by important factors set forth in today's press release, a company's filings with the FCC, which could cause actual results to much.

Really differ from those in such forward looking statements information discussed on today's call is accurate as of today and we do not intend to propagate with that let me turn the call over to date.

Thanks, Paul Good afternoon, and thank you for joining us.

First and foremost everyone staying healthy and we would like to extend our gratitude to everyone who's working so hard to address the cold in 19 pandemic open the pot lines as well as those working to develop treatments in backing.

We are working and unprecedented times has anything else in companies around the globe meet challenges.

That's an he says you're prioritizing the safety of our employees and the patients and our ongoing decoupled and trial, while maintaining business continuity.

As you know children's place orders were mandated in the San Francisco Bay area in mid March and as such our employees have been working from home.

And we have worked closely with our sites in CLL to ensure that our phase won't be too that the burden of trial activities are in line with the FDA issued guidance on the conducting clinical trials during this pandemic.

Well, it's fine we continue to make progress on both a backup but net and PDK. One programs. We still expect initial response assessments for the 500 milligram cohort in the phase one piece of your benefit this quarter as well both assessments from patients from lower dose cohorts, we remain on treatment.

Well, there's potential for delays in back of recent development due to the impact from covert 19 that we work to address.

All such next steps and provide updates at the cobot 19 situation involved and data from phase one be portion of the trial emerge.

We continue to advance our proprietary PDK, one inhibitor SNS by 10.

In March we reported encouraging results from the in vitro combination study, indicating that as soon as 510 can combine synergistically with several drug classes.

We're completing I N D, enabling studies, Brett SNS by 10 with a target to file an I'd by the end of 2020 with that I will turn the call over did you need to go into more detail on our current progress.

Thanks <unk>.

We're currently in the seven cohort as a phase one day two trial exactly <unk> said.

Seven cases, the around treatment across three cohorts.

<unk> 405 hundred milligram.

See evidence of clinical <unk> and as Dave mentioned, we'll have you thought it was a 500 milligram cohort hersey sponsors [laughter] this quarter.

In a 300 milligram cohort stable is to see disease with absurd and three years heart patients.

<unk> is continue on treatment and is currently completing cycle 10.

Hi, Jason had a second response assessment, a stable disease like a 47% reduction in tumor burden improving from their initial 41% reduction and normalized team parameters.

Okay and is currently scheduled for a third response assessment engineering.

In California.

He was a three CLL patients had stable disease. Upon first response assessment, including Okay sounds like a 48 reduction tumor burden.

Okay and progressive disease.

Yes on treatment Guy investigator request as the patient is receiving benefits.

Three patients remain on treatment and are in cycle seven.

We expect second response assessment for the cohort to be available this quarter.

In California, seven to 500 milligram cohort fixation.

And with CLL and two with mantle cell lymphoma clarity safety evaluation period, and three of these patients remain on treatment.

Britain has been very well tolerated and a higher dose levels and we have seen an increasing exposure and decreases insider kinds remain consistent.

Of note patients and the higher dose cohorts 800 make the 500 milligram and apparently stayed on treatment longer than noticing a lower dose cohorts.

You're taking actions to respond to the challenges posed by the coven 19 pandemic patient safety and trial conduct aren't Paramount and we're taking appropriate steps to ensure I studied <unk>.

Covered 19 has necessitated changes based on protocols implemented at sites that minute nice resuscitation and site personnel.

So even assessments are being conducted locally and by telemedicine.

Staffing working remotely as possible and remote study monitoring has been implemented.

There are accommodations for study drug distribution directly to patients from site rather than requiring patients come in free see drugs.

I mean, most isn't it had an impact on timeliness of data collection and we're working with sites to address these challenges as we receive additional clinical data from the phase one be study, we will evaluate next steps in conjunction with how the pandemic evolve.

We will be providing updates as we move forward.

Turning to our other program Asinine 510, as a novel potential first in class inhibitor PDK, one a target of longstanding interests in the oncology community.

And then fine SNS five tenths interaction with T.K., one inhibits both PR three case signaling npis pixthree independent pathways integral to many malignancies and PDK. One can also be over expressed in breast lung prostate chemo logic and other cancers.

We recently reported that tumor mutations or deletions, and the syndicate and to 18, where particularly sensitive to Ethernet 510, and he true.

Adoration CDK until they are associated with many different cancer type.

As an aside can also show synergistic activity when combined with inhibitors CDK for six.

Okay rest you talk C or D. C. L. Two in breast cancer, K rationing and one common cell line.

Our congrats as soon as five tend to the R&D, enabling program and are in discussion with a number a tail wells as we establish pre clinical and preclinical collaboration suffer the characterize Ethernet side of town and it all clinical plans for solid tumor and human logic malignancies.

The investigator for your current have University expressed enthusiasm for the program.

For two assembling our clinical advisory boards in the coming month.

Transmitters that preclinical findings in the second half of the year.

I'll now turn the call over to date in three years financial results.

Thank you Judy in the first quarter, we continued backerboard moved and SNS by 10 development, while operating would not within our budget.

Cash used in operating activities was 5.7 million in the first quarter of 20 point as compared to 6.1 million for the same period in 2019, resulting primarily from the net loss of 5.8 million and changes in operating assets and liabilities.

Cash position at the ended the first quarter was 28.9 million sufficient to get us through our next milestones.

As you may have seen our chief financial officer weakening of the company recently to pursue other opportunity. We thank him for his efforts you have some nieces and wish him the best of luck in his future endeavors.

Our existing leadership team remains strong and we have appointed two megawatt as our principal accounting officer and promoted hurts, a vice President finance.

Joints in each is nearly two years ago with extensive experience, an accounting and finance in the biotech industry.

I like to conclude diesel most acknowledging the industry wide in parts of Coca 19, and I'm proud of the flexibility and commitment that our entire team has demonstrated to me paint business continuity. During this unprecedented time.

With that let's open the call to your questions operator.

As a reminder to ask a question you will need to press Star. One you tell sounds to me try a question. Please press the pound.

Please stand by vehicles like you many roster.

Our first question comes from the lineup, which I think chemo from Oppenheimer. Your line is open. Please ask your question.

Oh good afternoon, everyone. Thanks for taking my question the progress on escalation seems to be trending well and we're certainly looking forward the initial standard parking or mix.

Before you sort of get those results I was just for curious.

Appreciate the need to have progressed the study once reaching a clinically effective dose but are there any pod by which you would be able to expand the study while also exploring further dose escalation.

Either through sort of protocol changes that enable escalation.

Additional cohorts.

Yeah. Thanks. Thanks for your question all Judy answer that yeah. Thanks for the questions. So the kind of call. It on as it currently stands allows us to expand one or more dose cohorts to confirm a recommended there.

And we have made plans if the decision is made.

To a lousy dose escalation so we have amended the protocol.

Oh, Great and then maybe can you just walk us through the dose expansion process and what work might need to be gone follow identification of the phase two though.

Whether it's sort of increasing the number of clinical site I know currently there's a lot unless the.

Any RV approvals et cetera.

Yeah. So we currently have 11 site and we feel that's enough to complete a dose expansion.

So all that's really required to go to that stuff would be to hold a safety review committee meeting with our investigators and.

You can't approval to expand and at what doses them that expansion might occur.

Okay got it thanks.

And then my last question I was just maybe on sort of the patient baseline characteristics.

For those that weren't included in the Arash up they can you give her friends of maybe the baseline characteristics of the recent more recently added patients whether by disease severity or prior lines of treatment you know maybe on a high level, where they more or less consistent with the prior population.

So we'll give more details on a on patient population. We did note that we had our have for CLL and two M.C.L. king patients and we've seen a similar mix of you know he patients that.

Are more heavily pre treated and then a number of patients who are less heavily pretreated.

Okay, great. Thank very much and I'll hop back in Q.

Thanks.

Our next question comes from the line of Mark from from Cowen.

Your line is open.

Thanks for taking my question, maybe just follow up on my last one mentioned the per cost amended to potentially allow higher doses.

Yes, first what doses or amount contemplated within the protocol and then second your I guess, what will you be looking for from cohorts seven that would trigger you time democracy those.