Q1 2020 Earnings Call

[music].

Good afternoon, ladies and gentlemen, and welcome to the worker Therapeutics first quarter 2020, <unk> earnings Conference call. At this time all participants are any listen only mode. Later, we'll conduct a question answer session and instructions will be given at that time.

As a reminder, this conference call is being recorded.

So my pleasure to introduce your host Mr. Toady, Kim Chief Financial Officer. Please go ahead.

Thank you and welcome everyone to our first quarter 2020 earnings call.

A press release reporting our financial results is available in the news section of our corporate web site at marker Therapeutics dotcom.

Thank you for the call today, our Peter <unk>, our President and Chief Executive Officer, Dr., One Vera Chief Development Officer, and Dr. myself leasing Nair, Chief Medical Officer.

As a reminder, we will be making forward looking statements. During today's call. These statements are subject to risks and uncertainties that may cause actual results to tomatoes materially differ from does forecasted.

A description of these risks can be found in our most recent form 10-Q on file with the FCC.

I'd now like to turn the call over to Peter fall.

Thank you Jeremy.

Remember one of them boats with learning it's a before we get started I'd love to take a moment to address the totaled 19.4, making that as opposed to all those today [noise].

Most important all sorts of with the patients their families with them directly impacted and to the healthcare workers were on the front lines. We are a major great keeping yourself places, but he was also.

In the situation continues to evolve.

We remain nimble in our decision, making regarding our business operations and strongly focused on the wellbeing of our employees and the patients at least through with their health and safety, beating our top priority as such we implemented a work from home policy in March and continue to follow local and federal Health authority recommendations regarding trouble inscriptions quarantines and social distance.

Amongst other measures welcome to the buyers.

The situation remains in Flubs, it's challenging to predict the full impact emitted 19 pandemic, our business and healthcare system as a whole at this time, we are experiencing some immediate effect on the Tommy Board planned phase two trial in acute myeloid leukemia or amount, resulting from delays experienced by our supply chain partners.

Our team has worked diligently to mitigate these effects, but it's clear that these developments maybe negative they'll be worried email sorry, Michael we will address the details are in a situation just a moment, we remain optimistic and we do not expect long term material impacts.

Really the unpredictability liquor environment. However, it's around included 19 pandemic, we believe that it's prudent to withdraw probably guidance on the timing of or you know trial until the outlook qualifies for clinical and supply chain partners. We continue to monitor the situation closely of course and make decisions based on health and wellness of our employees with that I would.

Just to hand, the call over the mightily to give a brief overview of the current landscape on the clinical from Michael.

Thank you Peter.

As you recall based on data collected from academic sponsored study, but the Baylor College of medicine, or bcm spending various liquid and solid can't Kumer cancers, we collected and now they're lead indication.

And the DCM trial patients treated with our novel all play T., a specific T cell therapy demonstrated durable responses, some locking more than five years with minimal to no treatment related toxicities.

In February we ever cleared by the FDA furnishing initiate what will be our first company sponsored trial, beginning with a D.V. didn't portion which were all about fixation.

Under our amended trial protocol. The first three patients were clear to be goes with their legacy reagent, while the remaining three patients NFI beat it would be goes with empty for lunch and multi specific T cell product manufactured using a new reagent from an alternative supplier.

A partial clinical hold remains on the trial until the FTC refused to accept the final data and you're going to get up analysis for the any reagent can be provided by the alternate supplier.

Well, we're eager to get the first three patients enrolled in our phase two study.

Baylor College of Medicine research and GMP facility, the ladder of which we currently utilized to pretty study drug supply remain closed due to safety precautions surrounding the Coca 19 pandemic.

But the Baylor manufacturing and research facilities remain close well into the second half of this year, we may need to pause patient enrollment for this eating portion of the study.

And we are uncertain at this time once balers facility will become available but remain optimistic that once we are able to open. The study there will be significant patient interest.

Also during a pandemic our supplier has notified us that it will be easily providing to new reagent along with the information to satisfy the at these requirements for lifting the partial hold.

The remaining close communication with them and will provide updates as it become available.

Any interim we continue to remain active identifying clinical trial sites and also working to complete process development and I'd related to experiment.

Acquired for the initiation of our study and the Buildout of our own manufacturing capability.

We are moving with a sense of urgency as we recognized the need for new and improved therapy, the nano which affects more than 60000 people in United States alone.

Despite adjustments to our guidance, we remain confident and the potential of our multi a specific T cell therapy.

After several weeks ago, the FDA granted orphan drug designation tacky for one or lead drug candidate for patients with post transplant and now which we believe is yet another strong indicator of its promise in a challenging to treat disease.

As we've seen in DCM sponsored studies multi a specific T cell therapy consistently demonstrate several advantages over standard approaches as well as other T cell therapies in development across multiple tumor type.

Because of their potential to recognize multiple antigen multi a specific T cells may enable epitope, spreading which may lead to more potent and durable anti tumor response.

Also in contrast to transplants, which require hospital state multi a specific T cells are administered in outpatient, but which not only safer and more convenient for the patients, but it's beneficial to the health care system as a whole.

To that end, we are currently evaluating opportunities in other indications. In addition to our planned phase two trial in 'cause transplant and all patients.

Beyond email multi specific T cell therapy has demonstrated encouraging early results and various other cancers, including solid tumors such as pancreatic cancer. We've previously reported interim data front for an ongoing phase one clinical trials multi specific T cell therapy for the treatment of pancreatic adenocarcinoma being conducted by DCM.

And the frontline treatment arm in combination with standard of care chemotherapy reenter the clinical benefit correlated with opposed confusion detection of tumor reactive T cells in the patients peripheral blood <unk>.

<unk> T cells exhibit activity against those targeted antigen and non targeted T.H., indicating induction of antigen spreading.

Today, we have not observed any cytokine release syndrome or neurotoxicity in this trial.

An update for the study will be presented during the annual meeting at the American Society of clinical oncology later, this month, which as you know would be held virtually this year on accounted the code cover 19th and dynamic.

The abstract will be available this Wednesday may 13th around five P.M. eastern it on the after web site at which point, we look forward to being able to discuss in further detail with that I will turn it over to Tony to review financials and after that we look forward to taking your question.

Thanks, Mike Kelly.

We ended the first quarter with 40.39 in cash and cash flow.

We believe we will have enough cash on hand to take us into the second quarter 2021.

This excludes a cash available to us from our recent common stock purchase agreement of up to 30 million would aspire capital and institutional investor and long term shareholder of marker.

Net loss for the quarter ended March 31st 20, 26.5 million compared to a net loss of 5.3 million for the quarter ended March 31st 29 team.

Research and development cost during the three months ended March 31st 2020, with 3.8 million compared to 2.8 million. During the three months ended March 31st 29 to.

The increase of 1 million was primarily attributable to head count related personnel expenses.

General and administrative expenses were 2.8 million during the three months ended March 31st 2020 ended March 31st 29 check.

With that I would like to open the call for questions operator.

Thank you another dreamed up to your question answer session. If you like to be placement question. Two please press star one under telephone keypad appropriately for until well into two why isn't the question to you repressed far too if you'd like to every question from the Q.

For participants using speaker equipment to be necessary to pick your per handset before pressing star one.

One moment, please for we pull for questions.

My first question three is coming from that'd be hurt from Oppenheimer. Your line is the life.

Hey, guys. Thanks for taking my questions and thanks to the update.

Peter I had a question about the sequencing of patients in the MLP trial, just remind me per your discussion with the FDA do you have to wait for the first three patients to be treated before you can switch to the new reagent treated patients or assuming the agency.

Except the preclinical package for the revised reagents could you maybe possibly enroll all six of the lead in cohort at the same time.

Hey, Matt. Thanks for the question does a great question My do you ever take that.

Sure. Thanks.

So to address your question the patients that are enrolled we see.

Previous reagent those patients can be enrolled at the same time as the patients that are going to.

Be treated with empty for a while I'm using a new manufacturer.

<unk> for the reagent and I'm. The only issue is that each patient needs to have a two week span between their first treatment side from not both sets of patients can be it a gold.

Simultaneously.

Okay. So there's no requirement for you first to enroll three patients with the old reagents before you can switch to the than new regions. It really just depends on when the manufacturer can turnaround the certificate of analyses.

That's correct.

Okay, Great that makes sense and then maybe if you can provide me with any detail on on the pancreatic cancer trial update.

Could we expect maybe biopsy data from groups C, which was the Neoadjuvant arm on and then maybe anything else you can tell me in terms of data flow from the other Baylor trials. This year would be appreciated. Thanks.

Yeah, absolutely no.

With respect to go there pancreatic trial, the the uptake or ask Joe will be abstracts will become law is only then there's at least at five PM Eastern time. So we'll look but will it supports the providing more of these are the Oh you know after everything that you have jumped out and of course when the.

ER when Oh the presentation, it's actually given that the ask your confidence.

Yeah. The second question you Hazmat was.

About the other Baylor ongoing trials.

Yeah, Mike you want to talk a little bit about the all the ongoing trials.

Yeah, I mean, a at this time as Peter mentioned, we are.

Looking forward to the presentation at ASCO at the pancreas data and we plan to provide updates on additional trials as they become available.

Oh yeah.

Okay. Thanks, guys.

Okay, that's great.

Next question to me is coming from Christopher Myride from go more is that your line is alive.

Hello. This is Jackson Harvey on for Christopher Marai. Thanks for taking the question I was just curious about the ongoing fail a child's I I recognize you will be having some updates later this year, but I'm just curious if they've been affected by the Coolfit 19 Penn.

Nick at all or have you been able to collect time points on these patients in particular patients to the AD spend trial and that do high dose arm that was recently added thank you.

Yeah, Mike you want to comment.

Sure I'm you know as as Peter mentioned that you know difficult to predict the timeline given the current environment I'm also monitoring this situation and in general.

The studies at Baylor.

College and data center proceeding as planned I would say that there was one patient in the highest dose level of the phase one study and mouse study I'm the husband enrolled but between them has been delayed due to togut 19 as far as I know that is the only delay.

The where oh regarding the Baylor study.

Okay understood and then just pretty terms says the pancreatic cancer trial, what kind of five data would you like to see before maybe deciding that this would be something that you would pursue as a company sponsored trial as well. Thank you.

Yeah. They should I assume that's a good question you know we continue to monitor the data is it as it develops a as you know last year when he a win win we are presenting the the original pancreatic don't results. We had the data from nine patients I'm, including.

Response rates.

No I mean is it 10 patients will be based study well at this point, we're looking for a further evidence of efficacy. Obviously, we're now I'm about nine months from the time that we originally presented there David stage at this point you know I think that we want to continue to can monitor.

How these patients they usually not just from a response rates perspective that with respect to progression free survival in April alternative.

And ER and determine whether what we think that we're seeing a.

A meaningful therapeutic benefit that would justify it acquired one company sponsored study.

Great. Thank you so much.

Thank you as reminder, that star one to be please ask your question Q.

Next question is coming from Tony Butler from Roth Capital Your line is alive.

Thanks, a lot Peter Omar.

I appreciate the color around the two week interval.

And the patients in the <unk> you didn't cohort of the email trial. My question, it's actually at the end of the six total patients of the we Didnt cohort.

What then would you need to report to the FDA to move to Oh God the.

If you will have a larger portion or the larger cohort of that particular study and importantly is there a time limit upon which you need to submit the those are those data. Thank you.

Thanks, Tony Let me turn more pressure for them, obviously as well.

Yes. Thank thank you for your question regarding the parameters that we're looking for for the patients in the seeking meet in the protocol davita outline dose limiting toxicities that are.

Provided in detail and those are the things that we believe looking for in terms of safety for these patients.

No dose limiting toxicities occur as outlined in the protocol. We can then proceed into the phase two study.

There is no specific timeline that that is outlined for us to achieve this school, but obviously, we'd like to do it in.

Huh.

In a manner that is safe and expedient.

But we do not need to necessarily while we will report that the FDA, it's not our pre requisite <unk> and starting the phase two portion of the study.

So they are apologize if I may just continue on that.

Thank you for that color, but.

You're also suggesting that there once you report the deal the deal piece whatever they may be you can simply mode move into that phase two trial, you don't need to wait on yeah. Good true response is that am I understanding correct.

Correct I mean, it depends on obviously the safety issues that are identified in the safety began but assuming no deal team are identified that is correct.

That's perfect. Thanks, so very much.

Yeah.

Thank goodness question today is coming from.

John from.

Yes, Sir your line is a lot.

Hi, Thank you for two questions. So on the pancreatic cancer did agree though soon is correct to assume that there will be updated data from all three group the responsive nonresponsive towards the respectful tourism and also I think Peter talked about patient enrollment before the roster to read out back in July.

Locked you're able to season can Mcdonald presume Goldman after the data readout in July.

[noise], Oh, Hey, you booked for the question through out the first requested.

We Oh actually let me let me just address the yeah typically limits does give us I'm going to ask you to wait until the yes. That's a release there with respect to the the or the overall patient count we want to be mindful of Ascos timelines here and as I said before we do expect that there will be releasing that.

On Wednesday of this week at five PM with respect to the the the poster presentation.

That's a that's determined by the Baylor investigators in this case I do believe that that they have focused on an army of the trial that is the patients who are receiving therapy in conjunction with unfortunately standard of care.

Okay. Thank you.

Thank you, we reach and I do apologize.

To apologize.

Star ones replaced the question Q1 moment, please we pull through.

One of them. Please I do apologize delayed our next question today is coming from Jordan Fantuzzi from Piper Salmon. Your line is their lives.

Hi, everyone, Mr and along the Ted Thanks for taking my question I was just wondering what the.

I didn't answer is under the fire capital purchase agreement have you announce price for sure but for two issues, though then.

But included in your parent cash position for the quarter. Thanks.

Hey, guys and thanks for the question, let me I refer you question, what would be to religion, our CFO.

Yes.

So for the shares that we issue to entered the clinic and disclosing our recent form 10-K.

We have yet to draw down on any capital right now with the aspire capital agreement and we've been monitoring these capital markets very closely as we sit right now with our cash balance a $43 million. It into Q1, we don't have any immediate term needs to to draw down on that capital at this point, but again, we are monitoring the situation very close.

C and no we were drawn down when we feel it's perfect for us.

And I think you asked a question about whether it's incorporated in my cash runway Jordan are that the cash runway with cats are tracking and and these points out. The goal is is already.

It is I believe not reflected in that.

Yes.

Like if we should have our question answer session I like to turn the floor back over to management for any further a closing comments.

Thank you very much. So thank you all yet when you look over there, we've coupons and hope to beauty apparel moves or the helping safe when things in time.

Hi, everyone. Please reach out to us if you have any additional questions. Thank you.

Thank you that does conclude today's teleconference. You may disconnect your lines of farm. Another wonderful day, we thank you for your participation today.