Marker Therapeutics Inc (MRKR) 2020 Q1 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Marker Therapeutics First Quarter 2020 Earnings Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

It's now my pleasure to introduce your host, Mr. Tony Kim, Chief Financial Officer. Please go ahead.

Thank you, and welcome, everyone, to our first quarter 2020 earnings call. The press release reporting our financial results is available in the News section of our corporate website at markertherapeutics.com.

Joining me for the call today are Peter Hoang, our President and Chief Executive Officer; Dr. Juan Vera, Chief Development Officer; and Dr. Mythili Koneru, 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 materially differ from those forecasted. A description of these risks can be found in our most recent Form 10-Q on file with the SEC.

I would now like to turn the call over to Peter Hoang.

Thank you, Tony. Good afternoon, everyone, and thanks for joining us. Before we get started, I'd like to take a moment to address the COVID-19 pandemic that is affecting all of us today. Most important, our thoughts are with the patients and their families who have been directly impacted. And to the health care workers who are on the front lines, we are immensely grateful for your sacrifices that keep us all safe.

As the situation continues to evolve, we have remained nimble in our decision-making regarding our business operations and strongly focused on the well-being of our employees and the patients that we serve with their health and safety being 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 travel restrictions, quarantines and social distancing amongst other measures to help contain the virus.

As the situation remains in flux, it's challenging to predict the full impact of the COVID-19 pandemic in our business and the health care system as a whole. At this time, we are experiencing some immediate effects on the timing of our planned Phase II trial in acute myeloid leukemia, or AML, resulting from delays experienced by our (inaudible) and supply chain partners. Our team has worked diligently to mitigate these effects, but it's clear that these developments may negatively (inaudible) in our study. Mythili will address the details around the situation in just a moment, but we remain optimistic, and we do not expect long-term material impacts.

Due to the unpredictability of the current environment, however, surrounding COVID-19 pandemic, we believe that it's prudent to withdraw our prior guidance on the timing of our AML trial until the outlook clarifies for our clinical and supply chain partners. We continue to monitor the situation closely, of course, and make decisions based on the health and wellness of our employees.

With that, I would like to hand the call over to Mythili to give a brief overview of the current landscape on the clinical front. Mythili?

Thank you, Peter. As you recall, based on data collected from academic-sponsored studies at the Baylor College of Medicine, or BCM, spanning various liquid and solid tumor cancers, we selected AML as our lead indication. In the BCM trials, patients treated with our novel MultiTAA-specific T-cell therapy demonstrated durable responses, some lasting more than 5 years with minimal to no treatment-related toxicities.

In February, we were cleared by the FDA to initiate what will be our first company-sponsored trial, beginning with the safety lead-in portion, which will enroll about 6 patients. Under our amended trial protocol, the first 3 patients were cleared to be dosed with our legacy reagent, while the remaining 3 patients in the safety lead-in would be dosed with MT-401, a MultiTAA-specific T cell product manufactured using a new reagent from an alternative supplier. A partial clinical hold remains on the trial until the FDA reviews and accepts the final data and certificate of analysis for the new reagent to be provided by the alternate in supplier.

While we are eager to get the first 3 patients enrolled in our Phase II study, Baylor College of Medicine's Research and GMP facility, the latter of which we currently utilize to produce study drug supply, remains closed due to safety precautions surrounding the COVID-19 pandemic. If the Baylor manufacturing and research facilities remain closed well into the second half of this year, we may need to pause patient enrollment for the safety lead-in portion of the study. We are uncertain at this time when Baylor's facility will become available but remain optimistic that once we are able to open the study, there will be significant patient interest.

Also, due to the pandemic, our supplier has notified us that it will be delayed in providing the new reagent along with the information to satisfy the FDA's requirements for lifting the partial hold. We remain in close communication with them, and we'll provide updates as it become available.

In the interim, we continue to remain active, identifying clinical trial sites and also working to complete process development and IND-related experiments required for the initiation of our study and the build-out of our own manufacturing capabilities. We are moving with a sense of urgency as we recognize the need for new and improved therapies in AML, which affects more than 60,000 people in the United States alone.

Despite adjustments to our guidance, we remain confident in the potential of our MultiTAA-specific T cell therapy. In fact, just several weeks ago, the FDA granted orphan drug designation to MT-401, our lead drug candidate for patients with post-transplant AML which we believe is yet another strong indicator of its promise in a challenging-to-treat disease.

As we have seen in BCM-sponsored studies, MultiTAA-specific T cell therapy consistently demonstrates several advantages over standard approaches as well as other T cell therapies in development across multiple tumor types. Because of their potential to recognize multiple antigens, MultiTAA-specific T cells may enable epitope spreading, which may lead to a more potent and durable antitumor response. Also, in contrast to transplants, which require hospital stays, MultiTAA-specific T cells are administered in an outpatient setting, which is not only safer and more convenient for the patient but is 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 II trial in post-transplant AML patients.

Beyond AML, MultiTAA-specific T cell therapy has demonstrated encouraging early results in various other cancers, including solid tumors such as pancreatic cancer. We previously reported interim data for an ongoing Phase I/II clinical trial of MultiTAA-specific T cell therapy for the treatment of pancreatic adenocarcinoma being conducted by BCM. In the frontline treatment arm, in combination with standard of care chemotherapy, we observed the clinical benefit correlated with the post-infusion detection of tumor reactive T cells in the patient's peripheral blood. These T cells exhibited activity against both targeted antigens and nontargeted TAAs, indicating induction of antigen spreading. To date, 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 of the American Society of Clinical Oncology later this month, which, as you know, will be held virtually this year on account of the COVID-19 pandemic. The abstract will be available this Wednesday, May 13, around 5 p.m. Eastern on the ASCO website, 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 questions.

Thanks, Mythili. We ended the first quarter with $40.3 million in cash and cash equivalents. We believe we will have enough cash on hand to take us into the second quarter of 2021. This excludes the cash available to us from our recent common stock purchase agreement of up to $30 million with Aspire Capital, an institutional investor and long-term shareholder of Marker.

Net loss for the quarter ended March 31, 2020, was $6.5 million compared to a net loss of $5.3 million for the quarter ended March 31, 2019. Research and development costs during the 3 months ended March 31, 2020, was $3.8 million compared to $2.8 million during the 3 months ended March 31, 2019. The increase of $1 million was primarily attributable to headcount-related personnel expenses.

General and administrative expenses were $2.8 million during the 3 months ended March 31, 2020 and March 31, 2019.

With that, I would like to open the call up for questions. Operator?

(Operator Instructions) Our first question today is coming from Matt Biegler from Oppenheimer.

Peter, I had a question about the sequencing of patients in the AML trial. Just remind me, per your discussions with the FDA, do you have to wait for the first 3 patients to be treated before you can switch to the new reagent-treated patients? Or assuming the agency accepts the preclinical package for the revised reagents, could you maybe possibly enroll all 6 of the lead-in cohort at the same time?

Matt, thanks for the question. That's a great question. My, do you want to take that?

Sure. Thanks, Peter. So to address your question, the patients that are enrolled with the previous reagent, those patients can be enrolled at the same time as the patients that are going to be treated with MT-401 using the new manufacturer for the reagent. And the only issue is that each patient needs to have a 2-week span between their first treatment. Aside from that, both sets of patients can be enrolled simultaneously.

Okay. So there's no requirement for you first to enroll the 3 patients with the old reagents before you can switch to the new reagents. It really just depends on when the manufacturer can turn around the certificate of analysis?

That is correct.

Okay. Great. That makes sense. And then maybe if you could provide me with any detail on the pancreatic cancer trial update. Could we expect maybe biopsy data from Group C, which was the neoadjuvant arm? And then maybe anything else you can tell me in terms of data flow from the other Baylor trials this year would be appreciated.

Yes, absolutely, Matt. With respect to the pancreatic trial, the update for ASCO, the abstracts will become live on Wednesday this week at 5 p.m. Eastern Time. So we'll -- we'll look forward to providing more data to it after the abstract to that. And of course, when the presentation is actually given at the ASCO conference.

The second question you had, Matt, was...

About the other Baylor ongoing trials.

Yes. My, do you want to talk a little bit about the ongoing trials?

Yes. I mean at this time, as Peter mentioned, we are looking forward to the presentation at ASCO of the pancreas data, and we plan to provide updates on additional trials as they become available. So yes.

Our next question today is coming from Christopher Marai from Nomura Instinet.

This is Jackson Harvey on for Christopher Marai. I was just curious about the ongoing Baylor trials. I recognize you'll be having some updates later this year. But I'm just curious if they've been affected by the COVID-19 pandemic at all, or have you been able to collect time points on these patients, in particular, patients in the ADSPAM trial and that new high dose arm that was recently added?

Yes, My, do you want to comment?

Sure. As Peter mentioned, it's difficult to predict the time line given the current environment. We're still monitoring the situation. And in general, the studies at Baylor College of Medicine are proceeding as planned. I would say that there is 1 patient in the highest dose level of the Phase I study, AML study that has been enrolled, but the treatment has been delayed due to COVID-19. As far as I know, that is the only delay I'm aware of regarding the Baylor study.

Okay. Understood. And then just in terms of the pancreatic cancer trial, what kind of 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?

Yes, thanks, Jackson. That's a great question. We continue to monitor the data as it develops. As you know, last year, when we presented the original pancreatic results, we had data from 9 patients, including response rates for 9 of the 10 patients who have been dosed to date. At this point, we're looking for further evidence of efficacy. Obviously, we are now about 9 months from the time that we originally presented that data. And so at this point, I think that we want to continue to monitor how these patients are doing, not just from a response rate perspective, but with respect to progression-free survival and overall survival, and determine whether we think that we're seeing a meaningful therapeutic benefit that would justify a follow-on company-sponsored study.

(Operator Instructions) Our next question is coming from Tony Butler from Roth Capital.

I appreciate the color around the 2-week interval between the patients in the lead-in cohort of the AML trial. My question is actually at the end of the 6 total patients of the lead-in cohort, what then would you need to report to the FDA to move to the, if you will, the larger portion or the larger cohort of that particular study? And importantly, is there a time limit upon which you need to submit those data?

Thanks, Tony. Let me turn the question to Mythili as well.

Yes. Thank you for your question. Regarding the parameters that we're looking for, for the patients in the safety lead-in, the protocol specifically outlines dose-limiting toxicities that are provided in detail, and those are the things that we will be looking for in terms of safety for these patients. If no dose-limiting toxicities occur as outlined in the protocol, we can then proceed into the Phase II study.

There is no specific time limit that is outlined for us to achieve this goal. But obviously, we'd like to do it in a manner that is safe and expedient. But we do not need to necessarily -- while we will report this to the FDA, it's not a prerequisite in starting the Phase II portion of the study.

So the -- I apologize if I may just continue on that, and thank you for that color, but you're also suggesting that there -- once you report the DLTs, whatever they may be, you can simply move into that Phase II trial. You don't need to wait on the FDA to respond. Is that -- am I understanding correctly?

Correct. I mean it depends on, obviously, the safety issues that are identified in the safety lead-in. But assuming no DLTs are identified, that is correct.

The next question today is coming from Yun Zhong from Janney.

On the pancreatic cancer data readout, is it correct to assume that there will be updated data from all 3 groups, the responsive, nonresponsive plus the resectable patient?

And also, I think, Peter, you talked about patient enrollment before the last data readout back in July last year. Are you able to say anything about patient enrollment after the data readout in July?

Yun, thanks for the question. So the first question, we -- actually, let me just address the patient enrollment question. I'm going to ask you to wait until the abstracts are released there with respect to the overall patient count. We want to be mindful of ASCO's time lines here. And as I said before, we do expect that they would be releasing that on Wednesday of this week at 5 p.m.

With respect to the poster presentation, that's determined by the Baylor investigators. And in this case, I do believe that they have focused on Arm A of the trial that -- the patients who are receiving therapy in conjunction with first-line standard of care.

(Operator Instructions) Our next question today is coming from Jordyn Fantuzzi from Piper Sandler.

This is Jordyn on for Ted. I was just wondering with the commitment shares under the Aspire Capital purchase agreement, have you announced the price per share that -- for which you issued those? And is that included in your current cash position for the quarter?

Jordyn, thanks for the question. Let me refer your question over to Tony Kim, our CFO.

So for the shares that we issued to enter the commitments have been disclosed in our recent Form 10-K, but we have yet to draw down on any capital right now with the Aspire Capital agreement. We've been monitoring the capital markets very closely. As we sit right now with our cash balance of $40.3 million at the end of Q1, we don't have any immediate term needs to draw down on that capital at this point. But again, we are monitoring that situation very closely. And we will draw down when we feel it's appropriate for us.

And I think you asked the question about whether it's incorporated in the cash run rate, Jordyn. The cash run rate reflects our cash on hand and the Aspire Capital is, I believe, not reflected in that.

Thank you. We reached the end of our question-and-answer session. I'd like to turn the floor back over to management for any further or closing comments.

Thank you very much. So thank you all again for joining the call today. We appreciate your time and hope that you and your families are healthy and safe in this challenging time. Stay well, everyone, and 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 at this time, and have a wonderful day. We thank you for your participation today.