Q3 2020 Marker Therapeutics Inc Earnings Call

Good afternoon, ladies and gentlemen, and welcome to the worker Therapeutics Conference call. At this time all participants are in listen only mode. Later, we will conduct a question its recession and instructions will be given at that time.

As a reminder, this conference call is being recorded I would also like to handle all over to Mr., Tony Kim Chief Financial Officer at marker. Please go ahead.

Thanks, and welcome everyone.

A press release reporting our financial results is available in the news section of our corporate website at market Therapeutics Dot com.

As a reminder, we will be making forward looking statements regarding our financial outlook. In addition to regulatory product development and commercialization plans and research activities. These.

These statements are subject to risks and uncertainties that may cause actual results to materially differ from those forecasted.

Description of these risks can be found in our most recent form 10-Q and 10-K on file with the FCC I.

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

Thanks, Tony.

Good afternoon, and thank you for joining us today I hope everybody continues to be safe and healthy during this challenging time. So we're in the pandemic.

Given the external situation, particularly around stupid 19th in May we made a decision to withdraw our prior guidance on the timing of our planned phase two trial in patients with acute myeloid leukemia or email [laughter] well certain factors still remain in flux, specifically around our key supply chain partners I'm extremely happy to report that.

This quarter, we were able to initiate our first marker sponsored trial in post transplant and now having enrolled the first patient in the safety lead in portion of that trial I will note that we were able to achieve this milestone is consistent with the guidance that we provided prior to.

Despite the significant disruptions, we saw throughout our clinical and supply chain shapes.

We currently have several sites open and enrolling patients our chief Medical Officer Dr., Michael Generics will provide further details surrounding our email trouble just a moment and we look forward to taking your questions at the end of todays call.

Additionally, we are initiating our phase two trial, we're also making significant progress with the build out of our leasing the second facility and are on track to complete its construction by year end with.

We expect the facility located in Houston to be operational in early 2021 at which time, we will have the ability to independently manufactured products to support our fees to a multiple and potential future trials. In addition, we've been hard at work evaluating the <unk>.

Well through our NOL.

Yes, and it meets several adjustments that we believe will maximize efficiencies and streamline our manufacturing process as a whole our chief development Officer Dr. Juan Bureau has joined US today to provide details about these important process improvements before I conclude I want to acknowledge our research persist adult regulatory.

Clinical and quality teams for their hard work and commitment to advance our CML trial. Despite the challenging external situation as a reminder, today adult patients with post transplant and now have a 25% chance of five year survival. The started this trial is a significant milestone for our company and a critical first step.

Towards potentially bringing novel therapy to the thousands of patients who are running at a Bible treatments at this time I'd like to hand over the call to Dr. care, mostly.

Thank you Peter as.

As you just heard this has been an important quarter for us as we began enrolling in if he could lead in portion of a phase two clinical trial in patients with post transplant ammo to briefly recap in February 2020, we announced that the FDA lifted the clinical hold on this trial permitting us to initiate the <unk> portion, which is expected to enroll approximately six patients.

Three patients will be dosed with drilling only so Brent Ti for one our lead product candidate manufacturing with the legacy region, which we use in a phase one trial conducted by our partners at the Baylor College of medicine through.

The remaining three patients will be dosed with study drug manufactured using a new region from an alternative supplier.

Study remains on partial clinical hold pending to review the final data and subsequent acceptance of certificate of analysis for this new reagent by the FDA [noise].

In parallel to working with our suppliers to receive the required information satisfactory for listing the partial hold which we anticipate could be in Q1 of 2021. Our team remains hard at work identifying trial sites enrolling eligible patients in currently open site. This.

At this time, we have four sites have been activated and can enroll patients and we plan to have additional two to three sites by yearend.

Moreover, beginning next year, we will open approximately 20 sites in total for the phase two portion of the study.

We're making solid progress and have already enrolled our first patient and anticipate treating this patient by January or earlier.

To give you a clearer picture of the treatment challenges faced by oncologists today and why we're so encouraged by this data and the post transplant and offsetting I would like to briefly review some important details about this devastating disease.

According to the American Cancer Society, there will be about 60000, new cases of opinion 2020 with about 20000 of those representing in all patients.

The main seek treatment today's chemotherapy, sometimes in combination of bone marrow transplant, but unfortunately, approximately half the patients who relapsed <unk>, but many within the first year, thereby highlighting the unmet medical need.

Our self help therapy was designed to address the shortcomings of current treatments, while maintaining patient safety.

Many cellular therapies in development today are pursuing a singles or even dual targets. However, this approach has demonstrated limited improvements in patient outcome.

In contrast, we believe our mall play interesting approach has the potential to induce a lasting anti tumor effect.

Well with the patients own T cells to expand and kill cancer cells.

By targeting multiple entry into an EPS kids present within the tumor we believe our multi a T cell therapy can effectively address the tumor heterogeneity, while recruitment of the dosh community. We've the implication of immune response by epitope spreading.

The phase two study represents our first company sponsored clinical trial.

A reminder, empty for one was granted orphan drug designation in post transplant AML and has been well tolerated in an ongoing phase one clinical trial conducted by our partners at the Baylor College of Medicine in this setting as reported in March 20, 1911 of the 13 patients in the adjuvant setting.

Dose with the multi a specific T cell therapy after receiving an allogeneic stem cell transplant survived ranging from six weeks did you put in five years post infusion well nine of these remaining patients and continuing complete remission or CCR.

Survival of the six patients with <unk> disease ranged from four to 21 month as compared to historical survival rate of approximately 4.5 months for patients who received the standard of care post transplant.

In the phase one study conducted by our academic collaborators and DCM, our products show to be well tolerated with no incidence of cytokine release syndrome, neurotoxicity or grade three or four gvhd and the punch allergenic setting important.

Importantly, it demonstrated antitumor effects as well as significant in vivo expansion of T cells.

To this end, we believe our novel multi specific T cell therapy could potentially offer clinical benefit for these patients without the toxicities of standard of care treatment.

Can you need to be encouraged by the early data and are looking forward to working with our clinical sites to continue enrolling patients in our phase two study as a reminder, this multicenter animal study well be evaluating the clinical efficacy of our product in patients with an all in both an advent and after he setting following an allogeneic stem cell transplant the dose administered will be the math.

Well tolerated dose from the Baylor sponsored phase one study in the adjuvant setting across 920 patients will be randomized one to one.

Hi, there empty for Alon at 90 days post transplant versus standard of care observation all about 40 patients with active disease will receive empty for a one as part of the single arm group.

The primary objective of the trial or to evaluate relapse free survival and he actually.

And determined to complete remission rate and duration, a complete remission any active disease patients.

Additional objectives include pediatric group overall survival and graft versus host disease relapse free survival, while additional objectives for the actors Eastgroup include overall response rate duration of response progression free survival and overall survival.

And with that I'd like to hand, the call over to Dr. wanted era, our chief Development Officer.

Thank you my feeling as Peter mentioned earlier in the call. We have continued to make solid progress. We did build out of our new manufacturing facility, which would be used to support the manufacture and potential commercialization of empty for one and <unk> specific T cell products.

When we first ambition. This facility. We also began thinking more critically about the manufacturing process and how to improve it.

As a consequence for the past 12 months, we have been working diligently to simplify and streamline the manufacturing process, while improving the T cell phenotype and antigen specificity of the final drug product.

Improvements, which should have an impact on the clinical performance of the drug product in the upcoming critical this study.

These benefactor of conversations can be categorized under two major areas technical and biological.

Today, we have incorporated several technical improvements such as a 50% reduction in their manufacturing time got into production to only 16 days, resulting in a decrease being today and time and increase throughput often manufacture.

Second a decrease in the number of technical interventions by approximately 95% simply find dramatically the complexity of the manufacture and potential risk of contamination.

A third technical improvement includes increases the consistency and grit producibility of the manufacturing process, which will reduce the potential of manufacturing failures.

Finally, despite the reduction in the manufacturing time, we're now able to produce significantly higher number of T cells. The only ensuring patients will be able to receive that require cell dose in the upcoming seem to go the study, but also providing us with an opportunity to potentially increase the cell dose in the future.

Well those technical improvements will allow the manufactured to be faster simpler more reproducible and allow your cell dose that particular significant due to biological proof points that demonstrate the truck product the only to be the same but better.

Due to a favorable T cell phenotype, a more potent T cell product with a greater magnitude of antigen specificity on a more diverse targeted profile.

The combination of these technical and biological improvements would be critical into clinical performance Odessa Communist study named mill for which we're really excited.

With that I would like to turn the call to 20, Kim our Chief Financial Officer for a review and financials Tony.

Thanks Juan.

We ended the third quarter with 27 million in cash and cash equivalents, we raised 2.2 million in Q3 $3 million to $30 million common stock purchase agreement be previously entered into with aspire capital.

Utilizing the remaining 27.8 million available to us from aspire and with current cash available funds our operations into Q1 2022.

Net loss for the quarter ended September 32000, $27.4 million compared to a net loss of 5.5 million for the quarter ended September Thirtyth 2019.

Research and development costs. During the three months ended September Thirtyth, 2020 was $4.8 million compared to $3.1 million. During the three months ended September Thirtyth 2019.

The increase of 1.7 million was primarily attributable to an increase in research and development personnel as well as an increase in process development expenses.

General and administrative expenses were $2.6 million during the three months ended September at September Thirtyth 2020, compared to 2.5 million during the three months ended September Thirtyth 2019.

Now before we open up for Queuing day I wanted to summarize the upcoming milestones for the company.

We enrolled the first patient in or email trial and expect to treat this patient with our empty for a one product by Q1 2021.

We received the altering reagent for a manufacturing process and plan to submit the required data to ft to lift the partial clinical hold in Q1 2021.

We've entered the final stages of construction of our GMP manufacturing facility and expect to complete the construction in Q4 and begin treatment of the first patient under the new facility in the first half of 2021.

At this time, we'd like to open the call up to questions operator.

Thank you well now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is another question.

They probably start to uproot like true <unk> question from a Q purpose.

For participants using speaker equipment, maybe necessary to pick up your handset before pressing star one one moment. Please what we poll for questions.

First question today is coming from <unk> <unk> from Oppenheimer. Your line is now what.

Hey, guys. Congrats on that's really really nice for progress Peter could you just walk us through the logistics of enrolling needs leading patient you know specifically, how you're sourcing the graphs and then the turnaround time, you're expecting from signing that consent to actual treating and <unk> all right just to be clear are you use.

I think the new manufacturing process for the lead in patients.

Hi, guys. Thanks for the question. That's a great question, we are using them and the new improved manufacturing process for all of the patients that will be treated in our hasty political trucks, but with respect to your question. Let me turn it over to Mike that you never have to talk about the patient intake cross.

And the the donut procurement process.

Oh, Thank you Matt <unk> question on so regarding the CPV, Dan as we mentioned we have an old the first patients on to the process involves the investigator or oncologist I'm submitting in enrollment form once that's been submitted and sent to US We review the information regarding.

The peach and determine if the donor was a matched unrelated donor matched unrelated donor or a haploidentical all three of which are options.

This study then we need to identify a.

Hmm, where if the donor is if the donor is a matched unrelated donor weekly schedule the donor with the infusion or the site. However, if the patient or donor is a matched unrelated donor we need to use even match Q on Q.

Consent, the donor and schedule the donor for inquiry. So so that the timing of which can differ because you can imagine if it involves a family member of the patient DEA scheduling is is a bit faster. However, we have to go through equinox shaking.

Take a little bit longer to identify we identified the donor and.

And re consent, then and and schedule them for free for recess on in terms of.

The manufacturing process for the C.D. redone, we will be.

The manufacturing at Baylor College of Medicine, However, moving forward, we will offer the phase two portion of the study will be manufacturing at or in house facility, but won could talk further about those details.

One.

Sure Yes.

And I think one of the questions. So you mentioned was related to the incorporation of the new.

CMC updates.

Just to confirm as Peter mentioned.

These patients will be treated as tasty leading will be.

Generated using the new manufacturing process that <unk>, no aren't being filed with the S.D.A.

And my mention day safety lead the portion of the study will be manufacturing drug product out of our collaborators at Baylor College of Medicine, and we anticipate that our manufacturing facility will be operational afford they manufacture of the day.

Second portion would be day, Dave and.

Hey, starting the next part of next year.

Got it awesome. Thanks for that color wanted my maybe just one more question for me I wanted to ask about dosing for the phase two it as I understand Baylor is now exploring a high dose I think it's like 100 million cells per meter squared [noise].

On do you have any update on that cohort and also do you have any intention to explore that goes in your phase two AML trial or or are you pretty set on the dose that you have right now.

Mike.

[music].

Thanks, Thanks for that question, Matt on so.

That is correct Baylor College of Medicine is still has their phase one study that is open and they are currently exploring higher doses just levels for exploring 50 million cells per meter squared and dose level five exploring 100 million cells per meter squared.

We currently have the do that what has since that has been completed and transfer it to a flock and seeing if they can million cells. However, we are closely in touch with Dr. Pamela the investigator of the phase one and all study at Baylor College.

Medicine, and we're following that study closely to determine when dose level four and five are completed and at which point, we can integrate some of that information into our phase two study.

Study.

Prior to well incorporate that information into the safety lead in prior to starting the phase two study as Juan has discussed multiple different improvements in the manufacturing process. We can we feel comfortable that we could manufacture more comfortably or more easily at the tired and.

So I guess the bottom line is that we are interested in potentially exploring higher doses ultimately depending on how the remaining portion of the seas, one dealer said he.

Is completed.

Great. Thanks, guys.

Thank you as a reminder, that star one to be placed in the question Q1.

One moment, please what we poll for further questions.

Our next question today is coming from Tony Butler from Roth Capital Partners. Your line is not a lot.

Good afternoon. This is tough stuff I'm on for Tony.

Well first of all thank you for taking my question second of all I'm I was wondering if you could.

Give us some.

I'll update on when we may be we may expect some up some additional updates on the up and go to count the beta following what you presented at.

At ASCO.

Thanks, very much my would you like pizza.

Sure. Thank you for your question.

So regarding the pancreatic phase one study that was done at Baylor currently we don't have any additional updates on that study Baylor provided their latest update.

Of their study during the virtual ASKO backing back in June of this year. The study has completely enrolled the patient numbers, particularly on a 13 patients had been enrolled and no further patients will be enrolled in that portion of the study.

The only potentially additional information that would be of interest is long well a little up more longitudinal endpoints, some particularly overall survival.

And we're currently in discussion with Baylor to determine when the appropriate time to collect and release that information will be.

Okay. Thank you.

Mm.

Once you have that star one to be placed in the question.

One moment, please while we pull for further questions.

Ladies and gentlemen, we reached end of our question answer session I like to turn the floor back.

Corporate management pretty further closing comments.

Thank you very much and thank you once again to everyone for joining the call today. We appreciate your time and hope that you and your families remain safe and healthy things pandemic stay well, everyone and please reach out to us. It can you just spoke of.

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Thank you that does conclude today's teleconference. You may disconnect. Your line at this time and have a wonderful day.

Thank you for your participation today.