Q2 2020 Bellicum Pharmaceuticals Inc Earnings Call
Ladies and gentlemen, please standby the conference will begin momentarily. We thank you for your patience enough that you. Please remain on the line.
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Greetings and welcome to the Telecom Pharmaceuticals to Q Twentytwenty financial results and incorporate update conference call.
In the presentation, all participants will be no listen only mode.
Doors, we will conduct a question answer session.
Time, if you have a question. Please press the wonderful about a four on your telephone.
At anytime during the conference you need to reach and operator. Please press Star Zero as a reminder, this conference is being recorded Thursday August six Twentytwenty I would now like to turn the conference over to Steven Casper from West Mike. Please go ahead.
Thank you.
Good afternoon, everyone and thank you for joining the call.
With me today on the call is Rick Fair Telecoms, President and Chief Executive Officer, and Auto Boston Carty, Chief Financial Officer.
Later during the Q many session Aaron Foster head of research will also be available.
Earlier. This afternoon delicate released financial results for the second quarter and six months ended June Thirtyth 2020.
If you have not received this release or if you'd like to be added to the distribution list you can do so on the Investor Relations page of the company's website.
As a reminder, today's conference call will include forward looking statements made under the private Securities Litigation Reform Act of 1995, including statements regarding Bellicum to research and development plans clinical trials plans regarding regulatory filings review and approval of its product candidates commercialism.
Nation expectations and our financial outlook.
These forward looking statements involve a number of risks and uncertainties and reflect sell it comes opinions only as of the date this call.
Become undertakes no obligation to revise or publicly released the results of any revisions to these forward looking statements in light of new information or future events.
Actual results may differ from those indicated these forward looking statements due to numerous factors, including those discussed in the risk factor section of dollar comes form 10-K for the year ended December 30, Onest 2019, and 10-Q for the quarter ended June Thirtyth 2020 filed with the Securities and Exchange Commission.
And now I will turn the call over to Rick Fair Telecoms, President and CEO.
Thanks, Stephen Good afternoon, everyone and thanks for joining us.
Our call today I'll provide an update on or go car pipeline and out of OCC, We'll update you on our financial results.
Before I talk about our individual programs, let me briefly remind you how go cars differentiated from other cell therapy approaches.
That form is unique in two distinct ways.
First we've engineered go car to deliver more potent and durable efficacy relative to current generation cell therapies.
We believe we can accomplish this primarily through our co activation domain Mighty 88, CD 40 or M.C.
We believe and see signaling can boost effector cell proliferation and survival.
Enhance functional persistence by resisting exhaustion and the suppressive tumor microenvironment and stimulate the cancer patients on immune system to attack tumors.
Second we've engineered go car for higher performance relative to current generation cell therapies potentially offering superior controlled via our molecular switch technology.
Other cell therapies behave unpredictably due to their autonomous activity.
Go car antitumor effects can be controlled by the scheduled intermittent administration of Remediated.
Car activity can be dialed up or down by adjusting the interval between remediated doses or suspending further and they do sit administration.
In our dual switch product candidates, we can further improves control ability by incorporating or cast besides safety switch, which we can it can a rapidly eliminate cells when triggered to manage acute toxicities if they occur.
We believe our go car platform made dress many of the shortcomings of current cell therapies. Our preclinical investigations have demonstrated some of these potential benefits and we are now observing support supportive evidence of these effects in the clinic.
We are pursuing to strategic strategic paths to establish clinical proof of concept.
First we are targeting solid tumors, where the effects of M.C. signaling may help overcome the challenges of the hostile tumor micro environment T cell exhaustion and heterogeneous antigen expression that if confounded previous car T efforts.
Our two solid tumor car T go car T candidates are BPX excel, one targeting P.S. Yang and BPX <unk> three targeting her too.
Our second strategy is the pursuit of an allogeneic off the shelf cell therapy.
We believe that our go car platform has the potential to drive puller proliferation, and persistence of allogeneic immune cells into stimulate a host immune response, both of which will be critical to delivering effective off the shelf therapies.
We seek to demonstrate the value of our approach with RBC. It may go current Kay.
Let me now provide an update on each of these programs.
BPX, except one targets prostate stem cell antigen or P.S. CA.
The clinical data, we presented to date from an ongoing phase one two dose escalation trial in pancreatic cancer, because showed encouraging safety biologic activity and biomarker data that support the hypothesized benefits of the go car platform in solid tumors.
Specifically, we are particularly encouraged by observations of tumor infiltration go car T mediated immunomodulation persistence of cells for up to nine months and changes in gene expression in the tumor microenvironment consistent with it productive car T cell immune response.
We're now enrolling cohorts I see our first in human evaluation that repeat or maybe you sit dosing.
Our preclinical experience suggests that regular remit you said dosing can reactivate and expand go car T cells and the presence of tumor antigen overtime without creating T cell exhaustion, and thus maximize the clinical efficacy potential.
We plan to present interim results from this cohort at a medical meeting by the end of this year.
Like many others, we've experienced a code at 19 related impact on screening and enrollment, which may impact the number of patients and duration of follow up that we will present.
In addition, primarily due to cover the 19 restrictions that are study sites, we had been unable to to date to collect coast treatment biopsies in cohort five see limiting to some degree what we can assessing these patients.
We will continue to work with our investigators to overcome these covered 19 obstacles to the extent possible and are in the process of adding a few more sites to the study to increase prescreening activity.
Looking ahead, we have submitted a protocol amendment to the FDA with several modifications to the study.
Upon FDA and I are be clearance of this amendment, we plan to expand eligibility to third line pancreatic cancer patients, which we believe will enable more pre screening.
Second informed by the risk benefit profile, we've observed to date, we will extend dose escalation to 10 million cells per kilogram.
Lastly, we will add a cohort of patients with hormone refractory metastatic castration resistant prostate cancer.
Assuming prompt ft clearance of this amendment, we expect to begin enrollment under this amended protocol later this year.
Based on the data we've seen so far and the proposed study amendments we remain optimistic about XXL one both as a product candidates and as proof of concept for our go car platform.
Now, let me update you on BPX <unk> three.
This program is Bella comes first dual switch product candidate, which has been designed to target solid tumors that expressed her too.
Academic car T trials targeting her to have demonstrated clinical activity in reasonable safety.
We believed that our dual switch technology and BPX xothree, maybe uniquely suited to improve upon these earlier efforts by driving greater efficacy through M.C. signaling and providing an extra layer of safety via our switch platform.
The FDA recently cleared our eye in D. for BPX accessory and we are currently in study start up to initiate a phase one two clinical trial later this year.
The trial is a traditional three plus three dose escalation followed by phase two expansions in multiple her two positive cancers.
Dose escalation will begin at 100000 cells per kilogram at a basket of her to call it positive solid tumors.
And patients will be sequentially enrolled throughout dose escalation.
Patients will receive standards loose I conditioning, followed by P.P. xothree cells.
First patient and each dose cohort will be followed without subsequent treatment, while the remaining patients in each cohort will receive weekly religious it to either dose limiting toxicity or disease progression.
We're excited to get this study underway and we'll keep you posted on our progress.
Now, let's move to RBC. It May go car NK program.
Car NK cells represent an intriguing next wave and the evolution of cell therapy. We are excited about the potential for our first off the shelf go current K candidate.
NK cells may be particularly well suited for allogeneic cell therapy since they have a neat cytotoxicity with low propensity for causing graft versus host disease.
We presented encouraging preclinical data from our and K discovery program at the 2019th City meeting and published a paper on this work in blood advances this year in May.
The data showed that our go car platform Synergizes with secreted aisle 15 to enhance NK cell proliferation survival and cytotoxic function.
In addition go car NK cells expressing our EMS eco activation domain and I. All 15 resulted in superior in vivo efficacy in multiple preclinical tumor models.
Based on these initial investigations, we believe that go car NK cells have the potential to be a best in class off the shelf cell therapy.
We selected Bcm is the target for our initial program since it as well validated from autologous car T studies, and we expect cell therapy to play a major wall in multiple myeloma treatment.
The next step for the field is to deliver similar clinical benefit within off the shelf therapy.
Which may provide faster and more certain time to treatment greater scalability convenience and a lower cost to manufacture.
Based on our two preclinical findings, we believe that go car in K may deliver more durable efficacy than other off the shelf soft therapy strategies, we will seek to demonstrate this in our development program.
Our preclinical development is ongoing we expect to present additional data for this program by the end of 2020.
That concludes the summary of our programs. So let me now turn the call over dotted box for review of our financial results.
Thank you Rick.
R&D expenses were 11.8 million for the second quarter 2020, compared to 20 million for the second quarter of 29 team.
The reduction in expenses and the second quarter of 2020 was primarily due to reduced expenses related to produced reversal related activities reduced expenses, resulting from the April 2020 manufacturing facility sale and the reduction enforce that was implemented during the second half of 29 <unk>.
It was reduced expenses were partially offset by increased expenses related to our go carty and broker and K programs.
General and administrative expenses were 3.8 million for the second quarter of 2020 compared to seven and a half million during the comparable period in 2019.
The lower expenses and the second quarter of 2028 was primarily due to the reduction and reversal related commercialization activities and the effect of the reduction enforce the reduced employee related charges.
Oh come reported a net loss of 43.2 million for the second quarter 2020, compared to a net loss of 26.9 million for the comparable period in 2019.
The second quarter 20, 2020 results included a noncash loss of 30.7 million related the change in fair value of warrant liability and that came on dispositions of 3.8 million due to the manufacturing facilities sale.
Turning to start turning to our balance sheet as of June Thirtyth 2020, cash cash equivalents unrestricted cash totaled $68 million.
In the second quarter, we had a cash loss from operations from approximately $14.2 million, which was a decrease from prior quarters given the steps we've taken to streamlined organization.
In April they'll come close the transaction in which the MD Anderson cancer Center acquired our manufacturing facility in Houston for $15 million.
Concurrent with the transaction Bellicum repaid $7 million of its Oxford finance debt obligation.
Based on current operating plants, bellicum expects cash utilization or $55 billion to $65 billion with for your 2020.
Compared to cash loss from operations of approximately 30.5 million for the six months ended June Thirtyth 2020.
We believe that the current cash resources will be sufficient to meet operating requirements into the second half the 2021.
Now I'll hand, the call back over the Rick.
Thanks, a lot about.
Reviewing our accomplishments so far in 2020 I'm pleased by the advancement of our go kart pipeline across our three programs.
I'm, particularly enthusiastic as we anticipate an increasing number of potential data milestones.
Over the next 24 months for VX six so one we expect to present to updates and pancreatic cancer and our first data in prostate cancer.
For VX six of three we expect study start in our first presentation patient dose escalation.
Before I go car NK program, we expect multiple preclinical presentations and I'd submission.
I remain excited about balchems future potential of our go car pipeline and look forward to updating you on our future progress, including our first in human data with repeat remedies to dosing and preclinical data on or go car and K program later this year.
I'll now open the call two questions operator.
Thank you.
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One moment please for the first question.
And our first question comes from a line of Jim.
Yes.
Wells Fargo Securities. Please go ahead with your question.
[noise] jump into it so they can legitimately.
Keeping us on autos they live in new ways to register drifted up your question [noise].
The first thing Rick on on six so Wuhan.
So has there been any read through from emerging repeat dose remain <unk> data that's sort of led to this.
I think well, we'd interpret as a renewed interest in expanding the six I one program.
No I think the expansion into prostate, which is probably what you're referring to Nick is.
Then a longstanding interest of hours and I think we've now you know we're approaching the end of the dose escalation that we initiated in <unk> and pancreatic cancer I Nows, the time to explore and expansion mode. A different tumor types I think we all acknowledge the pancreatic cancer is a very challenging tumor and we certainly don't want I missed the signal by not looking a little more broadly. So I think this is really.
He just fulfillment of the previously articulated plan.
Okay, and then in in terms of the patient that you'll be enrolling with prostate cancer to they have to sell a specific number of lines and treatment and then just from a no perspective of this isn't very bones centric can send to do you have to.
You know preclinical data that supports it picks I wanted to able to penetrate unmet.
Yeah on your first question eligibility inclusion criteria patient after received an anti Andrew androgen therapy, and either received or our ineligible where taxing.
And then for the subsets of patients. They qualify you know either and ESI high for P. anti PD, one or Bracken you for a PARP inhibitor or have to have received those therapies as well. So it's up you know that's all it later line a patient population.
As far as a bone that I don't think we have any specific preclinical data for the ex except one, but we will certainly be looking or a at the translational data as we embark in treats patients in the study.
And then just on six that's where you gave us some outlines you know the trial designs and 3.3 those patients so that the first patient at every dose level.
I wouldn't know receive.
Committee.
Yeah, that's correct a the so it's a traditional three plus three design with some modifications and that's certainly one of them or so so you would expect in each in each cohort and dose level and each of.
Of the study at the first patient would receive cells only in the second to patients and the absence of it doesn't have any toxicity with would receive cells plus weekly agreement to said.
And I'm presuming that first patient then you know will stay in hospital. The intensively monitored <unk> do you have I mean, what can you discuss what would be you know triggers a goal administering the vertical owed to act I think the killed switch.
I think.
In summary, depending on the toxicity, it's essentially failure of standard of care.
So so these patients as you say will be admitted and will be monitored carefully.
The.
On target off tumor effects that you'd be most interested in what this antigen of course or.
Cardiopulmonary, so certainly will be active monitoring and if a adverse events occur they'll be treated with standard of care for whatever the adverse events and that.
Standard of care ourselves then overseas.
Hi, Tim So all in a small molecule activator, if the safety switching this construct.
Okay.
All right, Thanks, and look forward to further updates.
Thanks, Nick.
Our next question comes from the line of kit.
With Jefferies. Please proceed with your question.
Hi, This is kit on on footprint I think it so much for taking my question.
I'm wondering what type of response can we expect a with Xx a one into current trial.
What would be the bar to move this for it into phase two trial. Thank you.
Sure Thanks get.
So it depends on the tumor type of course, I think what we've we've said about pancreatic cancer is that you'd need to see up something like a 15% response rate with a six month duration of response.
To be meaningful activity and the setting.
A and B worth a expansion in prostate cancer.
Probably a bit higher on the response rate something more like a 30% to 35% a response rate with similar to our ability to be a meaningful a candidate to advance. So those are those are the threshold that we're looking at.
Thank you.
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As a reminder to register for a question Chris one floor.
Our next question comes from a line of lengthy Lee with Landenburg. Please proceed with your question.
Hey, Thanks for taking my questions.
The.
No one.
Would you mind it to put it anymore color on the Russian node effect, because Oh your decision to expand into said line in those so a couple of that goes.
Sure.
So in the pancreatic portion of the study I think as you recall.
In the early part of the study we were treating second and later line pancreatic cancer as we were getting towards the maximum dose contemplated the dose escalation, we narrowed the inclusion criteria to a second line only population we were looking for a more on a genius population to begin to start to look for efficacy signal.
And I think as we previously communicated that certainly impacted prescreening activity and then enrollment in the study.
I think in light of that and in light of Ah you know subsequent covert 19 impact on enrollment I think were eager to have access to more patients to to pre screen. So we're really making two changes there one is adding back third line eligibility. So now this will be a second and third line.
Population that were accruing and we're also adding several additional sites. So certainly expect that will.
Address the the enrollment problem I'd say as an added benefit third line pancreatic cancer patients as you know really don't have.
You know meaningful a therapy available so.
Really high unmet need there if we saw a clinical activity that would be potentially a an area for accelerated approval.
Yeah, I think you're saying how about the dose.
Yes.
Yeah, So of course.
We're looking to maximize the benefit a risk here and and so you know we the the thing that drove our initial dosing decisions what when we designed the protocol up to 5 million cells per kilogram.
It was really based on other car T studies in targeting different antigens in different tumors and sort of where theyre dosing in Atlanta, So we really than the apriori have.
A deep understanding of what might be required for solid tumor efficacy epic now we're into the study and weve been able to evaluate the the safety and be activity as weve dose escalated and we think further dose escalation could be useful.
We believe that 10 million cells per kilogram is a this week and also manufacturer from of pancreatic cancer patients. So that's an important consideration to as a feasible and so I think that that's what let.
What's let our decision making to add a couple of additional does courts get up to 10 million cells per kilo.
Okay got it in and then are you familiar pull 'em on you mentioned the code 90.
ER I got a number of patient you're going to be then later this year, if I remember correctly, initially and I think it about five patients or any color.
How much impact how many patients <unk>.
Or did a presentation that a year, but good bye.
Yeah, we think a approximately five patients is the right number.
Okay got it.
Okay and then.
She was geared to be VIX sticking to your worn.
Great via cleared and I, India.
The had over the previous guidance in the basin, but then the if you can share anymore color on.
I know the reason to read about potential toxicity own targets ocular toxicity, maybe any color you can share what are white or a that are convinced oh yeah.
The schedule.
Sure. So I think your questions about BPX <unk>, three and the idea there.
Hey, good as we previously communicated the FDA had requested a further nonclinical information on the the potential level of interaction of BPX exceed six of three with healthy tissues that express lower levels of her to you know as a predictor of potential on target off tumor toxicities in humans.
We predict presented some additional in vitro data that showed a nice antigen dependency of car T activation, so you'd expect higher levels of activation with high expression of tumors relative to <unk> lower expression and lower levels of expression healthy tissue, which is what you'd want to see and Additionally, we provided.
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In vivo data from mice looking at the rapidity of the sell killed with the activation of our safety switch cast beside showing that most of the BPX <unk> three cells in those models were eliminated within a couple of hours. So I think that was further support for the potential utility of the safety switch to mitigate potential toxicity should they occur.
So with that dataset and with some of the clinical trial modifications that I've described to I think that the it was comfortable and cleared the I'd.
Hey.
Thanks for taking my question or do you.
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Yeah me too thanks.
Yeah.
Thank you ladies and gentlemen, there are no further questions at this time I'll now turn the call back two weeks here.
Please continue with your closing comment.
Thanks, very much and thanks, everyone for participating today as always I'd like to think are passionate team of deletions, our collaborators investigators for their efforts and these extraordinary times.
They are making progress on progress is not easy.
As always I'd like to think that patients and families who participate in their clinical trials to they inspire our our effort every day.
You have additional questions piece, please feel free to contact us and thanks, everyone have a radio.
That does conclude the conference call for today, we thank you for your participation I thought you. Please disconnect your line.
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