Q3 2020 CTI Biopharma Corp Earnings Call
Good day, ladies and gentlemen, and thank you for standing by welcome to see T. I Biopharmas third quarter 2020 earnings call. During todays presentation, all parties will be in a listen only mode. After.
After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone this.
This conference is being recorded today November 10th 2020, I would now like to turn the conference over to Dr., Adam Craig Chief Executive Officer. Please go ahead.
Thank you and welcome to this afternoons call. Joining me today are David Coskey, Chief Financial Officer, and Bruce CD, Chief operating officer.
Oh, sorry, providing an update on our recent progress JV provides a summary of third quarter financials. Following formal remarks, the conference call will be open for questions.
Before we begin peacemaker during this call we will be making forward looking statements based on current expectations such forward looking statements represent our views only as of the date took this cool.
Not guarantees of future performance are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward looking statements additional information concerning these risks and uncertainties is contained in todays press release.
For a further description of risks uncertainties that could cause actual results to differ materially from those expressed in the forward looking statements as well as risks relating to our business. Please see our periodic reports filed with the FCC.
This past quarter was walnut remarkable progress the ctr and more importantly for modified crisis patients with severe thrombocytopenic, yeah. That's free up all trial recruitment development program.
Last month, we announced the initiation initiation of our rolling NDA submission for Christmas in myelofibrosis patients with severe forms such female [laughter] finders platelet counts less than 50000 ton microliter with the expectation that we will complete our submission in the first quarter of two.
She tried to work with.
The commercial Rouge subject to actually I, probably should review and approval Lisa Twentytwenty one.
This development recent result, three is a constructive dialogue with the Sq ft on how quickly could you address unmet medical need myelofibrosis patients were actually grant from the Sox Pena patient group the expenses poor treatment outcomes, primarily due to the significant limitations of a pretty fair.
Yes.
Discussion with the agency focus on the safety outcomes from the past two or three study and the available data from the completed persist one and persist two faced reach started and that's.
That's a frenzy a meeting a proposal for an NPK submission based on the available data from this garbage since expenses.
The NPK submission will focus on the severely thrombocytopenic patients enrolled in these studies will include data from bike trunk line treatment naive patients and patients with prior exposure to try to keep it yes.
How long during phase three the Supercuts trial is now expected to be completed as opposed to approval confirmatory study.
With regards to this trial, that's we've previously announced we can say neutral enroll patients. The Romans great. It's currently slower than planned due to the ongoing COVID-19 pandemic and that person we anticipate the primary analysis data Twentytwenty chief.
To ensure that we are preparing for the potential commercial launch of Pacritinib can trenching front coupon, we began to execute on key pre commercial activities, including market access and medical Affairs [laughter].
Hi, how head of marketing.
As previously announced we also investigating for Christmas can cope with 19 patients treat prevents a randomized double blind people placebo controlled multi center phase three clinical study for Christmas in hospital patients with severe cause at 19%.
When compared to quickly plus standard of care for US is to C. Bernstein do okay in hospitalized patients with severe kind with my team.
Army endpoints of the trial will assess the proportion of patients who progressed to basic mechanical ventilation and Doe extra corporal membrane option nation or die by day 28.
We look forward to providing an update on our phase three present trial at the interim analysis is 200 patients with data expected in the first half of 2021.
With that I'll, let David provided to review the quarterly financials David.
Thank you Adam.
We ended the quarter with cash and cash equivalents totaling $57.4 million compared to 33.7 million as of December 31, 2019, we.
We currently expect our cash position will enable us to fund our operations into the fourth quarter of 2021.
And as we progress through the regulatory process and engage in additional pre commercial activities, we anticipate our spending to increase and that's what we will provide updated guidance as we move further into the pre launch phase.
Operating loss was $11 million and 33 million for the three and nine months ended September Thirtyth 2020, respectively, compared to an operating loss of $9.7 million and 31.2 million for the respective periods in 2019.
Net loss for the three months ended September 32020 was $11.3 million or 15 cents per basic and diluted loss per share.
Compared to net loss of $10 million or 17 cents per basic and diluted loss per share for the same period in 2019.
Net loss for the nine months ended September 32020 was $37.4 million or 54 cents.
Per share basic and diluted loss per share compared to a net loss of $31.8 million or 55 cents per basic and diluted loss per share for the same period in 2019.
As Adam mentioned pre commercialization activities for Pacritinib are underway and we're taking steps to build out our commercial team.
With the cash runway through the end of next year, we're in a strong financial position to focus our number one priority in the company that is the completion of our rolling in D.A. submission for Pacritinib.
However, in tandem progressing our pacifica and prevent clinical trials.
So with that I will now hand, it back to Adam.
Thank you David.
Summary realize it has begun the submission of the main day that may lead to the approval to cook need for treatment of mollified price is patients with severe thrombocytopenic very important marathon met medical need.
We look forward to completing the submission with us cautious next year with the potential commercial launch subject to regulatory approval thereafter 2021.
This concludes our formal remarks, operator, please open the call for questions.
Q.
Ladies and gentlemen, as a reminder to ask the question you will need to press Star then one on your telephone.
Withdraw your question press the pound key again, that's not wanting to ask the question.
Stand by while we compile the <unk> roster.
Our first question comes from a lot of Ren Benjamin with JMP Securities.
Line is open.
Hey, good afternoon, guys. Thanks for taking the question I have a couple maybe just starting off with the with the commercialization process and I know that you hired a head of marketing can you give us a sense you know how big is the sales force potentially going to be in and what kind of remains to be done.
Between now and you know potential losses.
Launch in the second half of next year.
Yes, so the first component sales FUSRAP and by the way. Thank you for your question. The most component you socialists was very much in keeping with the size of other comprehensive loss.
Just a UK a small niche indications in hematology oncology Approx me somebody between 69 achieved rents.
All kind of in the second part of the question to Bruce Who's working on this Uh huh.
Yes, we speak first.
Well. Thanks for the question. We've spent focused right now on a couple of things one is bringing in are the key leadership positions. So as you heard retired.
An accomplished leader for our marketing effort.
We currently have ER openings for medical affairs market access and some other marketing support roles that will be part of our first initial bull.
Bolus of hires we don't expect to get into the more significant hiring of the commercial organization until later next year as we approach launch and as far as the activities that we've got underway. We are doing extensive market research right. Now we have several market research efforts that are.
Ongoing presently and.
Those are working on demand research to be able to offer a mop. The forecast. We also have our activities that are more landscape things to be able to help us understand the marketplace.
Today, the marketplace at time of launch and to be able to help us set our positioning.
Got it.
And.
That's my last question has to do with your maybe ex U.S. activities I don't know if I've asked this before in the past I don't but I.
How are you thinking about the X.U.S. opportunity is.
Is that is that something that you that you will pursue are really you're just going to focus on the in the U.S. and [noise].
Oh skill sets brand, it's within the U.S. not the near the team that Bruce is leading and operationally where were more debt to the U.U.S.
For Pacritinib to be approved in Europe.
We would need to complete Pacifica and.
The we met with the DNA and I think a year ago that I made it clear they want to do another trial. So once I am Pacific or is complete. We then have the option of I think I get to get land or partnering in Europe, and nice given that skill set I suspect Palmer and would be a better option for us.
Okay.
Got it.
The final one from me is the upcoming Ash presentation.
You know we have the potential for pacritinib in their acute gvhd can you talk to us a little bit about you know what exactly you would have us focus on and you know do you have a sense if already if maybe you will move this from the ice tea that is to have more corporate.
Richard program going forward.
Yes, well, that's certainly not of interest for US we're very excited by the ice tea block that has come out to the Mayo clinic Moffitt and what it shows is the only part of the study very very good.
Response to therapy, including.
Pacritinib with tuck in Lima sensor line, this and showing a significant reduction in the.
Acute graft versus host rates in patients within the first 100 days therapy compared to historical controls.
That's very encouraging to us and we believe it's a proof of concept that trial currently is expanding into a phase two that's being conducted as a nice tea and bath from that data. If the data continues to show promise them we would.
Taking it on as a company sponsored activity and conducting a computer company sponsored trial in acute graft versus host. So overall, we're very very pleased with the day. So I'm glad you brought it up today and what Greene County should we do see it as an opportunity to develop the drug in a new indication.
Perfect. Thank you very much and good luck going forward.
Thank you.
Thank you.
Next question comes from the Lad lot of Chad Messer with Needham and company. Your line is open.
Hello, everyone. This is go on for Chad and thank you for taking my questions.
Unfortunately, my Gvhd question with taken so.
If you could remind us a little bit about the mechanism of action for Pacritinib and co, but I remember it has something to do with.
Also having some interaction with Iraq, and how have shaq inhibitors fared and and covert patients so far.
Thank you this isn't a tone question I feel the the the pay down. So here is the use of pacritinib in kind of it makes sense, particularly in the cytokine storm setting because it has multi kinase activity. It has potential down regulation of interleukin, one and six through its activity.
Two.
Eric one and it also sure its activity on sense. If one now has a potential to down regulate the macrophage activation that can be part of the the cytokine storm. So that's why we thought it was an attractive proposition and obviously it was the right thing for US is not completed and to respond to that.
Public health crisis and conducts trial.
Not setting we can we think pre clinically we compare favorably to the other jaktwo inhibitors because of the multi kinase effect, we don't specifically have one kinase that we work on.
For example, just trying to we have other color news is and as you alluded to it obviously beyond Mark one.
To the T., we think it's a very important in this setting.
All right. Thank you very much and.
Congratulations on all the progress and while we'll be keeping an eye out for our PDUFA date.
Thank you for that I appreciate it.
Thank you. Our next question comes from the line of Thomas Flattened with Lake Street Capital markets. Your line is open.
Great. Thanks, and thanks for taking the questions I was just a quick question on the covert study.
I haven't you said that you would be doing interim analysis based on 200 patients.
He serves there was a there was a different.
Preliminary endpoint, maybe 150 or so patients.
The futility look can you explain maybe I got that wrong, but could you just can you bring you up to speed on it.
Yes, the the standards, yes, we trace the number from 150 to 200, which were inspections are rolled up 200 patients in the first quarter of next year. In fact, we had quite a significant increase enrollment at the last few weeks I'm just kind of bit pandemic in the U.S. has.
Increased we increase the sample size because the standard of care change between lumbar disastrous design. The study in April and from when we started.
Well, so we felt to make a good decision of a more precise decision about the injury and we needed to launch a sample size. So that's the reason why the main changes that into the care has been a change in practice and the use of ventilators.
And so therefore to be conservative as we always are within one hour estimations to be more conservative increase the sample size.
Got it and then.
If you complete the submission in India in the first quarter. What's the earliest you might expect to hear on a priority viewed as a priority review decision, but yeah.
Oh, we should hear within two months after has two months to review the application and make sure. It's a complete before accepting the filing.
And we should hear at that time.
Whether we get product to be we do expect to get prior to you briefly we have the right.
Application for that you know within an unmet medical need.
And the small indication so we do expect that to be pockets of success.
Thanks, It would give us an opportunity to have approval before the end just trying to 21.
Fantastic great. Thanks for taking the questions.
Thank you gentlemen.
Thank you.
I'm not showing any further questions in the queue I would now like to turn the call back over to Adam for closing remarks.
Well, thank you to Linda and thank everyone for joining the call today, we look forward to this fall.
Forward to try the conversations over the coming weeks.
[noise], ladies and gentlemen. This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.
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