Q1 2021 CTI Biopharma Corp Earnings Call
Good day, ladies and gentlemen, thank you for standing by.
Welcome to CPI Biopharma first quarter 2021 earnings call.
During todays presentation, all parties will be in a listen only mode. So if you require operator assistance. Please press Star then zero.
After the speaker's presentation, there will be a question and answer session to ask a question during the session you'll need the press Star then 1.
This conference is being recorded today June 1st of 2021.
I'd now like to turn the conference over to Dr. Adam Craig CEO and President of C. T. I Biopharma. Please go ahead.
Thank you Liz welcome to this afternoons conference call joining me today of David Koskey, Chief Financial Officer, and Bruce Seeley, Chief Operating officer. Following formal remarks, the conference will be items questions. Before I begin. Please note that during this call we will be making forward looking statements based on.
Current expectations such forward looking statements are not guarantees of future performance and 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 today's press release.
This quarter CGI continue to execute on the critical activities. The further advanced Procrit nib towards the potential U S approval and commercial launch later this year.
Most notably today, we announced the NDA submission for the use of <unk> in.
In patients with such a peanut modify prices such as those with severe thrombocytopenia defined as platelet counts of less than 50 times tenths of the 9 police.
Been accepted by the food and drug administration and has been granted priority review.
Our produce the target action date is November the 30th 'twenty 'twenty, 1 and the FDA has informed us that they are not currently planning to hold an advisory committee to discuss the application.
The NDA was accepted based on data from the 2 phase III persist trials on the phase 2 part 2 or 3 trial with a focus on the severely thrombocytopenic patients from road in these studies, who would who received <unk> 200 milligrams twice a day.
Population that includes frontline treatment naive patients and patients with prior exposure to JAK inhibitors.
In the persist 2 study in patients with severe thrombocytopenia, who were treated with <unk> 200 milligrams twice a day 29 percentage of patients had a reduction in spleen volume of at least 35 per cent compared to 3 percentage of patients receiving best available therapy 20.
3 percentage of patients had a reduction in total symptom score of at least 50 per cent compared to 13 percentage of patients receiving the best available therapy, which included rocks the lithia.
In the same population of patients treated with Procrit nib adverse events with generally low grade manageable with supportive care umbrella led to discontinuation.
Platelet counts in the hemoglobin was stabilized.
Following approval of the ongoing phase III Pacific of stop the study is now expected to be completed as of post approval confirmatory trial I will.
Last few months as the Covid pandemic because of abated in the U S. Enrollments on Pacifica has picked up significantly and we now expect to report top line primary efficacy data in 2022.
With the NDA accepted and the Purdue Photog date set where now even closer to being able to provide per chris' needs of patients with sides of peanut myelofibrosis, who are underserved by existing therapies.
As a reminder, 1 third of the existing myelofibrosis population has severe thrombocytopenia approximately 7000 patients.
To address this unmet medical need and to prepare to deliver.
<unk> of patients. This year, our team has been working diligently on pre commercialization activities, including market access distribution the supply chain.
Disease education.
And so force planning and deployments.
Moving on to an additional indication for <unk> last year, we launched the study of <unk> in severe COVID-19 patients in response to the pandemic. This study prevent is the randomized double blind placebo controlled multicenter phase III clinical trial, comparing the use of <unk> plus <unk>.
Of care versus placebo plus standard of care in hospitalized patients with severe COVID-19.
The primary endpoints of the trial will assess the proportion of patients who progressed to invasive mechanical ventilation and ore extra corporal membrane oxygenation or die by day 28, we.
We expect to report on the outcome of the interim analysis from the study in the third quarter of 2021.
Finally, as we have previously reported we are investigating the use of <unk> in the prevention of acute graft versus host disease or gvhd of.
At the American Society of Hematology meeting of Ash in December 'twenty 'twenty data was presented from an investigator sponsored phase 1.2 study showing the adding per chris' nabe to the standard prophylaxis of sour alignments on low dose chocolate line. This resulted in a significant reduction in the expected acute graft versus host.
Disease rates in patients within the first 100 days of therapy as compared to historical data without compromising the transplantation outcomes on without any new safety concerns.
The phase 2 component of the study continues to enroll and we remain on track to provide an update on the progress of the phase II trial and any potential regulatory interactions around the syndication later in the year.
I'll now turn the call over to David to review, our quarterly financials Davis. Thank you Adam as of.
At March 31, 'twenty 'twenty, 1 cash cash equivalents and short term investments totaled $37.2 million as compared to $52.5 million as of December 31, 2020.
On April 6 of this year, we completed an equity financing with net proceeds of $53.8 million, which extends our cash position to fund our operations into the fourth quarter of this year.
Operating loss was $17.1 million and $11.9 million for the 3 months ended March 31, 2021, and 2020, respectively.
No revenues were reported for the first 3 months ended March 31, 2021 or for the 3 months ended December 31.2020.
Net loss for the 3 months ended March 31, 2021 was $17.3 million or <unk> 23.
Basic and diluted loss per share as compared to a net loss of $12.2 million or 20 basic and diluted loss per share for the same period in 2020.
So without the Adam I'll hand, it back to you. Thank you David So in summary, we're very pleased of our NDA has been accepted by the FDA with the <unk> date of November the 30th 2021.
This represents a significant step forward in our efforts efforts to deliver a treatment.
Paradigm altering medicine to myelofibrosis patients in need.
Look forward to continuing to work collaboratively with the FDA over the coming months and to advance on a pre commercial activities in preparation for end of year product launch. This now concludes our remarks Lisa Please open the call for questions.
If you'd like to ask a question at this time. Please press. The Star then the number 1 key on your Touchtone telephone.
To withdraw your question press the pound key.
Our first question comes from Ben Burnett with Stifel.
Hi, Good does turn on this as Catalina Hi, My name's sent us all on sort of been Gordon.
Thank you for taking our first day on the channel Congrats on all of the Providence.
Hum humans from in your prepared remarks, you have lunch indifferently initiatives to support the commercialization of the name.
And claim this dislocation on customer engagement et cetera could you provide additional context on the same sort of ph D from activities.
Yeah.
Yes, all of alone on the question overseas the city. Thank you.
Carolina so the.
The activities for commercialization are well underway.
The teams have been following a very detailed launch planning.
The playbook.
To prepare for launch and the teams are already working towards that hiring is on time execution of the commercialization activities are on time as Adam mentioned in his opening remarks, we are spending a lot of time right now working on market.
SaaS activity is clearly for an oral compound that is going to be very important for us. We've hired a of very good team to be able to help us with that and those activities are are well underway I'm very confident debt that we will be able to meet the timelines to be prepared for launch.
Later on.
Cash targets.
If I if I may.
That's a low app.
When do you plan to complete the sales force on Andy on the commercial teams on.
Dave do you have of head count kind of gave sort of the sales force that you could share.
On <unk>, how long is the training process. They have to go true. Thank you.
So the so we've not made a specific timeline as to the hiring of the sales force in particular, we're focused on bringing in sales leadership right now.
The field force so it's going to.
The later on this year.
The little bit closer to launch.
As it relates to training, we've already completed the development of all of our training materials for.
For the sales organization the <unk>.
Total training timeline will be about 4 to 6 weeks for the sales representatives to be field ready at that time.
Got it thank you so much.
Thank you next question please.
Our next question comes from Reni, Benjamin with JMP Securities.
Hey, good afternoon, guys. Thanks for taking the questions and let me add my congratulations as well Adam can you just maybe take us through.
In terms of of how much drug is available.
What the kind of status of <unk>.
Manufacturing is in the script manufacturing, where it needs to be inspected as well as debt.
Or is that kind of already Don maybe just a sense of how thats progressing.
Yes, well, we I'll just give you brief of manufacturing as well.
Is it is under control we for some time had of.
The substantial amounts of drug products available.
So we do have commercial lots and we were ready to.
We're ready to launch if if the approval comes early.
Towards the light lots of pole of this year, we will be manufacturing some new new material for the moment, we are ready.
And able to move forward as and when the drug is approved.
Got it.
And then I guess just following up on the COVID-19.
So the study.
You had mentioned on the prepared remarks third quarter.
Just wanted to get a sense is that still should we still be should we still be considering the quite material for the company or now that you have the acceptance.
Really a lot more of our launch preparations should we really be focused on on that.
We will still go on too. Thank you Brian were still going to conduct the the interim correctly and.
Yes the.
Position of the drug once we have the straw the once we have the interim results. It's certainly not the main driver for the company at the moment majority of our focus of the vast majority of our focus is on the successful commercialization and launch of the drug at the end of this year.
But if there is an opportunity to move forward with Covid and based on the interim analysis. The more we will discuss it and we'll let the let the street know.
Terrific. Thanks.
Congratulations again thank.
Thank you and I appreciate it.
Our next question comes from Thomas Flaten with Lake Street capital markets.
Hey, good afternoon, guys on Kurt Congrats as well.
Just.
Curious Adam it looks like the MTN guidelines were updated in mid April do you have a sense. If that's on what on what time schedule there might be for another update there I don't know what how closely your team has been interacting with the CCN.
Guideline committee for MTN.
Bruce.
We'll take this question Thomas.
We've been thinking a lot about our entry fee on strategy.
There is an opportunity for NCC and for us to to inform and since the end of the data and so we have plans to be able to do that.
At the in the middle of the year and then towards the end of the year is generally when they when they meet although.
It is our expectation that time of approval.
The NCC NCC on committee can meet at the time of any new important approval on the marketplace. So.
That's what we expect.
Got it and Adam could you remind us did you submit the indication with or without the restriction for the platelet counts.
Top line indication was for primary and secondary myelofibrosis.
Got it and then just 1 final 1 from me is there anything you can share with us around your thoughts on pricing given the disparity in pricing between Jack and the federal on them.
All of this time some of us were not commenting on pricing.
Fair enough anyway, congrats guys. Thanks for taking the questions.
Do you.
Our next question comes from Chad Messer with Needham.
Great. Thank you good evening, thanks for taking my question.
Congratulations on the NDA acceptance.
Can you can you just talk a little bit about.
How patients who have low.
The counts.
How they're treated in the system in terms of are there any specialists, they see or you know.
How are you going to target them given that this is your label I guess is my question.
I'll hand that over to Bruce.
So our market research suggests that <unk>.
Community physicians are also quite comfortable treating myelofibrosis.
The myelofibrosis patients with low platelet counts.
When the patients are referred to the academic centers. They generally have a constitutional symptoms at which of would include the.
The spleen volume increases.
The community Oncologists, who is no longer comfortable treating in their offices so at that point they get referred.
From a deployment perspective, it's going to be important for us not to just focus on the academic centers, but also have outreach to the community centers as well they may not treat on an individual basis that many patients in general, but as and in aggregate. They do represent a very large portion of.
The treating population.
Alright, Thank you I appreciate that.
Thank you channel.
And the next question. Please this.
Our next.
Comes from Bert Hazlett with BTG.
Yeah.
Yes, let me add my congratulations on the priority of as well just a quick 1 on gvhd.
Could you remind of any.
Between the volume that's ongoing in the phase 1.
We are on.
We can't hear you properly it's very muffled.
Oh, sorry is that better.
Remind us first of all congratulations again on priority review and then with Gvhd could you remind us of the any differences between the phase II design.
The ongoing study and the phase 1 slash 2 RSP study, just any changes or tweaks on design or patient population or endpoints or anything of the like thank you no no.
Not really the substantially very similar the purpose of the phase 1 was to identify a.
Yes.
The safe and effective dose the go into phase 2 and then the phase 2 the number of patients with expanded but so.
Having tested 2 dose levels of phase 2 of 100 milligrams twice phase 100 milligrams twice a day with selected and that will be given in combination of sue alignment from top of alignment to all of phase.
Phase III patients.
Thank you look forward to the readout.
Thank you Beth.
Yes.
That concludes today's question and answer session I would like to turn the call back to Dr. Craig for closing remarks.
Thank you Liz and thank you everyone for joining the call today, we look forward to further conversations over the coming months.
This concludes today's conference call. Thank you for participating you may now disconnect.
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