Q2 2021 CTI Biopharma Corp Earnings Call

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Good afternoon, and thank for standing by and welcome to CDI Biopharma second quarter 2021 earnings call.

During todays presentation, all parties will be in a listen only mode. 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 1 on your telephone. This conference is being recorded today August 5.2021, I'd now like.

To turn the conference over to Doctor 8 and Craig.

Oh and president of P. D. I Biopharma. Please go ahead.

Thank you Lori and welcome to this afternoon's conference call. Joining me today are David Cascade, Chief Financial Officer, and Bruce Seeley, Chief operating officer, selling for and our remarks the conference call will be open for questions.

Before I begin. Please note that during this call we will be making forward looking statements based on current expectations such statements are within the meaning of the safe Harbor provisions of the private Securities Litigation Reform Act of 1995, including but not limited to the types of statements identified as forward looking.

<unk> and our 2020 annual report on form 10-K that was filed March 17th 2021, and our subsequent periodic reports filed with the FCC, which are available on our website and the investor section and such.

Such forward looking statements statements represent our views are and yes as of the day to this call and 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, including many that are beyond our control.

For further description of the risks and uncertainties that could cause actual results to differ materially from those expressed and the forward looking statements as well as risks related to our business. Please see our periodic reports filed with the assay sales.

This quarter, we have continued to advance per Chris hit towards the potential U S approval and commercial launch this year.

The Fda's acceptance with priority review of our NDA submission for the use of Procrit nib and myelofibrosis patients with thrombocytopenia underscores the unmet medical need in this area are produced action target action date is November 30th 2021, and the FDA is not currently planning and to her.

And Advisory Committee meeting to discuss the application.

As a reminder, the NDA was accepted based on data from phase III persist 2 and persist 1 and the phase III patch 3 clinical trials with a focus on the severely thrombocytopenic patients such as those with Kate accounts less than 50 times 10 to 9 per liter.

Patients enrolled in these studies with severe and trying to spend and besides PNM and patients receiving to Chris net 200 milligrams twice a day.

The focus at the end of day and included both frontline treatment naive patients and patients with prior exposure to <unk> 2 inhibitors.

1 says if the existing myelofibrosis patient population have severe thrombocytopenia approximately 7000 patients a population with suboptimal and limited treatment options and an urgent need for new therapies to address this need our team has been working diligently on pre commercialization activities.

<unk>, including market access distributions and supply chain disease education, and third force deployment.

We are eager to commercially launch per clicking it immediately upon approval from the FDA and given applications priority review status. We are prepared to launch on the Paducah date or earlier and preparation for and early launch we have completed the hiring of our field force leadership team and started.

Recruit recruit our key account managers, who will be our sales force.

Moving on from Myelofibrosis last year, we launched the study procrastinate and severe COVID-19 patients and response to the pandemic.

Study prevent is randomized double blind placebo controlled multicenter phase III clinical trial, comparing the use of <unk> plus standard of care versus placebo plus standard of care and hospitalized patients with severe COVID-19 debt.

Primary endpoint of the trial will assess the proportion of patients who progressed to invasive mechanical ventilation and ore extra copel membrane oxygenation or die by day 28, we continue to expect to report on the outcome of the interim analysis from this trial and.

And during this quarter.

Finally, as we have previously discussed we are investigating the use of <unk> and the prevention of acute graft versus host disease or gvhd. The investigator sponsored phase II comparison of the ongoing phase 1 and 2 study investigating the addition of <unk> to the standard price.

Prophylaxis of serum <unk> and low dose tack liners in the treatment of Gvhd continues to enroll and we remain on track to provide and update on the progress of the phase III trial and any potential regulatory interactions around this indication later in the year.

As a reminder.

The American Society of Hematology meeting in December 20, <unk> data was presented from this study.

Adding per Christmas to the standard prophylaxis regime resulted in a significant reduction in the expected acute graft versus host rates and patients within the first 100 days of therapy as compared to historical data without compromising transplantation outcomes and without any new safety concerns.

I will now turn the call over to David to review, our quarterly financials David.

Thank you Adam.

At June 32021, cash and cash equivalents and short term investments totaled $71.9 million as compared to $52.5 million as of December 31, 2020, operating loss was $19.5 million and $10 million.

For the 3 months ended June 30th 2021, and 2020, respectively.

No revenues were recognized for the 3 months ended June 30th 2021.

For the 3 months ended December 31.2020.

Net loss for the 3 months ended June 32021 was $19.7 million or 21 cents for basic and diluted loss per share as compared to a net loss of $14 million or 19 cents per basic and diluted loss per share for the <unk>.

And period in 2020, so with that I'll hand, it back to you Adam Thank.

Thank you David so with a potato fraction target action date of November 30th 2021, and commercial preparations well underway, we are well positioned for a potential U S. Launch later this year, we look forward to working closely with the FDA as it completes the final stages of the review of the application.

This concludes our formal remarks Laurie please open the call for questions.

And as a reminder to ask a question you will need to press star 1 on your telephone.

Our first question is from Ben Burnett of Stifel. Please ask your question.

Mr Brennan.

Your line is open.

Hi.

Yes, yes.

Okay.

Yes.

Sure.

Thank you for taking the question.

I have 1 quick 1 on the day that Keith.

COVID-19 coming in the third quarter could you elaborate on the type of day.

And we are.

And the bar.

And I would say in the context of other jacking television.

Okay.

With that and I can see you.

Okay.

Yes, Thank you Kathleen and I for your question. So the day analysis is a futility analysis.

And we have not made public nor will we what the borrowers, but well as we said we should be announcing the data later this quarter.

And I can't comment on the how based on that I can't comment on how we compare to other pack inhibitors and other JAK inhibitors.

Okay.

And a quick follow up also on day hiding.

And you are doing and tools.

The launch and keeping anything myelofibrosis and how.

How should we think about.

And Bob.

Higher magazine part question.

Yes, so obviously over the last 6 months, particularly since the NDA.

Filing was accepted we have expanded and we we have currently around 60 full time employees, we do expect that non material approximately double.

And as we complete the commercial hires.

And by the end of this year.

Okay. Okay. Thank you so much.

Thank you Kathleen.

Our next question is from Reni Benjamin of JMP Securities. Please ask your question.

Great. Thanks, very much for taking the questions guys and congratulations on all the progress.

Adam I know that we've talked about.

And how youre thinking about pricing of the <unk>.

And then.

When it comes out and likely to be.

I think as we've talked about in the past hopefully a pretty nice premium.

And to the JAK inhibitors that are already out there, but 1 of the things that we're always trying to get our hands around it.

Duration of therapy for Procrit and <unk> and.

And the phase III.

Ada that you've submitted to the FDA show is 1 thing, but I'm trying to get a good sense as to what is the average months of duration on therapy.

And that you've seen to date.

Yes Ren.

And I'm going to defer that question. So we've actually submitted some data for ash and if.

If the abstract is.

And is accepted you got to see it well so some of your questions. The data I'm talking buys from the expanded access.

With respect to the.

And on the on net.

The current trials from persist 1 and persist 2 we have <unk>.

<unk> on that but unfortunately, I'm unable to make that public for competitive reasons.

Okay and.

And then I guess, just turning to the commercialization side.

Can you just remind me have you guys already identified the sensors or the.

And the community docs that you'll be targeting or right off the bat or how should we be thinking about the and the initial phases of the launch.

Our first store Alonso.

Alright.

And the initial launch or non surprised I got to target.

The high volume accounts and the academic centers and and we've identified also the large community accounts.

Debt treat quite a few patients per group.

Group practice or the large group practices and Thats, where the far majority of the patients are treated.

And Bruce about how many.

Would you go how many accounts are there and academic versus community.

The.

It depends on how you look at it just in terms of number of physicians. The majority of physicians are going to be and the community accounts day treat anywhere from zero, 1 or 2 patients 2.5 ish patients. The large practices are the ones that we're going to be focused on and the academic centers and a focus on that can treat.

<unk> 50 patients per year, depending on the hall.

Got it thanks, very much guys and good luck.

Thank you.

Your next question is from Thomas Flaten of Lake Street Capital. Please ask your question.

Hey, guys. Thanks for taking the questions.

Adam how do you how should we think about Pacifica enrollment. Once you guys go live commercially do you see there being some cannibalization there or have you do you have a strategy for segregating patients and the study versus commercial product yes.

Yes, Charles Thank you, it's a very important question.

It's most likely the Pacifica will continue ex U S. After approval and.

And we are no doubt towards the end of the NDA process or we will have some discussions with the FDA around the program but.

Around that trial.

And may be some changes to it.

Big picture.

Expect that to be cannibalization of U S sales opportunities the.

And the drug is performing very well ex U S. At the moment and I think we could successfully complete the trial outside of the U S. All the time.

Yes.

You mentioned.

1 abstract submission to ash could you qualitatively share what other types of information, we might be seeing and ash coming out on procrit and <unk> been particular.

Yes, so 1 of them is duration of therapy on expanded access whichever already alluded too if accepted across that hasnt been the abstracts have been accepted we're also providing a lot.

We've put together abstracts, they really describe the safety profile of <unk>.

Chris Nib.

And the lower platelet count patients and with some comparison to the data we have and the safety profile box and listen if in that setting as well and we've got some nice some very favorable data that we're presenting on that at this point and Thomas I really prefer not to go any further and that because.

First we.

We have to be careful that we've done.

Break the rule.

Rules with Ash and I was rather.

In November when the abstracts are hopefully accepted.

No problem, just just 1 final 1 any any.

Intelligence on the MCC and.

Our guidelines update process.

Yes, so again a very important question. We are have already started our communications with the NCC and and we've sent a.

Preliminary notification of where we are and we do expect.

Once the drug is approved that will enter into okay.

Discussions with and quite quickly and net.

And we'll get on the NCI and <unk> and guidelines and as soon as possible after launch.

Excellent thanks, guys I appreciate it.

Thomas.

And our next question is from Gil Blum of Needham and company. Please ask your question.

Hi, everyone and.

Thanks for taking our questions and most of my questions have already been answered.

It may be a bit of.

Regulatory question here with the Spike in Covid.

You have to do for coming in November.

The FDA, having any issues accessing and production sites and factories that are making pet growth numbers. This is not an issue at all.

And we.

As I've said previously the inspection.

Process for US started out early with nearly.

And we're coming to the end of it we probably nearly completed debt, we've not encountered any issues with the FDA with respect to inspections.

Some of the some inspection work is being done remotely that has been very successful without any issues and sell and inspection work is being done in person.

And we haven't had counted any issues and we seem to have been.

The resources put by the FDA interline inspections and seem to be very good and it has so far gone very well.

Thank you.

And there are no further questions at this time I will now turn the call over back to Dr. Adam Craig for his closing remarks.

Laurie and.

Thank you everyone for joining the call today.

And we look forward to continuing the conversation and over the coming months.

We look forward to a potential approval of <unk> later this year. Thank you.

And this concludes today's conference call. Thank you for participating and you may now disconnect.

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