Q1 2020 Earnings Call
Good afternoon, ladies and gentlemen, and welcome to the one therapeutics first quarter 2020 financial results Conference call. At this time, all participants are honest listen only mode. Later, we will conduct a question and answer session and instructions will follow at that.
Operator: Good afternoon, ladies and gentlemen, and welcome to the G1 Therapeutics First Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host today, Mr. Jeff McDonald. Please go ahead, sir.
Time, if anyone should require assistance during the conference. Please press Star then Darryl on your Touchtone telephone.
As a reminder, this conference is being recorded.
I would now like to turn the call back over to your house today Mr., Jeff Mcdonald. Please go ahead Sir.
Jeff McDonald: Good afternoon, everyone, and welcome to the G1 Therapeutics First Quarter 2020 Corporate Financial Update. On today's call, Mark Vileka, Chief Executive Officer, Raj Malik, Chief Medical Officer, and Senior Vice President, R&D, and Jen Moses, Chief Financial Officer, will provide an overview of the quarter with Q&A to follow. Before we begin, I'd like to remind you that this call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to our filings with the SEC, which are available from the SEC or on our corporate website, for information concerning risk factors that could affect the company. Now, I'll turn the call over to Mark.
Thank you Angela.
Hi, everyone and welcome to the do you want Therapeutics first quarter 2020, corporate financial update.
This call Mark will like a chief Executive Officer, Raj Wallis, Chief Medical Officer, and senior Vice President R&D engine notice Chief Financial Officer will provide an overview like were once you need to follow.
Before we begin I'd like to remind you that this call will include forward looking statements based on current expectation.
Okay. That's represent management's judgment as of today, they involve risks and uncertainties that could cause actual results could differ materially from expected results.
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Mark Vileka: Thanks Jeff. Good afternoon everyone, and thank you for joining us. We hope that you and your families are well. On today's call, we'll provide an update on our key achievements in the first quarter, discuss how we are navigating the evolving COVID-19 environment, and review our first quarter results. After our prepared remarks, we'll open the call for questions.
Thanks, Jeff Good afternoon, everyone and thank you for joining us.
That you and their families are well.
On today's call will provide an update on our key achievements in the first for discuss how we're navigating the evolving corporate banking environment and review our first quarter results.
After our prepared remarks, well open the call for questions.
The covered 19 pandemic is affecting many aspects of our lives.
Mark Vileka: The COVID-19 pandemic is affecting many aspects of our lives, none more so than health. Like others in the field, we remain committed to advancing therapies that can benefit patients, even in these difficult circumstances. Our entire team has maintained a high level of collaboration and execution required to bring new therapies to people with cancer. I'd like to thank our employees for their passion and dedication to patients and for continuing to drive our company forward.
Or more than in health care.
Got it was in the field, we remain committed to advancing therapies that can benefit patients even in these difficult circumstances.
Our entire team has maintained a high level of collaboration and execution required to bring new therapies to people with cancer.
I'd like to thank our employees for their passion and dedication for patients and for continuing to drive our company forward.
Our highest priority is to make trials cyclists available to patients as quickly as possible.
Mark Vileka: Our highest priority is to make triacyclib available to patients as quickly as possible. Cancer patients experiencing chemotherapy-induced myelosuppression are an especially vulnerable population, and TrialCyclip has the potential to be the first proactively administered myelopreservation therapy for these patients. Our vision for trilocycline is that patients across a broad range of solid tumor types will receive trilocycline the first time and every time they are treated with chemotherapy. Clinical and patient-reported outcomes data have shown that trilocyclib has the potential to make chemotherapy safer, improve the patient experience, and in some settings, help patients live longer. We began a rolling new drug application, or NDA, for trilocycline in small cell lung cancer in the fourth quarter of 2019 and are on track to complete the filing this quarter. The FDA has done an outstanding job of meeting the demands placed on it by the COVID-19 pandemic while also keeping pace with sponsor interaction. Assuming this trend continues, we anticipate acceptance of our NDA in the third quarter, including assignment of a PDUFA date.
Cancer patients experiencing chemotherapy induced myelosuppression aren't especially vulnerable population and trials like lip has the potential to be the first proactively administered Milo preservation therapy for these patients.
Our vision for trial cycling is that patients across a broad range of solid tumor types will receive trials cycling. The first time and every time they are treated with chemotherapy.
Clinical and patient reported outcomes data have shown that trial cycling has the potential to make chemotherapy safer improves the patient experience and in some settings help patients live longer.
We began a rolling new drug application or Andy a for trial cycling in small cell lung cancer in the fourth quarter of 2019 and are on track to complete the filing this quarter.
The FDA has done an outstanding job meeting the demands placed on it by the covert 19 pandemic, while also keeping pace with sponsor interactions.
Assuming this trend continues we anticipate acceptance of our mdx in the third quarter, including assignment of the due for a day.
Mark Vileka: As a reminder, we received breakthrough therapy designation for trial cyclits based on the compelling myelopreservation data across three randomized trials in small cell lung cancer. Concurrent with our work on the NDA, we are preparing to make trialocyclic broadly available to patients with small cell lung disease. Our medical science liaisons are engaging virtually with health care providers to better understand their experience with chemo-induced myelosuppression and current approaches to reactively managing its complications.
As a reminder, we received breakthrough therapy designation for trial cyclic based on the compelling Milo preservation data across three randomized trial in small cell lung cancer.
Encouraged with our work on the and yet we are preparing to make trial sites, a broadly available to patients with small cell lung cancer.
Our medical science liaison are engaging virtually with health care providers to better understand their experience with chemo induced myelosuppression and current approaches to recap Dudley managing its complication.
On the commercial side, we are excited that somewhat group to join the G. One in March as our Chief commercial officer to lead the launch and try to cyclists.
Mark Vileka: On the commercial side, we are excited that Soma Gupta joined G1 in March as our Chief Commercial Officer to lead the launch of Trial-a-Cycle. Soma most recently led the global launch of VinteQuel at Pfizer, which has emerged as an important therapy for patients and is significantly outperforming initial commercial expectations. She has a strong oncology background, having previously led the global commercial team responsible for Pfizer's oncology portfolio. Under her leadership, we are continuing to refine a patient access strategy that will highlight the benefits of trial cyclin for patients, oncology practice centers, and the healthcare system. She is also advancing the development of our pricing, reimbursement, and sales strategy in preparation for a potential launch in early 2021. You can expect more color on our progress from SOMA as we roll out our commercial plan in greater detail in the second half of the year. Small cell lung cancer is our first opportunity to demonstrate the value tribal cyclists can provide patients.
So my most recently led the global launch as well as Pfizer, which has emerged as an important therapy for patients and a significantly outperforming initial commercial expectation.
She has a strong oncology background, having previously led the global commercial team responsible for advisors oncology portfolio.
Under her leadership, we're continuing to refine a patient access strategy that will highlight the benefits of trial in cyclic per patient oncology practice centers and the health care system.
She has also advancing development of our pricing reimbursement and sales strategy in preparation for a potential launch in early 2021.
You can expect more color on our progress from some as we rollout our commercial planning greater detail in the second half of the year.
Small cell lung cancer is our first opportunity to demonstrate the value travel cyclic can provide patients.
Mark Vileka: Based on the mechanism and existing preclinical and clinical data, we believe trilocycloid has the potential to improve outcomes across multiple solid tumors and chemotherapy regimens. We have a robust development program to evaluate additional indications, which Raj will discuss in more detail shortly. We have also made notable progress in the development of our oral CERD, RENTO-DESTRUCTIVE.
Based on the mechanism at existing preclinical and clinical data. We believe trial is frankly has the potential to improve outcomes across multiple solid tumors and chemotherapy regimens.
We have a robust development program to evaluate additional indications, which Rob will discuss in more detail shortly.
We've also made notable progress on the development of our oral surgery rents Odessa strength.
Mark Vileka: Findings from our ongoing monotherapy trial have informed our decision to select 800 milligrams as the go-forward dose in future trials. And, beginning in this quarter, we'll be evaluating rinthodestrin in combination with the CDK-4,6 inhibitor palocycline, which is being provided by Pfizer under a non-exclusive supply. Before I turn the call over to Raj, I'll make a few additional comments on our business operations relative to the COVID-19 pandemic. The Trilocyclic NDA remains on track for submission this quarter. There have been no interruptions to our scheduled interactions with the FDA regarding the filing or regarding development plans across our pipeline. We anticipate that initial recruitment for the two trials we are starting this quarter will be impacted, but we are making every effort to keep patient enrollment timelines on track. Our ongoing rent-a-desk-grant monotherapy trial is fully enrolled, and we are working with our sites and CRO partners to minimize disruption. We do not anticipate significant supply chain shortages. I'd now like to turn the call over to Raj for an update on our Trilocycline and Ritodestran development. Raj?
Findings from our ongoing monotherapy trial have informed our decision to select 800 milligrams has to go forward dose and future trials.
And beginning in this quarter, we'll be evaluating rents are just strength in combination with the CDK for six inhibitor helpful cyclists.
Which is being provided by Pfizer under a nonexclusive supply agreement.
Before I turn the call over to Raj I'll make a few additional comments on our business operations relative to the covert 19 pandemic.
The trial cyclist. Andy a remains on track for submission this quarter there have been no interruptions to our scheduled interactions with FDA regarding the filing or regarding development plans across our pipeline.
We anticipate that initial recruitment for the two trials, we are starting this quarter, but try last cycle of I just by two trial and the rental Deseret combination trial will be impacted but are making every effort to keep patient enrollment timelines on track.
Our ongoing rented debt strap monotherapy trial is fully enrolled and we're working with our sites and CRM partners to minimize disruption.
We do not anticipate significant supply chain shortages for delays.
I'd now like to turn the call over to Raj for an update on our trial cyclists and Richard that stress development programs Raj.
Rajesh K. Malik: Thanks, Mark, and good afternoon, everyone. As Mark noted, we are close to completing our NDA submission for tralocyclin in small cell lung cancer. We are also continuing to explore additional tumor tribes where tricyclic may benefit patients. We plan to initiate a registrational phase 3 trial in colorectal cancer in the fourth quarter of this year, with primary endpoints focused on myelopreservation. This trial will use a combination chemotherapy regimen used for treating GI malignancies such as colorectal cancer. This Full Fox Theory regimen contains 5-FU, oxaliplatin, and arenotecin and is highly myelosuppressive, particularly with regard to neutropenia.
Thanks, Mark and good afternoon, everyone.
As Mark noted we are close to completing our NDS submission for trial, aside and small cell lung cancer.
We're also continuing to explore additional too much rights were trying to cyclic may benefit patients.
We plan to initiate a registrational phase three trial in colorectal cancer in the fourth quarter of this year with primary endpoints focused on baila preservation.
This trial will use a combination chemotherapy regimen used for treating JPY malignancies, such as colorectal cancer.
This FOLFOX hear me regimen contains five if you look Sally platinum and arena T., Ken and his highly myelosuppressive, particularly with regard to neutropenia.
Five if you was used in many of our preclinical model preservation studies that show the benefits of trailer cycle.
Rajesh K. Malik: 5FU was used in many of our preclinical myelopreservation studies that showed the benefits of trallocytes. We have completed a pre-phase 3 meeting with the FDA to discuss the trial design and will provide more details once the protocol is finalized. We're also advancing tralocyclib in breast cancer, based on the survival data from our phase 2 triple negative breast cancer trial. Later this quarter, the tricyclic arm of the I-SPY-2 trial will open. This trial will examine the use of tralocyclic acid in all subtypes of breast cancer and also provide us with data for tralocyclic acid in combination with several broadly used chemotherapy classes and an anti-PD-1 immunotherapy. I-SPY-2 is an ongoing platform trial run by a consortium of established academic sites.
We have completed a pre phase three meeting with the FDA to discuss the trial design and we'll provide more details once the protocol is finalized.
We're also advancing child aside clip in breast cancer based on the survival data from our phase two triple negative breast cancer trial.
Later this quarter Atrotos cyclic arm of the I spy two trial will open.
This trial will examine the use of child aside clip and all sub types of breast cancer and also provide us with data for travelers cycling in combination with several broadly use chemo classes and an anti PD one immunotherapy.
I spy two is an ongoing platform trial run by a consortium with established academic sites in place.
Data from identified two and our ongoing phase two TMB see trial will inform future breast cancer trials.
Rajesh K. Malik: Data from I-SPY-2 and our ongoing Phase 2 TMBC trial will inform future breast cancer trials. We are planning to provide updated survival data from the TNVC trial in the fourth quarter of 2020. I'd also like to make a few comments about trilocycline relative to the ongoing COVID-19 pandemic. This global crisis has highlighted that cancer patients experiencing chemotherapy-induced myelosuppression are especially vulnerable, and recent commentary from the oncology community has highlighted the burden of managing myelosuppression. In fact, recent COVID-19 guidance from the NCCN specifically noted that broader strains on the healthcare system, such as limited blood supply and higher infection risk, call for practice changes to how clinicians address chemotherapy-induced mild suppression, with an important goal of reducing complications after chemotherapy. While we have always viewed the myelopreservation benefits of trialocycline as an important advance in patient care. The current situation has put this need into sharper focus.
We are planning to provide updated survival data from the T. NBC trial in the fourth quarter of Twentytwenty.
I'd also like to make a few comments about China cycling relative to the ongoing covert 19 pandemic.
This global crisis has highlighted at cancer patients experiencing chemotherapy induced myelosuppression, especially vulnerable.
And recent commentary from the oncology community has highlighted the burden of managing Myelosuppression.
In fact, recent cobot 19 guidance from the NCCN, specifically noted that broader strains on the healthcare system, such as limited blood supply and higher infection risk.
Cough up practice changes to how clinicians address chemotherapy induced myelosuppression with an important goal of reducing complications after chemotherapy.
While we have always viewed the miler preservation benefits of trial of cycling as an important advanced in patient care. The current situation has put this need into sharper focus.
Rajesh K. Malik: Turning now to our Oral CERD Rheumatoid Arthritis. Later in the second quarter, we plan to expand our phase one two-way trial to include an arm evaluating a combination of rinthodestrate and the CDK4-6 inhibitor, palvocyclin, commercially known as IBRAM. This arm will enroll approximately 40 patients with ER positive or two negative breast cams.
Turning now to our oral surgery rental das trends.
Later in the second quarter, we plan to expand our phase one two way trial to include an arm evaluating a combination of rental desk trap the CDK for six and head of inhibitor Palbo cycling commercially known as high brands.
This arm will enroll approximately 40 patients with GR positive hertwo negative breast cancer and as Mark alluded to earlier patients will receive an 800 milligram dose of rental desktop once daily.
Jen Moses: And, as Mark alluded to earlier, patients will receive an 800 milligram dose of RintoDestrat once daily. Recruitment will begin at sites currently involved in our monotherapy arm, with more sites coming online in the second half of the year. While early enrollment will likely be impacted by COVID-19, we anticipate the trial will be fully enrolled by the end of the year. I'd also like to point out that the rinto-destran monotherapy arm of the trial was fully enrolled last year, and we anticipate reporting updated safety and efficacy data from all 67 patients in the fourth quarter of 2020. I'd now like to turn the call over to Jen for a review of the financials. Jen?
Recruitment will begin at sites currently involved in our monotherapy arm with more sites coming online in the second half of dealer.
While early enrollment will likely be impacted by cobot 19, we anticipate the trial will be fully enrolled by the end of the year.
I'd also like to point out that the rental desk trend monotherapy arm us to trial was fully enrolled last year, and we anticipate reporting updated safety and efficacy data from all 67 patients in the fourth quarter off Twentytwenty.
I'd now like to turn the call over to Gen for a review of the financials Jen.
Jen Moses: Thanks, Raj. I'll review several items on today's call. Full financial results for the first quarter of 2020 are available in our press release and annual report. We reported a net loss of $31 million for the first quarter of 2020 compared to $24 million for the first quarter of 2019. Operating expenses were $31.8 million for the first quarter of 2020 compared to $25.9 million for the first quarter of 2019. GAAP operating expenses included stock-based compensation expense of $4.7 million for the first quarter of 2020, compared to $3.8 million for the first quarter of 2019. Research and Development Expenses for the first quarter of 2020 were $20.4 million, compared to $18.1 million for the first quarter of 2019. The increase in R&D expenses was primarily due to an increase in clinical program costs and costs for manufacturing active pharmaceutical ingredients. General and administrative expenses for the first quarter of 2020 were $11.4 million, compared to $7.8 million for the first quarter of 2019. The increase in GNA expenses was largely due to increases in compensation due to additional headcounts, pre-commercialization activities, medical affairs costs, and professional fees and other administrative costs necessary to support our operations.
Thanks Raj I interviewed several items on today's call full financial results for the first quarter of 2020 are available in our press release and 10-Q.
We reported a net loss 31 million at the first quarter of 2020 compared to 24 million for the first quarter 2019.
Operating expenses were 31.8 million for the first quarter 2020, compared to 25.9 million for the first quarter 2019.
Operating expenses included stock based compensation expense of 4.7 million for the first quarter of 2020 compared to 3.8 million for the first quarter of 2019.
Research and development expenses for the first quarter of 2020, or 20.4 million compared to 18.1 million for the first quarter 2019.
The increase in R&D expenses was primarily due to an increase in clinical program costs and cost for manufacturing active pharmaceutical ingredient.
General and administrative expenses for the first quarter 2020 were 11.4 million compared to 7.8 million for the first quarter 2019.
The increase in DNA expenses, largely due to increases in compensation due to additional headcount pre commercialization activities medical affairs cost and professional fees and other administrative costs necessary to support our operations.
As of March 31st 2020, we had 242.4 million in cash and cash equivalent from the balance sheet compared to 269.2 million as of December 30, Onest 2019.
Jen Moses: As of March 31, 2020, we had $242.4 million in cash and cash equivalents on the balance sheet, compared to $269.2 million as of December 31, 2019. We are reiterating our guidance of ending 2020 with between $110 million and $130 million in cash and cash equivalents and expect our current cash position to be sufficient to support operations into the fourth quarter of 2021. In addition, we are advancing discussions on several fronts to bring in non-dilutive capital during this calendar year. Our current guidance does not consider proceeds from partnerships, collaboration activities, or any other inflow of capital that we may realize in 2020. I'll now turn the call back over to Mark. Mark?
We are reiterating our guidance of ending 2020 with between 110 and 130 million in cash and cash equivalents and expect our current cash position is sufficient to support operations into the fourth quarter 2021.
In addition, we are advancing discussions on several fronts to bring in non dilutive capital during this calendar year.
Current guidance does not consider proceeds from partnership collaboration activities or any other inflow of capital that we may realize in 2020.
I'll now turn the call back over to Mark Art.
Thanks, Jen, we're particularly excited about the pending and da submission of trial cyclists and the near term opportunity to bring this breakthrough therapy to patients with small cell lung cancer, our medical education and commercial preparations are well underway.
And we will continue to invest in additional trials to evaluate the potential benefits of trial sites have been other tumors and with different chemotherapy regimens.
Mark Vileka: Thanks Jen. We are particularly excited about the pending NDA submission for trial cyclin and the near-term opportunity to bring this breakthrough therapy to patients with small cell lung cancer. Our medical education and commercial preparations are well underway, and we will continue to invest in additional trials to evaluate the potential benefits of TrialCyclib in other tumors and with different chemotherapy regimens. With regard to Rinta-Devstran, we believe this therapy has best-in-class potential among the oral SIRDS in development. We have selected our go-forward dose of 800 mg based on data from our ongoing monotherapy trial, and are initiating a combination trial with the CDK-4,6-inhibitor pelvic cyclin this quarter. Additional efficacy and safety data from the monotherapy arm will be presented in the fourth quarter.
With regard to rent the desk strength. We believe this therapy has best in class potential among the oral surgeon development. We have selected our go forward dose of 800 milligrams based on data from our ongoing monotherapy trial and are initiating a combination trial with the CDK for six inhibitor outlets high plant this quarter.
Additional efficacy and safety data from a monotherapy arm will be presented in the fourth quarter.
We are in a strong position to continue advancing these therapies on behalf of patient and look forward to updating investors on a number of regulatory clinical and corporate milestones in the second half of the year.
Before we go to Q in AG I would like to acknowledge all of the healthcare professionals, who are providing essential services through the cobot 19 pandemic.
We have the privilege to collaborate with oncologists nurses and patient support teams regularly.
Never have we've been so appreciative of their dedication and compassion for patients on behalf of everyone. At GE. One. Thank you for the sacrifices youre, making for all of us during this challenging time.
Mark Vileka: We are in a strong position to continue advancing these therapies on behalf of patients and look forward to updating investors on a number of regulatory, clinical, and corporate milestones in the second half of the year. Before we go to Q&A, I would like to acknowledge all of the health care professionals who are providing essential services during the COVID-19 pandemic. We have the privilege of collaborating with oncologists, nurses, and patient support teams regularly. Never have we been so appreciative of their dedication and compassion for patients. On behalf of everyone at G1, thank you for the sacrifices you are making for all of us during this challenging time. That concludes our prepared remarks. Operator, please open the call for questions.
That concludes our prepared remarks, operator, please open the call for questions.
Ladies and gentlemen, Thank you asked a question at this time. Please press Star then the number one key on your test time telephone. If your question I was going to answer the he wants to move yourself from the can you. Please press the pound key.
Our first question comes from the line of Dane Leone with Raymond James. Please go ahead sorry.
Hi, Thank you and a good to hear the updates and things are progressing.
I just wanted to get some updated thoughts on.
To that well I guess two things one rent so.
Operator: Well, ladies and gentlemen, if you have a question at this time, please press the star and the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Our first question comes from the line of Dane Leone with Raymond James. Please go ahead, sir.
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In kind of context for what you'll be looking for.
One from the monotherapy update later this year and then.
Kind of confirmation of what the Cabo with Palbo would do for the business development plan on that front.
Dane Vincent Leone: Hi, thank you, and good to hear the updates and how things are progressing. I just wanted to get some updated thoughts on two things. One, RENTO in kind of context for what you'll be looking for; and one, from the monotherapy update.
And then secondly, do.
Do you have any updates in terms of what the plan is with the letters that club program.
Going forward. Thank you.
Thanks, Dan its mark I can tell us that rochman chime in but I'll start with rent the best Trent.
Dane Vincent Leone: and then kind of confirmation of what the combo with Palbo would do for the business development plan on that front. And then, just secondly, do you have any updates in terms of what the plan is with the Laracyclib program going forward? Thank you.
No we fully enrolled the 67 patients in monotherapy and the last year and we have the data in hand and that formed our decision to move forward with 800 milligrams, you'll see those data will share some in the fourth quarter.
And we're moving forward with how the cyclic combination as you mentioned.
Mark Vileka: Thanks, Dane. It's Mark.
Mark Vileka: I can take that. Rajesh might chime in, but I'll start with a rinse of death strength. You know, we fully enrolled the 67 patients in monotherapy at the end of last year. And we have the data in hand, and that informed our decision to move forward with 800 milligrams. You'll see those data. We'll share them in the fourth quarter. And we're moving forward with the albicyclic combination, as you mentioned. As far as benchmarks go...
As far as benchmarks for that it's really similar to pull on less Ray This is.
A more and the credit sensitive patient population. So I'm looking at polycyclic plus fall. This trend we should be seen similar response rates in CV ours with how the cyclists and rental desk strategy.
And then obviously couldn't floor.
Some of the partnering dialogue that we are starting to have so that would be.
Mid next year, when we have those data.
Assuming that trial gets fully enrolled ish this year, which is our assumption.
With regards to layer on pipeline.
We are progressing a number of partnering discussions we will update the data for the 150 milligram and 200 milligram.
Cohorts that were fully enrolled again last year, we have days on hand, that's informed our decision that 150 milligrams VIP. It's the come forward dose. So present those data in the third quarter and are progressing a number of partnering discussion.
Mark Vileka: It's really similar to Paloma 3. This is a more endocrine-sensitive patient population. So, looking at pelviciclip plus fulbastrin, we should be seeing similar response rates in CBRs with pelviciclip and rinta-destrin. And that obviously could inform some of the partnering dialogue that we're starting to have so that would be, you know, mid-next year when we have...
Excellent. Thank you very much.
Your next question is from the line of Chris Shibutani with Cowen. Please go ahead.
Hi, good afternoon CJ on for Chris This evening, Thanks for taking the question.
Mark Vileka: All of that data, assuming that trial gets fully enrolled this year, which is our goal. With regard to larylcycline, we are progressing a number of partnering discussions.
With respect to the colorectal trial, it's going to be starting at the end of this year.
I was curious about how you're thinking about the endpoints for my old preservation, there and whether you'll be potentially adapting those that were used initially in.
Mark Vileka: We will update the data for the 150mg and 200mg cohorts that were fully enrolled again last year. We have the data in hand, and that's informed our decision that 150mg PIV is the go-forward dose. So we'll present those data in the third quarter and are progressing a number of partnering discussions.
The phase two trials.
To perhaps account for something like additional chemo cycles, which we saw in triple negative trial, and then also with respect to giving us some idea of potential timelines. Originally we had been thinking that this was going to be somewhat larger trial focused on survival benefits. This now look more like the size of the phase twos for small.
Dane Vincent Leone: Excellent. Thank you very much.
Operator: And your next question is from the line of Chris Chibutani with Crowan. Please go ahead.
Chris Chibutani: Hi, good afternoon. This is CJ on for Chris this evening.
Chris Chibutani: Thanks for taking the question. With respect to the colorectal trial that's going to be starting at the end of this year, I was curious about the endpoints for myelopreservation there and whether you'll be potentially adapting those that were used initially in the phase 2 trials to perhaps account for something like additional chemocycles, which we saw in the triple negative trial. And then also with respect to giving us some idea of potential timelines, originally, we had been thinking that this was going to be a somewhat larger trial focused on survival benefits. Would this now look more like the size of the phase twos for small cell and triple negative? Thank you.
So and triple negative.
Thank you Jay its Mark I'll, let Raj handle that question, Yes, Hi, CJ, yes, so the the endpoints will be a mild preservation endpoints so similar to what we.
Evaluated in the small cell program.
Yeah, and there maybe some additional ones as well when we.
When we provide details on the on the study obviously, we'll we'll do so.
We are as I mentioned, we had this pre phase three.
Meeting with the FDA already.
We are of course also interested in looking at tumor efficacy readouts as well and that you of course reference the TWC study as a.
Rajesh K. Malik: I'll let Raj...
Rajesh K. Malik: I will handle that question.
Rajesh K. Malik: Yeah, hi, CJ. Yeah, so the, you know, the endpoints will be mild preservation endpoints, so similar to what we evaluated in the small cell program. Yeah, and there may be some additional ones as well when we, you know, when we provide details on the study, obviously, we'll do so. We are, as I mentioned, already had this pre-phase three meeting with the FDA. We are, of course, also interested in looking at tumor efficacy readouts as well, and you, of course, referenced the TMBC study as a... It's something that we're interested in looking at, too.
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Something that we're interested in looking in this study also.
You want to comment on the number of patients Raj, Yes, I mean, this will really be yeah. It would be several hundred patients.
Study, that's really designed more for modeler preservation rather than.
Survival for example.
Right. So we'll need will need all of those patients for the model preservation and point them.
Yes, there are a number like in any study design their number of endpoints that one evaluates and so.
Rajesh K. Malik: Would you like to comment on the number of patients, Rajesh?
Studies going to be appropriately designed to evaluate the endpoints.
Rajesh K. Malik: Yeah, that's who it should be.
We will be which has only focus on model of preservation and those endpoints CJ smart again are available.
Rajesh K. Malik: This will really be, yeah, it will be several hundred patients, a study that's really designed more for malar preservation rather than... It's a Bible for us. So we'll need...
Yeah very soon after the trial spring rights our expectations data in early 2003.
And just to remediate reiterate what was just a few hundred patients.
Got it and it's a registrational trial, obviously this was a pretty favorably meaning.
Rajesh K. Malik: All right, so we'll need all of those patients for the myelopreservation endpoint then.
I'd say.
Rajesh K. Malik: Yeah, you know, like in any study design, there are a number of endpoints that one evaluates. And so, you know, the study is going to be appropriately designed to evaluate the endpoints that... We will be, which are going to be focused on malaprism.
Thank you.
And your next question is from the line I'd say that Myron garden with quite a bit securities. Please go ahead sorry.
Hi, Thanks for taking the question I heard.
I Wonder if you could kind of remind us and maybe lay out a little for or how you're thinking about the launch for trial aside for a very.
Rajesh K. Malik: and those N.Y.T.J.s
Mark Vileka: It's Mark again. Data is available, you know, very soon after the trial is fully enrolled. So our expectation is data in early 23 and just to reiterate what Rajesh said, it's just a few hundred patients. And it's a registrational trial, obviously, this was...
Obviously, starting or small cell lung.
But as you get additional data for breast and colon cancer are there any particular steps in there where you could file for perhaps in the San Diego sooner rather than later do you anticipate going through.
Mark Vileka: That's right.
Chris Chibutani: Perfect. Thank you.
Operator: And your next question is from the line of David Nierengarten with Redwich Securities. Please go ahead, sir.
The whole studies in order to add additional indications.
David Matthew Nierengarten: Hey, thanks for taking the question. I had one. If you could kind of remind us and maybe lay out a little bit of how you're thinking about the launch for trilocyte, obviously starting in small cell lung cancer, but as you get additional data for breast and colon cancer, are there any particular steps in there where you could file for perhaps an SNDA sooner rather than later? Do you anticipate going through all the studies in order to add the additional indications to a potential label? Thanks. [inaudible]
But to a potential label thanks.
Sure David.
Mark I'll take that question, you're going to hear a lot more about launch preparations from Soma grouped up our CEO at an upcoming call certainly in August.
Paul.
We are making a number of our preparations for that as you point out it will initially be in small cell lung cancer and.
Based on a potential priority will review will be ready to go early next year.
To your question.
Our expectation is that both the ISI two trial and Neoadjuvant breast cancer, all sub types and the Registrational phase three for colorectal will read out in early 2003.
About two years from launch.
Mark Vileka: Hi, it's Mark. I'll take that question. You're going to hear a lot more about launch preparations from Soma, Gupta, our CCO, on an upcoming call, certainly on the August call. We are making a number of preparations for that, and as you point out, it will initially be in small cell lung cancer, and based on a potential priority review, we'll be ready to go early next year. To answer your question,
And since then it's a registrational trial, yes, we'll be moving very quickly.
To file in FNB, yet as soon as possible.
And there may be other trials that we run obviously from 21.2 onward.
That we could publish and present.
And those will also be available to us so our expectation again early 23 for us by two and the colorectal study.
Okay.
Thank you.
Your final question is from the line that added quite a bit H.C. Wainwright. Please go ahead Sir.
Mark Vileka: Our expectation is that both the I-SPY-2 trial in neoadjuvant breast cancer, all subtypes, and the registrational phase 3 for colorectal, we'll read out in early 2023, about two years from launch. And since it is a registrational trial, yes, we'll be moving very quickly to file an SNDA as soon as possible. There may be other trials that we run, obviously, from 21, 22 onward, that we could publish and present, and those would also be available to us. So, expectation, again, early 23 for I-SPY-2 and colorectal.
Hi, Thanks for taking my questions.
So just to you had said the.
So are being done virtually already in preparation for the launch for trials I'm. Just wondering if you were also planning on a virtual launch.
Or how you're how you're handling that if everything is going to be digital or you're going to do the traditional planning for the traditional type of launch and then also just a question for Gen. I noticed that R&D expenses were down 17% sequentially I'm. Just curious you know you had mentioned.
David Matthew Nierengarten: Okay, thank you.
Operator: And your final question is from the line of Ed White with HC Wainwright. Please go ahead, sir.
Edward Patrick White: Hi, thanks for taking my question.
Edward Patrick White: So just to clarify, you had said the...
Why is up year over year I'm, just curious as to why it was down so much from last quarter. Thanks.
Edward Patrick White: MSLs are being done virtually already in preparation for the launch of TRILA. I'm just wondering if you are also planning on a virtual launch or, you know, how you're handling that, if everything's going to be digital or if you're going to do the traditional, planning for the traditional type of launch.
Thanks, Ed It's Mark I'll I'll answer the first part of question then turn it over to Gen.
Yes, I do believe that launch in drugs for the foreseeable future will be very different.
Than it has been.
Edward Patrick White: And also, just a question for Jen, I noticed that R&D expenses were down 17% sequentially.
We are looking to step up digital engagement that'll obviously, having effect on the size of the footprint out in the field.
Edward Patrick White: I'm just curious, you know. You mentioned why it's up year over year, but I'm just curious as to why it was down so much from last quarter. Thanks.
And as I mentioned on the prior question will be hearing a lot more about that from Soma.
So with that I'll turn it over to Jeff for the second part of question. So our high end.
Mark Vileka: Thanks, Ed. It's Mark.
The change in R&D expense was primarily due to the PDUFA fee that we paid in the fourth quarter that was a rather large be a couple of million dollars and so that is the main part of that variance.
Mark Vileka: I'll answer the first part of the question and then turn it over to Jen. Yeah, I do believe that, you know, launching drugs for the foreseeable future will be very different than it has been. But we are looking to step up digital engagement.
Okay, great. Thanks Jen.
Mark Vileka: And as I mentioned in the previous question, you'll be hearing a lot more about that from someone. So with that, I'll turn it over to Jen for the second part of the question.
And I'm showing no further questions at this time I would now like to have the conference back to Dr. Mark silica for closing remark.
Jen Moses: Sure. Hi Ed. The change in R&D expense was primarily due to the PDUFA fee that we paid in the fourth quarter. That was a rather large fee, a couple of million dollars, and so that is the main part of that variance.
Thank you operator that concludes the call. Please reach out to us with any questions. We look forward to engaging virtually with many of you around ASKO later this month at the Raymond James Conference in mid June. Thank you for joining us today and please stay well.
Edward Patrick White: Okay, great. Thanks, Jen.
Ladies and gentlemen. This concludes today's conference call. Thank you for your participation have a wonderful day you may all disconnect.
Mark Vileka: And I am showing no further questions at this time. I would now like to hand the conference back to Dr. Mark Vileka for closing remarks.
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Mark Vileka: Thanks.
Mark Vileka: Thank you, Operator. That concludes the call.
Mark Vileka: Please reach out to us with any questions. We look forward to engaging virtually with many of you around ASCO later this month and at the Raymond James Conference in mid-June. Thank you for joining us today, and please stay well. Ladies and gentlemen, this concludes today's...
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and have a wonderful day. You may all disconnect.
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