G1 Therapeutics, Inc. (GTHX) Q3 2020 Earnings Call Transcript

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G1 Therapeutics, Inc. (NASDAQ:GTHX)
Q3 2020 Earnings Call
Nov 4, 2020, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the G1 Therapeutics 3Q 2020 Financial Results Conference Call. [Operator Instructions]

I would now, like to hand the conference over to your first speaker for today, the Head of Investor Relations, Mr. Jeff Macdonald. Please go ahead, sir. Thank you.

Jeff MacdonaldSenior Director, Investor Relations & Corporate Communications

Thank you, operator. Good afternoon, everyone, and welcome to the G1 Therapeutics third quarter 2020 corporate financial update. Joining me today are Mark Velleca, Chief Executive Officer; Raj Malik, Chief Medical Officer and Senior Vice President, R&D Soma Gupta, Chief Commercial Officer; and Jen Moses, Chief Financial Officer. I’m also pleased to welcome Jack Bailey who previously announced will succeed Dr. Velleca, as Chief Executive Officer effective January 1, 2021. On today’s call the team 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.

And now, I’ll turn the call over to Mark.

Mark VellecaChief Executive Officer

Thanks, Jeff. Good afternoon, everyone, and thank you for joining us. We hope that you and your families are well. On our second quarter call, we highlighted that the financing and partnering agreements we executed this year would enable us to focus squarely on maximizing the potential of trilaciclib to benefit people with cancer across a range of indications. On today’s call the team will review our progress across regulatory, development and commercial initiatives for trilaciclib. We will also discuss rintodestrant and review the financials for the quarter. After our prepared remarks, we’ll open the call for questions.

Let me start by commenting on the company’s CEO transition. When I joined G1 in 2014 our long-term objectives were clear, advance trilaciclib from the lab to the clinic, develop a regulatory strategy for approval, build out the medical and commercial functions needed to support patient access to trilaciclib and solidify the balance sheet in order to sustain ongoing operations. Over the course of the past six plus years, I’ve had the privilege to work with an extremely talented team that accomplished all of those goals. I believe, that now is the right time for the company and for me personally to make a leadership transition. With a thoughtful succession plan in place, I worked closely with the rest of the Board of Directors on selection and transition process.

We are fortunate to have a highly capable leader on the G1 Board ready to assume the CEO role. Jack Bailey, is an ideal fit to lead G1, as we evolve to a commercial stage company. In his previous role as President of GSK’s pharmaceutical and vaccine business in the U.S. he oversaw multiple successful product launches and had extensive involvement in R&D, planning and execution. Jack joined the G1 Board earlier this year, as we were refining the blueprint for the launch of trilaciclib, and has already been providing valuable input in our strategic planning and is familiar with the entire organization.

Just as importantly, having known Jack for more than five years and working with him during his tenure on the Board he is an excellent cultural fit. The CEO transition has been going very smoothly and I’m excited to support G1 as a Board member and Senior Advisor going forward. This will be my last earnings call as the CEO of G1. So I’d like to thank all of our shareholders past and present who have supported G1 and shared our vision for trilaciclib’s potential to improve outcomes for patients receiving chemotherapy. And to our current and future shareholders, I am confident that you’ll find Jack to be a superb leader and steward of that vision.

With that, I want to turn the call over to our incoming CEO, Jack Bailey.

Jack BaileySenior Advisor

Thanks, Mark. I appreciate the introduction. Good afternoon, everyone. To start, I’d like to thank Mark and the rest of the Board of Directors for this opportunity and your confidence to lead this great company that we bring trilaciclib to patients and make it the standard of care in cancer treatment. To my G1 colleagues, as a Board member, I’ve been impressed with your dedication to patients and determination to rapidly advance new therapies. And I am excited to collaborate with you more closely on the execution of that work. And finally, to the members of the investment community, I look forward to sharing our progress with you, as we approach the potential approval and launch of trilaciclib, we continue to advance our development program.

Now, as Mark noted, I spend most of my career in commercial roles. Prior to joining G1, I was President of GlaxoSmithKline’s pharmaceutical and vaccine business in the U.S. During that time, we launched a number of innovative market disrupting drugs, which is very relevant as we get ready to launch trilaciclib. Products like natalizumab for severe salicylate asthma and DCMA in oncology, both represented step changes in innovation and clinical treatment paradigms much like trilaciclib will.

In addition, I served for many years on GSK’s investment committee for allocation of the company’s R&D budget. So ensuring resourcing and execution of robust development plans is something I’m familiar with and recognize the criticality of. In fact that’s what really energizes we are G1, the potential of trilaciclib to truly transform the chemotherapy experience. This is why, I started in life science industry nearly 30 years ago to bring this type of innovation to patients. I’m excited to get to work and help make that a reality for patients.

Now turning to progress in the third quarter, the headline was the FDA’s acceptance of our trilaciclib new drug application, which was assigned to priority review and PDUFA action date of February 15, 2021. Trilaciclib received breakthrough therapy designation in 2019 so our planning assumptions have been predicated on a high likelihood of receiving priority review and a potential approval in the first quarter of 2021. Our medical and commercial teams are continuing their work in anticipation of commercial availability in Q1 2021. And later in this call, Raj and Soma will both provide more color around the strategies and initiatives that their respective teams are working on.

We are excited about the near-term opportunities to bring this therapy to small cell lung cancer community, which has the potential to dramatically improve the chemotherapy experience for these patients. But that is not the only group that may benefit from trilaciclib, we are committed to evaluating trilaciclib across multiple solid tumors and different chemotherapy regimens. To that end, we expect to enroll the first patient in our Phase 3 metastatic colorectal cancer trial this quarter and anticipate data from that trial will read out in 2023.

After the findings in this trial, which support a supplemental NDA filing to the FDA to expand the trilaciclib label to include patients with CRC. Raj will provide more detail on that trial in just a minute. In 2021, we are planning to initiate a registrational trial in metastatic triple-negative breast cancer with a survival primary endpoint. We are also committed to evaluating trilaciclib’s benefit in other tumors that would further expand the number of patients who would be eligible for treatment.

Now turning to the development of our oral SERD rintodestrant, we have completed recruitment for the autumn of our Phase 1/2 trial that will evaluate rintodestrant in combination with the CDK4/6 inhibitor palbociclib. There was significant investigator interest in this trial and we were able to accelerate our recruitment timeline by several months despite the challenges that COVID-19 has presented to clinical trial enrollment.

Now before I turn the call over to Raj, I want to make a brief comment on our operations relative to the COVID-19 pandemic. As I’ve noted, we did not see an impact on recruitment for the rintodestrant trial. We monitor enrollment in all active trials to determine if COVID-19 is having an impact on recruitment timelines and will report any material delays. We have adequate commercial and clinical trial supply of trilaciclib to meet expected demand in 2021, as well as manufacturing and production contingency plans in place to reduce the risk of any future supply issues. Later on the call, Soma will discuss our approach to the commercial launch of trilaciclib in the context of the current environment.

Now, I’ll turn the call over to Raj to share the regulatory and clinical update for both trilaciclib and rintodestrant. Raj?

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Thanks, Jack, and good afternoon, everyone. I’ll start with the trilaciclib NDA. As Jack noted, we received priority review and a PDUFA action date of February 15, 2021. We continue to have a constructive dialog with the FDA and to-date, we have not seen any impact from COVID-19 on the agency’s normal review process and timelines. Given its multi-lineage benefit trilaciclib has the potential to become a standard of care for patients with small cell lung cancer. We believe trilaciclib will deliver the most benefit to patients, if it is used the first time and every time chemo is given, beginning in first-line treatment.

Protecting the bone marrow could not only improve patient outcomes in first-line, but could also be important when moving into additional lines of therapy. The largest number of patients receiving chemotherapy for small cell lung cancer is for the first-line treatment of extensive stage disease, and nearly all of these patients receive an etoposide and platinum based regimen, which is a regimen used in our two first-line trials.

In preparation for approval, our medical affairs team is focused on three key initiatives. Our first initiative is the NCCN guidelines. Inclusion and treatment guidelines is critical to adoption in clinical practice. We have notified both the Small Cell Lung Cancer and Hematopoietic Growth Factor guideline committees regarding our PDUFA date and have provided data on trilaciclib. Immediately following approval, a formal request will be submitted to NCCN, including the FDA approved package in SERD to evaluate trilaciclib for inclusion in those guidelines.

Our second initiative is scientific discourse. We have a robust publication and presentation plan to support medical education and this week our second third-line data on trilaciclib in small cell lung cancer was published. Last month, we presented new analysis of our small cell lung cancer data at the North American Congress on Lung Cancer and we have several manuscripts in review that we anticipate will be published this year and next, ranging from analysis of our randomized clinical trial data to patient reported outcomes and health economic outcomes research. We will submit additional analysis on trilaciclib for presentations at medical conferences throughout 2021.

Our third initiative is outreach to KOLs and healthcare professionals. Our team of field-based medical science liaisons, or MSLs are having regular engagements with academic KOLs and community oncologists, as well as pharmacists and nurses to better understand their approach to managing myelosuppression and the gaps in patient care that they are most concerned with.

In parallel to our work on small cell lung cancer, we are advancing a robust development plan. The next indication we are evaluating is metastatic colorectal cancer. The majority of patients with metastatic colorectal cancer receive a 5-FU based chemotherapy combination as first-line treatment, and the most effective chemotherapy combination FOLFOXIRI is extremely myelosuppressive, particularly with regard to neutropenia. We completed a pre-Phase 3 meeting with the FDA earlier this year and have incorporated their feedback into the trial protocol.

We are on track to enroll the first patient in this trial within the next several weeks. We anticipate enrolling approximately 300 participants in this randomized placebo-controlled trial in patients receiving first-line treatment for metastatic colorectal cancer. The trial will follow patients through induction and maintenance phases of treatment, with all patients randomized to receive either trilaciclib or placebo in addition to the FOLFOXIRI chemotherapy regimen.

Patients will be followed in the maintenance phase until they discontinue treatment. The primary outcome measure of this trial is myelopreservation with safety, tolerability, patient reported outcomes and survival measures also being assessed. More details on the trial protocol are available on the clinicaltrials.gov website.

We view breast cancer as an area where trilaciclib has potential to improve anti-tumor efficacy. Enrollment is ongoing in the I-SPY 2 trial with a goal of evaluating the potential for trilaciclib to enhance the pathological complete response rate for patients being treated with chemotherapy in the neoadjuvant setting. Next month, we will present the mature overall survival data from our Phase 2 trial in metastatic triple-negative breast cancer at the San Antonio Breast Cancer Symposium.

As a reminder, initial positive overall survival data were presented at the 2019 ESMO Congress and concurrently published in The Lancet Oncology. We plan to initiate a registrational trial in metastatic triple-negative breast cancer in 2021 and will provide more details on this trial design following the San Antonio data update.

With regard to our oral SERD rintodestrant, in October, we completed enrollment of 40 patients in the additional arm of our Phase 1/2 trial evaluating a combination of rintodestrant and the CDK4/6 inhibitor palbociclib commercially known as Ibrance. I’d like to point out that based on investigator enthusiasm and the dedicated work of our clinical operations team, we were able to accelerate recruitment and complete enrollment in approximately three months.

Because we were able to complete enrollment ahead of schedule, we now anticipate presenting initial safety, tolerability and efficacy data, including clinical benefit rate at 24 weeks or CBR 24 in the second quarter of 2021. The monotherapy arm of this trial was fully enrolled last year and we are presenting updated safety and efficacy data from all 67 patients at the upcoming San Antonio Breast Cancer Symposium.

I will now turn the call over to Soma. Soma?

Soma GuptaChief Commercial Officer

Thanks, Raj. So as both Jack and Mark mentioned, this is an exciting time, as we prepare to launch trilaciclib in the first of what we expect will be multiple indications. We have completed building a strong commercial organization at G1 that is advancing our launch strategy for trila in small cell lung cancer and we are excited to be working with Boehringer Ingelheim field sales team to bring trila to patients upon approval.

The three critical areas we are focused on for the launch are, first, disease state education highlighting the impact of myelosuppression on patients and the healthcare system. Second, ensuring we have the best team in place to successfully introduced a value of trilaciclib to physicians and patients. And third, ensuring broad and simple access to trilaciclib.

As part of our launch preparations, we have conducted a significant amount of market research as well as advisory boards, with oncology nurses and pharmacists. We recently completed a quantitative survey of about 150 oncologists in order to better understand the unmet need for patients. We found that over 90% of oncologists believed chemotherapy induced myelosuppression has a moderate to extremely negative impact on a patient’s quality of life.

In addition, 60% of oncologists surveyed were now more concerned with the consequences of chemo in this myelosuppression due to COVID-19 than they have been before the pandemic. Oncologists cited several features that differentiates trilaciclib from intervention views to reactively treat myelosuppression and represented clear advantages over the current standard of care, including trila’s multi-lineage mechanism, which prevents damage to the marrow, a trial design, covering the vast majority of small cell lung cancer chemo regimens, and its safety and tolerability profile. We’re encouraged by these findings, which indicate, prescribers will be receptive to learning more about trilaciclib.

Trilaciclib is a disruptive therapy, and we will need to change the mindset of healthcare professionals from reactive treatment of myelosuppression to proactive care preventive. To do so, we’re investing heavily in increasing awareness of the impact of chemo-induced myelosuppression on the patient experience. This extends not only to the oncologists, but pharmacists, support staff and perhaps most critically to nurses who in many cases have the most extensive contact with patients and see the effects of myelosuppression first hand.

We recently launched an online disease state education campaign about myelosuppression and are rolling out additional educational programs to key audience through CME and other online vehicles. We are also engaged with key professional organizations like the Oncology Nursing Society and patient advocacy groups, such as GO2 Foundation and Longevity. We have also built a strong commercial organization, which is ready to communicate the value of trilaciclib upon FDA approval. Our team is now fully in place and marketing — market access, key accounts, patient services, sales operations and other critical functions are being managed by talented individuals who’ve been through multiple oncology as a point of care launches.

I also want to touch on our sales force collaboration with Boehringer Ingelheim, which we are really excited about. Having an experienced sales team with existing relationships in the lung community on board this far an advance of launch has been instrumental in our pre-launch preparations. We’ve had the opportunity to gain alignment on launch priorities, access their team’s knowledge as we develop account profiles, got input from their sales leadership on core selling tools and begin robust disease state training for the field team.

In the COVID-era BI has long-term relationship with oncology packages will be especially critical, we anticipate that physical access to oncology centers will be limited for the foreseeable future, and the BI sales force, as well as our own highly experienced account teams will be able to more easily gain access to customers leveraging virtual channels based on their preexisting relationships. We feel confident based on how the team has been working together that we will be able to cover the approximately 2,500 oncologists treating the majority of small cell lung cancer cases. At launch we’ll have particular focus on those who see the highest concentration of patients and have potential for early adoption, which is based on criteria such as their use of prophylactic G-CSF and/or a history of early adoption of novel therapies.

Our third area of focus is optimizing the early launch experience, which means, making it easy for prescribers offer that staff to have access to trilaciclib. Our job is to ensure every passes has a great first experience with this novel treatment, which will lead to expanded use over time. Our market access team has been busy meeting with integrated delivery networks and group purchasing organizations, which are critical to act in the community treatment setting, but we know that vast majority of patients are seen.

In addition, we are beginning our pre-approval information exchange discussions with payers as well as business discussion with C-suite level population based decision makers at key oncology clinics to build upon the extensive feedback we have amassed over the summer to drive our final recommendations on price. Players acknowledge the unmet need we are addressing and we expect that trilaciclib will be added to formularies over the course of 2021, as payer CNC committees meet.

Prior to inclusion in a formal medical policy trials trilaciclib would be available via medical exception. Trilaciclib will be a bilingual product, meaning a practice or a hospital pharmacy will purchase it in advance of receiving reimbursement. So we are planning our support programs with that in mind, our comprehensive support hub will assist office staff and benefits investigation, addressing prior authorization requirements and a sales support. Overall, we’re very encouraged by the feedback we’re receiving from stakeholders about trilaciclib and we’re prepared to support a commercial launch as early as the first quarter of 2021.

And now, I’d like to turn the call over to Jen. Jen?

Jen MosesChief Financial Officer

Thanks, Soma. Full financial results for the third quarter of 2020 are available in our press release and 10-Q. Today, I’d like to focus on a few key points from our disclosures. We recognized license revenues of $26.6 million for the third quarter of 2020. Revenue was primarily driven by the upfront payments of $20 million and $6 million from EQRx and Genor, respectively. We expect to recognize revenue related to our Simcere partnership in the fourth quarter of 2020.

As of September 30, 2020, we had $238.3 million in cash and cash equivalents on the balance sheet compared to $269.2 million as of December 31, 2019. This total includes an initial $20 million drawdown from our Hercules financing and upfront cash proceeds from our agreements with EQRx, Genor and Simcere. We are updating our 2020 cash guidance to finishing the year with between $200 million and $205 million, up from our previous guidance of $185 million to $200 million. The primary driver for updating guidance is more clarity on expected commercial expenses, which takes into consideration the cost effective nature of our agreement with BI, as well as additional savings and cash inflows we expect to realize from our outlicensing of lerociclib and related interim supply agreements with Genor and EQRx.

As previously disclosed, we expect our current cash to support operations into 2022. When contemplating cash runway into 2022, we include licensing and collaboration payments we have received to-date and our debt drawdown of $20 million. We are also counting for all anticipated trilaciclib launch expenses and expenses related to our development program. Our guidance on cash runway does not consider any additional proceeds from current agreements that includes additional milestone payments, cost reimbursements or other inflows of capital that we may realize or revenue that we may generate from the sales of trilaciclib beginning in 2021.

Furthermore, our guidance does not reflect our ability to drawdown the additional capital from the Hercules facility we have in place. All of these items would further extend our cash runway beyond the guidance given today.

I’ll now turn the call back to Jack. Jack?

Jack BaileySenior Advisor

Thank you, Jen. Our highest priority is to make trilaciclib available to patients as quickly as possible. We are excited about the potential to deliver this much needed therapy to small cell lung cancer patients as early as the first quarter of 2021, and our focus on executing a successful commercial launch next year. This commercial effort complements the work of our medical team they are doing on scientific discourse and education.

Initial indication in small cell lung cancer will provide the opportunity for healthcare professionals to gain experience with trilaciclib and see first-hand how can it benefit their patients letting the foundation for uptake in future indications. With patent runway into the mid-2030s and a robust development plan that will generate data in additional tumor types over the next 24 to 36 months.

We have the opportunity to significantly expand the use of trilaciclib for the benefit of patients and at the same time create value for shareholders for their conviction in this therapy. We continue to view our oral SERD rintodestrant as the potential best-in-class therapy and expect to disclose rinto/palbociclib combination data in the second quarter of 2021.

Now, before we go to Q&A, I do want to take a moment to recognize all the healthcare professionals and frontline workers who are continuing to provide essential services. In particular, as our teams have been working with members of the oncology community, we have gained an even deeper appreciation for those that are focused on the health of our families, friends and neighbors.

That concludes our prepared remarks. Operator, please open the line for questions.

Questions and Answers:

Operator

[Operator Instructions] Our first question is from the line of Anupam Rama of J.P. Morgan. Your line is now open.

Anupam RamaJ.P. Morgan — Analyst

Hi, guys. Thanks so much for taking the question. Two quick ones from me. First for rintodestrant at San Antonio in December, what specific analysis would you point us to? And what’s kind of like in your mind a win scenario there? And then second question, just thinking about the NA — the North American Lung Cancer meeting you’re recently at, and the trilaciclib updates there, like how would you characterize can be awareness of the drug at the meeting? And where are you on sort of physical physician awareness and medical awareness of the drug relative to your internal expectations? Thanks so much.

Jack BaileySenior Advisor

Sure. I’m going to have, Raj, take the first one on San Antonio.

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Yeah. Hey, Anupam. So the data presented at San Antonio will be monotherapy data from the dose escalation as well as the expansion and we expanded at two different dose levels and picked the recommended dose that we then took forward into palbociclib combination. So it will be additional safety and efficacy data showing a safety profile that continues to look very competitive and evidence of activity in heavily pre-treated patient populations. And we are very excited about the combination with palbociclib that — those 40 patients enrolled very quickly in three months and we look forward to seeing those data next year, which could also be important for potential partnering at that time.

Regarding your second question at the North America Lung Cancer Congress. Yeah, so we had an oral presentation of the pool data, where we also presented new findings, where we saw significant reductions in hospitalizations due to chemotherapy induced myelosuppression or sepsis, which of course are very important also from an economic standpoint. In terms of awareness, as we are continuing to work in this area, clearly, this is something that maybe Jack can also comment on.

Jack BaileySenior Advisor

Yeah. Thank you Anupam for both of those questions. I think on the awareness front, we did start an online disease education program here several months ago, that I think is getting good traffic on. Obviously, we’ve got the medical team out there also at the various conferences like you discussed. I think in terms of your core question on, what is the level of awareness, I think we feel good with it right now. To be honest, if you look at a lot of our market research, what oncologists are signaling to us is a real willingness to try this once it’s approved. So we feel good with where we’re at right now, but obviously we’re going to continue with our efforts, both through the medical organization and other things like the online up until the approval. Thanks.

Anupam RamaJ.P. Morgan — Analyst

Thanks for taking our questions.

Operator

Your next question is from the line of Phil Nadeau of Cowen and Co. Your line is now open.

Philip NadeauCowen, Inc. — Analyst

Good afternoon. Thanks for taking the question. I guess, first is on the FDA review of trila, we’re just over three months away from the PDUFA. Any update on an outcome or has the FDA indicated that one could or might be necessary?

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

No, they’ve — actually, there is no outcome that they have indicated will be required.

Philip NadeauCowen, Inc. — Analyst

Perfect. And then second is on reimbursement for trila post-approval. I guess from your prepared remarks, it sounds like it’s likely to be Medicare Part B. Can you remind us of how that would work within — in the first year of launch, if it is approved in February? Presumably, you have to incorporate it in some group DRGs. So how does that work and is it possible to get an NTAP payment next year or does that have to wait for subsequent years?

Jack BaileySenior Advisor

Yeah, thanks, Phil for the question on the reimbursement. It is a Part B drug, a buy and bill drug. So in terms of the Medicare Part B process, obviously, we’ll file for a J-code that process has been refined over the last couple of years, so it will be quicker than it has been in the past. In addition, you’re correct, we did — we will file for an NTAP that will take a little bit longer and is dictated, obviously, as a little bit slower schedule. So both of those will come into play as it relates to reimbursement.

On the commercial side, obviously, it will be part of the medical policy and in most cases don’t make an exception until the PT [Phonetic] to those various payer organizations have a formal review of it and then hopefully adapt.

Philip NadeauCowen, Inc. — Analyst

At the level of an individual institution, will you have to have them revise their protocols for myelosuppression before you can get adoption or is there a fair amount of discretion within the institutions themselves for how myelosuppression is handled?

Jack BaileySenior Advisor

Yeah, I mean, obviously, it will be — put an overarching comment on it and then I can turn over to Raj to supplement. Clearly, we’ll be looking as both Raj and Soma mentioned, about working with both NCCN guidelines in other opportunities for various guideline organizations. Obviously, we want to get that as quickly as possible, because the vast majority of the treating physicians follow that. But to your point, where there are individual organizations who have — may have different guidelines included in that, we’ll certainly dig into those. We do have a major account, key accounting team that will be engaging with the large community practices. Raj, anything you like to add?

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Yeah, no, I think that’s exactly right. In terms of our medical team as well as Soma’s team is really working with these large community practices. And on the education side, and particularly, we think that the nurses are going to be really important in terms of having trilaciclib being front of mind for physicians as well as patients come in following diagnosis. And maybe, Soma, anything that you’d like to add?

Soma GuptaChief Commercial Officer

I think only a small thing, which is, I think that there is — I think that there will be use, I think it will take us — I think it will take a little while to get it into the kind of systems, if you will, EMR otherwise, which will really serve as a kind of a reminder to opt-in or opt-out of therapy as they are constructing regimens for small cell lung cancer patients. So I think prior to that, I think it’s what Raj said, that nurses will be really important as a kind of vehicle to remind physicians to consider it.

And so that’s a very key part of the strategy for us is to work with the nurses, partner there. So as I said earlier in my remarks, they are really the ones that see the consequences of myelosuppression and we believe will be motivated to take the actions.

Philip NadeauCowen, Inc. — Analyst

That’s very helpful. Thank you.

Jack BaileySenior Advisor

Thanks, Phil.

Operator

Next we have Tom Shrader of BTIG. Your line is now open.

Thomas ShraderBTIG — Analyst

Hi, good afternoon. Thanks for taking the questions. I’d like to thank Mark for the tireless effort to keep us up to date on data that’s been pretty subtle. So thanks a lot, I wish you luck. Going forward, I have a kind of a book-keeping question. So if you look at your slide deck, Slide 14, there is sort of a beautiful succinct table on myelosuppression, where you’re able to combine all your trials and come up with very clean data. Do you know if that’s what the label will look like? Are you confident that it will be that clean, that you’ll be able to combine everything? So the — it’s clearly three line myelosuppression or is that a work-in-progress with the agency?

Jack BaileySenior Advisor

Thanks, Tom. I’m going to have Raj respond to that.

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Yeah, so just to remind Tom, hi. It was actually the agency who has asked us to combine the data.

Thomas ShraderBTIG — Analyst

Yeah, I know.

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Yeah, so that’s right. And as you also know, obviously, label negotiations are ongoing through NDA review. And — but so, we have various strategies to get the appropriate data into the label, so that it really communicates the value of trilaciclib for patients.

Thomas ShraderBTIG — Analyst

Okay. And then just one quick question for Soma. Your comment about talking to users about the key areas of myelosuppression that they’re worried about. Are there any surprises there we should be thinking about?

Soma GuptaChief Commercial Officer

So I don’t think so. I think that there has been — I think the one thing that we’ve definitely heard is, sometimes when they think — it’s not a surprise, as I think we know this, but when they think about myelosuppression sometimes they think about neutropenia, and they don’t…

Thomas ShraderBTIG — Analyst

Yeah.

Soma GuptaChief Commercial Officer

Think about the multi-lineage effects, right. So that’s one thing. Obviously, the disease state education aims to educate on right is around the fact that this is a multi-lineage affect and data and that there is benefits to obviously doing something that affects at all. So to me, I wouldn’t say that there is a surprise in it, I think it’s more, that that is a pretty prevalent thing is that people think myelosuppression and I think neutropenia that does require some education.

Thomas ShraderBTIG — Analyst

All right, great. Thank you.

Jack BaileySenior Advisor

Thanks, Tom.

Operator

Next we have David Nierengarten of Wedbush Securities. Your line is now open.

David NierengartenWedbush Securities Inc. — Analyst

Hey, thanks for taking the question. I kind of had a — maybe a little off the wall or outside question. Now that we’ve had a couple quarters of commercial companies having either de novo or new or whatever you want to call it product launch in a wholly virtual environment and some companies that have had to convert, obviously, do virtual marketing for their products. Are there any — as we’re talking to BI, are there any lessons or mistakes or things that you’ve learned in your discussions that you can apply assuming that we’re still in the same spot when you launch trilaciclib?

Jack BaileySenior Advisor

Yeah, thanks, David. I’ll make a couple overarching comments, and I’ll ask Soma to add to it. Certainly the COVID situation is pretty unprecedented. What we do know is the oncology area was one of the most restrictive in terms of your personal selling, that’s been shown time and time again by the acuity of data and others. It’s only gotten more restrictive obviously because of some of the concerns around COVID.

So being able to look at other ways to access the oncology community is absolutely critical. Clearly, things like good digital content to supplement the personal selling, obviously, having a good medical organization to be there for questions that may arise by the practicing oncologists is key. So I think we’ve really looked at trying to do both, what is traditional, but also what has become prevalent with COVID, i.e., things like the digital approach.

So at these end it is what it is. I think we’re very confident that building upon the relationships that BI has will give us the access at a time, we’re doing it on our own, building sales force was not as capital efficient and probably would not have given us the access, but by also supplementing with digital. And being able to work with the nursing societies and the patient efficacy groups, these are all points of access for information that people involved in this cancer, small cell lung cancer community are going to seek to access. We want to be there to be able to provide that information. So Soma, what — I’ll turn it over to you to add to that.

Soma GuptaChief Commercial Officer

Yeah, no, I think you’ve captured it well, I think that is — we — I think you’ve heard me talk about this before, but one of the main reasons we did BI was because we could — we thought we’re seeing forward to this was not a short-term problem, this was going to be a longer-term issue. And we think of those preexisting relationships are critical to getting the access in this environment. So if they have something new to talk about, that they will be able to get in, even if it’s a virtual channel, then the information will get across. So we feel great about the fact that we made that decision knowing kind of what it looks like the spring and winter are probably going to be like.

But I think it’s important that we also have — we’re really spending a lot of effort to equip our BI sales partners with industry-leading technology for live virtual engagements and kind of augmenting their efforts with targeted digital messaging, virtual speaker program, national launch broadcast, virtual conventional presence.

I think the one benefit that perhaps we had that companies that have the launch in the middle of all this is time. So we’ve had the time to plan it, so that we weren’t just having to change on a dime and maybe were coming up with a sub-optimal solution. I think we’ve actually done quite a bit to make sure that the reps are kind of built for digital, if you will, and are able to execute in that way. And of course, our digital approach, as Jack mentioned, is also really to try to reach customers where they are. So leveraging peer-to-peer sites like OncLive, social media platforms, things that where they can actually access the information where they go anyway.

And so I think that between those two things, we have — we are — we recognize the issues that it can — I would say that this possess, but we feel really good about the level of support we’re going to give the BI routes in terms of their ability to digitally engage, but also to supplement with kind of a more supercharge digital to drive awareness.

Jack BaileySenior Advisor

And David, while — this is — while the engagement model as Soma and I both shared, I think we feel good with. I think the tailwind that COVID has given us has really heightened the notion of providers being more acutely aware of preventative steps they can take, which clearly falls into what we see with trilaciclib, it moves us from a reactive approach, the traditional reactive approach in terms of applying rescue interventions to obviously being prevented it. So we’ve seen that come out of the market research quite clearly. So there are as you can say some benefits from the COVID situation, is that heightened sensitivity to any preventive steps that can be taking to help assist patients.

David NierengartenWedbush Securities Inc. — Analyst

And presumably the NCCN guidelines have only increased its importance, is that fair?

Jack BaileySenior Advisor

Yeah I think the — go ahead, Soma.

Soma GuptaChief Commercial Officer

So just quickly. Yeah, no, I mean, we do think that that is how we — it’s — we do think it’s having an immediate impact. I mean, we’ve actually seen that number, people who are taking preventative measures kind of maybe in March, April to now is gone up pretty significantly. And when we talk to even in outdoors informally, we have heard that there is an increased usage of prophylactic measures. And again, maybe guidelines drive in, maybe just people being worried, but we’re definitely seeing a move in that direction.

David NierengartenWedbush Securities Inc. — Analyst

Great. Thanks.

Jack BaileySenior Advisor

Thanks, David.

Operator

All right. Next we have Chad Messer of Needham and Company. Your line is now open.

Simon GillNeedham & Company — Analyst

Good afternoon, everyone. This is Gill on for Chad, and thank you for taking our questions. Also congratulations to Jack on starting out and best wishes to Mark in your next endeavors. I’d like to first ask a question, we know that trilaciclib is moving into colorectal, how much more would be required for a tumor agnostic label? Like kind of remind us what the plan is there?

Jack BaileySenior Advisor

Yeah. Raj? Yes, yeah, so the colorectal trial is obviously an important step because 5-FU based chemotherapy, as I mentioned, is the standard of care there. And it’s also used across other GI malignancies beyond colorectal. So for example, gastroesophageal, pancreatic and so on. And so we think that the colorectal trial will be an important stepping stone toward potentially broader usage in some of those other GI malignancies as well. Even beyond well the — looking at trials that predominantly focused on myelopreservation, we are also considering trials that are going to be looking at anti-tumor efficacy because that’s another important aspect of the mechanism of action of trilaciclib and one of those, of course, is the triple-negative study that we’ve already discussed here.

Simon GillNeedham & Company — Analyst

And kind of let me on to the next question, so a bit of a drill down on the colorectal cancer study. My understanding that this is going to be a treatmental progression, is there any accounting for a potential of increase overall doses would this confound some of the safety data?

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

You’re right. The — we — the standard of care is to treat on the progression. And what we saw in triple-negative breast cancer is that patients were actually able to tolerate it better. That was another scenario where chemotherapy was given on progression and the safety profile actually was very comparable to that of chemotherapy alone. And so as that comes to pass in the colorectal trial that increased chemotherapy exposure could also potentially play a role in improving anti-tumor efficacy, which is also something that we’re looking for in that trial.

Simon GillNeedham & Company — Analyst

That’s…

Jack BaileySenior Advisor

Those go…

Simon GillNeedham & Company — Analyst

Go ahead.

Jack BaileySenior Advisor

Go ahead, Gill.

Simon GillNeedham & Company — Analyst

Kind of a — maybe more of a — kind of a — maybe something more a bit of a notice here. It seems interesting that you were able to enroll your rintodestrant combination study pretty quickly and — during COVID, and maybe that’s not surprising, considering it’s an oral combo. Is this something physicians are paying attention to, as you mentioned before?

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Yes. Well, absolutely. I think the rapidity with which a trial enrolls I think is a sign obviously of investigator interest and also patients wanting to enroll onto the trial. So completely agree.

Simon GillNeedham & Company — Analyst

Alright, excellent. Thank you for taking our questions and congrats on all the progress and we will be looking forward to the PDUFA date.

Jack BaileySenior Advisor

Thanks, Gill. And we appreciate the well-wishes to both Mark and myself.

Operator

Next we have Tony Butler from ROGH [Phonetic] Capital. Your line is now open.

Tony ButlerRoth Capital Partners, LLC — Analyst

Thank you, it’s Roth Capital, but that’s a bit relevant for the question. Raj, I wanted to ask you about preserve one and CRC. Is — it might — is the dosing and schedule the same as you would have seen in SCLC or has that changed? That’s question A. And B is, I noticed and sorry to be picky, but only two sites open to-date, I’m sure about that will increase, and I wondered if you could just speak to, sort of, the timing of that increase and how you think about site enrollment? In part, it could be COVID-related, in part may not necessarily be. But I’m curious if you would speak to that. And I too wanted to yet again welcome Jack, but also say, Mark, thank you very much.

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Hi, Tony. Yeah, so in the colorectal trial, the 5-FU is given as a 48-hour infusion and the chemo — the other chemotherapy is given on day one. So trilaciclib will be given for two days, both on day one and they two, with every cycle a FOLFOXIRI. If you recall in the small-cell studies in the triple side carboplatin regimen and first-line, that is a three-day chemotherapy regimen. So this is a multi-day chemotherapy regimen where trilaciclib was given with chemotherapy.

Tony ButlerRoth Capital Partners, LLC — Analyst

I actually think that, yeah. Thank you.

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Yeah. And the second, for the sites, it’s — the study is — actually there is a lot of investigator enthusiasm and we are at the initial part of site activation. So we expect a rapid ramp-up on — in that and as well as enrolling our first patient soon.

Tony ButlerRoth Capital Partners, LLC — Analyst

Thanks, Raj.

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Sure.

Jack BaileySenior Advisor

Thanks, Tony.

Operator

And there are no further questions at this time. I will now turn the call over to or back to CEO, Jack Bailey for closing remarks.

Jack BaileySenior Advisor

Thank you, operator. Well, this concludes the call. Certainly, feel free to please reach out to us with any other questions you may have. I will look forward to connecting with many of you at the upcoming Stifel and also Evercore ISI virtual conferences. Thanks again for joining us today and please stay well.

Operator

[Operator Closing Remarks]

Duration: 50 minutes

Call participants:

Jeff MacdonaldSenior Director, Investor Relations & Corporate Communications

Mark VellecaChief Executive Officer

Jack BaileySenior Advisor

Raj MalikM.D. Chief Medical Officer and Senior Vice President, R&D

Soma GuptaChief Commercial Officer

Jen MosesChief Financial Officer

Anupam RamaJ.P. Morgan — Analyst

Philip NadeauCowen, Inc. — Analyst

Thomas ShraderBTIG — Analyst

David NierengartenWedbush Securities Inc. — Analyst

Simon GillNeedham & Company — Analyst

Tony ButlerRoth Capital Partners, LLC — Analyst

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