G1 Therapeutics Inc (GTHX) 2020 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the G1 Therapeutics 3Q 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. (Operator Instructions) As a reminder, today's program may be recorded. And now I'd 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.

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 as 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 would 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.

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 will 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 6 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 the leadership transition.

With a thoughtful succession plan in place, I worked closely with the rest of the Board of Directors on the selection and transition process. We were 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 5 years, and working with him during his tenure on the board, he's 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.

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 their confidence in me to lead this great company as 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'm 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, and continue to advance our development program.

Now, as Mark noted, I spent 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 mepolizumab for severe eosinophilic asthma, and BQMA in oncology both represented step changes and innovation, and clinical treatment paradigms, much like trilaciclib will.

In addition, I served for many years on GSK's investment committees for allocation of the company's R&D budget. So ensuring the resourcing and execution of robust development plans is something I'm familiar with and recognize the criticality of.

And frankly, that's what really energizes me about G1, the potential of trilaciclib to truly transform the chemotherapy experience. This is why I started in the 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 priority review and a 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 opportunity 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. The findings in this trial would 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 the 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 arm of our Phase 1/2 trial that will evaluate rintodestrant in combination with the CDK 4/6 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 in 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 updates for both trilaciclib and rintodestrant. Raj?

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 dialogue 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-layered benefits, 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 2 first line trials.

In preparation for approval, our medical affairs team is focused on 3 key initiatives. Our first initiative is the NCCN guidelines. Inclusion in 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 insert, 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 analyses 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 analyses of our randomized clinical trial data, to patient purported outcomes, and health economic outcomes research. We will submit additional analyses 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 indication 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 new adjuvant 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 a CDK 4/6 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 3 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'll now turn the call over to Soma. Soma?

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 trilaciclib in small cell lung cancer, and we are excited to be working with Boehringer Ingelheim's field sales team to bring trilaciclib to patients upon approval.

The 3 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 introduce the 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 believe that chemotherapy-induced myelosuppression has a moderate to extremely negative impact on a patient's qualify of life.

In addition, 60% of oncologists surveyed were now more than concerned with the consequences of chemo-induced myelosuppression due to COVID-19 than they had been before the pandemic. Oncologists cited several features that differentiate trilaciclib from interventions used to reactively treat myelosuppression and represented clear advantages over the current standard of care, including trilaciclib'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 to prevent it.

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 audiences 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 market access, key accounts, patient services, sales operations, and other critical functions are being managed by talented individuals who have been through multiple oncology and supportive 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 in 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, get input from their sales leadership on core selling tools, and begin robust disease state training for the field team.

In the COVID era, BI's long-term relationship with oncology practices 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 2,400 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 and office staff to have access to trilaciclib. Our job is to ensure every practice 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 a community treatment setting, where we know the vast majority of patients are seen. In addition, we are beginning our pre-approval information exchange discussion with payers as well as business discussions 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.

Payers acknowledge the unmet need we are addressing and we expect that trilaciclib will be added to formularies over the course of 2021 as payer P&T committees meet. Prior to inclusion in a formal medical policy, trilaciclib would be available via medical exception. Trilaciclib will be a buy and bill product, meaning a practice or a hospital pharmacy will purchase it in advance of receiving imbursement. So we are planning our support programs with that in mind.

Our comprehensive support hub will assist office staff and benefit investigations, addressing prior authorization requirements, and appeal 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 2021.

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

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 out-licensing 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 received to date and our debt drawdown of $20 million. We are also accounting for all anticipated trilaciclib launch expenses and expenses related to our development program.

Our guidance 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 draw down 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?

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 doing scientific discourse and education. The initial indication in small cell lung cancer will provide the opportunity for healthcare professionals gain experience with trilaciclib and see firsthand how it can benefit their patients, laying 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 opportunities 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 with 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 historical 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.

(Operator Instructions) Our first question is from Anupam Rama of JPMorgan.

Two quick ones from me. First, for rintodestrant, at San Antonio in December, what specific analyses would you point us to and what's in your mind a win scenario there? And then second question. Just thinking about the North American Lung Cancer Meeting, you were recently at and the trilaciclib update there, how would you characterize the awareness of the drug at the meeting? And where are you on physical -- physician awareness and medical awareness of the drug relative to your internal expectations?

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

So the data presented at San Antonio will be monotherapy data from the dose escalation as well as the expansion and we expanded at 2 different dose levels and picked -- we recommend the 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. Those 40 patients enrolled very quickly in 3 months and we look forward to seeing those data next year, which could also be important for potential partnering at that time.

Regarding the second question at the North America Lung Cancer Congress. So we had an oral presentation of the pooled data where we also presented new findings where we saw significant reductions and hospitalizations due to chemotherapy-induced myelosuppression and 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.

Thank you, Anupam for both those questions. I think on the awareness front, we did start an online disease education here several months ago that I think is getting good traffic on. Obviously, we've got the medical team out there also with the various conferences like you've 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.

Your next question is from Philip Nadeau of Cowen and Co.

I guess first is on the FDA review of trila. We're just over 3 months away from the PDUFA. Any update on an Adcom? Has the FDA indicated that one could or might be necessary?

No, there is no Adcom that they have indicated will be required.

And then second is on the reimbursement for trial 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 the first year of launch if it is approved in February? Presumably, it will have to be incorporated in some group DRG. So how does that work and is it possible to get an NTAP payment next year or does it have to wait until subsequent years?

Thanks 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 years so it will be quicker than it has been in the past.

In addition, you're correct. We will file for an NTAP. That will take a little bit longer and is dictated, obviously, at 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, they'll make an exception until the Ps and Ts of those various payer organizations have a formal review of it and then hopefully adopt.

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 about how myelosuppression is handled?

Let me put an overarching comment on it and then I can turn it over to Raj to supplement. Clearly, we'll be looking as both Raj and Soma mentioned, about working with both NCCN guidelines and other opportunities for various guidelines organizations.

Obviously, we want to get that as quickly as possible because the vast majority of these treating physicians follow that. But to your point, where there are individual organizations who may have different guidelines included in that, we'll certainly dig into those. We do have a major account, key account team that will be engaging with the large community practices.

Raj, anything you'd like to add?

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 mine for physicians as well, as patients come in following diagnosis.

Maybe Soma, anything that you'd like to add?

I think only a small thing, which is I think that there will be use. I think it will take a little while to get it into the systems, if you will, EMR and otherwise, which will really serve as 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. I think the nurses will be really important as a vehicle to remind physicians to consider it. So that's a very key part of the strategy for us is to work with the nurses, partner there. Because 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 action.

Next, we have Tom Shrader of BTIG.

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 bookkeeping question. So if you look at your slide deck, Slide 14, there's 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 it's clearly 3-line myelosuppression? Or is that a work in progress with the agency?

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

So just to remind, Tom, it was actually the agency who had asked us to combine the data. So that's right and as you also know, obviously, label negotiations are ongoing through NDA review. And so we have various strategies to get the appropriate data into the label so that it really communicates the value of trilaciclib for patients.

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?

So I don't think so. I think that there's been -- I think the one thing that we've definitely heard is sometimes when they think -- it's not a surprise. We know this but when they think about myelosuppression, sometimes they think about neutropenia and they don't think about the multi-lineage effect. So that's one thing obviously that the disease state education aims to educate on is around the fact that this is a multi-lineage effect and that there's benefit to obviously doing something that affects it all.

So to me, I wasn't sure that there was a surprise in it. I think it's more that that is a pretty prevalent thing is that people think myelosuppression, they think neutropenia. That does require some education.

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

I had a little off the wall or outside question. Now that we've had a couple quarters of commercial companies having either a de novo or renewal, whatever you want to call it, project launch in a wholly virtual environment and some companies that have had to convert, obviously, to 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?

Thanks, David. I'll make a couple overarching comments. Then 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 [CV] data and others. It's only gotten more restrictive, obviously, because of the concerns around COVID.

So being able to look at other ways to access the oncology community is absolutely critical. Clearly, things like digital content to supplement the personal selling. Obviously, having a good medical organization to be there for questions that may arise by the practicing oncologist 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 day's 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 where doing it on our own, building the 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 advocacy groups, these are all points of access for information that people involved in this, 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, let me turn it over to you to add to that.

I think you've captured it well. I think that we -- I think you've heard me talk about this before. But one of the main reasons we did BI was because we were seeing forward to that this was not a short-term problem. This was going to be a longer-term issue and we think that 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 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 spending a lot of effort to equip our BI sales partners with industry leading technology for live virtual engagements and augmenting their efforts with targeted digital messaging, virtual speaker programs, national launch broadcasts, virtual convention presence.

I think the one benefit that perhaps we had that companies have had to 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 time 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 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 onlive, social media platforms, things where they can actually access the information where they go anyway.

And so I think that between those 2 things, we recognize the issues that this poses but we feel really good about the level of support we're going to give the BI reps in terms of their ability to digitally engage but also to supplement with a more supercharged digital to drive awareness.

While the engagement model that 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 preventative. 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, it's that heightened sensitivity to any preventative steps that can be taken to help assist patients.

And presumably, the NCCN guidelines have only increased the importance. Is that fair?

Just quickly, we do think that that is -- we do think it's having an impact. We've actually seen that number of people who are taking preventative measures kind of maybe in March/April to now has gone up pretty significantly. And when we talk to even the NAV boards informally, we have heard that there is an increased usage of prophylactic measures. And again, maybe guidelines driven, and maybe just people being worried but we're definitely seeing them move in that direction.

Next, we have Chad Messer of Needham and Company.

This is Gil on for Chad. Congratulations to Jack on starting out and best wishes to Mark on 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? Remind us what the plan is there.

So the colorectal trial is obviously an important step because 5-FU-based chemotherapy, as I mentioned, is a standard of care there. And it's also used across other GI malignancies beyond colorectal. So for example, gastro-esophageal, pancreatic, and so on.

And so we think that the colorectal trial will be an important stepping-stone towards potentially broader usage in some of those other GI malignancies as well. Even beyond looking at trials that predominantly focus on myelopreservation, we're 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.

Led me onto this next question. So a bit of a drill down on the colorectal cancer study. Is it my understanding that this is going to be treatment of progression. Is there any accounting for a potential of increased overall doses? Would this confound some of the safety data?

You're right. The standard of care is to treat overall 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 overall 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.

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

Yes. 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.

Congrats on all the progress and we'll be looking forward to the PDUFA date.

Thanks, Gil and we appreciate the well wishes to both Mark and myself.

Next, we have Tony Butler from Roth Capital.

Raj, I wanted to ask you about [Preserve 1] in CRC. 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 2 sites opened to date. I'm sure that will increase and I wondered if you could just speak to the timing of that increase and how you think about site enrollment. In part, it could be COVID related. In part, it may not necessarily be. But I'm curious if you would speak to that. And I too wanted to, again, welcome Jack but also say, Mark, thank you very much.

So in the colorectal trial, the 5-FU is given as a 48-hour infusion and the other chemotherapy is given on day 1. So trilaciclib will be given for 2 days, both on day 1 and day 2 with every cycle of FOLFOXIRI. If you recall in the small cell studies in the etoposide carboplatin regimen in first line that is a 3-day chemotherapy regimen. So this is a multi-day chemotherapy regimen where trilaciclib is given with chemotherapy.

And the second, the study, actually, there's a lot of investigator enthusiasm and we're at the initial part of site activation. So we expect a rapid wrap-up in that as well as enrolling our first patients.

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.

Thank you, operator. 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.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. Enjoy the rest of your day. Keep safe and you may now disconnect.