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Edited Transcript of GTHX.O earnings conference call or presentation 7-Aug-19 8:30pm GMT

Q2 2019 G1 Therapeutics Inc Earnings Call

DURHAM Aug 10, 2019 (Thomson StreetEvents) -- Edited Transcript of G1 Therapeutics Inc earnings conference call or presentation Wednesday, August 7, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jeff Macdonald

G1 Therapeutics, Inc. - Head of Investor & Public Relations

* Jennifer K. Moses

G1 Therapeutics, Inc. - CFO

* Mark A. Velleca

G1 Therapeutics, Inc. - CEO, President & Director

* Rajesh K. Malik

G1 Therapeutics, Inc. - Chief Medical Officer and Senior VP of R&D

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Conference Call Participants

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* Anupam Rama

JP Morgan Chase & Co, Research Division - VP and Analyst

* Chad Jason Messer

Needham & Company, LLC, Research Division - Senior Analyst

* Christopher John Zopf

Cowen and Company, LLC, Research Division - Associate

* David Matthew Nierengarten

Wedbush Securities Inc., Research Division - MD & Head of Healthcare of Equity Research

* Harshita Polishetty

B. Riley FBR, Inc., Research Division - Analyst

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Presentation

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Operator [1]

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Good afternoon, ladies and gentlemen, and welcome to the G1 Therapeutics second quarter corporate and financial updates. (Operator Instructions) As a reminder, this conference call may be recorded.

I would now like to turn the conference over to your host, Mr. Jeff Macdonald, Head of Investor Relations. Sir, please go ahead.

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Jeff Macdonald, G1 Therapeutics, Inc. - Head of Investor & Public Relations [2]

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Thank you, operator. Good afternoon, everyone, and welcome to the G1 Therapeutics Second Quarter 2019 Update. Joining me are Mark Velleca, Chief Executive Officer; Raj Malik, Chief Medical Officer and Senior Vice President, R&D; and Jen Moses, Chief Financial Officer.

Before we begin, I would like to remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and 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.

I'll now turn the call over to Mark.

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Mark A. Velleca, G1 Therapeutics, Inc. - CEO, President & Director [3]

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Thanks, Jeff. Good afternoon, everyone, and thank you for joining us today.

In the first half of 2019, we made significant progress advancing all 3 of our clinical stage therapies, trilaciclib, lerociclib and G1T48. On today's call, I'll provide a summary of that progress and highlight upcoming clinical and regulatory milestones, then Raj will discuss today's announcement regarding Breakthrough Therapy Designation for trilaciclib and preview data that have been accepted for presentation at the upcoming European Society for Medical Oncology or ESMO meeting. Of note, we'll be hosting an investor event and webcast at ESMO on the evening of Sunday, September 29 to review key data and share updated development and commercial plans for all 3 of our investigational therapies. Following Raj's comments, Jen will review the financials for the quarter, then we'll open the call for questions.

Let's turn first to the potential of G1's pipeline for people living with breast cancer. Emerging data from trials across our 3 investigational therapies suggest that all of them could significantly improve outcomes for patients with breast cancer, including in early stages of their disease. Our overarching development strategy for all 3 programs is to design and execute clinical trials that will enable us to rapidly advance into first-line and adjuvant settings where these therapies can provide the most benefit to patients.

Looking more specifically at each therapy, I'll begin with trilaciclib. We now have data showing that trilaciclib can provide both myelopreservation and overall survival benefits. These benefits will vary by tumor type, and our development plans for 2020 and beyond include settings where we would expect to see benefits in survival, myelopreservation or potentially both.

We remain on track to file marketing applications in both the U.S. and Europe in 2020 for myelopreservation in small cell lung cancer based on positive feedback from regulatory agencies. We have a pre-NDA meeting scheduled with the FDA in September, and we will be able to provide a more precise time line on an NDA submission once we receive written minutes from that meeting.

In September, we are also having parallel discussions with the FDA regarding the preliminary data from our Phase II metastatic triple-negative breast cancer or mTNBC trial that demonstrated a statistically significant and clinically meaningful overall survival benefit in this aggressive type of breast cancer. We'll be able to provide an update on next steps once we receive written minutes from that meeting, and we look forward to presenting detailed data from the trial at a medical conference later this year.

Turning to lerociclib. Our goal has been to identify a dose with 2 key attributes: one, comparable efficacy to currently approved CDK4/6 inhibitors; and two, a better safety profile compared to approved agents, including better GI tolerability and less Grade 3/4 neutropenia, which could translate to less frequent blood count monitoring. In market research, oncologists stated that these are key points of differentiation that are particularly important to using oral CDK4/6 inhibitors in the adjuvant breast cancer setting.

In the fourth quarter of 2019, we expect to present data at a medical meeting demonstrating lerociclib's differentiated clinical profile and the dose that we will bring forward into a pivotal trial that we'll initiate in 2020. That trial will be in patients with ER+, HER2-negative breast cancer, whose disease has progressed following endocrine therapy. Positive data from this trial would support regulatory filings and provide a development path for lerociclib into the adjuvant breast cancer setting.

The first clinical data from our third program, G1T48, will be presented at ESMO this year. Raj will provide more details regarding what to expect in that presentation.

We believe G1T48 can be the best-in-class oral SERD and expect to identify a dose by the end of the year that we will take forward into pivotal trials in 2020. That trial will be an important step in enabling G1T48, either in combination or as monotherapy, to move into the adjuvant setting, which is where an oral SERD could become standard of care. The adjuvant setting represents a significant opportunity to improve outcomes for hundreds of thousands of people living with breast cancer worldwide.

To summarize, trilaciclib will be submitted for regulatory approval in both the U.S. and Europe in 2020, and we will initiate trials in new indications measuring both survival and myelopreservation benefits. We are also initiating pivotal trials in breast cancer for both lerociclib and G1T48 in 2020, with the objective of these trials enabling development in the adjuvant setting.

Before I turn the call over to Raj, I would like to welcome Mark Avagliano to the G1 management team as Chief Business Officer. Mark has an impressive track record of significant corporate level transactions while heading Pfizer's mergers and acquisitions, transactions and valuations and out-licensing groups. He will lead our partnership and corporate development initiatives as we approach filing, approval and launch of trilaciclib and achieve significant clinical milestones for lerociclib and G1T48.

And now Raj will provide the regulatory update and discuss our upcoming data presentations at ESMO. Raj?

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Rajesh K. Malik, G1 Therapeutics, Inc. - Chief Medical Officer and Senior VP of R&D [4]

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Thanks, Mark. As Mark mentioned, we'll be quite busy at this year's ESMO meeting that begins on September 27 presenting new data on each of our investigational therapies.

Before providing context around those data, I want to briefly touch on where we are in the trilaciclib regulatory process. In this afternoon's press release, we announced the FDA has granted Breakthrough Therapy Designation based on myelopreservation data in small cell lung cancer patients from our 3 randomized Phase II trials.

Breakthrough status is designed to expedite development and review of drugs intended for serious or life-threatening conditions. Our pre-NDA meeting has been scheduled for next month, and we will provide an update on next steps and a more definitive NDA submission time line once we have received written minutes from that meeting.

We are also having parallel discussions with FDA regarding the recent positive overall survival findings from the metastatic triple-negative breast cancer trial. We did not have these data during our end-of-Phase II discussions with the FDA, and we're looking forward to getting their feedback on the TNBC survival data. We will provide an update on next steps for TNBC once we have received written minutes from that meeting.

Turning to ESMO. We are excited to present the first clinical data on G1T48, our selective estrogen receptor degrader or SERD. First, some background on estrogen-targeted therapies in breast cancer and why there is such enthusiasm in the field for an oral SERD.

The estrogen receptor is one of the best understood targets in oncology. And therapies that block estrogen production or its effects, such as aromatase inhibitors in tamoxifen, have proven to be effective drugs that are widely used to treat ER+ breast cancer. In head-to-head trials, the intramuscular injectable SERD, fulvestrant, has been shown to be more effective than dose therapies, demonstrating that degrading the estrogen receptor is the most effective approach for blocking ER-mediated signaling.

However, fulvestrant has poor bioavailability, and the injections can be painful and are needed monthly. This profile has precluded its development and use in the adjuvant setting. A well-tolerated oral SERD that can improve on the efficacy and tolerability profile of fulvestrant would have the potential to become standard of care for the treatment of first-line advanced disease and in the adjuvant setting.

Treatment in the adjuvant setting is often for 5 years or longer. In order for an oral SERD to be used in this setting, the safety and tolerability profile needs to meet or exceed existing therapies, such as aromatase inhibitors and tamoxifen. Safety is also an important consideration for combination therapy since many patients would receive an oral SERD in combination with a CDK4/6 inhibitor and other targeted agents.

G1T48 data being presented at ESMO will include PK, FAS [path], safety, tolerability and efficacy. There have been no dose-limiting toxicities or serious adverse events reported with G1T48 to date. We have completed the dose escalation portion of the trial and are now enrolling patients in the Phase II dose expansion. And by the end of the year, expect to have the dose defined for pivotal trials in 2020.

We believe that G1T48 has a profile necessary to be best-in-class and overcome the safety and tolerability issues that have challenged other oral SERDs in development. G1T48's proprietary chemistry, which is based on a drug with a proven safety database in millions of women, differentiates it from other oral SERDs in development.

There are a few points to keep in mind regarding the antitumor efficacy data that will be reported. One, we will be presenting data from the dose escalation portion in approximately 25 patients, and most of the patients did not receive the dose we will be taking forward into pivotal trials. Two, the patient population has been heavily pretreated with the majority having received either a CDK4/6 inhibitor, fulvestrant or both, and we will be presenting early data with limited duration of treatment. Three, PFS and OS and not response rate, are the approvable endpoints in first- and second-line advanced breast cancer.

Clinical benefit rate, which includes response rate and prolonged stabilization of disease, can serve as an indicator of meaningful clinical activity for this typically slow-growing tumor and is a reasonable target for PFS. So given the prior treatment history and heterogeneity of patients in this trial, we will be showing patient level efficacy data to provide context.

We are excited to share these promising G1T48 data at ESMO. While still early in development, we believe that the high degree of target validation for the class, coupled with the favorable AE profile that we are seeing with G1T48, is very encouraging. In addition to the G1T48 data, abstracts on 2 other trials have been accepted by ESMO: the trilaciclib plus chemo and Tecentriq trial in small cell lung cancer; and the Phase I/IIa lerociclib plus Tagrisso trial in nonsmall cell lung cancer.

Last year, we reported myelopreservation data for the trilaciclib+chemo+ Tecentriq trial, which showed meaningful improvements across multiple myelopreservation measures. The results being presented at ESMO will provide detailed myelopreservation data and an update on tumor efficacy. As we've noted previously, small cell lung cancer is not a particularly immune-sensitive tumor, and we do not expect to see a significant improvement in tumor efficacy in this small trial. Data from the lerociclib plus Tagrisso trial will focus on tolerability and safety from the first several cohorts in the dose escalation portion of the trial. It is too early to have any meaningful efficacy data.

Finally, I'd like to make a few comments about the recently announced trilaciclib TNBC data, which showed a statistically significant and clinically meaningful improvement in overall survival for women receiving trilaciclib and a chemotherapy regimen of gemcitabine and carboplatin compared with chemotherapy alone. We announced preliminary data from this trial at the San Antonio Breast Cancer Symposium in 2018, which showed encouraging progression-free survival trends and a favorable safety and tolerability profile. The recent overall survival data comes from the next pre-specified data cut following San Antonio. This is a 102-patient trial with 3 arms: 2 trilaciclib arms and a control arm. The overall survival benefits in each of the trilaciclib arms was statistically significant compared to the control arm, which performed as expected to historical data.

In reviewing the data, we believe that the survival benefit is likely due to an immune-mediated response and is consistent with trilaciclib's mechanism of action, that of transient G1 cell cycle arrest of T lymphocytes and enhancement of antitumor immunity. While patients in the trilaciclib arms did receive more doses of chemo compared to the control arm, additional chemotherapy alone would not be expected to drive the magnitude of the OS benefit seen in this randomized trial.

These are very promising findings. We look forward to presenting detailed data at a medical meeting later this year and discussing them with the FDA next month.

I'll now turn the call over to Jen for a review of the financials. Jen?

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Jennifer K. Moses, G1 Therapeutics, Inc. - CFO [5]

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Thanks, Raj. I'll review several items on today's call. For full financial results for the second quarter, they're available on our press release and 10-Q.

We reported a net loss of $30.7 million for the second quarter of 2019 compared to $20.9 million for the second quarter of 2018. Operating expenses were $32.6 million for the second quarter of 2019 compared to $21.7 million for the prior year period. Operating expenses included noncash stock compensation expense of $3.7 million for the second quarter of 2019 compared to $2.1 million for the prior year period. Research and development expenses for the second quarter of 2019 were $23.5 million compared to $18.4 million in the second quarter of 2018. The increase in expense was due to an increase in clinical program costs, drug manufacturing and development costs and personnel-related costs due to additional headcount.

General and administrative expenses for the second quarter of 2019 were $9.1 million compared to $3.3 million for the prior year period. The increase in G&A expense was largely due to an increase in pre-commercialization activities and increase in headcount and an increase in other costs necessary to support our operations as a public company.

As of June 30, 2019, we had $324.9 million in cash and cash equivalents on the balance sheet compared to $369.3 million as of December 31, 2018. We are confirming the annual guidance that we announced in June and expect to end the year with between $260 million and $270 million in cash and cash equivalents.

I'll now turn the call back over to Mark. Mark?

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Mark A. Velleca, G1 Therapeutics, Inc. - CEO, President & Director [6]

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Thanks, Jen. A quick summary before we go to Q&A. We are meeting with the FDA in September to discuss our NDA for trilaciclib in small cell lung cancer. We'll provide an update on those discussions after we receive written minutes. We plan to submit filings for small cell lung cancer in both the U.S. and Europe in 2020. Breakthrough Therapy Designation from the FDA provides us with an opportunity for even closer collaboration with the agency as we continue to work on the NDA and development of trilaciclib in other indications. We are also meeting with FDA in September to review the data from our trilaciclib trial that demonstrated an overall survival benefit in triple-negative breast cancer and to discuss next steps. We will provide an update on those discussions after we receive written minutes. We look forward to moving trilaciclib into additional registrational trials in 2020 so that patients being treated with chemotherapy have the potential to benefit from this important investigational therapy.

We will present data on all 3 of our investigational therapies at ESMO and are particularly excited to share the first clinical data on G1T48. We are planning to host an investor event at ESMO on Sunday evening, September 29, to review the data. An external expert will provide commentary. Additionally, we will review our development plans that will enable moving all 3 therapies into early lines of breast cancer treatment. We will also share our long-range commercial plans for all 3 therapies and discuss the total addressable market of patients that could benefit across multiple indications. The event will be webcast, and we'll be providing additional information in the near future.

Finally, we are in a solid financial position with sufficient cash to advance our development programs and reach additional value-creating clinical and regulatory catalysts. As we do so, we expect that partnership discussions will accelerate and are very pleased to have an experienced and highly accomplished Chief Business Officer, Mark Avagliano, leading that effort.

Our accomplishments in the first half of the year have set up an exciting slate of milestones over the remainder of 2019 and into 2020. We look forward to sharing our progress and to bringing important new therapies to people with cancer.

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

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question is from the line of Chris Shibutani from Cowen and Company.

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Christopher John Zopf, Cowen and Company, LLC, Research Division - Associate [2]

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This is CJ on for Chris. Congratulations on the quarter and all the progress across the pipeline. I was curious -- a question on G1T48. It sounds like you are, if I understand correctly, in the dose expansion stage of the trial, but it sounds like you're still confirming the recommended Phase II dose. I'm curious if the expansion that's currently ongoing has the potential to be rolled into larger registration-directed expansion as a monotherapy. Are there still plans to do monotherapy expansion next year? And then for the combination, are you looking to partner for the combination trials? Or purchase the CDK4/6? What are your kind of expectations there?

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Mark A. Velleca, G1 Therapeutics, Inc. - CEO, President & Director [3]

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Thanks, CJ. It's Mark. I'll let Raj answer the first part of that question and I can address the second part re partnership. Raj?

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Rajesh K. Malik, G1 Therapeutics, Inc. - Chief Medical Officer and Senior VP of R&D [4]

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Yes. So CJ, the design of the study was a dose escalation, which we've completed, and an expansion. And because the drug is well tolerated, we're actually using the expansion phase to define the dose. So we get a larger safety database, and we're looking at other endpoints as well.

The goal -- and we expect to have the dose defined by the end of the year. The goal will then be to take the recommended -- the dose that we define into registration trials next year, which will be randomized trials in combination with the 4/6 inhibitor, as we mentioned.

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Mark A. Velleca, G1 Therapeutics, Inc. - CEO, President & Director [5]

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And regarding access to that 4/6 inhibitor, it could be in the context of a nonexclusive partnership. It could be in the context of an exclusive deal. And remind you, we have our own oral CDK4/6 inhibitor, lerociclib, so multiple options for us regarding partnerships.

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Christopher John Zopf, Cowen and Company, LLC, Research Division - Associate [6]

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Great. And just to clarify, maybe I missed this for your conversations on TNBC for trilaciclib that you've had with regulators. Did you say when we might hear about how those have gone? Are you waiting for minutes?

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Mark A. Velleca, G1 Therapeutics, Inc. - CEO, President & Director [7]

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That's a separate discussion also in the September time frame. So we'll provide feedback once we have written minutes.

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Operator [8]

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Next question is from the line of Anupam Rama from JPMorgan.

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Anupam Rama, JP Morgan Chase & Co, Research Division - VP and Analyst [9]

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Congrats on all the progress. Just a quick one for me. As you think about the ESMO update, to what extent will there be incremental new data in the abstracts for the 3 update versus, say, having to wait for the full presentation for a better picture of what's going on?

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Mark A. Velleca, G1 Therapeutics, Inc. - CEO, President & Director [10]

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Yes, absolutely. Again, I'll start with that, it's Mark. Thanks for the question, Anupam. As you can imagine, abstracts are written months before the actual data is put together for a poster or a presentation. So there will be some patient quantitative data in the abstract, and you could expect, very simply, more patients and more data around those patients in the actual presentation. And I think that's really across the board for all 3 of the presentations that we expect to make.

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Operator [11]

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Next question is from the line of David Nierengarten from Wedbush.

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David Matthew Nierengarten, Wedbush Securities Inc., Research Division - MD & Head of Healthcare of Equity Research [12]

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I had one on the design and expansion of the T48 study. Will we see dose combinations or the dose selection data in combination with the CDK4/6? Or will it all be monotherapy? As we look for the next couple of sets of data, obviously, the pivotal study will be in combination but will there be any interim step there in combination with the CDK4/6?

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Rajesh K. Malik, G1 Therapeutics, Inc. - Chief Medical Officer and Senior VP of R&D [13]

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Yes, David, this is Raj. So the majority of -- so the dose -- the expansion has just recently started. So the majority of the data that we'll be presenting will actually be from the dose escalation part of the study. But it is a -- we're going to define the dose as a monotherapy and then take it into combinations.

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David Matthew Nierengarten, Wedbush Securities Inc., Research Division - MD & Head of Healthcare of Equity Research [14]

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Okay. And then just a quick follow-up, if I could, on the monotherapy. Thinking back across other SERDs, is there any particular aspect that you think is -- I guess, I'm asking you to highlight what you're going to highlight, but there is -- are we looking at tolerability or efficacy across board or we'll just wait and see?

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Rajesh K. Malik, G1 Therapeutics, Inc. - Chief Medical Officer and Senior VP of R&D [15]

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Yes. That's -- it's a good question. This is -- it's a Phase I heavily pretreated patient population. And it's really safety, safety and tolerability, and we'll, of course, present the efficacy data we have. I think it's important to keep in mind what the goal of developing the SERD eventually is, and that is to move it into earlier stages of treatment, so first-line advanced setting and then, importantly, into the adjuvant setting, both as a monotherapy and in combination. So the key is to assess the safety and tolerability. I think that's where the focus should be.

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Operator [16]

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Your next question is from the line of Chad Messer from Needham & Company.

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Chad Jason Messer, Needham & Company, LLC, Research Division - Senior Analyst [17]

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I wanted to congratulate you guys on the Breakthrough status for trilaciclib. I believe in the FDA's own definition that, that means they recognize myelopreservation is a life-threatening unmet need and your data is showing reasonable signs of efficacy, so a really good buy in there.

I know we'll get an update on time lines post minutes, but given the close interaction that you get with the FDA and some of the other bell and whistles from breakthrough, do you see this affecting your own sort of internal time lines in terms of things you need to be prepared for in terms of filing and potential approval?

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Rajesh K. Malik, G1 Therapeutics, Inc. - Chief Medical Officer and Senior VP of R&D [18]

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Yes. Hey, Chad, thanks. We're obviously very excited about the BTD, and it's good to see that the agency recognizes the real need that trilaciclib can fill for patients who need this drug for not only myelosuppression but also efficacy with the early TNBC data.

So we -- after we got the -- had a positive end-of-Phase II meeting, we were -- we've been planning to file an NDA. So we've been moving on that path. Having the Breakthrough certainly helped, as you said. We just recently got it and announced it. And it does mean that we'll be working very closely with the agency to just get this drug to patients, which is great.

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Chad Jason Messer, Needham & Company, LLC, Research Division - Senior Analyst [19]

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And I'm looking forward to ESMO.

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Operator [20]

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Next question is from the line of Harshita Polishetty from B. Riley FBR.

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Harshita Polishetty, B. Riley FBR, Inc., Research Division - Analyst [21]

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Great updates today. Let me offer my congratulations as well. I had one on trila which has been answered, so just another quick one for me. With T48 data on the corner, very exciting. I guess piggybacking off of David's question sort of, I was curious if you've done any preclinical competitor analysis to other oral SERDs in development, I guess, such as Radius Health's molecule, which I believe is in late-stage development. So I was just curious if you have any color on that.

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Mark A. Velleca, G1 Therapeutics, Inc. - CEO, President & Director [22]

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Yes, we have. We actually presented some preclinical data a couple of years ago at AACR, demonstrating that G1T48 is more potent than many of the oral SERDs in development, including the Radius compound. That drug is in a pivotal trial in a second-/third-line setting, not in a first-line setting.

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Rajesh K. Malik, G1 Therapeutics, Inc. - Chief Medical Officer and Senior VP of R&D [23]

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And I think just to add that the Radius compound is really not a pure SERD, either. I think that's also an important distinction.

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Operator [24]

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No further questions. I turn the call back over to Dr. Mark Velleca.

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Mark A. Velleca, G1 Therapeutics, Inc. - CEO, President & Director [25]

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Thank you, operator. That concludes the call. Please reach out to us with any questions. As a reminder, we'll be at the BTIG Conference on August 12 and the Wedbush Conference on August 13. We look forward to seeing many of you at those meetings in New York and at ESMO in Barcelona in late September. Thank you for joining us, and have a good evening.

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Operator [26]

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That does conclude our conference for today. Thank you for your participation in today's conference. You may now disconnect.