G1 Therapeutics Inc (GTHX) 2018 Q2 法說會逐字稿

Good afternoon. My name is Jesse and I'll be your conference operator today. At this time, I would like to welcome everyone to the G1 Therapeutics Second Quarter 2018 Corporate Update. (Operator Instructions) Thank you.

Jeff Macdonald, head of Investor Relations, you may begin your conference.

Thank you, operator. Good afternoon, and welcome to G1 Therapeutics Second Quarter 2018 Corporate Update. Joining me are Mark Velleca, Chief Executive Officer; Raj Malik, Chief Medical Officer and Senior Vice President, R&D; and Buck Phillips, Chief Financial Officer and Senior Vice President, Corporate Development.

Before I turn the call over to Mark, 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 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.

I'll now turn the call over to Mark.

Thanks, Jeff. Good afternoon, everyone, and thank you for joining us today. In the second quarter of 2018, we achieved important milestones across all three of our clinical stage programs, each of which have the potential to improve the lives of those affected by cancer. On today's call, we'll provide an update on those three programs: trilaciclib; lerociclib; and G1T48, focusing on upcoming clinical data readouts for trilaciclib. After our prepared remarks, we will be available to take your questions.

2018 is a data rich year for trilaciclib, our most advanced clinical program. In March, we announced positive Phase II topline data showing robust myelopreservation benefits of trilaciclib versus placebo in small cell lung cancer patients receiving first-line chemotherapy. I am pleased to report that we will be presenting additional data from that trial at this year's European Society of Medical Oncology Meeting, or ESMO, in October.

We also expect data readouts from other trilaciclib Phase II trials later this year. Raj will discuss the trilaciclib program in more detail momentarily.

I'll turn now to lerociclib, formerly referred to as G1T38, our potential best-in-class oral CDK4/6 inhibitor. We presented positive Phase Ib data at ASCO on the lerociclib Faslodex trial in breast cancer. Based on the encouraging findings from the dose escalation portion of that trial, we have initiated enrollment of the Phase IIa portion, with patients receiving lerociclib 500 milligrams, once daily, without a dosing holiday.

In addition, we continue to enroll patients in the lerociclib Tagrisso Phase Ib-II trial in non-small cell lung cancer that we initiated in April and expect to provide preliminary Phase Ib data in the second half of 2019.

Finally, we are excited to have opened the first clinical trial of

G1T48, our oral selective estrogen receptor degrader, or SERD, in June. This trial will initially study G1T48 as monotherapy in ER-positive, HER2-negative breast cancer. Pending the preliminary findings from that trial, we plan to also test a lerociclib G1T48 combination regimen in 2019.

I will now turn the call over to Raj to provide more color on trilaciclib.

Thanks, Mark and good afternoon everyone. As Mark noted, 2018 is an important year for trilaciclib with positive preliminary data from the first line small-cell lung cancer trial providing compelling proof of concept, and we expect to report much more data by the end of the year.

In the second quarter, we completed enrollment for two randomized Phase II trials, one in second-/third-line non-small cell lung cancer and the other in metastatic triple negative breast cancer. We expect to report preliminary data from both of these trials in the fourth quarter of this year. In addition, we have an ongoing randomized, placebo controlled, Phase II trial of trilaciclib in combination with chemotherapy and Tecentriq, Roche-Genentech's checkpoint inhibitor in first line small cell lung cancer.

This trial, which was fully enrolled in the first quarter, includes more than 100 patients. Given the recent announcement from Roche-Genentech regarding positive data for Tecentriq on progression free survival and overall survival in first line small cell lung cancer patients receiving chemotherapy, we are excited about the potential for trilaciclib to further improve patient outcomes.

We are in the process of meeting with the FDA and European regulatory authorities to review the first line trilaciclib chemotherapy small cell lung cancer data. To date, the meetings with the various regulatory agencies have been collaborative and constructive. We plan to build on these meetings by engaging with regulatory authorities again in early 2019 to share the totality of the randomized trilaciclib data that we will have available to us at the end of 2018.

I will now turn the call over to Buck for a discussion of the second quarter financials. Buck?

Thank you, Raj, and good afternoon, everyone. Our second quarter financial results can be found in our earnings press release, which is available on our website. I'd like to take this opportunity to walk you through the financial highlights contained in that release.

We reported a net loss of $20.9 million for the second quarter of 2018 compared to $15.2 million for the second quarter of 2017. Operating expenses were $21.7 million for the second quarter of 2018 compared to $15.4 million for the prior year period. GAAP operating expenses include noncash stock based compensation expense of $2.1 million in the second quarter of 2018 compared to $769,000 for Q2 of '17.

Research and development expenses for the second quarter of 2018 were $18.4 million compared to $13.7 million for the prior year period. The increase in expenses was driven by an increase in clinical program costs, and increased personnel costs to support the growth in our clinical program.

General and administrative expense for the second quarter of 2018 were $3.3 million compared to $1.7 million for the second quarter of 2017. The increase in expense was largely driven by an increase in personnel costs, professional fees, and other corporate expenses.

As of June 30, 2018, we had $188.2 million in cash, cash equivalents, and short-term investments. In the second quarter, we filed a shelf registration statement and a $125 million ATM to provide the company with options and flexibility to prudently access capital as needed to support our business objectives.

The recent positive data from both trilaciclib and lerociclib warranted specific additional investments to accelerate and broaden their development. The 50% increase in stock price since our March secondary offered an opportunity to access that specific amount of capital through the use of the ATM, while limiting dilution.

Between June 18 and August 2 of 2018, we sold 752,000 shares of common stock, resulting in $36.1 million in net proceeds with $12.1 million received in the second quarter and $24 million received between July 1 and August 2.

The total net proceeds realized from the ATM sales during this period satisfy the capital needed to fund those additional specific investments for trilaciclib andlerociclib. As always, we will be measured in our use of these and other financial instruments in order to advance our clinical programs and best serve the interests of our shareholders.

Looking ahead, I would like to reiterate that our cash burn guidance for 2018 will be between $75 million and $85 million.

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

Thanks, Buck. To summarize our accomplishments this quarter and upcoming milestones. By the end of the year, we will have data on trilaciclib from multiple randomized Phase II clinical trials. We plan to continue our dialogue with U.S. and European regulators in early 2019 to discuss the totality of these data. At ASCO, we reported encouraging Phase Ib safety, tolerability, and anti-tumor activity of the lerociclib Faslodex combination regimen in ER-positive, HER2-negative breast cancer.

Based on those data, we have begun enrolling the Phase IIa portion of that trial, with patients receiving lerociclib 500 milligram once daily without a dosing holiday.

Enrollment in the lerociclib Tagrisso Phase Ib-II trial in non-small cell lung cancer is on track and we expect to report preliminary Phase Ib results in the second half of next year. We've initiated a Phase I trial of G1T48, our oral SERD in ER-positive, HER2-negative breast cancer and we now have three clinical stage programs in our pipeline.

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

(Operator Instructions) Your first question comes from Chris Shibutani with Cowen & Co. Your line is open.

A few questions on the trilaciclib in TNBC and second line SCLC. Can you give us some idea of what type and scope of data we can look forward to when it's presented in the fall and maybe some idea, TNBC maybe at San Antonio?

Raj, go ahead.

Yes, so the TNBC data, as we said, will be presented at a medical meeting in the fourth quarter. I think you might be able to surmise potentially which one. And the second-/third-line small cell data will be reported in the form of a press release in the fourth quarter.

And perhaps I missed it. Were these also part of the discussion with regulators or was that only focused on the Tecentriq combo?

Chris, I can't comment on specifics. We had very productive discussions with the regulators. We presented our first line small cell data and asked questions as they related to the development of trilaciclib and the feedback was very helpful.

Your next question comes from Chad Messer with Needham and Company. Your line is open.

Maybe starting with one on trilaciclib. Obviously, I know you’ve got ongoing regulatory discussions and lots of data to come. But could you potentially walk us through maybe a range of scenarios, if you will, of how you think this might get brought forward? I know you're still gathering feedback but what do you think is in the realm of possibility at this point?

Chad, as you know, regulatory discussions is really an ongoing dialogue and so our current discussions, as I mentioned, are - we're really focused on familiarizing the regulatory authorities with our data and discussing key endpoints or key questions I should say for further development.

We are planning, once we have data from the fourth quarter, to go back and meet with U.S. and European regulators in early 2019. I think we'll have a better sense at that point in terms of what the array of options could be.

Fair enough. Maybe just then on 48. I know you said after you get some preliminary data, pending if that looks good. One thing you're very interested in doing is moving that ahead in your own combination trials. What do you think the bar is on that preliminary data? Is that just PK? Do you need to some preliminary response efficacy? How much do you need out of that preliminary data to be able to make a go-forward combo decision?

Good question, Chad. I think it's a combination of all of the above. So it's going to be safety, PK, and of course, efficacy as well, because we'll be evaluating a population that is partly would have received prior progastrin, for example, and also prior 46. So we'll be looking at what the data looks like across different patients or populations to give us a sense of where to take it.

And as we mentioned in the press release, we do plan on sharing those data in 2019.

I'll look forward to that and other good things to come. Thanks for taking my questions.

Those are all the questions we have today. With that, I'll turn the call back to Dr. Velleca for any closing remarks.

Thanks, operator. Thanks all for joining the call. Please reach out to us with any additional questions. We look forward to seeing many of you at the upcoming Wedbush, Wainwright, and Citi conferences in August and September. Have a good evening.

This concludes today's conference call. You may now disconnect.