Q3 2019 Earnings Call
Good afternoon, ladies and gentlemen, and welcome to the G. One therapeutics third quarter 2019 financial results Conference call.
Operator: Ladies and gentlemen, and welcome to the G1 Therapeutics third quarter 2019 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. If you would like to ask a question, please press star then the number 1 on your touchtone telephone. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Jeff McDonald, Head of Investor Relations for G1 Therapeutics. Please go ahead, sir.
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Head of Investor Relations for Q1 Therapeutics. Please go ahead sorry.
Jeff McDonald: Good afternoon everyone, and welcome to the G1 Therapeutics 3rd Quarter 2019 Corporate and Financial Update. Joining me are Mark Vileka, Chief Executive Officer, Raj Malik, Chief Medical Officer, and Senior Vice President, R&D, and Jen Moses, Chief Financial Officer.
Thank you operator and everyone welcome to the if you want their units third quarter 2019, corporate financial update.
Peter Bartholow, Good Chief Executive Officer, Raj Malec, Chief Medical Officer in Senior Vice President R&D agenda, as Chief Financial Officer.
Jeff McDonald: 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 on the SEC website or our corporate website, for information concerning risk factors that could affect a company. I'll now close with a call to the mark.
Before we begin I'd like to remind you had this call will include forward looking statements based on current expectations such statements represent management's judgment as of today and they involve risks and uncertainties that could cause actual results could differ materially from expected results.
Please refer to our filings with the FCC, which are available on the FCC website or corporate website for information concerning risk factors that could affect the company.
Mark Vileka: Thanks, Jeff. Good afternoon, everyone, and thank you for joining us. On today's call, we'll review our progress in the third quarter and provide an update on upcoming clinical and regulatory milestones expected this year and next. These milestones provide a foundation for the successful launch of our first commercial product, Trial-a-Cycle, and physician Laro Cyclib and G1T48 as important new treatment options for people living with breast cancer. Raj will discuss data on trilocyclic and G1T48 that were presented in September at the European Society for Medical Oncology meeting, or ESMA. He will also preview data on larocyclin being presented at the San Antonio Breast Cancer Symposium in December. Following Rajesh's comments, Jen will review the financials for the quarter, then we'll open the call for questions.
Mark Thanks, Jeff.
Afternoon, everyone and thank you for joining us on today's call will review process, our progress in the third quarter and provide an update on upcoming clinical and regulatory milestones expected this year and Max.
These milestones provide a foundation for the successful launch of our first commercial products travel cyclists.
And position Lerro cyclists and you want to 48 as important no treatment options for people living with breast cancer.
Roger will discuss data on trials cyclic and you want to 48 that were presented in September at the European Society for medical oncology meeting or asthma.
You will also preview data on Lerro cycling being presented at the San Antonio breast cancer Symposium in December .
Following Roger's comments General review the financials for the quarter, then we'll open the call for questions.
I'll begin with trial of cycling.
Mark Vileka: I'll begin with trilocytes. Based on advisory board feedback, meetings with key opinion leaders, and quantitative market research with healthcare professionals. We believe that trilocyclic acid can usher in a new standard of care that will benefit cancer patients who receive the most frequently administered chemotherapy regimen. Every year, hundreds of thousands of patients experience both the benefits and the negative consequences of chemotherapy. While chemo is a cornerstone of effective cancer treatment, it does not differentiate between healthy and cancer cells, killing both, including important stem cells in the bone marrow that produce white blood cells and red blood cells. This chemotherapy-induced bone marrow damage is known as myelosuppression. When white cells, red cells, and platelets become depleted, patients receiving chemotherapy are at an increased risk of infection, experience anemia and fatigue, and are at an increased risk of bleeding.
Just on advisory Board feedback meetings with key opinion leaders and quantitative market research with health care professionals. We believe the trial cyclist can usher in a new standard of care that will benefit cancer patients who received the most frequently administered chemotherapy regimens.
Every year hundreds of thousands of patients experienced both the benefits and negative consequences of chemotherapy.
While chemo is a cornerstone of affected cancer treatment. It does not differentiate between healthy and cancer cells, showing both including important stem cells in the bone marrow that produce white blood cells red blood cells and placements.
This chemotherapy induced bone marrow damage is known as Myelosuppression.
When white cells red cells, and platelets become depleted patients receiving chemotherapy ardent are at an increased risk of infection experience anemia, and fatigue and are in increased risk of bleeding.
Mark Vileka: Myelosuppression can impair a patient's ability to complete the full course of chemotherapy on schedule and often requires the administration of rescue interventions such as growth factors and blood transfusions. Patients, oncologists, and payers recognize the need to improve on what has become accepted as the unavoidable downside of chemotherapy. Trilocyclib is positioned to address this need, making chemotherapy safer, reducing side effects, and improving the patient experience. Data from our three small cell lung cancer trials clearly demonstrate that Trilocyclib can reduce myelosuppression and improve patient-reported outcomes. These data were the basis for the FDA providing breakthrough therapy designation for the trial cycle. We are confident that trilocyclob has the potential to help not only those with small cell lung cancer but also people with other tumors treated with chemotherapy. First, I'll briefly summarize our pathway to approval in small cell lung cancer. Then, I will outline the plans for additional trials. And third, I will review the progress we are making to prepare for a successful launch.
Myelosuppression kennen parent patients ability to complete the full course of chemotherapy on schedule and often requires the administration of rescue interventions such as growth factors and blood transfusions.
Patients oncologists and payers recognized the need to improve on what has become accepted as he unavoidable downside of chemotherapy.
Try lets cycling is positioned to address this need making chemotherapy safer reducing side effects and improving the patient experience.
Data from our three small cell lung cancer trials, clearly demonstrate that trial of cyclist can reduce myelosuppression and improve patient reported outcomes. These data where the basis for the FDIC, providing breakthrough therapy designation for trial of cycling.
We are confident that trial of cycle of has the potential to help not only those with small cell lung cancer, but also people with other tumors treated with chemotherapy.
First I'll briefly summarize our pathway to approval and small cell lung cancer second I'll outline the plans for additional trials and third I will review the progress we are making to prepare for a successful launch.
Mark Vileka: Based on written feedback from our pre-NDA meeting with the FDA in September, we are beginning a rolling NDA submission this quarter and expect to complete the filing in the second quarter of 2020. We are also planning to submit a marketing authorization application to the European Medicines Agency in the second half of 2020. In parallel with our NDA filing for small cell lung cancer, we are working with the FDA to determine the most efficient pathway to additional labeled indications for trial cycle. In 2020, we plan to initiate a Phase III trial in patients with colorectal cancer treated with 5-FU-based chemotherapy, with myelopreservation as the primary outcome measure. This represents a significant opportunity to help patients. There are more than 500,000 cases of colorectal cancer globally treated with chemotherapy, the majority of which is 5-FU based.
Based on written feedback from our pre NDA meeting with the FDIC in September we are beginning a rolling NDA submission this quarter and expect to complete the filing in the second quarter of 2020.
We're also planning to submit a marketing authorization application to the European Medicines agency in the second half of 2020.
In parallel with our Anda filing for small cell lung cancer, we are working with the FDA to determine the most efficient pathway to additional labeled indications for trial cycling.
In 2020, we plan to initiate a phase three trial in patients with colorectal cancer treated with five if you based chemotherapy with Milo preservation as a primary outcome measure.
This represents a significant opportunity to help patients.
More than 500000 cases, colorectal cancer globally treated with chemotherapy.
Majority of which is five a few days.
Mark Vileka: Much of our preclinical data on a trial of Cyclib was generated using 5-FU, and this is a multi-day regimen that results in severe myelosuppression. We will also continue to explore trilocyclic's potential to improve survival in certain tumors. Raj will review the data from our phase two triple negative breast cancer trial, which we recently presented at ESMO, showing a significant overall survival benefit in patients with TMBC treated with trial cycle. We are continuing to collect important data from that trial and expect to initiate an additional TMBC trial in 2020. While we are excited about the long-term potential of triacyclob in multiple tumor types, we remain focused on the near-term opportunity to help patients with small cell lung cancer and are preparing across functions for a successful launch.
Much of our preclinical data on trial is cyclical has generated using five if you and this is a multi day regimen that results in severe myelosuppression.
We will also continue to explore trello cyclist potential to improve survival in certain tumor types.
Raj will review the data from our phase two triple negative breast cancer trial, which we recently presented at ESMO.
Showing a significant overall survival benefit in patients with TNBC.
Treated with trial cycling.
We are continuing to collect important data from that trial and expect to initiate an additional CNBC trial in 2020.
While we are excited about the long term potential of trial sites within multiple tumor types. We remain focused on the near term opportunity to help patients with small cell lung cancer and are preparing across functions for a successful launch I want I want to highlight three key areas of progress one.
Mark Vileka: I want to highlight three key areas of progress. One, commercial-grade manufacturing is on track, and we will have the drug product ready for the earliest possible launch date. Two, we have established a medical affairs team that is meeting with patient advocates, physicians, and key external experts to discuss current clinical practice in treating myelosuppression and to respond to inquiries about the trial of psych.
Commercial grade manufacturing is on track and we will have drug product ready for the earliest possible launch date.
Two we have established a medical affairs team that is meeting with patient advocates physicians and key external experts to discuss current clinical practice in treating myelosuppression and to respond to inquiries about trello cycle.
Mark Vileka: And three, we are continuing to get payer insights as we approach potential approval and launch. Research by our commercial team has shown that payers recognize the value of trialocyclabs as a proactive therapy that provides multiple benefits to patients. In addition, they see that it is clearly differentiated from rescue interventions that only address a single blood lineage. We expect unique product coding, which will further support payer acceptance. Our pricing philosophy will reflect the total value TrialCyclic delivers to patients in the healthcare system while supporting patient access. We are continuing to refine our budget impact model to demonstrate the extent to which trilocyclic can reduce costs associated with myelosuppression, including reducing the use of GCSF, transfusions, antibiotics, and hospitalizations, and decreasing chemotherapy dose delays and reductions.
And three we're continuing to get payer insights as we approach potential approval and launch research by our commercial team has shown that payers recognize the value of trial site club as a pro active therapy that provides multiple benefits to patients.
In addition, they see that it is clearly differentiated from rescue interventions that only address a single blood lineage.
We expect unique product coding, which will further support payer acceptance.
Our pricing philosophy will reflect the total value trial of cyclo delivers to patients in the healthcare system, while supporting patient access.
We are continuing to refine our budget impact model to demonstrate the extent to which trial site with can reduce costs associated with myelosuppression, including reducing the use of G. CSF transfusions, antibiotics, and hospitalizations and decreasing chemotherapy dose delays and reductions.
Mark Vileka: We will also share patient-reported outcomes data with payers, which highlights the benefits to their members. Turning to our other investigational therapies, we will soon have sufficient clinical data to advance both laracyclib and G1T48 into registrational trials. We presented the first clinical data on G1T48, our selected estrogen receptor degrader, or CERD, at ESMO in September. Data on laracyclib, our oral CDK4-6 inhibitor, will be presented at the upcoming San Antonio Breast Cancer... Both of these treatments have the potential to improve outcomes for women with ER-positive breast cancer.
We will also share patient reported outcomes data with payers, which highlights the benefits to their members.
Turning to our other investigational therapies, we will soon have sufficient clinical data to advance Polaris cyclic AMG lumpy 48 into Registrational trials, we presented the first clinical data up to one on she went to 48, our selective estrogen receptor degrader or third at ESMO on September data on Larrow side.
Clip oral CDK for six inhibitor will be presented at the upcoming San Antonio breast cancers symposium.
Most of these therapies have the potential to improve outcomes for women with the are positive breast cancer was Raj will provide an overview.
Mark Vileka: Raj will provide an overview of both programs momentarily. I want to conclude with a comment on our business development strategy. For all three of our therapeutic candidates, we believe that collaborating with partners with oncology development and commercialization expertise offers the best opportunity to make our therapeutic candidates broadly available to patients around the world. We anticipate that partnership agreements would be structured so that we can participate in commercialization in the U.S., and a partner would be responsible for markets outside the U.S. I'd now like to turn the call over to Raj to discuss recent and upcoming data presentations across our organization, Raj.
Overview of both programs and momentarily.
I want to conclude with the comment on our business development strategy.
For all three of our therapeutic candidates, we believe that collaborating with partners for the oncology development and commercialization expertise offers the best opportunity to make our therapeutic candidates broadly available to patients around the world.
We anticipate that partnership agreements would be structured so that we can participate in commercialization in the U.S and a partner would be responsible for ex us markets.
I'd now like to turn the call over to Raj to discuss recent and upcoming data presentations across our pipelines Raj. Thanks, Mark as Mark noted, we presented important data on Charlotte cyclists and she wants you 48 at ESMO in September .
Rajesh K. Malik: Thanks, Mark. As Mark noted, we presented important data on trialocyclin and G1T48 at ESMO in September. Today, I want to focus my remarks on the findings in these data sets and how they provide a strong rationale for advancing these programs. I'll start with Tralocyte. Our Phase II trial of 102 patients with triple negative breast cancer, or TMBC, showed that women lived significantly longer when receiving trialocyclic with chemotherapy, compared with chemotherapy alone. The median overall survival for all patients treated with Trelacycline in combination with the chemotherapy regimen of gemcitabine and carboplatin was 20.1 months, compared with 12.6 months for patients receiving chemotherapy alone, with a hazard ratio of 0.37. I'd like to take a few minutes to discuss the totality of the myelopreservation findings in this trial and, more specifically, provide context for how those data are relevant to the observed overall survival benefits.
Today I wanted to focus my remarks on the findings in these data sets and how they provide a strong rationale for advancing these programs.
I'll start with trial a cycle it.
Our phase two trial of 102 patients with triple negative breast cancer, our TMB see shows that women lives significantly longer when receiving trial of cycling with chemotherapy.
Compared with chemotherapy alone.
Median overall survival for all patients treated with shallow cycling in combination with the chemotherapy regimen of Jim side of being a carbo cloud was 20.1 months compared with 12.6 months for patients receiving chemotherapy alone.
But the hazard ratio of 0.36.
I'd like to take a few minutes to discuss the totality of the Milo preservation findings in this trial.
And more specifically provide context for how those data are relevant to the observed overall survival benefit.
To remind you we ran for exploratory phase two trials of trial aside live concurrently in small cell lung cancer and triple negative breast cancer.
Rajesh K. Malik: To remind you, we ran four exploratory phase two trials of trialocyclic concurrently in small cell lung cancer and triple negative breast cancer. We believed it was important to maintain consistent endpoints across the trials and chose duration and occurrence of severe neutropenia. In our three small cell lung cancer trials, the mean duration of severe neutropenia in the control arms was four days, and there was a statistically significant improvement for patients who received the trial aside. By contrast, in the TMBC trial, the mean duration of severe neutropenia in the control arm was only 0.8%. With that short duration of severe neutropenia, we did not hit the primary end. However...
We believed it was important to maintain consistent endpoints across the trials and chose duration on occurrence of severe neutropenia.
And our three small cell lung cancer trials, the median duration of severe neutropenia in the control arms was four days.
And that was a statistically significant improvement for patients who receive trial aside.
By contrast in the TMB see trial amelioration of severe neutropenia in the control arm was only 0.8 days.
With that short duration of CVN utopian, yes, we did not hit the primary endpoint.
However.
Rajesh K. Malik: It is important to note that we did see evidence of milder preservation in the TMBC trial. Patients in the tricyclic arms were able to receive approximately 50% more chemotherapy yet had similar hematologic toxicity compared to the control arm. Also, tricyclic-treated patients experienced significantly lower rates of red blood cell transfusion, and patient-reported outcomes data indicated that trial-cyclic-treated patients experienced less... The significant improvement in overall survival observed in this trial is likely driven by a combination of factors. Patients receive significantly more chemotherapy, which we believe is tied to the myelopreservation benefits of trialocycline. Additionally, these model preservation benefits may have allowed patients to do better in subsequent lines of therapy. And we will have data on this hypothesis as we follow patients out further, separate from these model preservation benefits.
It is important to note that we did see evidence of Modeler preservation in the TWC trial.
Patients in the trial decisive arms were able to receive approximately 50% more chemotherapy, yet had similar hematologic toxicity compared to the controller.
Also try to sites that treated patients experienced significantly lower rates of red blood cell transfusions, and patient reported outcomes data indicated that child aside to treated patients experienced less strategic.
A significant improvement in overall survival observed in this trial is likely driven by a combination of factors.
Patients receive significantly more chemotherapy, which we believe is tied to the modular preservation benefits of Charles cycling.
Additionally, these models preservation benefits may have allowed patients to do better and subsequent lines of therapy, and we will have data on this hypothesis as we follow patients out further.
Separate from these modular preservation benefits child of cycling made directly enhance the anti tumor immune response, and we have plans to further evaluate this in our next trial.
Rajesh K. Malik: Tralocyclib may directly enhance the anti-tumor immune response, and we have plans to further evaluate this in our next trial. The survival findings were striking and warrant further study, and multiple key opinion leaders agreed. Therefore, we will be initiating an additional trial in TMBC next year. We also presented the first clinical data on G1T48, our Oral Selective Estrogen Receptor Degrader, or CERD, for treatment of ER-positive, HER2-negative breast cancer. Blocking signaling through the estrogen receptor is a proven way to extend survival for patients with ER-positive breast cancer. The injectable CERN Fulvestra has proven to be more efficacious than aromatase.
The survival findings were striking and warrant further study and multiple key opinion leaders agree.
Therefore, we will be initiating an additional trial in CNBC next year.
We also presented the first clinical data on June 2048 hour oral selective estrogen receptor degree to or cert for treatment of positive hertwo negative breast cancer.
Blocking signaling through the estrogen receptor is a proven way to extend survival for patients with you are positive breast cancer.
The injectable so full vestra.
It's proven to be more efficacious that aromatase inhibitors in first line therapy.
Rajesh K. Malik: However, Fulvestrant, even with superior outcomes, has not moved into the adjuvant setting because its administration requires a series of painful intramuscular injections, leaving aromatase inhibitors as a standard of care in Physician interviews have shown that an oral CERD would displace Fulvestra in the first line and also become a standard of care in the adjuvant setting. As ER-positive disease is the most common type of breast cancer, an oral surge could benefit hundreds of thousands of people worldwide every year. In our phase one trial of Q1T48, we observed a promising safety and tolerability profile with evidence of anti-tumor activity in a heavily pretreated patient population. With regard to safety and tolerability, The majority of adverse events were Grade 1, and there were no dose-limiting toxicities, and a maximum-tolerable dose was not reached.
However for investment even with superior outcomes has not moved into the adjuvant setting because its administration requires a series of painful intramuscular injection.
Leaving aromatase inhibitors as a standard of care in the agile them treatment.
Physician interviews have shown that an oral served with displace full investment in the first line and also become a standard of care in the agile and setting.
As you are positive disease is the most common type of breast cancer and oral sir could benefit hundreds of thousands of people worldwide every year.
In our phase one trial, if you want to 48.
We observed a promising safety and tolerability profile with evidence of anti tumor activity in the heavily pretreated patient population.
With regard to safety and Tolerability.
Majority of adverse events were grade one and there were no dose limiting toxicities and a maximum tolerated dose was not reached.
Rajesh K. Malik: Based on the findings in the dose escalation portion of this trial, we selected 601,000 milligram doses for evaluation in the ongoing phase 2a portion of the trial. Enrollment is almost complete, with 20 patients at each dose level. In addition to PK, tolerability, and efficacy, we are also collecting pre- and post-treatment tumor biopsies in a subset of patients to directly evaluate pharmacodynamic activity within the tumor. Data from these 40 patients should allow us to select a dose to move forward into phase 3 development. I am looking forward to it.
Based on the findings in the dose escalation portion of this trial.
We selected 601000 milligram doses for evaluation in the ongoing phase two a portion of the trial.
Enrollment is almost complete with 20 patients per dose level.
In addition to PK Tolerability and efficacy. We are also collecting pre and post treatment tumor biopsies in a subset of patients to directly evaluate pharmacodynamic activity within the tumor.
Data from these 40 patients should allow us to select a dose to move forward into phase three development.
Looking forward, we presented data on Lerro cyclists at the San Antonio breast cancer Symposium in December .
Rajesh K. Malik: and Forward.
Jen Moses: We are presenting data on Leracyclid at the San Antonio Breast Cancer Symposium in December. This Phase 1b, 2a trial is evaluating laracyclib dosed without a holiday in combination with Fulvestrin in patients with locally advanced or metastatic ER positive HER2 negative breast cancer that had progressed on prior endocrine therapy. At ASCO in 2018, we presented preliminary safety, tolerability, and efficacy findings from 33 patients in the dose escalation portion of this trial. At San Antonio, we will present safety and tolerability data from 110 patients, including 66 patients from the expansion portion of the trial, and focus on 41 patients who received either 150 or 200 milligrams twice daily. Early efficacy data will be included in this post, but it is important to note that due to the short duration of follow-up for the expansion cohorts, this data is immature. I'll now turn the call over to Jen for a review of the financials. Jen?
This phase one be to a trial is evaluating laira cyclists dosed without a holiday.
In combination with full investment in patients with locally advanced or metastatic IAR positive hertwo negative breast cancer.
Had progressed on prior endocrine therapy.
At ASCO in 2018, we presented preliminary safety Tolerability and efficacy findings from 33 patients in the dose escalation portion of this trial.
At San Antonio, We will present safety and Tolerability data from 110 patients, including 66 patients from the expansion portion of the trial with a focus on 41 patients who received either 100 5200 milligrams twice daily.
Early efficacy data will be included in the poster.
But it is important to note that due to the short duration a follow up for the expansion cohorts. This data is immature.
I'll now turn the call over to Chen for a review of the financials Jen.
Jen Moses: Thanks, Raj. I'll review several items on today's call, both financial and...
Thanks Raj.
Several items on today's call full financial results for the third quarter are available in our press release against 10-Q.
Jen Moses: We reported a net loss of $32.4 million.
Jen Moses: Compared to $19.9 million for the third quarter of 2018, operating expenses were $34 million for the third quarter of 2019, compared to $20.8 million for the prior year period. Operating expenses included non-cash stock compensation expense of $4.4 million for the third quarter of 2019, compared to $3.3 million for the prior year period. Research and Development Expenses for the third quarter of 2019 were $22.9 million, compared to $15.9 million for the prior year period.
We reported a net loss of 32.4 million for the third quarter of 2019 compared to 19.9 million the third quarter 2018.
Operating expenses were 34 million for the third quarter 2019, compared to 20.8 billion for the prior year period.
Operating expenses included noncash stock compensation expense of 4.4 million for the third quarter of 2019 compared to 3.3 million for the prior year period.
Research and development expenses for the third quarter.
Were 22.9 million compared to 15.9 million in the third quarter of 2018.
Jen Moses: The increase in expenses was primarily 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 third quarter of 2019 were
The increase in expenses, primarily due to an increase in clinical program costs drop manufacturing and development costs and personnel related costs due to additional headcount.
General and administrative expenses for the third quarter 2019 were 11.1 million compared to 4.9 million for the prior year period.
Jen Moses: Compared to 4.9 million,
Jen Moses: The increase in GNA expense was largely due to an increase in headcount, an increase in medical affairs costs related to trilocyclic pre-commercialization activities, and an increase in other costs necessary to support our operation. As of September 30, 2019, we had $299.9 million in cash and cash equivalents on the balance sheet, compared to $369.3 million as of December 31, 2018. We are narrowing the range of the annual guidance that we announced in June of $260 million to $270 million in cash and cash equivalents and expect to end the year with between $265 million and $270 million. I'll now turn the call back over to Mark.
The increase in DNA expense was largely due to an increase in head count and increase in medical affairs costs related to trial excitement.
The commercialization activities and an increase in other costs necessary to support our operations.
As of September 32019, we had 299.9 million in cash cash equivalents on the balance sheet.
Compared to 369.3 million as of December 30, Onest 2018.
We are narrowing the range of the annual guidance that we announced in June 260 to 272 hundred 70 million in cash and cash equivalents and expect to answer here with between 265 and 270 million.
I'll now turn the call back over to Mark Mark.
Mark Vileka: Thanks, Jen. A quick summary before we go to Q&A. We are beginning our rolling NDA submission for the trial cycle of small cell lung cancer this quarter and expect to complete the NDA in the second quarter of 2020. We are also moving forward with additional clinical trials in colorectal cancer and triple negative breast cancer. We are continuing to advance Lerocyclop and G1T48, with emerging data on both therapies to support their use as first-line treatments in breast cancer. We are in a solid financial position with sufficient cash to fund operations well into 2021. Identifying partnership opportunities for our three clinical stage therapies is a key strategic objective with a priority on the near-term commercial opportunity for trial cycles. That concludes our prepared remarks. Operator, please open the call for questions.
Thanks, Jen a quick summary, before we go to Q in AG.
We are beginning our rolling NDA submission for trial sites of in small cell lung cancer this quarter and expect to complete the NDA in the second quarter of 2020.
We're also moving forward with additional clinical trials in colorectal cancer in triple negative breast cancer.
We are continuing to advance lerro cyclic and Gtwenty 48 with emerging data on both therapies to support their use as first line treatments in breast cancer.
We are in a solid financial position with sufficient cash to fund cash to fund operations well into 2021.
Identifying partnership opportunities for our three clinical stage therapies is a key strategic objective with a priority on the near term commercial opportunity for trial of cycling.
That concludes our prepared remarks, operator, please open the call for questions.
Operator: Thank you, sir. And your first question comes from the line of Dane Leone with RJS.
Thank you Sir your first question comes from the line of Dane Leone with RJ.
And thanks for the update I think all of US are starting to look towards I say BCS now.
Dane Vincent Leone: And thanks for the update. I think all of us are starting to look towards SABCS now. So thanks, Raj, for setting the table a bit.
So thanks Raj for setting the table a bit I'm, just curious could you maybe dive into a little bit more detail of.
Dane Vincent Leone: I was just curious, could you maybe dive into a little bit more detail of when we look at those 110 patients in the 66 expansion phase and then, I think, the 40 odd ones in the dosing that you think is going to be optimal to obviate neutropenic monitoring? What, like, what cohorts do you think we'll need to focus on or have enough available follow-up to focus on clinical effects? Because I think that's going to be a big question for people: beyond neutropenic monitoring, are we seeing clinical effects at those doses at the end? Thank you.
When we look at those 110 patients in the 66 expansion phase and then I think the 40 some odd in the dosing.
That you think is can be optimal to obviate neutral peanut monitoring.
What like what what cohorts do you think will need to focus on or have enough available follow up to focus on clinical effect.
Because I think thats going to be a big question for people of beyond neutral monitoring are we seeing clinical effect that those doses at this point. Thank you.
Rajesh K. Malik: Thanks, Dan. I'll let Raj answer that question.
Yes, Thanks, Dan ill, let Raj answer that question, Hey, Dave Raj here, yes.
Rajesh K. Malik: Hey Dane, Raj here. Yeah, I think the two cohorts to focus on would be the 150 milligrams and the 200 milligrams twice a day because one of those two doses is going to be the dose that will go forward into phase three. As I mentioned, the efficacy data is going to be less mature, particularly given that the expansion cohorts only completed enrollment several months ago. However, obviously, the safety data should be evaluated.
I think the two cohorts to focus on would be.
150 milligrams and the 200 milligrams twice a day because one of those two doses is going to be the.
The dose will take forward into phase three.
As I mentioned.
The efficacy data is going to be less mature, particularly given.
That the expansion cohorts already completed enrollment several months ago.
However, obviously the safety data should be a valuable.
Okay and will do you think there'll be a signal within the total 66 patient expansion phase at doses similar to the subgroup that have more follow up or is there is there going to be a good way to kind of tease out the signal.
Rajesh K. Malik: Okay, and do you think there will be a signal within the total 66 patient expansion phase at doses similar to the subgroup?
<unk> for that dosage level.
So we will present efficacy for the entirety of the study and certainly that will that will.
Rajesh K. Malik: So we will present efficacy for the entirety of the study, and certainly that will give a sense of the efficacy of lerocycline in combination with Fulvestrin. My point regarding the 150 and 200 was that in those two particular dose cohorts, the duration of follow-up is relatively short.
Give us on Sophie.
The efficacy of Valero sites of in combination with full restaurant.
My point regarding the 150 and 200 was.
That in those two particular dose cohorts the duration of follow up is relatively.
Rajesh K. Malik: Okay, let me, just finally, so the 33 patients from ASCO, we'll get long-term follow-up on those patients. Exactly.
Shorter compared to the rest of the study.
Okay, Let me.
Just finally stood at 33 patients are masco, we'll get long term follow up on those patients exactly yes, okay, alright, thats, Okay, Oh, yes, yes, absolutely. The the every single patient who has been enrolled in the study so far will be included in the efficacy. So.
Rajesh K. Malik: Alright, that's what I was getting at.
Rajesh K. Malik: Oh yeah, absolutely. Every single patient who has been enrolled in the study so far will be included in the efficacy. You will see the efficacy for the entirety of the enrolled population.
You will see the efficacy for the entirety of the enrolled population.
Dane Vincent Leone: Okay, and sorry, I'd misheard it. Was it about 40 patients at 150 MIG and 200 MIG BID? Forty-one combined, yes. Okay. Alright. Thank you so much. Shabbat shalom.
Okay, all right I'd Miss heard it was it about 40 patients that 150, Meg and 200 bank.
Our 41 combined yes, okay alright, thank you so much.
Sure.
Operator: Your next question comes from the line of Anupam Rama with J.P. Morgan.
Your next question comes from the line of.
Rama with JP Morgan.
Anupam Rama: Hey guys, thanks for taking the question and congrats on all the progress. Um, just a quick one from me, can you...
Hey, guys. Thanks for taking my question Congrats on all the progress.
Just a quick one for me can you remind us as a timeline for completing the various portions of the IND submission for title cycle up in small cell and remind us if any outstanding gating factors on the preclinical side that needs to be completed before the submission can complete.
Anupam Rama: Please remind us of the timeline for completing the various portions of the NDA submission for Trilocyclic and Small Cell.
Mark Vileka: Remind us if there are any outstanding gating factors on the preclinical side that need to be completed before...
Anupam Rama: Please see the complete disclaimer at https://sites.google.com
Hi, Thanks and apartments Mark.
Mark Vileka: Thanks Anupam, it's Mark. We're on track, actually starting the rolling process this quarter.
We're on track.
Actually starting to rolling process this quarter.
All of the preclinical to your specific point Don.
Mark Vileka: All of the pre-clinical, to your specific point, done. That'll be among the first things we file, and we expect to have everything else filed in the second quarter. Thanks for taking our questions.
That will be among the first things we file.
And expect to have everything else filed in the second quarter.
Great. Thanks for taking my question.
Your next question comes from the line of Chris Shibutani with Cowen.
Operator: Your next question comes from the line of Chris Shaboutani with Caroline.
Chris Shaboutani: Great, thanks very much. Two questions, if I may. For TRILA, the TMBC trial that you're planning on initiating in 2020, can you highlight for us any distinctions in terms of the design of that trial that you hope might be informing a little bit more in terms of how you can replicate the benefit that you saw in the first trial and, in particular, what sort of data points might help us better understand the factors that were driving that overall survival benefit? Is there something about the trial design that is distinctive that you can share with us?
Great. Thanks, very much two questions. If I may for trial the on CNBC trial that you're planning on initiating in 2020 can you highlight for us any distinctions in terms of the design of that trial that you hope might be in forming a little bit more in terms of how you can replicate.
The benefit that you saw in the first trial and in particular, what sort of.
Data points might help us better understand the factors that we're driving overall survival benefit is there something about the trial design that is distinctive but you can share with us.
Rajesh K. Malik: Thanks Chris, I'll let Raj take that.
Thanks, Chris I'll, let Raj take that yes, Hey, Chris.
Rajesh K. Malik: Yeah, hey, Chris. So there are really two data points that are going to inform the design of the next trial. And so one of them comes from our trial; of course, with a longer duration of follow-up, we will get information on subsequent therapies that patients got. But another important data point is looking at tumor PD-L1 expression and how patients did in our TMBC trial if their tumors were PD-L1 positive or PD-L1 negative. The second important data point is, of course, the Keno 355 study, where Keytruda is being tested in combination with three different chemotherapeuts. And so there are a couple of points here of importance. One, do they see activity in the entire patient population or only in the PD-L1 positive population, similar to what was seen with Atizo? And the second, of course, is which chemo backbone is, you know, are they all equivalent, or is one better than the other?
So there really to.
Data points.
That are going to inform the design of.
The next trial and so one of them comes from our trial of course with longer duration, a follow up you will get information on.
Subsequent therapies that patient Scott, but another important.
Data point is looking at the tumor PDL, one expression and how patients did an hour TMC trial, if that tumors or PDL, one positive or PDL one negative.
The second important data point is of course, the keynote 355 study where keytruda is being tested in combination with three different chemo regimens.
And so there are couple of points here.
Important Swan.
Do they see activity in in the entire patient population are only in the PDL. One positive population similar to what was seen with a T cells and the second of courses, which chemo.
Backbone.
Is the all equivalent or is one better than the others. So I think all of those factors need to be taken into account.
Rajesh K. Malik: and many more.
Rajesh K. Malik: in the design of the next study, of course, then followed by regulatory discussions.
In the design of Pemex study of course, then followed with the regulatory discussions.
Chris Shaboutani: Great. And then I could follow up on the world of SIRDS. This is an area in which we've seen increasing levels of activity across the industry. Just this afternoon, an update from one of the competing agents, Elastostrat from Radius, announced that they are not going to be doing any further clinical development themselves beyond their current emerald study and are looking for strategic options there. This is an area that seems to have had development run into some issues. A lot of companies are going after this. I would love to get your initial thoughts on that news and how you feel you're planning to see if you can optimize your own probability of success.
Great and then if I could follow up in the world absurd.
One this is an area, which we've seen increasing levels of activity across the industry. Just this afternoon.
Update from one of the competing agent Elas distract from radius, they announced that they are not going to be doing any further clinical development themselves beyond their current Emerald study and are looking for strategic options. There. This is an area that seems to have had development run into some issues.
A lot of companies are going after this love to get your initial thoughts to that news and how you feel youre planning to see if you can optimize your own probability of success.
Mark Vileka: Yeah, thanks, Chris. I can't comment on the specific regions or radius, but rate the decision by radius. I can comment that we believe that the profile that we've been able to show at ESMO and continuing data that we gather from this, from the dose expansion cohorts, shows that we've been able to overcome, again, some of the GI, LFT, cardiac issues that have been shown in other products that were in development. We are aware of other competitors, and we are keen to see data. We've seen the Sanofi CERD at ASCO. We expect to see the third generation Roche CERD at San Antonio, and we're aware that AZ has a second generation compound. But we remain confident in the validated mechanism of a CERD, given the efficacy of Fulvastrin, and that a well-tolerated oral CERD could supplant Fulvastrin in first line and ultimately move it to the adjuvant setting.
Yes, Thanks, Chris.
I can't comment on specific regions for radius rate the decision by radius.
I can comment that we believe that profile that we've been able to show at ESMO and continuing data that we gather from this.
From the dose expansion cohorts.
That the Tolerability profile for 48.
Shows that we've been able to overcome again some of the guy LSP cardiac issues that have.
Sean and other.
Products that were in development, we are aware of other competitors and we are keen to see data we've seen the sanofi.
Third at ASCO.
We expect to see the third generation Roche served at San Antonio.
And we're aware of it as he has a second generation count, but we remain confident.
In the validated mechanism of a third given that the efficacy of fall this trend.
And that a well tolerated oral circuits had supplant fall this trend in first line and ultimately move into the judgment setting.
Chris Shaboutani: Great. It certainly does seem to be an interactive opportunity. Good luck with your continued progress. Thanks for your responses.
Great. It certainly does seem to be an attractive opportunity. Good luck with their continued progress. Thanks for your responses.
Operator: Thank you.
Thank you.
Your next question comes from the line of Chad Messer Needham and company.
Chad Messer: Your next question comes from the line of Chad Messer with Needham and Company.
Chad Messer: Great. Good evening, and thanks for taking my questions. I'm going to start with one on Lero.
Great Good evening and thanks for taking my questions.
If we could just.
Art with one on the euro.
I was wondering if you guys had any idea.
Chad Messer: I was wondering if you guys had any idea... Please, be Raj if someone did... what the other CDK46 inhibitor data kind of looked like at this stage in development, if it indeed was presented at all.
Be Roger if someone did what the other CDK for Syk inhibitor data Kingdom looked like at this stage in development if it in deep Luke was presented at all.
Rajesh K. Malik: And thanks, Chad. Go ahead, Raj.
Thanks, Chad go ahead rush Chad.
Rajesh K. Malik: Yeah, hey, Trav. Yeah, I think the closest study I would say would be the Paloma3, the combination of, you know, palvocyclib and fulvestrant. There's data now, of course, with all four, six inhibitors, plus fulvestrant as well, but we designed our study closest to the Paloma3 in terms of eligibility. So that would be the study I would refer to.
Yes, I think the the closest.
Study I would say would be the alone let three the combination of.
Publicize central investment.
Yes, Theres data now of course with all four six inhibitors plus was close for investment as well, but although we designed our study closest to the Paloma three in terms of eligibility so that will be the study atwood.
Referred to.
Alright, great thanks for that.
Chad Messer: All right, great. Thanks for that.
And then on on on trials, so at ESMO Doctorow O'shaughnessy Sorta ended presentation with.
Chad Messer: And then on Trila, so at ESMO, Dr. O'Shaughnessy sort of ended the presentation with some data on ex vivo CD8 T-cell responses kind of to support this idea you're talking about of potential immune activation, and then also talked about something you were talking about on this call, which is looking into the PD-L1 status. Are those two things the sort of gist of the biomarker effort going on right now, or are there other things that are worth looking at that would sort of give you an idea of whether we are indeed preserving or boosting immune activity?
Some data on.
Vivo CDH T cell responses kind of it.
To support this idea of you're talking about.
Potential immune activation and then also also talked about some you were talking about on this call.
Which is looking into the PDL one status.
Are those two things that sort of just of the biomarker effort going on right now were there or are there other things that are worth looking at that would sort of give you an idea of whether we are indeed.
Preserving or boosting immune activity.
Yes, we are looking at other.
Rajesh K. Malik: Yes, we are looking at other, you know, we did peripheral blood immunophenotyping, and what we presented was data from the analysis of T-cells stimulated ex vivo. We are looking at other immune cells in the peripheral blood as well, such as the myeloid compartment. So those analyses are ongoing, and I mentioned PD-L1, as well. I think that's going to be important, not only to understand where we saw efficacy with trialocyclic but could also help in future development.
We did peripheral blood immuno phenotype thing and what we presented was data from the analysis of T cells stimulated ex vivo. We are looking at other immune cells in the peripheral blood as well such as the modeling compartment.
So those those analyses are ongoing and I mentioned the PDL one.
As well I think thats going to be important.
Not only to understand the.
Where we saw efficacy with Travis I flip, but could also help in future development.
Okay, and then just on the development plans for trial I kind of picked up on a slight change your wording, maybe nothing but I'll ask you guys about it in.
Chad Messer: Okay, and then just on the development plans for the trial, I kind of picked up on a slight change in wording, and maybe it's nothing, but I'll ask you guys about it. At ESMO in September, you were talking about a Phase 3 TMBC trial, and now you're talking about a trial. Are we considering more potential options for how to go forward?
And it won't September you're talking about eight.
Three.
CNBC trial.
You're talking about the trial, where we are considering.
More potential options for for how to go forward or.
Mark Vileka: I'll take that one, it's Mark. We are considering all options, and to Rajesh's point, we really want to see the keynote data. We had expected to see it this year, but we may now not see it until the middle of next year. We don't want to delay the next trial, hence that small change in language.
Right over reading this.
No.
Take that want to tomorrow, we are considering all options and to Rogers point.
We really want to see the keynote data.
We had expected to see it this year, we may we may not see it until the middle of next year.
We don't want to delay the next trial.
Since that small change in language.
Okay, alright, thanks, so much.
Chad Messer: Okay. All right. Thanks so much.
Your next question comes from the line of Tom Shrader with BTI team.
Operator: Your next question comes from the line of Tom Schrader with BTIG.
Tom Schrader: Good afternoon, thanks for taking the question. It's really a follow-up, quick follow-up to what Chad just asked, but if you approach the FDA as triple negative, this is kind of a straight oncology drug, so will you move within the agency? Will you talk to them as a hybrid drug? Just your thoughts.
Good afternoon. Thanks for taking the question, it's really a follow up quick follow up or what Chad just asked but if you approached the FDA and triple negative. This is kind of a straight oncology drugs. So will you moved within the agency will you talk to them as a hybrid drug just just your thoughts because it's really kind.
Tom Schrader: It's really kind of a different drug now.
But different drug though.
Oh, yes, yeah, we actually have already begun a dialogue with the oncology division. So prior to the CNBC data our interactions had bandwidth hematology division.
Rajesh K. Malik: Yeah, we have actually already begun a dialogue with the Oncology Division.
Rajesh K. Malik: Division, but we've now opened up a dialogue with the Oncology Division, and we'll continue that dialogue to discuss our ideas for this next trial. Yeah, okay, great, thank you.
But we now have opened up a dialogue with the oncology division and we'll continue that dialogue to discuss our ideas for this next trial.
Okay, great. Thank you.
Tom Schrader: Yeah, okay, great. Thank you.
Any other questions operator.
Operator: Any other questions, Operator?
Mark Vileka: I'm showing no further questions at this time. I would like to turn the conference back to Dr. Mark Vallecca.
I'm showing no further questions at this time I would like to turn the conference that back to Dr. Mark the Alaska.
Mark Vileka: Thank you, operator. That concludes the call.
Thank you operator that concludes the call. Please reach out to us with any questions. As a reminder, we will be at the Stifel Conference. Later this month and at the Evercore ISI Conference in early December we look forward to seeing many of you at those meetings. Thank you for joining us and have a good evening.
Operator: Please reach out to us with any questions. As a reminder, we will be at the Stiefel Conference later this month and at the Evercore ISI Conference in early December. We look forward to seeing many of you at those meetings. Thank you for joining us.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and hadn't had a wonderful day you may all disconnect.
Operator: Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.
Yes.
Operator: [inaudible]