Q4 2019 Earnings Call
Good day, ladies and gentlemen, and welcome to that she wants their accudate fourth quarter. Its full year 2018 financial results.
Operator: Today, ladies and gentlemen, and welcome to the G1 Therapeutics fourth quarter and full year 2019 financial results. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. 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 call over to your host, Jeff McDonald, Senior Director of Investor Relations.
This time, all participants are in listen only mode.
Sure we will conduct a question and answer session and instructions will follow at that time, if anyone should require assistance. During the conference. Please press Star then zero on his touchtone telephone.
A reminder, this conference call is being recorded I would now like to turn the conference over to your host Jets Mac Donald Senior director of Investor Relations. Please go ahead.
Jeff McDonald: Thank you, operator. Good afternoon, everyone.
Thank you operator.
Good afternoon, everyone welcome to the G. One [laughter] fourth quarter full year 2019 financial update joining me on heart Blackout, Chief Executive Officer, Bosch, Molly Chief Medical Officer, Senior Vice President R&D agenda, Chief Financial Officer.
Jeff McDonald: Welcome to the G1 Therapeutics fourth quarter and full year.
Jeff McDonald: Joining me is Mark Pillai.
Jeff McDonald: Chief Financial Officer, Raj Malik, Chief Medical Officer, and Senior Vice President of R&D, and Jen Moses, 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 judgments as of today and may involve risks and uncertainties that could cause actual results to differ.
We began I'm not sure why is this call once before long Steven this 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.
Jeff McDonald: Please refer to our filings with the SEC, which are available on the SEC website.
Yes, you see which are available and yes, you see warmer website.
Jeff McDonald: or our corporate website for information concerning risk factors that could affect the company. Now, I'll turn the call over to Mark.
Concerning risk factors affecting.
Now I'll turn the call over to Mark.
Mark: Thanks, Jeff. Good afternoon, everyone, and thank you for joining us. On today's call, Raj, Jen, and I will highlight our key achievements in 2019, discuss the clinical and regulatory priorities and milestones expected in 2020, and review the financials. I'll conclude with additional comments on our corporate strategy moving forward, after which we'll open the poll for questions. First, I'll begin with the key milestones that we achieved in 2019.
Thanks, Jeff Good afternoon, everyone and thank you for joining us on today's call Bosh, Jan and I will highlight our key achievements in 2019 discussion clinical and regulatory priorities and milestones expected in 2020 and review the financials I'll conclude with additional comments on our corporate strategy moving forward.
After which we'll open the poll for questions.
I'll begin with the key milestones that we achieved in 29 gene.
First we received breakthrough therapy designation for trial of type one based on compelling Milo preservation data across three randomized trials in small cell lung cancer.
Mark: We received breakthrough therapy designation for trialocyclin based on compelling myelopreservation data across three randomized trials in small cell lung cancer, and we are on track to file an NDA and an MAA for small cell lung cancer this year. Second, data from our Phase 2 trial in triple negative breast cancer showed a significant overall survival benefit in patients receiving trial cyclits along with chemotherapy. These findings support further evaluation of trilocyclic acid in TMDC, as well as other breast cancer subtypes.
And we are on track to file in India, and everything for small cell lung cancer. This year.
Okay.
Data from our phase two trial in triple negative breast cancer showed a significant overall survival benefit patients receiving throws fiber along with chemotherapy.
These findings support further evaluation of travel cycling in T.N.B.C. as well as other breast cancer sometime.
Sure.
Mark: We announce promising early data on rintodestrin, formerly G1T48, our oral-selective estrogen receptor degrader, or CERD. We believe that RENTO-DEFTRAN's preliminary safety and tolerability profile could have advantages over the competition, particularly in the adjuvant setting. Based on our findings to date, we are investing in further development of Ritodestrin as a potential best-in-class treatment for ER-positive HER2-negative breast cancer. Lastly, additional data on our oral CBQ. Laris Cyclin showed a differentiated profile from other drugs in the class.
No no promising early data on rent Odessa, formerly do you want to 48, our oral selective estrogen receptor degrader horses are.
We believe that rental jastrem preliminary safety and Tolerability profile could have advantages over the competition, particularly in the AD driven setting.
Based on our findings to date, we are investing in further development of Richard just right as a potential best in class treatment for your positive hertwo negative breast cancer.
Lastly, additional data on Oh, CDK <unk> inhibitor lurks lifeless showed a differentiated profile from other drugs blocks.
Coming back to trial sites that are most significant accomplishment and 29 team, what's establishing a clear regulatory pathway.
Mark: Coming back to trialocyclic, our most significant accomplishment in 2019 was establishing a clear regulatory path. We received feedback from the hematology division of the FDA that the positive myelopreservation data from our three randomized phase two small cell lung cancer trials support an NDA filing. We began a rolling NDA submission in the fourth quarter of 2019, which we expect to complete in the second quarter of this year. As a reminder, we've been engaged with the HEIM division since the beginning of the trial cycling program. This is the division that reviewed and approved the growth factors GCSF and Erythropoietin more than 20 years ago, which was the last significant advancement in treating malice depression. We believe that trial cycles can improve patient care in a straightforward and valuable way by preserving bone marrow immune system function during chemotherapy.
We received feedback from the hematology division of pickups, yet, but the positive mild preservation data from our three randomized phase two small cell lung cancer trial support and endeared filings.
We began a rolling endearing submission in the fourth quarter 2019, which we expect to complete in the second quarter of this year.
As a reminder, we've been engaged with the huge division since the beginning of the trial cycle program. This is a division of reviewed and approved the growth factors gcs that an original powergen more than 20 years ago, which was the last significant advancement and treating mouse fresh.
We believe the trial cycles can improve patient care can I, just straight forward and valuable way by preserving bone marrow immune system function during chemotherapy.
Mark: Administering triacyclic acid prior to chemo protects the marrow rather than the current practice of using growth factors to attempt to rescue a marrow that has already been damaged by chemo. We've had productive discussions with national health authorities in Europe regarding small cell lung cancer. Similar to the U.S., we received feedback that our existing data supports a filing, and we plan to submit a marketing authorization application to the European Medicines Agency in the fourth quarter of 2020, in parallel to the submission of regulatory filings for small cell lung cancer and colorectal and breast. I'd now like to turn the call over to Raj to discuss our development plans for trial of cycling, as well as to provide an update on rinta Raj?
Administer a trial of cycling prior to chemo protects the marrow rather than the current practice of using growth factors to attest to rescue marrow that has already been damaged I came about.
We've had productive discussions with national health authorities in Europe regarding the small cell lung cancer.
Similar to the U.S., we received feedback that our existing data supports the filing and we plan to submit a marketing authorization application to the European medicines agency in the fourth quarter of 2020.
In parallel to the submission of regulatory filings for small cell lung cancer.
Securing a robust development plan that will evaluate trials like what's the potential benefits in colorectal and breast cancer.
I'd now like to turn the call over to Raj to discuss our development plans for trials cycle as well as to provide an update on rent adjust rat and laterals.
Right.
Thanks, Mark I'm going to focus my remarks on our development and regulatory plans for 2020.
I'll start with travel sites.
We have already begun our rolling Andy's submission for small cell lung cancer and are on track to complete the filing and the second quarter.
Raj: Thanks, Mark. I'm going to focus my remarks on our development and regulatory plans for 2020. I'll start with Traumasites.
The FTC has 60 days to decide whether to accept the filing for review so we anticipate providing a status update in the third quarter, including the PDUFA date.
Raj: We have already begun our rolling NDA submission for small cell lung cancer and are on track to complete the filing in the second quarter. The FDA has 60 days to decide whether to accept the filing for review, so we anticipate providing a status update in the third quarter, including the PDUFA date. Concurrently, we're working on a Marketing Authorization Application, or MAA, for submission in Europe. We have had several interactions with national health authorities who have confirmed that our data package is sufficient to file an MAA. And we have been assigned a rapporteur and co-rapporteur. There is significant overlap between the content required for the NDA and the MAA, and we expect to file the MAA in the fourth quarter of 2020.
Concurrently we are working on a marketing.
Authorization application or M&A for submission in Europe.
We've had several interactions with national health authorities.
That data package is sufficient to five an m. <unk>.
And we have been assigned a rapid far and co rapidly.
There was significant overlap between the content required for the N D a and B M. A.
Expects to file the I mean, a in the fourth quarter on 2020.
We are excited to have an opportunity to make charter cycle of available to patients with small cell lung cancer.
At the same time, we're initiating additional trials this year.
Alleyways potential benefits I'll try to site live and other tumors and with additional chemotherapy regimens.
We plan to initiate a phase three trial in patients with colorectal cancer treated with five a few based chemotherapy in the fourth quarter on Friday 20, with Molla preservation as the primary outcome measure.
This represents a significant opportunity to help patients globally. There are more than 500000 cases of colorectal cancer treated with chemotherapy each year. The majority of which is five if you based.
Raj: We are excited to have the opportunity to make Trialocyclib available to patients with small cell lung cancer. At the same time, we are initiating additional trials this year to evaluate the potential benefits of trilocycline in other tumors and with additional chemotherapy regimens. We plan to initiate a Phase III trial in patients with colorectal cancer treated with 5FU-based chemotherapy in the fourth quarter of 2020, with tumor preservation as the primary outcome measure. This represents a significant opportunity to help patients. Globally, there are more than 500,000 cases of colorectal cancer treated with chemotherapy each year, the majority of which is 5F-U based. Much of our preclinical data on trialocyclic was generated using 5-FU, and this is a multi-day treatment regimen used to treat a variety of GI tumors that results in severe myelosuppression. In addition,
Much of our preclinical data on trial the cycle. It was generated using five at you and this is a multi day treatment regimen used to treat a variety of GE tumors that results in severe myelosuppression.
In addition, China cyclic was accepted into the long standing and successful I spy to breast cancer trial.
Childless likely will be evaluated for neoadjuvant treatment of locally advanced breast cancer, including GR positive her two positive and triple negative disease in combination with a standard chemotherapy regimen with or without a PD one checkpoint inhibitor.
The primary endpoint up the trial as pathological complete response rate, which has been shown to parlayed with event free survival in triple negative disease.
But also obtained adverse event data to assess modeled preservation effects.
We expect data from both the colorectal and I spy trials in late 2022 too early 2023.
Raj: in addition.
Raj: Charles Heitkamp was accepted into the long-standing and successful I-SPY-2 breast cancer trial. Tralocyte will be evaluated for new algebraic treatment of locally advanced breast cancer, including ER positive, HER2 positive, and triple negative disease in combination with a standard chemotherapy regimen with or without a PD-1 checkpoint.
Moving to rental desktop.
The ESMO 2019 Congress, we reported preliminary dose escalation data from our phase one two way trial, demonstrating a potential best in class safety and Tolerability profile with evidence of anti tumor activity in a heavily pre treated patient population.
In the fourth quarter of 29 team, we fully enrolled additional study cohorts evaluating dosing at 600 on a thousand milligrams.
Raj: The primary endpoint of the trial is pathological complete response, which has been shown to correlate with event-free survival in triple negative patients. We will also obtain adverse event data to assess model preservation effects. We expect data from both the colorectal and I-SPI trials in late 2022 to early 2023. Moving to RINTO-DESTRA.
Data from these cohorts are being used to establish our go forward dose.
We anticipate reporting preliminary data from all 67 patients both the dose escalation and dose expansion cohorts in the fourth quarter. This year.
We are initiating an additional armistice trial to evaluate the combination of rental desktop or the CDK for six inhibitor of palbo cycling or hybrids.
We expect to begin enrolling patients with this combination and the second quarter off this year.
Raj: At the ESMO 2019 Congress, we reported preliminary dose escalation data from our Phase 1, 2A trial demonstrating a potential best-in-class safety and tolerability profile with evidence of anti-tumor activity in a heavily pretreated patient population. In the fourth quarter of 2019, we fully enrolled additional study cohorts evaluating dosing at 600 and 1,000 milligrams. Data from these cohorts are being used to establish our go-forward dose. We anticipate reporting preliminary data from all 67 patients, both the dose escalation and dose expansion cohorts, in the fourth quarter. We are initiating an additional arm of this trial to evaluate the combination of rind-to-destrat and the CDK4-6 inhibitor of pelvic cichlid, or iVRAT. We expect to begin enrolling patients with this combination in the second quarter of this year.
Well.
You see disclosed we are completing our metro cyclic breast cancer, a non small cell lung cancer trials are either positive or two negative breast cancer trial in combination with full invest fabs showed promising safety and tolerability data that is differentiated from other CDK for six inhibitors with a comparable EPS.
I see profile.
We plan to report updated safety and efficacy data in the third quarter of this year.
Data from a trial with Tagrisso and non small cell lung cancer showed that the combination was well tolerated.
Given the robust treatment effect of Tagrisso monotherapy data are not mature enough to evaluate the anti tumor efficacy on the combination regimen.
We believe that let recycling has the potential to benefit patients in combination therapy across a range of cancer types.
We do not plan to initiate additional that recycling trials ourselves and our focusing our resources on traveler cyclists and rental industry.
I'll now turn the call over to Gen for a review of the financials Jan.
Thanks, Josh.
He is several items on today's call full financial results for the fourth quarter and full year 2019 are available in our press release and 10-K.
Raj: As previously disclosed, we are completing our larocyclic breast cancer and non-small cell lung cancer trial. Our ER-positive, HER2-negative breast cancer trial, in combination with Fulvestrant, showed promising safety and tolerability data that is differentiated from other CDK4-6 inhibitors with a comparable efficacy profile. We plan to report updated safety and efficacy data in the third quarter of 2020. Data from our trial with Tegristo and non-small cell lung cancer showed that the combination was well tolerated. Given the robust treatment effect of Tadrissel monotherapy, the data are not mature enough to evaluate the anti-tumor efficacy of the combination regimen. However, we believe that lerocyclid has the potential to benefit patients in combination therapy across a range of cancer types. We do not plan to initiate additional larycyclic trials ourselves and are focusing our resources on trialocyclic and rentodestroid. I'll now turn the call over to Jen for a review of the financials. Jen?
We reported a net loss of 35.4 million for the fourth quarter 2019, compared to 24.1 million fourth quarter at 28.
Net loss for the full year 2019 was 122.4 million compared to a net loss of 85.3 million the prior year.
Operating expenses were 36.6 million for the fourth quarter 2019.
Pair to 26.1 billion at the fourth quarter 2018.
GAAP operating expenses included stock based compensation expense of 4.5 million fourth quarter 2019, compared to 3.3 million fourth quarter 2018.
Operating expenses for the full year 2019 for 129 million compared to 89.3 million the prior year.
Based compensation expense for the full year 2019, a 16.4 million compared to 10.2 million prior here.
Research and development expenses fourth quarter, 2019, or 24.5 million compared to 19.1 million fourth quarter 2018.
R&D expenses for the full year, 2019, or 89 million compared to 70.7 million prior year.
The increase in R&D expenses was primarily due to an increase in clinical program costs.
Jen: Thanks, Raj. I'll review several items on today's call. Full financial results for the fourth quarter and full year 2019 are available in our press release and 10-K. We reported a net loss of $35.4 million for the fourth quarter of 2019, compared to $24.1 million for the fourth quarter of 2018. Our net loss for the full year 2019 was $122.4 million, compared to a net loss of $85.3 million for the prior year. Operating expenses were $36.6 million for the fourth quarter of 2019.
For manufacturing active pharmaceutical ingredients and personnel costs due to additional headcount.
General and administrative expenses for the fourth quarter 2019 were 12.1 million compared to 7 million for the fourth quarter 2018.
DNA expenses for the full year 2019 were 40 million compared to 18.6 million prior year.
The increase in DNA expenses, largely due to the increase in compensation due to additional headcount increase and pre commercialization activities increased and medical affairs cost and an increase in professional fees and other administrative costs necessary to support our operation.
As of December 31, 2019, we had 269.2 million cash cash equivalents on the balance sheet.
Appeared to 299.9 billion as at September 32019.
Jen: compared to $26.1 million for the fourth quarter of 2018. Gap operating expenses include stock-based compensation expense of $4.5 million for the fourth quarter of 2019, compared to $3.3 million for the fourth quarter of 2018. Operating expenses for the full year 2019 were $129 million, compared to $89.3 million for the prior year. The stock-based compensation expense for the full year 2019 was $16.4 million, compared to $10.2 million for the prior year. Research and development expenses for the fourth quarter of 2019 were $24.5 million, compared to $19.1 million for the fourth quarter of 2018. R&D expenses for the full year 2019 were $89 million, compared to $70.7 million for the prior year. The increase in R&D expenses was primarily due to an increase in clinical program costs, costs for manufacturing active pharmaceutical ingredients, and personnel costs due to additional headcount.
369.3 million as of December 31, 2018.
We expect the cash will be sufficient to fund our operation the second half of 2021.
As noted in the press release, we're providing 2020 guidance and expect to end the year 110 to 130 million in cash and cash equivalent.
We expect our cash burn will increase this year compared to 2019, primarily due to investments required to complete U.S. and European regulatory filings for trial is cyclists and prepare for a successful commercial launch in the U.S.
This guidance does not include consideration proceeds from partnership collaboration activities or other sources of capital that we may realize 2020.
I'll now turn the call back over to Mark arc.
Next Gen. In summary, a very productive 2019 has created opportunities in 2020 for our company to advance therapies that can improve patient care and create value for shareholders.
Our top priorities are getting trials like with to patients with small cell lung cancer that need better treatment option and the continued evaluation of trials cyclically and other tumor types and additional chemotherapy regimens.
Our vision for trial is that patients across a broad range of solid tumor types will receive trial looks like with the first time and every time they are treated with chemotherapy.
Clinical and patient reported outcomes data have shown that trial cyclic has the potential to make chemotherapy safer improve the patient experience.
And in some settings help patients live longer.
Based on our market research and interactions with relevant stakeholders. We believe that these benefits will be recognized and highly valued I patient health care providers and payers.
Jen: General and administrative expenses for the fourth quarter of 2019 were $12.1 million, compared to $7 million for the fourth quarter of 2018. DNA expenses for the full year 2019 were $40 million, compared to $18.6 million for the prior year. The increase in GNA expenses was largely due to an increase in compensation due to additional headcount, an increase in pre-commercialization activities, an increase in medical affairs costs, and an increase in professional fees and other administrative costs necessary to support our operations.
Our first opportunity to demonstrate this value the patient is in small cell lung cancer do you want is well positioned to launch trials like live in the U.S. and retain full commercial rights well, we continue to unlock the value of trials nightclubs potential in colorectal and breast cancer.
Treatment of the approximately 30000 patients with small cell lung cancer in the U.S. is concentrated in large community oncology practices. Therefore, we can efficiently and effectively provide education to providers about the benefits of this unique breakthrough therapy.
We will have much more to say about our watch plans in the U.S. over the course of 2020.
We will continue discussions with potential ex us partners as we do not plan to build out infrastructure outside the U.S.
Jen: As of December 31, 2019, we had $269.2 million in cash and cash equivalents on the balance sheet, compared to $299.9 million as of September 30, 2019, and $369.3 million as of December 31, 2018. We expect that this cash will be sufficient to fund our operations into the second half of 2021. As noted in the press release, we are providing 2020 guidance and expect to end the year with $110 to $130 million in cash and cash equivalents. We expect our cash burn will increase this year compared to 2019, primarily due to investments required to complete U.S. and European regulatory filings for tricyclists and prepare for a successful commercial launch in the U.S. This guidance does not include consideration of proceeds from partnerships, collaboration activities, or other sources of capital that we may realize in 2020. I'll now turn the call back.
Turning to rent attach rate.
We believe rental Jastrem has best in class potential among the oral surgeons development, we plan to advanced front to test ran through additional clinical development milestones, including evaluation of its use in combination with how the cycle.
We're making significant investments in trials type within renter, just strategy, which is where we believe we can benefit patients most and where the investment of resources can achieve most timely returns.
There are cycling has shown the clinical profile that is differentiated from other CDK for six inhibitors and we are exploring partnerships that will enable further development, while we focus on trial and risk.
We enter 2020 and a strong financial position to make these investments we have sufficient cash to fund operations into the second half of 2021.
And we continue to explore non dilutive opportunities to further capitalize the company.
We're particularly excited about the pending FDA review of trial of cycling and the near term opportunity to bring this breakthrough therapy to patients travel cycling is the first and only therapy with the potential to significantly improve the chemo experience, which is acutely needed by patients who suffer through the immediate and long.
Long term consequences of Myelosuppression.
We need to do better for these patients.
We believe the trial cyclists offers patients and physicians is solution that they had been lacking for far too long.
That concludes our prepared remarks, operator, please open the call for questions.
Jen: Now I'll turn the call back.
Mark: Mark. Mark.
Ladies and gentlemen, if you have a question at this time. Please press the star and the number one key on your Touchtone telephone. If your question has been answered are you wish to remove yourself from the Q. Please press the pound key.
Mark: Thanks Jen. In summary, a very productive 2019 has created opportunities in 2020 for our company to advance therapies that can improve patient care and create value for shareholders. Our top priorities are getting trial cyclic to patients with small cell lung cancer that need better treatment options, and the continued evaluation of trial cycles in other tumor types and additional chemotherapy regimens. Our vision for Trila is that patients across a broad range of solid tumor types will receive Trilacycline the first time and every time they are treated with chemotherapy.
Your first question comes from the line of gain on Leon from Raymond James Please ask your question.
Hi, Thank you congrats on a very productive 2019.
And a great update on 2020.
Just had a couple of question.
The first one could you.
Just kind of provide a little bit more color when you.
Got to clinical supply agreement with Pfizer and.
You know to what extent does that play out you know is it just for this study or would it be into additional studies or or more advanced studies as well.
Mark: Clinical and patient-reported outcomes data have shown that trilocycline has the potential to make chemotherapy safe, improve the patient experience, and in some settings, help patients live longer. Based on our market research and interactions with relevant stakeholders, we believe that these benefits will be recognized and highly valued by patients, healthcare providers, and payers. Our first opportunity to demonstrate this value to patients is in small cell lung cancer. G1 is well positioned to launch trilocyclib in the U.S. and retain full commercial rights while we continue to unlock the value of trilocyclib's potential in colorectal and breast cancer. Treatment of the approximately 30,000 patients with small cell lung cancer in the U.S. is concentrated in large community oncology practices.
And then I just have a few following up.
Yes. The current supply agreement is further current study, which as we disclosed previously it's about 40 patients.
Okay and is there.
Any plans to further discuss that or is there anything built into that.
To extend that into a more advanced study or is it yeah, just I guess the step by step process.
Oh, yes step by step process for now a nonexclusive supply agreement.
Okay, great in terms of the right.
Partnerships for leverage cyclical.
What what kind of makes sense to your team are you looking for partnerships in more of the traditional CDK for six development area or are you.
Looking to be more creative and other areas.
Where CDK for six inhibitor could make sense.
[laughter] borrowing.
We're certainly looking ex U.S. and kind of the traditional foursix bayside breast cancer.
But also acknowledging the four six could play a role and other tumor types. So I think it's fair to say we're exploring Bob.
Okay, and then just finally on trial US the club Yeah late last year, you talked about partnerships with that program.
Mark: Therefore, we can efficiently and effectively provide education to providers about the benefits of this unique breakthrough therapy. We will have much more to say about our launch plans in the U.S. over the course of 2020. We will continue discussions with potential ex-US partners as we do not plan to build out infrastructure outside the US. Turning to rent-a-desk.
It seems to be alluding that you would like to retain full rights in the U.S. here and explore a partnership acts U.S. I'm, giving you a file or your plan to filed.
In the fourth quarter or what am I.
When are you still guiding for a partnership on trial the cycle during 2020 or has that changed.
So we do have time to explore partnership opportunities X U.S.
As you alluded to we are going to file the M&A in the fourth quarter has an 18 month clock on approval. So so we do have time to make sure we're doing the right deal.
Mark: We believe RintoGestRand has best-in-class potential among oral surgeon development candidates. We plan to advance RintoGestRand through additional clinical development milestones, including evaluation of its use in combination with Talbocyclib. We are making significant investments in Trilocyclib and RintoGestRand, where we believe we can benefit patients most and where the investment of resources can achieve the most timely return. Leracyclib has shown a clinical profile that is differentiated from other CDK4-6 inhibitors. And we are exploring partnerships that will enable further development while we focus on trial and error. We enter 2020 in a strong financial position to make these investments. We have sufficient cash to fund operations into the second half of 2021, and we continue to explore non-dilutive opportunities to further capitalize the company.
The best interest to shareholders.
Okay. Thank you very much.
Your next question comes from the line of I know some Rama from JP Morgan. Your line is now open.
Hi, guys. This is tough on the call Tonight on upon hope you guys are while a bang for the uptake from taking my questions I'm, just wondering one child Corbin Movielab.
Mark you alluded to this a little bit but on your education I kind of initiative, but crops. We can just to remind us what precommercial activities are currently ongoing.
And then how are you thinking about sort of that size in the scope of the sales force that if needed for an emotional launch here in the U.S. so much.
Sure. Thanks.
For the question, Yes education is very important for truck cycle, so that providers not just oncologists, but practice administrators nurses and pharmacists can understand the impact that myelosuppression has on their practice in small cell lung cancer patients.
Mark: We are particularly excited about the pending FDA review of trialocyclin and the near-term opportunity to bring this breakthrough therapy to patients. Trialocyclin is the first and only therapy with the potential to significantly improve the chemo experience, which is acutely needed by patients who suffer through the immediate and long-term consequences of myelosuppression. We need to do better for these patients. We believe that Trial Cyclibs offers patients and physicians a solution that they have been lacking for far too long. That concludes our prepared remarks. Operator, please open the call.
Well T trial of cycling a.
We have a.
Field Force, a medical science liaison educating again, both oncologists and nurses.
And others at these large centers, where you see a lot of small cell lung cancer.
Specially in the southeast and southwest.
We know these providers new sites very well many of them enroll patients in our three small cell lung cancer studies.
We believe this this is a lift we can do on our along with the Salesforce that so less than 50 people.
Great and then so much for taking my question.
[laughter].
Your next question comes from the line of Chris Shibutani from Cowen. Your line is now open.
Thank you very much good afternoon, thanks for the questions.
Try low and thinking about other indications in particular for colon, you've talked about how you're going to be doing additional work can you confirm that you've had discussions that assure you in terms of what exactly needs to happen for instance in indications like coal and to continue to further.
Operator: Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question comes from the line of Dane Leone from Raymond James. Please ask your question.
Expand the label, particularly in terms of.
Trial size, and what sort of accumulated a data point, you'll need in order to be considered by the FDA sufficient to continue to expand two additional opportunities like coal and others that you have your contemplate.
Dane Vincent Leone: Hi, thank you. Congratulations on a very productive 2019 and a great update on 2020. I just had a couple of questions. The first one, could you just kind of provide a little bit more color when you talk about the Clinical Supply Agreement with Pfizer and, you know, to what extent does that play out, you know, is it just for this study or would it be into additional studies or more advanced studies as well?
Yeah, Thanks, Chris I'll, let Rod [laughter] question Raj, Yes, Hi, Chris Yes, So we have plans to meet with with the FDA as well as.
European country authorities to discuss the protocol and.
And gain agreement on the endpoints as you said up for approval in colorectal cancer, including study size and all the critical design parameters. So that will all be agreed to before we start the study later this year.
Mark: Yeah, the current supply agreement is for the current study, which, as we disclosed previously, is about 40 patients.
Mark: Okay, and are there any plans to further discuss that, or is there anything built into that to extend that into a more advanced study, or is it, you know, just this step-by-step?
Got it and then to follow up on rental where I believe you talk about being able to have some.
Initial preliminary data on the fourth quarter of 20, just to be clear will that include any data of retail in combination with palbo at that point.
Mark: Thank you. Yeah
Mark: Okay, great. Um, in terms of Partnerships for Lerocyclibs, what kind of partnership makes sense for your team? Are you looking for partnerships in more of the traditional CDK4-6 development area, or are you looking to be more creative in other areas where a CDK4-6 inhibitor could make sense?
No.
We'll really be additional it would be data on the.
The the coal or that we previously presented which are the dose escalation as well as the expansion cohort. So in total approximately 65 patients worth of data from a from that portion of the study.
Great. Thank you very much.
Your next question comes from the line of Tom Shrader from BTI Ji. Please ask your question.
Mark: I think both. We're certainly looking outside the U.S. in kind of the traditional 4-6 space, i.e., breast cancer, but also acknowledging that 4-6 could play a role in other tumor types, so I think it's fair to say we're exploring both.
Good afternoon. Thanks for taking the question its kind of remedial question on ice by so you have three different types of breast cancer. It sounds like for treatment arms are they all mixed for some size cohorts and then cohorts graduate is it still work that way and the real question is what's the most data you could get in any.
Mark: Okay, and then just finally on Trilocyclib, you know, late last year you talked about partnerships with that program, and it seems to be alluding that you would like to retain full rights in the U.S. here and explore a partnership outside the U.S., giving you a file or your plan to file in the fourth quarter with the EMA. When are you still guiding for a partnership on TriathleteClub during 2020, or has that changed?
Cancer treatment line combination at the end of this trial is it enough to considered to be considered an accelerated package.
Tom I'll, Yeah. So I spy is a it's a platform trial with the goal of bringing a novel agents that can improve the efficacy.
Mark: So we do have time to explore partnership opportunities outside the US. As you alluded, we are going to file the MAA in the fourth quarter. There's an 18-month clock on approval, so we do have time to make sure we're doing the right deal, in the best interest of Sheldon.
The backbone chemotherapy.
And the way it's set up is patients are enrolled into.
Ah, yes, our positive her two positive as well as triple negative setting. In addition, there will some other biomarkers that are that are part of that stratification.
This is an adaptive design.
And so the data is continuously evaluated.
Dane Vincent Leone: Okay, thank you very much.
As each arm as patients compete chemotherapy half surgery, and then an evaluation has made about whether that was pathological complete response within their respective specimen.
Operator: Your next question comes from the line of Anupam Rama from J.P. Morgan. Your line is now open. Hi, guys. This is Tessa on the call tonight for Anupam.
Then.
Since the endpoint as Pat CR rates.
There is a comparison to the control arm and this adaptive type of design is what it results in a predictive probability and the graduation probability that ice five has as stated as that if a experimental arm has a predictive problem.
Anupam Rama: Hope you guys are well, and thanks for the updates and taking our questions. Just one for me on Trilethic Web in the US. Mark, you alluded to this a little bit, but on your education kind of initiative. But perhaps you could just remind us what pre-commercial activities are currently ongoing. And then how are you thinking about the sort of size and the scope of the sales force that is needed for an initial launch here in the US?
As many of 85%, Ohio that it would succeed against that same Rs into phase three that armed and graduates. So so that's what happened for example, with Keytruda, which then.
Look forward into that keynote five to two study in the Neoadjuvant setting and TMB C, which resulted in a positive study.
Mark: Thanks so much.
Mark: Sure, thanks, Tessa, for the question. Yeah, education is very important for trotsychists so that providers, not just oncologists, but practice administrators, nurses, and pharmacists can understand the impact that myelosuppression has on their practice in small cell lung cancer and anonymity of Trial of Psych. We have a field force of medical science liaisons educating, again, both oncologists and nurses, and others at these large centers where you see a lot of small cell lung cancer, especially in the southeast and the southwest. We know these providers and these sites very well. Many of them have enrolled patients in our three small cell lung cancer studies. So we believe that this is a list we can do on our own with a sales force of less than 50 people.
So it's really a very it's a very good way of assessing.
The where to focus a phase three with the highest probability of success. It is a phase two study. So this will so these data will not be sufficient for registration.
But so graduation is a blend of cohorts size and treatment effect, it's a profitability correct correct and the way. The way works is if there are certain arms that don't have enough activity there shutdown.
When patients are enrolled to those arms with activity is C and that's that internal adoptive portion of the design.
Alright, great. Thank you very much.
Your next question comes from the line of Chad and that's true from Needham <unk> co. Please ask your question.
Great. Thanks, Thanks, Good evening, and let me add my congratulations on a on a great 20 or 18 for for Big though is we get now into the combination studies, which is where we've always wanted to be can can you discuss what you think the the sort of efficacy bar is there.
Mark: Great. Thanks so much for taking our questions. Your next question comes from the line of Chris Shibutani from Cohen. Your line is now open.
Operator: Thank you very much. Good afternoon. Thanks for the questions.
Chris Shibutani: And thinking about other indications, in particular for the colon, you've talked about how you're going to be doing additional work.
Sure I mean, just kinda for oral surgeon general.
Operator: Thank you all for joining us today. Trial size and what sort of accumulated data points you'll need in order to be considered by the FDA sufficient to continue to expand to additional opportunities like colon and others that you're contemplating.
I think in combination Chad.
It's mark here in combination since we are now doing a study with outside but you can think of pull on the three that's a reasonable bar.
Yeah that was with while the strength and our view is that efficacy equivalent to fold the strength.
It's sufficient because the real benefit to patients we believe with an oral surgeons in the gadgets setting.
Raj: Yeah, thanks, Chris. I'll let Raj take that question. Raj?
So good tolerability good safety.
Raj: Yeah, hi Chris. Yeah, so we have plans to meet with the FDA as well as some European country authorities to discuss the protocol and gain agreement on the endpoints, as you said, for approval in colorectal cancer, including study size and, you know, all of the critical design parameters. So that will all be agreed to before we start the study later this year.
Is critical therefore on the AD setting as well with with efficacy that's equivalent to pull the strike. So I think plummet three is a reasonable benchmark for this this is 40 patients that were enrolling.
Palestine.
Okay, Great and then for for trial, a I know you talked about having a lot of preclinical data with my that you are not being big part of the rationale for colorectal, but can you just kind of go through digging tox profile of five a few maybe comparing contrast, it a little bit with the with the too.
Chris Shibutani: And then to follow up on Rinto, where I believe you talk about being able to have some.
Latin regiments and small cell is it are different.
Raj: Initial preliminary data on the fourth quarter of 2020, just to be clear; will that include any data on Rinto in combination with Paldo at that point?
Yes.
Turning to similarities or differences between the between the heme talks.
Raj: Now, it will really be additional data, it will be data on the cohort that we previously presented, which was the dose escalation, as well as the expansion cohort. So in total, you know, approximately 65 patients' worth of data from that portion of the study. Great.
Yes, so the restaurant that we'll be using is.
Actually a combination between five that you know saleem flatten and Reno T. can so it is it's a combination regimen called FOLFOX Erie and D. A the molla toxicity of this regimen.
As you know I would say how would equate it to the first line small cell lung cancer type of toxicity.
Chris Shibutani: Thank you very much.
The top a t. can you talk site carbo happy.
Operator: Your next question comes from the line of Tom Schrader from VTIG. Please ask your question. Good afternoon.
Jim and in first line.
So, but you got in second third line is much more Thompson.
Alright, great. Thank you.
Tom Schrader: Thanks for taking the question. It's kind of a remedial question on iSpy. So you have three different types of breast cancer. It sounds like four treatment arms. Are they all mixed for some size cohorts, and then do cohorts graduate? Does it still work that way? And the real question is, what's the most data you could get on any cancer treatment line combination at the end of this trial? And is it enough to be considered an accelerated package?
Again, ladies and gentlemen, if you have a question at this time. Please press Star then the number one our yard telephone keypad.
There are no further questions at this time I will not trying to call over back to Dr. Mark can fill that go for his closing remarks.
Thank you operator that concludes the call. Please reach out to us with any questions. As a reminder, we will be at the Cowen Raymond James and Barclays conferences in the coming weeks, we look forward to seeing many of you at times meeting thanks for joining us and have a good evening.
Raj: I-SPY is a platform trial with the goal of bringing in novel agents that can improve the efficacy of Backbone Chemotherapy. And the way it's set up is that patients are enrolled.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful or pay you may all disconnect.
Raj: the ER positive, HER2 positive, as well as triple negative setting. In addition, there are some other biomarkers that are part of that stratification.
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Raj: This is an adaptive design, and so the data is continuously evaluated as each arm, as patients complete chemotherapy, and have surgery, and then an evaluation is made about whether there was a pathological complete response within the rejected specimen. Then, since the endpoint is the pathological CR rate, there is a comparison to the control arm, and this adaptive type of design is what results in a predictive probability. And the graduation probability that I-SPY has stated is that if an experimental arm has a predictive probability of 85 percent or higher that it would succeed against that same arm in phase three, that arm then graduates. So that's what happened, for example, with Keytruda, which then Merck took forward into their Keynote 522 study in the neoadjuvant setting in TMBC, which resulted in a positive study. So it's really a very good way of assessing where to focus phase three with the highest probability of success. It is a phase two study, so these data will not be sufficient for registration.
Raj: So graduation is a blend of cohort size and treatment effect; it's a probability.
Raj: Correct, and the way it works is if there are certain arms that don't have enough activity, they're shut down, and patients are enrolled in those arms where the activity is not. And that's that internal adaptive portion of the design.
Mm Hmm.
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Operator: All right, great. Thank you very much. Your next question comes from the line of Chad Messer from Needham & Co. Please ask your question.
Chad Messer: Great. Thanks. Thanks. Good evening. And let me add my congratulations on a great 2019. For Rinto, as we get now into combination studies. Um, you know where we've always wanted to be.
Chad Messer: Can you discuss what you think the sort of efficacy bar is there for, I mean, just kind of for oral surge in general?
Mark: I think in combination, Chad, it's Mark here, in combination, since we are now doing a study with albiciclis, you can think of Paloma3 as a reasonable bar. Yeah, that was with Fulvastrin. And our view is that efficacy equivalent to Fulvastrin is sufficient because the real benefit to patients, we believe with an oral CERT, is in the adjuvant setting. So good tolerability, and good safety are critical, therefore, in the adjuvant setting as well, with efficacy that's equivalent to Fulvastrin. So I think Pelluma-3 is a reasonable benchmark for these 40 patients that we're enrolling with Pellicycline.
Chad Messer: Okay, all right, and then for Trila, I know you talked about having a lot of preclinical data with 5-FU and that being a big part of the rationale for colorectal, but can you just kind of go through the heme-tox profile of 5-FU, maybe compare it, and contrast it a little bit with the two platinum regimens in small cell? Are there different, are there similarities and or differences between the hem
Raj: Yeah, so the regimen that we'll be using is actually a combination between 5-FU and Oxaliplatin and Irinotecan. So it is a combination regimen called Full Fox Erie. And the myelotoxicity of this regimen is, you know, I would say I would equate it to the first-line small cell lung cancer type of toxicity. You know, Topatecan, i.e. The Etoposide Carboplatin regimen in first line. Topatikan and 2nd and 3rd line is much more toxic.
[laughter].
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Raj: All right, great. Thank you. Again, ladies and gentlemen, if you have a question at this time, please press star then the number one on your telephone keypad. There are no further questions at this time. I will now turn the call over back to Dr. Mark Zaleka for his closing remarks.
Mark: Thank you, operator. That concludes the call.
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Mark: Please reach out to us with any questions. As a reminder, we will be at the Cowan, Raymond James, and Barclays Conferences in the coming weeks. We look forward to seeing many of you at those meetings. Thanks for joining us, and have a good evening.
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Operator: Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.
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