Q3 2020 G1 Therapeutics Inc Earnings Call

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Ladies and gentlemen, thank you for standing by and welcome to the June One Therapeutics Threeq you had 2020 <unk> financial results Conference call. At this time, all participants are in a listen only mode.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the G1 Therapeutics 3Q2020 Financial Results Confirmation. At this time, all participants are either in a listen-only mode or in a question-and-answer session. If you would like to ask a question, you will need to press star 1 on your telephone. If you require any further assistance, please press star zero.

After the speaker's presentation, there will be a question and answer session to ask a question you will need to press star one on your telephone keypad if.

If you require any further assistance please press star zero I.

Operator: Thank you all. Good afternoon, everyone, and welcome to the G1 Therapeutics 3rd Quarter 2020 Corporate Financial Update. Joining me today are Mark Bilecka, Chief Executive Officer; Raj Malik, Chief Medical Officer and Senior Vice President, R&D; Soma Gupta, Chief Commercial Officer; and Jen Moses, Chief Financial Officer.

I would now like to hand, the conference over to your first speaker for today, the head of Investor Relations Mr., Jeff Mcdonald's. Please go ahead, Sir thank you.

Thank you operator.

And everyone and welcome to the G., one therapeutics third quarter 2020, corporate financial update joining me today are Mark Black Chief Executive Officer, Robert Molly Chief Medical Officer, and senior Vice President R&D somewhat good Chief commercial officer, and Jeff noted as Chief Financial Officer I'm also pleased to welcome Jack Daily with previously announced.

Mark Velleca: I'm also pleased to welcome Jack Bailey, who, as previously announced, will succeed Dr. Volekka as Chief Executive Officer, effective January 1, 2021. On today's call, the team will provide an overview of the quarter with Q&A to follow. Before we begin, I'd 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... The Bulletproof Executive 2013, For more information, please visit www. FEMA.gov. I'll turn the call over to them.

Dr. Miller, Chief Executive Officer effective January one 2021.

All the team will provide an overview of the quarter accumulated Paula.

Before we begin I would like to remind you that this call will include forward looking statements based on current expectations.

Such statements represent managements judgment as of today and may involve risks and uncertainties.

Cause actual results to differ materially from expected results.

I refer to our filings with the FTC, which are available from the FCC more on our port website.

Question concerning risk factors that could affect the company.

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

Jeff: Thanks, Jeff. Good afternoon, everyone, and thank you for joining us. We hope that you and your families are well. On our second quarter call, we highlighted that the financing and partnering agreements we executed this year would enable us to focus squarely on maximizing the potential of trials to benefit people with cancer across a range of indicators. On today's call, the team will review our progress across regulatory, development, and commercial initiatives. We will also discuss Rinta Destrant and review the financials for the quarter. After our prepared remarks, we'll open the call for questions. Let me start by commenting on the company's CEO trend. When I joined G1 in 2014, our long-term objectives were clear: advance the trial of CYCLIP from the lab to the clinic, develop a regulatory strategy for approval, build out the medical and commercial functions needed to support patient access to the trial, and solidify the balance sheet in order to sustain ongoing operations.

Thanks, Jeff Good afternoon, everyone and thank you for joining US we hope that you and your families are well.

On our second quarter call, we highlighted that the financing and partnering agreements. We executed this year would enable us to focus squarely on maximizing the potential of trial, a cyclic to benefit people with cancer across a range of indications.

On today's call the team will review, our progress across regulatory development and commercial initiatives for trial of cycling.

We will also discuss rent a debt strategy and review the financials for the quarter.

After our prepared remarks, we'll open the call for questions.

Let me start by commenting on the company's CEO transition.

When I joined you want in 2014, our long term objectives were clear.

Advanced trial, a cyclic from the lab to the clinic device.

Develop a regulatory strategy for approval.

Build out the medical and commercial functions needed to support patient access to trial, a cyclic and.

And solidify the balance sheet in order to sustain ongoing operations.

Over the course of the past six plus years I've had the privilege to work with an extremely talented team that accomplished all of those goals.

Jeff: Over the course of the past six plus years, I've had the privilege of working with an extremely talented team that accomplishes all of those goals. I believe that now is the right time for the company and for me personally to make a leadership transition. With a thoughtful succession plan in place, I worked closely with the rest of the Board of Directors on the selection and transition process.

I believe that now is the right time for the company and for me personally to make a leadership transition.

With a thoughtful succession plan in place I worked closely with the rest of the board of directors on selection and transition process.

We were fortunate to have a highly capable leader on the GE, one board ready to assume the CEO role Jack.

Mark Velleca: We are fortunate to have a highly capable leader on the G1 board ready to assume the CEO role. Jack Bailey is an ideal fit to lead G1 as we evolve to a commercial stage. In his previous role as president of GSK's pharmaceutical and vaccine business in the U.S., he oversaw multiple successful product launches and had extensive involvement in R&D planning and... Jack joined the G1 board earlier this year as we were refining the blueprint for the launch of the trial cycle, has already been providing valuable input into our strategic planning, and is familiar with Just as importantly, having known Jack for more than five years and working with him during his tenure on the board, and an excellent culture.

Jack Bailey is an ideal fit to lead Gi one as we evolve to a commercial stage company.

In his previous role as president of Gs case, pharmaceutical and vaccine business in the U.S. He.

He oversaw multiple successful product launches and had extensive involvement in R&D planning and execution.

Jack joined the G. One board earlier this year as we were refining the blueprint for the launch of trial a cyclic.

And has already been providing valuable input and our strategic planning and as familiar with the entire organization.

Just as importantly, having known Jack for more than five years and working with him. During his tenure on the board. He has an excellent cultural fit.

Mark Velleca: The CEO transition has been going very smoothly, and I'm excited to support G1 as a board member and senior advisor going forward. This will be my last earnings call as the CEO of G1, so I'd like to thank all of our shareholders, past and present, who have supported G1. We shared our vision for trialacyclib's potential to improve outcomes for patients receiving chemotherapy with our current and future shareholders. I am confident that you'll find Jack to be a superb leader and steward of that.

The CEO transition has been going very smoothly and I'm excited to support G., one as a board member and senior advisor going forward.

This will be my last earnings call as the CEO of Q1, so I'd like to thank all of our shareholders past and present, who have supported Chyone and shared our vision for trial, a site clips potential to improve outcomes for patients receiving chemotherapy.

And to our current and future shareholders I am confident that you'll find Jack to be a superb leader and Stewart of that vision.

Mark Velleca: With that, I want to turn the call over to our incoming CEO, Jack. Thanks, Mark. I appreciate the introduction. Good afternoon, everyone.

With that I want to turn the call over to our incoming CEO Jack Bailey.

Thanks, Mark I appreciate the introduction good afternoon, everyone. Just start I would like to thank Mark and the rest of the board of directors for this opportunity and the confidence to.

John E. Bailey: To start, I'd like to thank Mark and the rest of the Board of Directors for this opportunity and their confidence in me to lead this great company as we bring trial-of-sight to patients and make it the standard of care in cancer treatment. To my G1 colleagues, as a board member, I've been impressed with your dedication to patients and determination to rapidly advance new therapies, and I'm excited to collaborate with you more closely on the execution of that work. And finally, to members of the investment community, I look forward to sharing our progress with you as we approach the potential approval and launch of TrilocyteLib and continue to advance our development program. Now, as Mark noted, I spent most of my career in commercial roles.

To lead this great company.

Try to fight with the patients to make up the speaker to cure cancer treatment.

My two one colleagues as a board member I've been impressed with your dedication to patients and determination to rapidly therapies.

Finally to collaborate with you more closely on the execution of that work.

And finally to the members of the investment community.

Look forward to sharing our progress with you as we approach the potential approval and launch of trying to fight.

Tim you to advance our development program.

Now as Mark noted I've spent most of my career in commercial roles. Prior to joining Q1 I was president of Glaxosmithklines pharmaceutical and vaccine business in the us.

During that time, we launched a number of innovative market disrupting drugs, which is very relevant so just ready to launch try to fight.

Products like not to lose about persevered, Susan Filyk asthma.

Hey in oncology, both representative step changes in innovation and clinical treatment paradigms much like trauma cyclical.

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

And frankly, that's what really energized about you won't but the capex will try the cyclic to truly transform the chemotherapy experience.

John E. Bailey: Prior to joining G1, I was president of GlaxoSmithKline's pharmaceutical and vaccine business in the U.S. During that time, we launched a number of innovative, market-disrupting drugs, which is very relevant as we get ready to launch Tribal Fight. Products like Methiluzumab for severe synophilic asthma and BCMA in oncology both represented step changes in innovation and clinical treatment paradigms, much like tri In addition, I served for many years on GSK's investment committees for the allocation of the company's R&D budget, so ensuring the resourcing and execution of robust development plans is something I'm familiar with and recognize the criticality of.

This is why I started in life science industry, nearly 30 years ago to bring this type of innovation to patients.

Starting to get to work and help make that a reality for patients.

Now turning to progress in the third quarter. The headline was the FDA acceptance of our trial. This hike with new drug application, which was assigned to priority review and putting action date of February 15 to 2021.

From a cyclic received breakthrough therapy designation in 2019, so our planning assumptions have been predicated on a high likelihood of receiving priority review and potential approval in the first quarter of 2021.

Medical and commercial teams are continuing their work in anticipation of commercial availability in Q1 2021 and later in this call Roger that some will provide more color around the strategies and initiatives, but their respective teams are working.

We are excited to be excited about the near term opportunity to previous therapy to small cell lung cancer.

Which has the potential to dramatically improve the chemotherapy experience for these patients.

It's not the only group that may benefit from private side.

We are committed to a balanced evaluating trial the cyclist across multiple solid tumors and different chemotherapy regimens.

To that end, we expect to enroll the first patient in our phase three metastatic colorectal cancer trial this quarter and anticipate data from that trial will read out in 2023.

John E. Bailey: And frankly, that's what really energizes me about G1, the potential of trilocyclic acid to truly transform the chemotherapy experience. This is why I started in the life science industry nearly 30 years ago to bring this type of innovation to patients. Now turning to progress in the third quarter, the headline was the FDA's acceptance of our trilocyclic new drug application, which was assigned to priority review and the PDUFA action date of February 15, 2021. Trial and Cycle received breakthrough therapy designation in 2019, so our planning assumptions have been predicated on a high likelihood of receiving priority review and a potential approval in the first quarter of 2021. Our medical and commercial teams are continuing their work in anticipation of commercial availability in Q1 2021. And later in this call, Raj and Soma will both provide more color around the strategies and initiatives that their respective teams are working on.

The findings of this trial will support the supplemental NDA filing to the FDA to expand the trial sites live label to include patients with CRC.

Raj will provide more detail on that trial in just a minute.

The 2021, we are planning to initiate the registrational trial in metastatic triple negative breast cancer with the survival primary endpoint.

We are also committed to evaluating you try to fight clips benefit yes.

Other tumors said would further expand the number of patients who would be eligible for treatment.

Now turning to the development of our oral surgeon rental industry and we have completed recruitment for the arm of our phase one two trial that will evaluate when rebooked restaurant in combination with the CDK four six inhibitor palbociclib.

There was significant investigator interest in this trial and we were able to accelerate our recruitment of timeline by several months. Despite the challenges that COVID-19, that's presented to clinical trial enrollment.

Now before I turn the call over to Raj I wanted to make a brief comment on our operations relative to the COVID-19 pandemic.

As I've noted, we did not see the impact on recruitment for the rest of the restaurant trial.

We monitor enrollment in all active trials to try to determine if COVID-19 is having an impact on recruitment times.

We'll report any material delays.

John E. Bailey: We are excited about the near-term opportunity to bring this therapy to small cell lung cancer communities, which has the potential to dramatically improve the chemotherapy experience for these patients. But that is not the only group that may benefit from tricycline. We are committed to evaluating tricycline across multiple solid tumors and different chemotherapy regimens. To that end, we expect to enroll the first patient in our Phase 3 metastatic colorectal cancer trial this quarter and anticipate data from that trial will read out in 2023. Positive findings in this trial would support a supplemental NDA filing to the FDA to expand the trial cycle of the label to include patients with CRC. Raj will provide more detail on that trial in just a minute.

We have adequate commercial and clinical trial supplies try what cyclists to meet expected demand in 2021, as well as manufacturing and production contingency plans in place to reduce the risk of any future supply issues.

Later on the call somebody will discuss our approach to the commercial launch of trying to cycling in the context of the current environment.

Now I'll turn the call over to Raj just shared the regulatory and clinical update for both try the cyclic and rental industry Raj.

Thanks, Jack and good afternoon, everyone ill.

Ill start with the child a cyclist ending.

As Jack noted received priority review and a PDUFA action date of February 15 2021.

We continue to have a constructive dialogue with the FDA and to date, we have not seen any impact from COVID-19 on the agency's normal review process and timelines.

Given its multi lineage benefit Tata science that has the potential to become a standard of care for patients with small cell lung cancer.

We believe toddler cyclist will deliver the most benefit to patients. If it is used the first time and every time chemo is given beginning in first line treatment.

Protecting the bone marrow could not only improve patient outcomes in first line, but could also be an important when moving into additional lines of therapy.

John E. Bailey: In 2021, we are planning to initiate a registrational trial in metastatic triple-negative breast cancer with a survival primary endowment. We are also committed to evaluating Charlotte Cyclab's benefit in other tumors, which would further expand the number of patients who would be eligible for treatment. Now turning to the development of our oral CERD rinthodestrin, we have completed recruitment for the arm of our Phase 1-2 trial that will evaluate rinthodestrin in combination with the CDK4-6 inhibitor albocyclin. There was significant investigator interest in this trial, and we were able to accelerate our recruitment timeline by several months, despite the challenges that COVID-19 has presented for clinical trial enrollment. Now, before I turn the call over to Raj, I want to make a brief comment on our operations relative to the COVID-19 pandemic. As I've noted, we did not see an impact on recruitment for the RENT-O-Destrin trial.

The largest number of patients receiving chemotherapy, our small cell lung cancer is for the first line treatment of extensive stage disease and nearly all of these patients receive any top aside and platinum based regimen, which is the regimen used in our two first line trials.

In preparation for approval our medical affairs team is focused on three key initiatives.

Our first initiative is the NCCN guidelines.

Inclusion and treatment guidelines is critical to adoption in clinical practice.

We have notified both the small cell lung cancer and hematopoietic growth factors guideline committees regarding our PDUFA date and have provided data on trial the site.

Immediately following approval a formal request will be submitted to NCCN, including the FDA approved package insert to evaluate Charles site lift for inclusion in those guidelines.

Our second initiative is scientific discourse we.

We have a robust publication and presentation plan to support medical education and this week, our second third line data on China sites live in small cell lung cancer was published.

Last month, we presented new analyses off our small cell lung cancer data at the North American Congress on lung cancer, and we have several 90 scripts and review that we anticipate will be published this year and next ranging from analysis of our randomized clinical trial data to patient reported outcomes and health economic outcomes.

John E. Bailey: We monitor enrollment in all active trials to determine if COVID-19 is having an impact on recruitment timelines, and will report any material delay. We have adequate commercial and clinical trial supply of tricyclic to meet expected demand in 2021, as well as manufacturing and production contingency plans in place to reduce the risk of any future supply issues. Later in the call, Soma will discuss our approach to the commercial launch of Trilocycline in the context of the current environment. Now, I'll turn the call over to Raj to share the regulatory and clinical updates for both trilocyclib and rentodestrin. Raj?

Research.

We'll submit additional analyses on trial, a cyclic presentations at medical conferences throughout 2021.

Our third initiative is outreach to K 12, and health care professionals, our team of field based medical science liaisons, our MSR sales are having regular engagements with academic AOL and community oncologists as well as pharmacists and nurses to better understand their approach to managing myelosuppression.

And and the gaps in patient care that they are most concerned with.

In parallel we will work on small cell lung cancer, we are advancing a robust development plan.

The next indication we are evaluating is metastatic colorectal cancer.

The majority of patients with metastatic colorectal cancer receive a five a few based chemotherapy combination as first line treatment and the most effective chemotherapy combination FOLFOX Erie is extremely myelosuppressive, particularly with regard to neutropenia.

We completed a pre phase three meeting with the FDA earlier this year and have incorporated that feedback into the trial protocol.

Rajesh K. Malik: Thanks, Jack, and good afternoon, everyone. I'll start with the trilocyclib NDA. As Jack noted, we received priority review at a PDUFA action date of February 15, 2021. We continue to have a constructive dialogue with the FDA, and to date, we have not seen any impact from COVID-19 on the agency's normal review process and timeline. Given its multilinear benefits, trial-assisted has the potential to become a standard of care for patients with small cell lung cancer. We believe tricyclic will deliver the most benefit to patients if it is used the first time and every time chemo is given, beginning in first-line treatment. Protecting the bone marrow could not only improve patient outcomes in the first line but could also be important when moving into additional lines of therapy. The largest number of patients receiving chemotherapy for small cell lung cancer are for the first-line treatment of extensive stage disease.

We are on track to enroll the first patient in this trial within the next several weeks.

We anticipate enrolling approximately 300 participants and this randomized placebo controlled trial in patients receiving first line treatment for metastatic colorectal cancer.

The trial will follow patients through induction and maintenance faces of treatment with all patients randomized to receive either trial, a cyclic or placebo. In addition to the full Fox Erie chemotherapy regimen.

Patients will be followed in the maintenance phase until the discontinued treatment approach.

The primary outcome measure office trial, as Milo preservation with safety Tolerability patient reported outcomes and survival measures also being assessed.

More details on the trial protocol are available on the clinical trials dotcom website.

We view breast cancer, as an area, where Thomas high set us potential to improve anti tumor efficacy.

Enrollment is ongoing in the I spy two trial with a goal of evaluating the potential for trying to size that to enhance the pathological complete response rate of patients being treated with chemotherapy in the neoadjuvant setting.

Next month, we will present the mature overall survival data from our phase two trial in metastatic triple negative breast cancer at the San Antonio breast cancer Symposium.

As a reminder, initial positive overall survival data were presented at the 2019, ESMO Congress and concurrently published in the lancet oncology.

Rajesh K. Malik: And nearly all of these patients receive an etoposide and platinum-based regimen, which is the regimen used in our two first-line trials. In preparation for approval, our medical affairs team is focused on three key initiatives. Our first initiative is the NCCN Guidelines.

We plan to initiate a registrational trial in metastatic triple negative breast cancer in 2021 animal.

And we'll provide more details on this trial design following the San Antonio data update.

With regard to our oral surgery rental desk trends in.

Rajesh K. Malik: Inclusion in treatment guidelines is critical to adoption in clinical practice. We have notified both the Small Cell Lung Cancer and Hematopoietic Growth Factor Guideline Committees regarding our PDUFA date and have provided data on trial of sites. Immediately following approval, a formal request will be submitted to NCCN, including the FDA-approved package insert, to evaluate tricyclic for inclusion in those guidelines. Our second initiative is Scientific Discourse.

In October we completed enrollment of 40 patients in the additional arm of our phase one two trial evaluating a combination of rental bestride and the CDK four six inhibitor polycyclic commercially known as Ibrance.

I'd like to point out that based on investigator enthusiasm and the dedicated work of our clinical operations team, we were able to accelerate recruitment and complete enrollment in approximately three months.

Because we were able to complete enrollment ahead of schedule. We now anticipate presenting initial safety tolerability and efficacy data, including clinical benefit rate at 24 weeks or CVR 24 in the second quarter of 2021.

The monotherapy arm of this trial was fully enrolled last year and we are presenting updated safety and efficacy data from all 67 patients at the upcoming San Antonio breast cancer Symposium.

Rajesh K. Malik: We have a robust publication and presentation plan to support medical education, and this week, our second third-line data on trialocyclic and small cell lung cancer was published. Last month, we presented new analyses of our small cell lung cancer data at the North American Congress on Lung Cancer, and we have several manuscripts in review that we anticipate will be published this year and next, ranging from analyses of our randomized clinical trial data to patient-reported outcomes and health economic outcomes research. We'll submit additional analyses on Trial-A-Cyclic for presentations at medical conferences throughout 2021. Our third initiative is Outreach to KOLs and Healthcare Professors. Our team of field-based medical science liaisons, or MSLs, are having regular engagements with academic KOLs and community oncologists, as well as pharmacists and nurses, to better understand their approach to managing myelosuppression and the gaps in patient care that they are most concerned with. In parallel to our work on small cell lung cancer, we are advancing a robust development plan. The next indication we are evaluating is metastatic colorectal cancer. The majority of patients with metastatic colorectal cancer receive a 5-FU-based chemotherapy combination as first-line treatment, and the most effective chemotherapy combination, Full Fox-ERI, is extremely myelosuppressive, particularly with regard to neutropenia.

I will now turn the call over to Silva Selma.

Thanks Bryce.

Well Jack Good Mark mentioned this is an exciting time as we prepare the launch travel cycling in the first of what we expect will be multiple indications. We have completed building a strong commercial organization that Gee why that is advancing our launch strategy for trial in small cell lung cancer patients and we are excited to be working with Boehringer ingelheim.

Sales team to bring trial with the patients upon approval.

Three critical areas, we are focused on for the launch our first disease state education, highlighting impacted miles suppression on patients and the healthcare system.

Second ensuring we have the best team in place to successfully introduce the valley it looks like but to physicians and patients.

Third ensuring broad and simple access to trials like that that's part of our launch preparations we conducted a significant amount of market research as well as advisory boards with oncology nurses and pharmacists. We recently completed a quantitative survey of about 250 oncologists in order to better understand the unmet.

Need for patients we found that over 90% of oncologists believe chemotherapy induced myelosuppression has a moderate to extremely negative impact on a patient quality of life. In addition, 60% of oncologists surveyed were now more concerned with the consequences of chemo and if miles suppression DDIC over 19.

Then they had been before the pandemic oncologists cited several features that differentiate private cyclic from intervention views to reactively treatment with suppression and represented clear advantages over the current standard of care, including trial is multi lineage mechanism, which prevent damage to the marrow a trial design covering the basket.

Rajesh K. Malik: We completed a pre-phase 3 meeting with the FDA earlier this year and have incorporated their feedback into the trial protocol. We are on track to enroll the first patient in this trial within the next several weeks. We anticipate enrolling approximately 300 participants in this randomized placebo-controlled trial in patients receiving first-line treatment for metastatic colorectal cancer. The trial will follow patients through the induction and maintenance phases of treatment, with all patients randomized to receive either tralicyclic or placebo in addition to the full Fox Theory chemotherapy regimen. Patients will be followed in the maintenance phase until treatment is discontinued. The primary outcome measure of this trial is myelopreservation, with safety, tolerability, patient-reported outcomes, and survival measures also being assessed. More details on the trial protocol are available on the clinicaltrials.gov website. We view breast cancer as an area where trialocyclic has the potential to improve anti-tumor efficacy.

It's already a small cell lung cancer, chemo regimens and its safety and Tolerability profile.

Courage by these findings, which indicate prescribers will be receptive to learning more about private cycle ahead.

Is it safe to therapy, and we will need to change the mindset of healthcare professionals from react the treatment of myelosuppression to proactive care and prevented to do so we're investing heavily in increasing awareness of the impact of chemo induced myelosuppression on the patient experience. This extends not only to the oncologist.

But pharmacist support staff and perhaps most critically to nurses to in many cases have the most extensive contact with patients and see the effects of miles suppressing first hand, we recently launched an online disease State education campaign about mile suppression and are rolling out additional educational programs to key audio.

Answer to CMV and other online vehicles. We're also engage with key professional organizations like the oncology nursing society and patient advocacy groups, such as co two foundation and longevity we.

We also have built a strong commercial organization, which is ready to communicate the value of travel cyclic upon FDA approval. Our team is now fully in place and marketing market access key accounts patient services sales operations and other critical functions are being managed by talented individuals who have been through multiple oncology.

Rajesh K. Malik: Enrollment is ongoing in the I-SPY-2 trial with a goal of evaluating the potential for trialocyclic to enhance the pathological complete response rate for patients being treated with chemotherapy in the neoadjuvant setting. Next month, we will present the mature overall survival data from our Phase 2 trial in metastatic triple negative breast cancer at the San Antonio Breast Cancer Symposium. As a reminder, initial positive overall survival data were presented at the 2019 ESMO Congress and concurrently published in the Lancet Oncology. We plan to initiate a registrational trial in metastatic triple negative breast cancer in 2021, and we'll provide more details on this trial design following the San Antonio data. With regard to our oral CERT, RintoDestrat, in October, we completed enrollment of 40 patients in the additional arm of our Phase 1-2 trial, evaluating a combination of RintoDestrat and the CDK4-6 inhibitor, Palvocyclin, commercially known as IBRAM.

And supportive care launches.

I also want to touch on our sales force collaboration with Boehringer Ingelheim, which we're really excited about having an experienced sales team with existing relationship inline community onboard. This far in advance of watch has been instrumental in our pre launch preparations we had the opportunity to gain alignment a large priority access.

Our team's knowledge as we develop our profiles get input from their sales leadership encore sale selling tools and begin robust disease state screening for the field teams in the closet era. These long term relationships with oncology practices will be especially critical we anticipate the physical access to oncology centers will be limited for.

In the foreseeable future and the sales force as well as our own highly experienced account teams will be able to more easily gain access to customers leveraging virtual channels based on their pre existing relationships. We feel confident based on how the team has been working together that we will be able to cover the approximately 2500.

Rajesh K. Malik: I'd like to point out that, based on investigator enthusiasm and the dedicated work of our clinical operations team, we were able to accelerate recruitment and complete enrollment in approximately three months. Because we were able to complete enrollment ahead of schedule, we now anticipate presenting initial safety, tolerability, and efficacy data, including the clinical benefit rate at 24 weeks, or CBR 24, in the second quarter of 2021. The monotherapy arm of this trial was fully enrolled last year, and we are presenting updated safety and efficacy data from all 67 patients at the upcoming San Antonio Breast Cancer Symposium. I'll now turn the call over to Soma. Soma?

Oh this treaty the majority of small cell lung cancer cases.

Launch well have particular focus on those who see the highest concentration of patients and have potential for early adoption, which is based on criteria such as their use of prophylactic gcs apps indoor a history of early adoption of novel therapy.

Our third area of focus is optimizing the early launch experience, which means making it easy for prescribers off is that staff to have access to trials like that our job is to ensure every passes has a great first experience with this novel treatment, which will lead to expanded use overtime. Our market access team has been busy meeting with.

Priyanka Arun Grover: Thanks, Raj. As both Jack and Mark mentioned, this is an exciting time as we prepare the launch trial of CyClib and the first of what we expect will be multiple indications. We have completed building a strong commercial organization at G1 that is advancing our launch strategy for Trila in small cell lung cancer, and we are excited to be working with Berenger Ingelheim's field sales team to bring Trila to patients upon approval. The three critical areas we are focused on for the launch are first, disease state education, and highlighting the impact of mild suppression on patients and the healthcare system. Second, ensuring we have the best team in place to successfully introduce the value of tablocyclics to physicians and patients, and third, ensuring broad and simple access to trilocytes.

Integrated delivery networks and group purchasing organizations, which are critical to activewear community treatment setting, where we know the vast majority of patients are seen. In addition, we're beginning our pre approval information exchange discussion with payers as well as business discussion with C suite level population based decision makers.

Keith Causey clinics to build upon the extensive feedback we have amassed over the summer to drive our final recommendations on price.

Knowledge, the unmet need we are addressing and we expect the travel segment will be added to formulary over the course of 2021 as parents GNC committees means fire to inclusion in a form of medical policy trials likely would be available by a medical exception, Charles Peco will be a buying they'll product, meaning a practice or a hostile.

Pharmacy will purchase of their advance or receiving reimbursement. So we're planning our support programs with that in mind, our comprehensive support hub will assist office staff and benefits investigation addressing prior authorization requirements and appeal support.

Priyanka Arun Grover: As part of our launch preparations, we have conducted a significant amount of market research, as well as advisory boards with oncology nurses and pharmacists. We recently completed a quantitative survey of about 150 oncologists in order to better understand the unmet need for patients. We found that over 90% of oncologists believed chemotherapy-induced myelosuppression has a moderate to extremely negative impact on a patient's quality of life. In addition, 60% of oncologists surveyed were now more concerned with the consequences of chemo-induced myelosuppression due to COVID-19 than they had been before the pandemic. Oncology cited several features that differentiate trilocyclic from interventions used to reactively treat myelosuppression and represented clear advantages over the current standard of care, including trilo's multilineage mechanism, which prevents damage to the marrow, a trial design covering the vast majority of small cell lung cancer chemotherapeutic agents, and its safety and tolerability profile.

Overall, we're very encouraged by the feedback were receiving from stakeholders about how a cyclic and we're prepared to support the commercial launch as early as the first quarter 2021, and now I'd like to turn the call over to Jack Jack.

Thanks, Selma full financial results for the third quarter of 2020 are available in our press release and 10-Q today I'd like to focus on a few key points from our disclosures we've.

We recognized license revenues of 26.6 million for the third quarter of 2020.

Revenue was primarily driven by the upfront payment of 20 million and 6 million from each Rx engine or respectively.

We expect to recognize revenue related to our sincere partnership in the fourth quarter of 2020.

As of September Thirtyth 2020, we had 238.3 million in cash and cash equivalents on the balance sheet compared to 269.2 million as of December 30, Onest 2019.

This total includes an initial 20 million drawdown from our Hercules financing an upfront cash proceeds from our agreements with each of our assets dinnerware and sincere.

We are updating our 2020 cash guidance to finishing the year with between 200 and 205 million up from our previous guidance of 185 to 200 million.

The primary driver for updating guidance is more clarity unexpected commercial expenses, which takes into consideration the cost effective nature of our agreement with the Guy.

Large additional savings and cash inflows, we expect to realize from our Outlicensing alaris nightclub and related interim supply agreement with Genworth and each of our actions.

Priyanka Arun Grover: We're encouraged by these findings, which indicate prescribers will be receptive to learning more about trilocyclic. Trial and cycle is a disruptive therapy, and we will need to change the mindset of healthcare professionals from reactive treatment of myelosuppression to proactive care to prevent it. To do so, we're investing heavily in increasing awareness of the impact of chemo-induced myelosuppression on the patient experience. This extends not only to the oncologist but pharmacists, support staff, and perhaps most critically to nurses, who in many cases have the most extensive contact with patients and see the effects of mild suppression firsthand. We recently launched an online disease state education campaign about myelosuppression and are rolling out additional educational programs to key audiences through CME and other online vehicles.

As previously disclosed we expect our current cash to support operations into 2020 to.

When contemplating cash runway into 2022, we include licensing and collaboration payments, we have received to date and our debt drawdown of 20 million.

Also accounting for all anticipated trailer cycle at launch expenses and expenses related to our development program.

Our guidance on cash runway does not consider any additional proceeds from current agreements that includes additional milestone payment cost reimbursement or other inflows of capital that we may realize or revenue that we may generate from the sales of trial look like but beginning in 2021.

Furthermore, our guidance does not reflect our ability to draw down additional capital from the Hercules facility, we have in place.

All of these items will further extend our cash runway beyond the guidance given today I'll now turn the call back to Jack Jack Thank you Jim.

Our highest priority is to be trying to strike was available to patients as quickly as possible.

We are excited about the potential to deliver this much needed therapy to small cell lung cancer patients as early as the first quarter of 2021 and are focused on executing a successful commercial launch next year there's.

Theres commercial effort complements the work of our medical team there.

We're doing on scientific discourse in education.

The initial indication in small cell lung cancer will provide the opportunity for health care professionals to gain experience with tremendous likely.

First hand, how it can benefit their patients laying the foundation for uptick in future.

With patent runway into the mid 20, Thirtys robust development plan that will generate data in additional tumor types over the next 24 to 36 months, we have the opportunity to significantly expand the use of trying to fight with for the benefit of patients and at the same time creates value for shareholders.

Priyanka Arun Grover: We are also engaged with key professional organizations like the Oncology Nursing Society and patient advocacy groups such as GoToFoundation and Longevity. We have also built a strong commercial organization that is ready to communicate the value of trilocyclic upon FDA approval. Our team is now fully in place, and marketing, market access, key accounts, patient services, sales operations, and other critical functions are being managed by talented individuals who have been through multiple oncology and supportive care launches. I also want to touch on our Salesforce collaboration with Beringer Ingelheim, which we are really excited about.

For their conviction in Mr.

We continue to view, our all serve rental industry has the potential best in class therapy, and expect to disclose rutile publicize with combination data in the second quarter of 2021.

Now before we go into Q1, I think I do want to take a moment to recognize all the health care professionals and front line workers, who are continuing to provide the central services.

Particular is our teams have been working with members of the oncology community. We have gained an even deeper appreciation for those that are focused on the health of our families friends and neighbors.

Concludes our prepared remarks, operator, please open the line for questions.

Thank you Mr. Mcdonald, ladies and gentlemen, if you would like to register a question. Please press the star followed by the number one on your telephone keypad.

Priyanka Arun Grover: Bringing an experienced sales team with existing relationships in the lung community on board this far in advance of launch has been instrumental in our pre-launch preparations. We've had the opportunity to gain alignment on launch priorities, access their team's knowledge as we develop account profiles, get input from their sales leadership on core selling tools, and begin robust disease state training for the field team. In the COVID era, VR's long-term relationships with oncology practices will be especially critical.

If your question has been answered and you would like to withdraw your registration.

Please press the pound.

Please stand by while we compile the culinary roster.

Our first question is from the line of no Palm Rama of JP Morgan. Your line is now open.

Hi, guys. Thanks, so much for taking the question.

Two quick ones from me first for Rindo distress at San Antonio in December what specific analyses would you point us to and what's kind of like in your mind a win scenario there and then second question.

Priyanka Arun Grover: We anticipate that physical access to oncology centers will be limited for the foreseeable future, and the VI Salesforce, as well as our own highly experienced account team, will be able to more easily gain access to customers leveraging virtual channels based on their pre-existing relationships. We feel confident, based on how the team has been working together, that we will be able to cover the approximately 2,500 oncologists treating the majority of small cell lung cancer cases. At launch, we'll have particular focus on those who see the highest concentration of patients and have potential for early adoption, which is based on criteria such as their use of prophylactic GCSF and or a history of early adoption of novel therapies. Our third area of focus is optimizing the early launch experience, which means making it easy for prescribers and office staff to have access to trial cyclin.

Just thinking about the any the north American lung cancer meeting you are recently out and and the trial is cyclical uptick there like how would you characterize kind of the awareness of the drug.

At the meeting and where are you on sort of physical physician.

When it's and medical awareness of the drug relative to your internal expectations. Thanks, so much.

Sure Im going to have a rough split the first one.

And until we do.

Yes.

[music].

So the data presented at San Antonio will be monotherapy data from the dose escalation as well as the expansion and we expanded at two different dose levels and picked the recommended dose that way then.

Forward and the pelvis sites of combination.

So it'll be additional safety and efficacy data showing a safety.

The safety profile that continues to look very competitive and evidence of activity in heavily pretreated patient populations.

And yes, we're very excited about the combination with Palbo cycling that those 40 patients enrolled very quickly.

Priyanka Arun Grover: Our job is to ensure every practice has a great first experience with this novel treatment, which will lead to expanded use over time. Our market access team has been busy meeting with integrated delivery networks and group purchasing organizations, which are critical to access in a community treatment setting where we know the vast majority of patients are seen. In addition, we are beginning our pre-approval information exchange discussions with payers as well as business discussions with C-suite-level population-based decision-makers at key oncology clinics to build upon the extensive feedback we have amassed over the summer to drive our final recommendations on price. Payers acknowledge the unmet need we are addressing, and we expect that trial recycler will be added to formulas over the course of 2021, as payer P& Prior to inclusion in a formal medical policy, trial recycling would be available via medical exception.

And three months. So we look forward to seeing those data next year. It could also be important for potential offering at that time.

Regarding your second question at the North America lung cancer Congress, Yes, So we had an oral presentation off the.

Of the pool data, where we also presented.

New findings, where we saw significant reductions at hospitalizations due to chemotherapy induced myelosuppression as sepsis, which of course are very important also from an economic standpoint in terms of awareness. We are continuing to work in this area.

Clearly this is something that maybe Jack can also comment on yes. Thank you on a comparable to those questions I think on the awareness front. We did start an online disease education program here several months ago that I think is getting good traffic I'm. Obviously, we've got the medical team out there also at the various conferences like you discussed.

I think in terms of your core question on what is the level of awareness I think we feel good with it right now to be honest. If you looked at a lot of our market research what oncologists are signaling to us it's a real willingness to try this once its approved so we feel good with where we're at right now, but obviously, we're going to continue with our efforts both through the medical organization.

And other things like the offline, but until the approval. Thanks.

Thanks for taking our questions.

Yes.

Your next question is from the line of Phil Nadeau of Cowen and co. Your line is now open.

Good afternoon. Thanks for taking the question I guess first is on the FTC review of Trialing for just over three months away from the the PDUFA any update on an outcome has the FDA indicated that one could or might be necessary.

Jen Moses: Trilocyclib will be a buy-and-sell product, meaning a practice or a hospital pharmacy will purchase it in advance of receiving reimbursement. So we are planning our support programs with that in mind. A comprehensive support hub will assist office staff in benefits investigations, addressing prior authorization requirements, and appeals support. Overall, we're very encouraged by the feedback we're receiving from stakeholders about Trilocyclib, and we're prepared to support a commercial launch as early as the first quarter of 2021. And now I'd like to turn the call over to Jen. Thanks, Oma. Full financial results for the third quarter of 2020 are available in our press release and 10-Q.

No that Dave actually that there is no.

Combat they have indicated will be required.

Perfect.

Then second is on.

Reimbursement for trial.

Gross profit I guess from your prepared remarks, it sounds like it's likely to be Medicare part B.

You remind us of how.

How that would work within the first year of launch if it is approved in February.

Presumably you have to be incorporated in some some group guarantees.

How does that work in.

Is it possible to give and pep payment.

Next year, which is afterwards subsequent years.

Yes, Thanks Bill for the question.

On the reimbursement it is a part b drug defined build drawn so.

In terms of the Medicare part D process, obviously, we'll file for a J code that process has been refined over the last couple of years. So it will be quicker than it has been in the past. In addition, you're correct. We do we will file for and then tap that.

Jen Moses: Today, I'd like to focus on a few key points from our disclosure. We recognize license revenues of $26.6 million for the third quarter of 2020. Revenue was primarily driven by the upfront payments of $20 million and $6 million from EQRX and Genor, respectively. We expect to recognize revenue related to our sincere partnership in the fourth quarter of 2020. As of September 30, 2020, we had $238.3 million in cash and cash equivalents on the balance sheet compared to $269.2 million as of December 31, 2019.

We'll take a little bit longer is dictated obviously have a little bit slower central so both of those will come into play as it relates to reimbursement on the commercial side, obviously it will be part of the medical policy in most cases, so make an exception until the Pcs are those various payer organizations have a formal review a little bit.

Hopefully adopt.

At the level of insight individual institution will you have to have them revised their protocols from a suppression before you can get adoption.

Or is there is there a fair amount discretion within the institutions themselves.

It was person sandal.

Yes, I mean, obviously, we put an overarching comment on and then I can turn it over to Raj to supplement.

We will be looking good both Raj and someone mentioned about.

Working with both NCCN guidelines.

Other opportunities for various guideline organizations appear.

If you want to just as quickly as possible because the vast majority of these.

Treating physicians follow them, but to your point, where there are individual organization to have may have different.

Jen Moses: This total includes an initial $20 million drawdown from our Hercules financing and upfront cash proceeds from our agreements with EQRX, Genore, and Sincere. We are updating our 2020 cash guidance to finish the year with between $200 million and $205 million, up from our previous guidance of $185 million to $200 million. The primary driver for updating guidance is more clarity on expected commercial expenses, which takes into consideration the cost-effective nature of our agreement with BI, as well as additional savings and cash inflows we expect to realize from our out-licensing of Laracyclib and related interim supply agreements with Genore and EQRx. As previously disclosed, we expect our current cash to support operations into 2022. When contemplating cash runway into 2022, we include licensing and collaboration payments we have received to date, and our debt drawdown of $20 million. We are also accounting for all anticipated trial-cyclic launch expenses and expenses related to our development program. Our guidance on Cash Runway does not consider any additional revenues from existing agreements.

Guidelines, including that we'll certainly take a good though we do have a major account key account team that will be engaging with the large community practices, Russia, if you like.

Yes, no I think that's that's exactly right in terms of our medical team as well as Somos team is really working with with these large community practices.

And on the education side, and particularly when we think that the nurses are going to be really important in terms of.

Having.

Got a cyclic being.

Front of mind for physicians as well as patients come in.

Selling.

Doses and maybe some on anything that you'd like to add.

I think only a small thing which is I think that there's I think that there will be years I think it will take that I think it will take a little while to get into that kind of stuff is that the well.

PM or otherwise, which will really serve as a kind of a reminder to opt in or opt out of therapy as they're constructing regiments for small cell lung cancer patients. So I think prior to that I.

I think that's what Raj said that in the nursing will be really important.

Kind of vehicle to remind opposition to consider it and so thats a very key key outside of the strategy for US is to is to work with the nurses partner there.

Because as I said earlier in my remarks, they are really the ones that see the consequence of a mile suppressor night, and we believe will be motivated to take action.

That's very helpful. Thank you.

Phil.

Next we have Tom Shrader.

BTI gene your line is now open.

Hi, good afternoon, thanks for taking the questions I would like to thank mark for the tireless effort to keep us up to date on data that's been pretty subtle. So thanks, a lot and I wish you luck.

John E. Bailey: That includes additional milestone payments, cost reimbursements, or other inflows of capital that we may realize, or revenue that we may generate from the sales of Trilocyclic beginning in 2021. Furthermore, our guidance does not reflect our ability to draw down additional capital from the Hercules facility we have in place. All of these items would further extend Cash Runway beyond the guidance given today. I'll now turn the call back to Jack.

Going forward I have a kind of a bookkeeping question. So if you look at your slide deck slide 14, there's sort of a beautiful succinct.

Table on Myelosuppression, where you're able to.

Combine all your trials and come up with very clean data do you know if that's what the label will look like are you confident that it will be that clean that you'll be able to combine everything so it's clearly.

John E. Bailey: Thank you, Jen. Our highest priority is to make Trilocyclic available to patients as quickly as possible. We are excited about the potential to deliver this much needed therapy to small cell lung cancer patients as early as the first quarter of 2021, and our focus on executing a successful commercial launch next year. This commercial effort complements the work of our medical team, who are doing scientific discourse and education. An initial indication in small cell lung cancer will provide the opportunity for healthcare professionals to gain experience with tricyclics and see first-hand how it can benefit their patients, laying the foundation for uptake in future indications.

Three line Myelosuppression or is that a work in progress with the agency.

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

Yes, so on so just to remind Tom Pike.

It was actually the agency, who had asked us to combine the data.

[laughter], so thats right and and as you also know.

Obviously label negotiations are ongoing through Endear review.

And so we have various strategies to get the appropriate data into the label.

So that really communicate the value of trial a cyclic for patients.

Okay and then just one quick question for Soma, you comment about talking to users about.

The key areas of Myelosuppression that they're worried about are there any surprises there we should be thinking about.

So I don't think so I think the third thing I think that the one thing that weve definitely heard is sometimes when they think about kind of surprise music. We know this but.

John E. Bailey: With Patent Runway into the mid-2030s and a robust development plan that will generate data in additional tumor types over the next 24 to 36 months, we have the opportunity to significantly expand the use of trilocyclic for the benefit of patients, and at the same time, create value for shareholders for their conviction in this therapy. We continue to view our oral CERD, rentodestrin, as a potential best-in-class therapy and expect to disclose rentopavlocyclic combination data in the second quarter of 2021. Now, before we go to Q&A, I do want to take a moment to recognize all the healthcare professionals and frontline workers who are continuing to provide essential services. In particular, as our teams have been working with members of the oncology community, we have gained an even deeper appreciation for those that are focused on the health of our families, friends, and neighbors.

When they think about myelosuppression, sometimes they think about neutropenia.

They don't get about the multi lineage effect right. So that's one thing obviously the that is the disease state education aims to educate on right is around is around the fact that this is a multi lineage.

Effect, and and and data and that there is benefits are obviously doing something that affects at all so to me I wouldn't say that theres a surprising it I think it's more you know that that is a pretty prevalent thing is that people think miles per person I think neutropenia that does require some education.

All right great. Thank you.

Thanks, Tom.

All right next we have David Nierengarten of Wedbush Securities. Your line is now open.

Hi, Thanks for taking the question I kind of had to or maybe a little.

Off the wall or or Outsides question now that we've had a couple quarters of.

Commercial companies having either.

The novo or renewal or whatever you want to call it product launch in a wholly virtual environment and some comfort.

Companies that have you had to convert.

John E. Bailey: That concludes our prepared remarks. Operator, please open the line for questions. Thank you, Mr. McDonnell. Ladies and gentlemen, if you would like to register a question, please press star followed by the number 1 on your telephone keypad. If your question has been answered and you would like to withdraw your registration, please press star followed by the number 1 on your telephone keypad.

Yes, they do.

Virtual marketing for their products are there any that as we're talking to be right.

Are there any lessons or mistakes or things that you learned in your discussions that you can apply.

Assuming that we are still in the same spot when you launch a trailer cycle.

Yes, Thanks, David I'll make a couple overarching comments and I'll ask so much to add to it.

Certainly the corporate situation is pretty unprecedented what we do know is the oncology Aereo was one of the most restrictive in terms of your personal selling that's been shown timing on doing our job to.

Judea data and others.

Operator: [inaudible] and bye while we compile the Q&A last. Our first question is from the line of Anupam Rama of J.P. Morgan. Your line is now open.

It's only gotten more restrictive are squeezed because some of the.

Concerns around cold and so being able to look at other ways to access the oncology community is absolutely critical clearly things like digital content to supplement the personal selling obviously, having a good medical organization easier for questions that may arise by the practicing oncologist is key.

Anupam Rama: Hi, guys. Thanks so much for taking the questions. Two quick ones from me. First, for Rinto Distrant at San Antonio in December, what specific analysis would you point us to? And what's, in your mind, a win scenario there?

So I think we've really looked at trying to do both what is traditional but also what has become prevalent with coated are the things like the digital approach. So.

Thank you Tim.

It is what it is I think we're very confident that building upon the relationships that beyond this will give us the access at a time, we're doing it on our own building Salesforce was not as capital efficient and probably would not have given us the access, but probably also supplementing with digital.

Also to work with the nursing societies in the patient advocacy groups. These are all points of access for information that people involved in this cancer small cell lung cancer community are going to see to access we want to be there to be able to provide that information. So some will turn it over to that add to the yeah.

Rajesh K. Malik: And then second question, I'm just thinking about the NA, the North American Lung Cancer meeting you were recently at and the tricyclic updates there. How would you characterize the awareness of the drug at the meeting, and where are you on? [inaudible] Awareness and Medical Awareness of the Drug Relative to Your Internal Expectations. Sure, I'm going to have Raj take the first one in San Antonio.

Yeah, No I think you captured it well I think that is yeah. We.

I think you've heard me talk about this before I go one of the main reasons. We did the I was because because we started we're seeing forward too. Yeah. This was not a short term problem. This was going to be a longer term issue.

And you know and.

And we will and we think that those pre existing relationships are critical to getting the access in this environment. So they have something new to talk about that they will be able to get in even if it's a virtual channel than the information we'll get across the we feel great about the fact that we made that decision knowing kind of what it looks like the spring.

John E. Bailey: Yeah, Anupam, so the data presented at San Antonio will be monotherapy data from the dose escalation as well as the expansion, and we expanded at two different dose levels and picked the recommended dose that we then took forward in the palocyclic combination. So it will be additional safety and efficacy data showing a safety profile that continues to look very competitive and evidence of activity in heavily pretreated patient populations. And, you know, we're very excited about the combination with Pelvis-Viclib.

On winter are probably going to be like but I think it's important that we also have you know we're really spending a lot of effort to equip our VIP partners with industry, leading technology for Liveperson engagements I'm kind of augmenting their efforts with targeted digital messaging personal speaker for ground national last frac jobs virtual comp.

Rajesh K. Malik: Those 40 patients enrolled very quickly in three months, and we look forward to seeing those data, you know, next year, which could also be important for potential, you know, partnering at that time. Regarding your second question at the North America Lung Cancer Congress, yeah, so we had an oral presentation of the pool data where we also presented new findings where we saw significant reductions in hospitalizations due to chemotherapy-induced myelosuppression as sepsis, which of course are very important also from an economic standpoint. In terms of awareness, you know, we are continuing to work in this area. Clearly, this is something that, maybe, Jack can also comment on.

I'm not sure.

I think the one benefit that perhaps we had that companies that have the launch in the middle of all this is his time. So you know we've had the time to plan. It so that we weren't just having to change on a dime and maybe we're coming up with a sub optimal solution I think we've we've actually done quite a bit to make sure that the reps are kind of built for.

Digital with you well and are able to execute in that way and of course.

Digital approach as Jack mentioned is also really to try to reach customers, where they are so leveraging care care sites like ours.

John E. Bailey: Yeah, thank you, Anupam, for both those questions. I think on the awareness front, we did start an online disease education program here several months ago that I think is getting good traffic. Obviously, we've got the medical team out there also at the various conferences, as you've discussed. I think in terms of your core question about what the level of awareness is, I think we feel good with it right now, to be honest. If you look at a lot of our market research, what oncologists are signaling to us is a real willingness to try this once it's approved. So we feel good with where we're at right now, but obviously, we're going to continue with our efforts both through the medical organization and other things like the internet up until approval. Thanks.

Social media platforms on things that where they can actually access information, where they go anyway, and so I think that between those two things you know we are we are we recognize.

The issue is that it can I would say that that's the poses but out but we feel really good about the level.

Support we're going to give the b. I wrapped in terms of their ability to digitally engage but also to supplement with kind of a more supercharge digital to drive awareness.

The biggest wildcard.

This is Bob engagement model as Soma, both shared I think we feel goodwill.

The tailwind that comp would have given us is really heightened the notion of providers be more acutely aware of preventative steps vision, Terry which clearly falls into what we see with trying to fight with it moves us from a reactive.

Approach the traditional reactive approach in terms of applying rescue intervention, obviously being preventative so weve seen that come out of the market research quite clearly so diverse that you can save some benefits from the Coca situation. This heightened sensitivity to preventative steps that can be taken to help assist patients.

Phil Nadeau: Thanks for taking our questions. Your next question is from the line of Phil Nadeau of Cohen & Co., Your Alliance Network. Good afternoon, thanks for taking the question. I guess the first is on the FDA review of Trilab. We're just over three months away from the PDUFA deadline. Any update on an adcom? Has the FDA indicated that one could or might be?

Presumably at the NCCN.

Guy guidelines level may increase as important in the importance is that fair.

Yes.

Go ahead.

Just quickly I know I really do think that that is that if we do that is having an impact I mean, we've we've actually seen that number.

John E. Bailey: No, they've actually, there is no ADCOM that they have indicated will be required. Perfect. And then the second is on reimbursement for the trial of post-approval. I guess from your prepared remarks, it sounds like, likely to be Medicare Part B.

People, who are taking preventative measures kind of you know maybe March April to now is gone up pretty significantly and then when we talk to even an AD boards informally we have heard that there is an increased usage on a prophylactic measures and again, maybe Mike maybe guidelines driven maybe.

Priyanka Arun Grover: Can you remind us of how that would work in the first year of launch if it is approved in February? Presumably it will have to be incorporated into... and Group DRG, so how does that work? Is it possible to get an NTAP payment?

Yes.

People being worried but we're definitely seeing a move in that direction.

Okay I understood.

All right next we have the Chad Messer of.

John E. Bailey: Here. Yes, thanks, Phil, for the question on the reimbursement. It is a Part B drug, a buying bill drug, so in terms of the Medicare Part B process, obviously, we'll file for a J code. That process has been refined over the last couple of years, so it will be quicker than it has been in the past. In addition, you're correct, we will file for an NTAP. That will take a little bit longer and is dictated, obviously, at a little bit slower schedule, so both of those will come into play as it relates to reimbursement. On the commercial side, obviously, it will be part of the medical policy. In most cases, they'll make an exception until the P&Ts of those various payer organizations have a formal review of it and then hopefully, adopt it. At the level of an individual institution, will you have to have them revise their protocols for myelosuppression before you can get adoption, or is there a fair amount of discretion within the institutions themselves?

Net and company. Your line is now open.

Good afternoon, everyone. This is give on for Chad and thank you for taking our question as well so.

Regulation to check on starting out.

Best wishes to Mark in your next endeavors.

I'd like to first ask a question we know that.

Total eclipse is moving into a.

Colorectal how.

How much more would be required for.

Tumor I've been asked that label.

To remind us what the plan is there.

Yes.

Yes, yes, so the colorectal trial is obviously an important step because.

Five a few based chemotherapy as I mentioned is the standard of care there and it's also used across other GE malignancies.

Beyond colorectal. So for example, gastroesophageal pancreatic and so on and so so we think that the colorectal trial will be an important stepping stone towards.

You know potentially broader usage and some of those other geon malignancies as well.

Even beyond valor.

While the.

Looking at trials that predominantly focused on model preservation. We are also considering trials that are going to be looking at anti tumor efficacy because that's another important aspect of the mechanism of action of.

Rajesh K. Malik: Bahamela's Persons Yeah, I mean, obviously, let me put an overarching comment on it, and then I can turn it over to Raj to supplement. You know, clearly, we'll be looking, as both Raj and Soma mentioned, for working with both NCC and Guidelines in other opportunities for various Guidelines organizations. Obviously, we want to get that as quickly as possible because the vast majority of these treating physicians will follow that. But to your point, where there are individual organizations who may have different Guidelines included in that, we'll certainly look into those. We do have a major account and key account team that will be engaging with the large community practices. Rajesh, anything you'd like to add? Yeah, no, I think that's exactly right in terms of, you know, our medical team as well as SOMA's team is really working with, you know, with these large community practices and, you know, on the education side, and particularly, we think that nurses are going to be really important in terms of... having Trelocyclib being, you know, front of mind for physicians as well as patients comes in following diagnosis. And maybe, Soma, is there anything that you'd like to add?

Hello cyclists on one of those of course as the Triple negative study that Weve already discussed here.

Kind of a.

Let me onto the next question, so a bit of a drill down on the on the colorectal cancer study.

It's my understanding that this is going to be.

Treatment until progression there any accounting for a potential of increase overall doses would this consolidate some of the safety data.

Yes, you're right the Wi.

The standard of care is to treat other progression and what we saw in triple negative breast cancer is that patients were actually able to tolerated.

Better that was another scenario, where chemotherapy was give another progression at the safety profile actually was very comparable to that of chemotherapy alone and so that.

Comes to pass in the colorectal trial.

That increased chemotherapy exposure could also potentially.

It will play a role in improving.

Tumor efficacy, which is also something that we're looking for in that in that trial.

Thats counterproductive.

Sorry.

Go ahead.

Kind of maybe more of a.

Yes.

But maybe something more.

A bit of a notice here.

That seems interesting that you were able to.

And roll your rental destined combination study pretty quickly.

Priyanka Arun Grover: I think only a small thing, which is that there will be use. I think it will take a little while to get it into the kind of systems, if you will, EMR and otherwise, which will really serve as a kind of reminder to opt in or opt out of therapy as they're constructing regimens for small cell lung cancer patients. So prior to that, I think it's what Raj said.

And they are in Covance and maybe that's not surprising considering it's an all oral.

Combo is this something ER physicians are paying attention to as you mentioned before.

Yes.

Absolutely I think I think the rapidity with which are trial enrolls.

I think as a sign obviously up investigator interest and I'd also patients wanting to.

Priyanka Arun Grover: I think the nurses will be really important as a kind of vehicle to remind physicians to consider it. So that's a very key part of the strategy for us to work with the nurses, partner with them there. Because, as I said earlier in my remarks, they are really the ones that see the consequences of mild suppression and, we believe, will be motivated to take action.

To enroll onto the trial, so so completely agree.

Excellent. Thank you for taking our questions and congrats on all the progress and we'll be looking forward to.

Okay.

Thanks, Joe we appreciate the well wishes for both Mark and myself.

Next we have a Tony Butler from our own G.H. capital. Your line is now open.

Thank you talked a little bit, but it's a bit of relevant for the question.

Tom Schrader: That's very helpful. Thank you. Next, we have Tom Schrader of BTIG. Your line is now open. Good afternoon.

The.

Raj I wanted to ask you about preserve one.

Rajesh K. Malik: Thanks for taking the questions. I'd like to thank Mark for the tireless effort to keep us up to date on data that's been pretty subtle. So thanks a lot. I wish you luck. Going forward, I have kind of a bookkeeping question.

In CRC is Mike is the dosing and schedule.

As you would have seen in CLC or does that change the course to pay.

Because I noticed and sort of be picky, but only two sites open today I'm sure that'll increase and I wondered if you could just speak to sort of the timing of that increase and how you how you think about.

Tom Schrader: So if you look at your slide deck, slide 14, there's sort of a beautiful, succinct, [inaudible] Thanks, Tom. I'm going to have Raj respond to that. Yeah, so just to remind Tom, hi, it was actually the agency who had asked us to combine the data. Yeah, I know.

Site enrollment.

Yes.

The court could be covered related as import it may not necessarily be but I'm curious if you would.

I would speak to that.

Two wanted to double again welcome Jack but also say mark Thank you very much.

Rajesh K. Malik: So that's right. And as you also know, obviously, label negotiations are ongoing through NDA review. So we have various strategies to get the appropriate data into the label so that it really communicates the value of trialocyclic for patients. Okay, and then just one quick question for Soma: your comment about talking to users about the key areas of myelosuppression that they're worried about, are there any surprises there we should be thinking about? So, I don't think so.

Hi, Tony.

Yes, so in the in the correct for trial.

The five a few is given at a 48 hour infusion.

And that came with the other chemotherapy is given on day, one so trial the site that will be given.

But today, it's both on day, one and day to with every cycle of FOLFOX.

If you recall in the small cell studies in each up aside carbo platinum regimen in first line that is a three day chemotherapy regimen.

So just as a multi day chemotherapy regimen, where trial the cycle it was given with chemotherapy.

Priyanka Arun Grover: I think that there's been, I think that the one thing that we've definitely heard is sometimes when they think about, it's not a surprise, I don't think we know this, but you know, when they think about myelodyspression, sometimes they think about neutropenia, and they don't think about the multilineage effect, right? So that's one thing, obviously, that the disease state education aims to educate people on, right, the fact that this is a multilineage effect and, you know, and that there's a benefit to obviously doing something that affects it all. So, to me, I wouldn't say that there's any surprise in it.

Yeah.

Yeah, and the second for the sites. It's the study is.

Actually there is a lot of NVS investigator enthusiasm and where we are at the initial part of our site Activations. So we expect.

A rapid ramp up on that and as well as enrolling our first patient soon.

Thanks Roger.

Sure. Thanks, Tony.

And there are no further questions at this time I will now turn the call over to ER back to CEO, Jack Bailey for closing remarks.

Thank you operator, well. This concludes the call certainly feel free to please reach out to us with any other questions. You may have I will look forward to connecting with many of you at the upcoming Stifel and also Evercore ISI virtual conferences. Thanks again for joining us today, if we stay well.

David Matthew Nierengarten: I think it's more, you know, that that is a pretty prevalent thing is that people think myelodyspression, they think neutropenia, that does require some education. All right, great. Thank you. Thanks, Tom. Alright, next we have David Nierengarten of Wedbush Securities on the line. Hey, thanks for taking the question. I kind of had a maybe a little, off the wall or outside question.

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

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John E. Bailey: Yeah, now that we've had a couple quarters of Novo or new, whatever you want to call it, product launches in a wholly virtual environment, and some companies that have, you know, had to convert, obviously, to virtual marketing for their products. Are there any, as we're talking to BI, are there any lessons or mistakes or, you know, things that you've learned in your discussions that you can apply, assuming that we're still in the same spot when you launch Trilosec? Yeah, thanks, David. I'll make a couple of overarching comments, and I'll ask Soma to add to them. You know, certainly, the COVID situation is pretty unprecedented. What we do know is that the oncology area was one of the most restrictive in terms of your personal selling. That's been shown time and time again by the IQD data and others.

John E. Bailey: It's only gotten more restrictive, obviously, because of some of the concerns around COVID. So being able to look at other ways to access the oncology community is absolutely critical. Clearly, things like good digital content to supplement the personal selling, and obviously, having a good medical organization to be there for questions that may arise from the practicing oncologist is key.

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John E. Bailey: So I think we've really looked at trying to do both what is traditional but also what has become prevalent with COVID, i.e., things like the digital approach. So at today's end, it is what it is. I think we're very confident that building upon the relationships that BI has will give us access at a time when we're doing it on our own. Building Salesforce was not as capital efficient and probably would not have given us access. But by also supplementing with digital and being able to work with the nursing societies and the patient advocacy groups, these are all points of access for information that people involved in this cancer, the small cell lung cancer community, are going to seek to access. We want to be there to be able to provide that information. So Selma, I'll turn it over to you to add to that. Yeah, no, I think you've captured it well.

Priyanka Arun Grover: I think that is, you know, we, I think you've heard me talk about this before. One of the main reasons we did D.I. was because we could, we sort of were looking forward to, you know, this was not a short-term problem; this was going to be a longer-term issue. And, you know, and we, and we think that those pre-existing relationships are critical to getting access in this environment. So if they have something new to talk about, they will be able to get in, even if it's a virtual channel; the information will get across.

Priyanka Arun Grover: So we feel great about the fact that we made that decision knowing kind of what the spring and winter are probably going to be like. But I think it's important that we also have, you know, we're really putting a lot of effort into equipping our D.I. partners with industry leading technology for live virtual engagements and kind of augments their efforts with targeted digital messaging, virtual speaker programs, national launch broadcasts, and virtual convention presence.

John E. Bailey: I think the one benefit that perhaps we had that, you know, companies that had the launch in the middle of all this had time. So, you know, we've had the time to plan it so that we weren't just having to change on a dime and maybe we're coming up with a suboptimal solution. I think we've actually done quite a bit to make sure that the reps are kind of built for digital, if you will, and are able to execute in that way. And of course, you know, our digital approach, as Jack mentioned, is also really to try to reach customers where they are. So leveraging peer-to-peer sites like OnClive, social media platforms, things where they can actually access the information where they go anyway.

Priyanka Arun Grover: And so I think that between those two things, you know, we have, we are, we recognize the issues that it can pose, but we feel really good about the level of support we're going to give the B.I. reps in terms of their ability to digitally engage, but also to supplement with kind of a more supercharged digital to drive, and David Lauba.

John E. Bailey: While the engagement model is someone I've both shared, and I think we feel good about, I think the tailwind that COVID has given us has really heightened the notion of providers being more acutely aware of preventative steps they can take, which clearly falls into what we see with trial and cycle. It moves us from a reactive approach, the traditional reactive approach in terms of applying rescue interventions to being obviously preventative. We've seen that come out of the market research quite clearly.

John E. Bailey: There are, if you can say, some benefits from the COVID situation. It's a heightened sensitivity to any preventative steps that can be taken to help assist patients, and presumably at the NCCN. Guidelines have only increased in importance. Is that fair?

Priyanka Arun Grover: Yeah, I think we're all listening. Go ahead. So, just quickly, yeah, no, I mean, we do think that that is, we do think it's having an impact. I mean, we've actually seen that the number of people who are taking preventative measures kind of, you know, maybe March, April to now has gone up pretty significantly.

Chad Messer: And when we talked to even an Ad Board informally, we heard that there is an increased usage of prophylactic measures. And again, maybe, maybe guidelines-driven, maybe just, you know, people being worried, but we're definitely seeing them move in that direction. Thank you. Next, we have Chad Messer of Nerem Company and Yolanis Network.

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Gil Joseph Blum: Good afternoon, everyone. This is Gil on behalf of Chad, and thank you for taking our questions. Also, congratulations to Jack on starting out and best wishes to Mark and your next endeavors. Um, I'd like to first ask a question.

Rajesh K. Malik: We know that tricyclob is moving into colorectal. How much more would be required for a tumor agnostic label? Kind of remind us what the plan is there, Rajesh?

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

Rajesh K. Malik: And so we think that the colorectal trial will be an important stepping stone towards potentially broader usage in some of those other GI malignancies as well. You know, even beyond Vallow, the... Looking at trials that predominantly focus on myelopreservation, we're also considering trials that are going to be looking at anti-tumor efficacy because that's another important aspect of the mechanism of action of Trelacycline. And one of those, of course, is the triple negative study that we've already discussed, kind of led me on to this next question. So, a bit of a drill down on the colorectal cancer study. My understanding is that this is going to be a treatmental progression. Is there any accounting for the potential of increased, you know, overall doses? Would this confound some of the, you know, safety data?

Rajesh K. Malik: You're right, the standard of care is to treat until progression, and what we saw in triple negative breast cancer is that patients were actually able to tolerate it better. That was another scenario where chemotherapy was given until progression, and the safety profile actually was very comparable to that of chemotherapy alone. And so if that comes to pass in the colorectal trial, that increased chemotherapy exposure could also potentially play a role in improving anti-tumor efficacy, which is also something that we're looking for in that trial. Bye. Thank you. I'm kind of a maybe more of a, kind of a maybe something more, a bit of a notice here.

Rajesh K. Malik: It seems interesting that you were able to enroll your rhinto-destrant combination study pretty quickly during COVID, and maybe that's not surprising, considering it's an oral combo. Is this something physicians are paying attention to, as you mentioned before? Yes. Well, absolutely. I think the rapidity with which a trial enrolls is a sign, obviously, of investigator interest and also patients wanting to enroll in the trial.

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Rajesh K. Malik: So, completely agree. Excellent. Thank you for taking our questions and congratulations on all the progress, and we'll be looking forward to the PDUFA date. Thanks, Kevin. We appreciate the well wishes for both Mark and myself. Do we have Tony Butler?

Tony Butler: R-O-G-H, capital G-O-L-I-N-G. Thank you. It's Roth Capital, but that's a bit irrelevant to the question.

Rajesh K. Malik: Raj, I wanted to ask you about Preserve 1 in CRC. Is the dosing and schedule the same as you would have seen in FCLC? Or has that changed?

Rajesh K. Malik: That's question A. And B is, I noticed, and sorry to be picky, but only two sites have opened to date. I'm sure that'll increase. And I wondered if you could just speak to sort of the timing of that increase and how you think about site enrollment. In part, it could be COVID-related. In part, it may not necessarily be.

Rajesh K. Malik: But I'm curious if you would speak to that. And I, too, wanted to welcome Jack again but also say, Mark, thank you very much. Hi Tony. Yeah, so in the cororectal trial, the 5-FU is given as a 48-hour infusion, and the other chemotherapy is given on day one. So, trial-of-the-cycle will be given for two days, both on day one and day two, with every cycle of the full-fox series. If you recall, in the small cell studies in the utoposite carboplatin regimen in first line, that is a three-day chemotherapy regimen.

Rajesh K. Malik: So, this is a multi-day chemotherapy regimen where trial-of-the-cycle was given with chemotherapy. Yep. Yeah, and the second, for the sites, the study is actually generating a lot of investigator enthusiasm, and we're, you know, we're at the initial part of site activation, so we expect a rapid wrap-up on that, you know, and as well as enrolling our first patients soon. Thanks, Tony. And there are no further questions at this time. I will now turn the call over to CEO Jack Bailey for closing remarks. Thank you, Operator. Well, this concludes the call. Certainly, feel free to reach out to us with any other questions you may have. I will look forward to connecting with many of you at the upcoming STFL and also Evercore ISI virtual conferences.

John E. Bailey: Thanks again for joining us today, and please stay well. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. Enjoy the rest of your day. Keep safe, and you may now disconnect.

Operator: ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Thank you. Copyright © 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. ? ? ? ? ? ? ? Copyright © 2020, New Thinking Allowed Foundation ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?.. [inaudible]