Q1 2021 G1 Therapeutics Inc Earnings Call

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Operator: Ladies and gentlemen, thank you for standing by, and welcome to the G1 Therapeutics 2021 first quarter financial results conference call. At this time, all participants are in a listen-only mode.

Ladies and gentlemen, thank for standing by and welcome to the G. One Therapeutics 2021 first quarter financial results Conference call. At this time, all participants are in a listen only mode.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star one on your telephone. If you require any further assistance, please press star zero. I would now like to hand the conference over to our speaker today, Mr. Will Roberts. Thank you, Jillian.

So to speak with presentation, there will be question and answer session.

I'll ask a question during the session you will need to press star one on your telephone keypad.

If you require any further assistance please press star zero.

I'd like to hand, the conference over to your Speaker today, Mr will Roberts. Please go ahead.

Thank you Julien good afternoon, everyone and welcome to the G. One conference call to discuss our first quarter 2021 financial results and business update.

William C. Roberts: Good afternoon, everyone. G1 conference call to discuss our first quarter 2021 financial results in business. The press release on these financial results was issued after market closed this afternoon, and we founded a new section of our corporate website, g1therapeutics.com. On this afternoon's call, the team will provide a business overview of the first.., including an update on our launch progress with Cosella, which was approved by the U.S. Food and Drug Administration on February 12, 2021, to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum etoposide-containing regimen or topatecan-containing regimen for extensive-stage small cell lung cancer, or ESSCLC, and it became available in the channel in early.

The press release on these financial results was issued after market close this afternoon and can be found in the news section of our corporate website human therapeutics Dot com.

On this afternoon's call the team will provide a business overview with the first quarter, including an update on our launch progress with Casella, which was approved by the U S food and drug administration on February 12, 2021 to decrease the incidence of chemotherapy induced myeloid suppression and adult patients when administered prior to a platinum etoposide containing.

Women or Toby chicken containing regimen for extensive stage small cell lung cancer or E. S. S. C. L C.

And it became available in the channel in early March.

William C. Roberts: The question and answer session will follow. Before we begin, I want to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by such forward-looking statements.

A question and answer session will follow the prepared comments.

Before we begin I want to remind you that today's webcast contains forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.

Such statements represent managements judgment as of today.

And may involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements from.

William C. Roberts: For more information on such risks and uncertainties, please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our website. Any forward-looking statements represent our views as of today, March 5, 2020. Joining me on the call today are Jack Bailey, our Chief Executive Officer, and Soma Gupta, our Chief Commercial Officer. Jen Moses, our Chief Financial Officer, and Raj Malik, our Chief Medical Officer. And with that, I'll turn the call over to Jack. Jack

For more information on such risks and uncertainties. Please refer to our filings with the Securities and Exchange Commission.

Which are available from the SEC or on our corporate website.

Any forward looking statements represent our views as of today March five 2021.

Joining me on the call today are Jack Bailey, our Chief Executive Officer, Soma Gupta, our Chief Commercial Officer, Jen Moses, our Chief Financial Officer, and Raj Malik Chief Medical Officer.

And with that I'll turn the call over to Jack.

Jack.

John E. Bailey: Thanks Will. Good afternoon everyone, and thank you for joining us on the call today. We certainly hope that you and your families are healthy and well. Today's headline is one of progress toward our mission via continued execution by the G1 team on both our launch efforts for Cocella in extensive stage small cell lung cancer and in our clinical efforts as we execute on our robust development plan. As many of you know, G1 was founded in 2008 by Dr. Norman Ned Sharpless, the current director of the National Cancer Institute, to discover novel therapeutics that target protein kinases that help mediate cell division.

Thanks good.

Good afternoon, everyone and thank you for joining us on the call today, we certainly hope that you and your families are healthy and well.

Today's headline is one on progress toward our mission to be a continued execution by the G. One team on both our launch efforts for consultants in extensive stage small cell lung cancer and in our clinical efforts as we execute on our robust development plan.

As many of you know G. One was founded in 2008 by Dr. Norman Ned Sharpless, the current director of the National Champions.

To discover novel Therapeutics that target protein kinases that help mediate cell division.

John E. Bailey: His mission, even then, was to improve the experience of chemotherapy and to improve and extend the lives of people living with cancer. And I'm happy to say that our mission has not changed as the company has evolved. The development, approval, and launch of Cocella, an extensive stage small cell lung cancer, is one example of how we are actively advancing that mission. Another is our tumor agnostic clinical program, with late stage clinical trials ongoing or soon to be initiated in multiple tumor types.

His mission, even then was to improve the experience of chemotherapy and to improve and extend the lives of people living with cancer and.

And I am happy to say that our mission has not changed as the company has evolved.

Element approval and launch of cross sell up in extensive stage small cell lung cancer is one example, we are actively advancing that mission.

Another is our tumor agnostic clinical program with late stage clinical trials ongoing or soon to be initiated in multiple tumor types.

John E. Bailey: Soma will share that the early indicators are suggestive of a drug that is being well received by oncologists and oncology nurses and is well covered by payers. Cocella is already being administered to patients. It fits well into the oncologist's workflow. Oncology nurses are being actively educated on its benefits. It's reasonably priced and supported by strong budget impact data.

So mobile share, but the early indicators are suggestive of a drug that is being well received by oncologists and oncology nurses.

As well covered by payers.

<unk> is already being administered to patients it fits well into the oncologists workflow oncology nurses are being actively educated on its benefits its reasonably price and supported by strong budget impact data.

John E. Bailey: It was quickly added to two NCCN guidelines, and it represents the start of a true paradigm shift in chemotherapy patient support, from reactive single lineage treatment with multiple drugs depending on the side effect to that of proactive multi-lineage myeloprotection. Equally good progress has been made in our clinical efforts with Cocella. Since the beginning of the first quarter, we started dosing patients in our pivotal colorectal cancer trial. We've initiated our pivotal TMDC trial. We have also opened an investigator-initiated trial portal, which is generating a number of interesting potential opportunities.

It was quickly added to two mtc and guidelines and it represents the start of a true paradigm shift in chemotherapy patients support from reactive single lineage treatment with multiple drugs, depending on the side effect tobacco proactive multi lineage Milo.

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Equally good progress has been made in our clinical efforts with herself.

Since the beginning of the first quarter, we started dosing patients in our pivotal colorectal cancer trial, we've initiated our pivotal <unk> trial. We also opened an investigator initiated trial portal, which is generating a number of interesting potential opportunities and we expect to initiate two.

John E. Bailey: And we expect to initiate two more phase two trials later this quarter in non-small cell lung cancer and bladder cancer. So by the end of the current quarter, we expect to have two phase 3 registrational trials and three phase 2 trials underway. Now, today's call will cover an important amount of information. I'll ask Soma to discuss our commercial efforts through the end of March, our first four weeks of being a commercial organization, and provide some leading and lagging indicators of Coastella's access and uptake.

More phase two trial later this quarter.

Non small cell lung cancer and bladder cancer.

So by the end of the current quarter, we expect to have two phase III Registrational trials in three phase III trials underway.

Now today's call will cover an important.

Amount of information all that so mark to discuss our commercial efforts through the end of March our first four weeks of being a commercial organization and provide some leading and lagging indicators of <unk> access and uptake.

John E. Bailey: Raj will then provide an update on our medical efforts and also our recent clinical milestones in the first quarter. Finally, Jen will provide the financial update for the first quarter of 2021. Then I'll be back for some concluding comments. I'll now turn the call over to Soma for her update on our commercial efforts and results over the first four weeks of sales. Soma?

Raj will then provide an update on our medical efforts and also our recent clinical milestones on the first quarter.

Finally, John will provide the financial update for the first quarter of 2021.

Then I'll be back for some concluding comments I'll now turn the call over to Soma for her update on our commercial effort and result over the first four weeks of sales Soma, Thanks, Jack and good afternoon, everyone and thanks for joining us on the call.

Priyanka Arun Grover: Thanks, Jack. And good afternoon, everyone. Thanks for joining us on the call. These are exciting and very busy times as we are launching Cosella. And though we are very early in the launch cycle, the indicators to date have been positive and suggest a high level of interest in adopting Cosella and the potential for strong coverage from payers. I'm very proud of the great work we have seen from this combined G1 and BI team.

It's an exciting and very busy time as we are launching for seller and though we are very early on the launch cycle indicators to date and time to debt and suggests a high level interest in adopting cross sell off.

Our strong coverage from payers.

Very proud on the great work, we have seen from this combined G. One MDI team.

Priyanka Arun Grover: Thanks to their efforts, we've booked approximately $600,000 in net sales as of March 31st. We're off to a solid start, and I'm optimistic that we can sustain this early momentum moving forward. Launching a drug during a pandemic is new territory for all of us, and the team has performed well. As we discussed on our last call, our sales training was completed the week of February 26th, and the team was in the field the following week to coincide with the availability of the drug on March 2nd. G1 and BI made good early progress even though the drug was available for only the last four weeks of the quarter. So, here are a few highlights.

Thanks to their efforts, we booked approximately $600000 in net sales as of March 31st.

First four weeks from availability, we're off to a solid start and I'm optimistic we can sustain this momentum moving forward.

Lodging and thrive during a pandemic is new territory for all of Us and the team has performed well.

Our last call our sales training was completed on the week of February price effects from the team was in the following week to coincide with a day, although they are on track on March 2nd.

G. One MDI made good early progress, even though drug was available for only the last four weeks of the quarter. So you highlight first thus far are targeted priority pairs had been covering Costello net written to label.

Priyanka Arun Grover: First, thus far, our targeted priority payers have been covering COSOA when written to label. Approximately 60% of it has been Medicare Part B, about 30% is commercial, and then 10% is government and other forms of coverage, as we had expected. We are seeing good initial traction with prescribing docs and nurses, with bios being ordered by 20 unique organizations in the month of March alone, nearly double that number since.

60% of it has been in Medicare part D. About 30% is commercial and then 10% is government and other forms of coverage as we had expected.

Hey, good initial traction with prescribing docs and nurses with vials being ordered by 'twenty unique organization in the month of March alone, we've nearly doubled that number of sense from an engine.

Priyanka Arun Grover: From an engagement perspective, as of the last week of March, again, only four weeks in, the team had already achieved a nearly 30% reach to our 2,500 target HCPs and, more generally, made an additional 3,000 calls to other prescription-enabling functions in the account. Almost a third of the calls were live, and when every week the country continues to open back up, we expect that trend to continue. That said, the team has proven itself to be entirely capable of virtual calls.

Cash from perspective as of the last week of March again, only four weeks and the team had already achieved a nearly 30% reach.

2500 target Hcp's and more generally made an additional 3000 cop.

From Sterne nameplate functions in the accounts.

Almost a third on the calls we're alive and every week. The country continues to open back up we expect that trend to continue.

On the team has proven itself to be entirely capable of virtual call.

Priyanka Arun Grover: And while not an indicator of usage, it's also good to see that the Salesforce shared voice among target positions is already in the same range as that of other products used by treating oncologists like Neulasta, Texentric, and Empinza. And, of course, we are leveraging our learnings from G1's initial national broadcast as well as other region-specific speaker programs that have been scheduled. We are very happy with the robust interest in these educational programs and also the strong interest in scheduling live programs versus virtual ones, which will likely have an even greater impact. Let's now go into a little more detail on sales performance, adoption, and market access. Sales performance for the first four weeks of product availability exceeded our internal demand target.

And while not a indicator on the usage. It's also good to see that the sales force share of voice among our target physicians is already in the same range as that of other.

Their product used by treating oncologist like Neulasta eccentric Andy.

And of course, we are leveraging our learnings from G. One initial national broadcast that's all other region specific speaker programs that have been scheduled and we're very happy with a robust interest in these educational programs and also the strong interest in Saskatchewan and live programs versus virtual wise, which we likely will likely have an even greater impact.

Let's now go into a little more detail on sales performance adoption and Mark rack pass sales performance for the first four weeks from product availability exceeded our internal demand target as would be expected approximately 60% on the demand cancer community hospitals and clinics with 40% coming from academic hospitals.

Priyanka Arun Grover: As would be expected, approximately 60% of the demand came through community hospitals and clinics, with 40% coming from academic hospitals. Regarding adoption, again, we are seeing promising early metrics. Twenty unique organizations, what we call parent accounts to which multiple accounts roll up, ordered Cocella in March, and most of them have reordered, as would be expected given patients typically get six doses per cycle and four cycles per patient. Sixty percent of these unique organizations did not participate in the clinical trials for Cocella, suggesting that we are focusing on the right targets and are generating good interest and awareness outside of the already aware and experienced cohort.

Regarding adoption again, we are seeing promising early metrics 20 unique organization, what we call current accounts.

Multiple accounts rollout.

Our in March and most of them have reorder as would be expected given the patients typically get six doses per cycle enforced cycles per patient.

60% of his unique organizations did not participate on the call.

Child for Costar, suggesting that we are focusing on the right targets and are generating good interest from awareness outside of the already aware an experienced cohort I'm on.

Priyanka Arun Grover: I'm also enthusiastic that seven of our 100 priority orgs, those that we consider critical to driving both depth and breadth of Cocella adoption, had already ordered as of March 31st. Our best estimates indicate that approximately 30 small cell lung cancer patients were helped with the decision to start Cocella in the first month of launch, which, given the infrequency of these patients presenting, is a good, strong start. The process to be made available for use in large institutions or community practices is individualized and very institution specific.

Also on Tuesday, I stick with seven of our 100 priority or those that we consider are critical to driving both depth and breadth of casella.

The option had already ordered as of March 31st.

Our best estimates indicate that approximately three small cell lung cancer patients were helped with the decision to start cross sell out in the first month of launch which given the infrequency of these patients presenting is at good strong start.

This has to be made available for use on large expectations, our community practices are individualized and barriers.

And as such will take time to work through all of them, but we are happy to report that we made some very important early progress on March for example, one of the largest GPO accounts in the southeast is a big and very influential accounts that drive volume, they're highly controlled accounts. So the key to unlocking on account like that.

Priyanka Arun Grover: And as such, it'll take time to work through all of them, but we are happy to report that we made some very important early progress in March. For example, one of the largest GPO counts in the southeast is a big and very influential account that drives volume. They're highly controlled accounts, so the key to unlocking an account like this is through the key decision makers at the top.

The key decision makers at the top our team immediately got to work on the key drivers from top down.

You EHR systems update on formulary inclusion from bottoms that nurse program from see any interaction physician awareness advocacy and pull through demand.

That process was completed in late March and since fan demand from non has been strong and we have seen orders nearly every day.

This is the process that we will repeat with all the large community practices.

Priyanka Arun Grover: Our team immediately got to work on the key drivers from top down, P&T review, EHR system updates, and formulary inclusion, from bottoms up, nurse programs and C&E interactions, physician awareness, advocacy, and pull through demand. That process was completed in late March, and since then, demand from them has been strong, and we are seeing orders nearly every day. This is the process that we will repeat with all of the large community practices, and while we are thrilled that this large GPO came on board with COSELLA so quickly after launch, we know each large community practice has its own process, and it will take some time to move through each one.

This large GPO came on board with Costar. So quickly after launch we know each large community practice has its own process.

It will take from time to move through each one.

Some of them like this one where they have a high degree of institutional control and acceptance can be determined by a few he decision makers well others well stick to their system dictated pathway, maybe something like fair value and I'm on waiting that decision as part of their overall Satsuma.

We will continue to work through all of them on an account by account basis, but the approach will be this thing.

For PMT reviews on inclusion and HR systems to open the account from the top while driving HCP awareness scheduling nursing pharmacy program and activating patient advocacy so demand is being generated from the bottom.

They are also influenced by MTN and adds Raj will discuss further in his remarks Lasalle was out into two emphases on guidelines during the last week on the quarter. So we are leveraging dot where appropriate.

A critical to selling or buying a product that requires a total office call by doing this critical upfront work our sales will be made it more easily available to interest prescribers those seven of our top priority or already ordered have also added it to their formularies and their EHR order thats for <unk>.

Priyanka Arun Grover: Some will be like this one, where there's a high degree of institutional control, and acceptance can be determined by a few key decision-makers, while others will prefer to stick to their system-dictated pathway. We will continue to work through all of them on a count-by-count basis, but the approach will be the same.

Paul for lung cancer. So when you see things more on generally calling on the right direction.

So what about every large community practices the same which you believe these other REIT general steps to succeed.

Exactly it takes work and some time and will be our focus for the next two quarters or so.

Priyanka Arun Grover: Support P&T reviews and inclusion in EHR systems to open the account from the top, while driving HCP awareness, scheduling nurse and pharmacy programs, and activating patient advocacy so demand is being generated from the bottom. Many are also influenced by NCCN, and as Raj will discuss further in his remarks, Micellar was added to two NCCN guidelines during the last week of the quarter, so we are leveraging that where appropriate. These steps are critical to selling a buy-and-build product that requires a total office call.

Great and experienced team that has done this before with over 20 different oncology products and we will get there switching to market access we made good progress with payers.

And of course, our presentations to priority payers representing over 80% on covered lives. These split into approximately 70% Medicare part B plans on 30% commercial on my house and from priority National payer published our first formal policy on March 31st with a prior authorization to label.

As expected on pay.

Erez will issue policies based on these presentations over the coming months, thus far our priority payers are proving prescriptions on a range.

Paul It's Bob.

I'll start on a permanent J code in March and they should be approved by September.

Those in the inpatient setting we start from what's called a new technology add on payment.

Priyanka Arun Grover: By doing this critical upfront work, Pracella will be made more easily available to interested prescribers. Those seven of our top priority orgs who have already ordered Pracella have also added it to their formularies and their EHR order sets for small cell lung cancer, so we see things more generally going in the right direction. So while not every large community practices the same, we do believe these are the right general steps to succeed.

That status by September as well.

However, even prior to the permanent codes, we are seeing very little pushback in terms of reimbursement about plans of course some practices typically those are smaller size, we'll hold off until a permanent J code. It this year, but overall, we are not seeing payer and reimbursement issues. Thanks to strong interest on the product endorsement by accessing on.

And of course, what we feel is a fairly priced offering.

Have also discussed the importance of aided and unaided awareness of course, all on the past and we are enthusiastic about progress we haven't seen in that regard three other.

Priyanka Arun Grover: To do this successfully takes work and some time and will be our focus for the next two quarters or so. We have a great and experienced team that has done this before with over 20 different oncology products, and we will get there. Switching to market access, we made good early progress with payers, including completion of COSEVO presentations to priority payers representing over 80% of covered lives. These split into approximately 70% Medicare Part B plans and 30% commercial plans.

March both awareness measures are well above baseline, but its a little early in the launch to attach significance Joanne will provide an update on that regard on the next call.

So that was a lot of information to summarize we are seeing good early metrics of engagement and ordering from priority or our demand sales came in line with our expectations for the first one from availability we have.

Progress on key large community G. P O accounts the other process.

So each one will take some time in front of a market access perspective, we have seen no issues on coverage next steps are permanent codes to issue in the second half of the year. So we are off to a solid start and we believe we are well positioned on the momentum we've generated in these first four weeks excellent parents of our teams we've been in.

Priyanka Arun Grover: Anthem, a priority national payer, published our first formal policy on March 31st with prior authorization to label, as expected. All payers will issue policies based on these presentations over the coming months. Thus far, our priority payers are approving prescriptions that are written to label. We filed for our permanent J&C codes in March, and they should be approved by September.

Well to meet every quest for product and support is very exciting time for the commercial team at G. One and at the IDE and on now I'll turn the call over to Raj Malik Raj.

Soma and good afternoon, everyone I'm going to cover three topics first I'll highlight some of our medical efforts during the quarter, including Costello's addition to the CCN guidelines on how our interactions with Hcp's are progressing.

Second I will describe some compelling budget impact model data that were recently presented at the Academy of managed care pharmacy or <unk> meeting in April.

Priyanka Arun Grover: For those in the inpatient setting, we filed for what's called a new technology add-on payment. We should know that status by September as well. However, even prior to the permanent codes, we are seeing very little pushback in terms of reimbursement of filed claims.

Finally, I'll provide an overview of our recently initiated a pivotal trial in triple negative breast cancer or <unk>.

Our medical Science team has held over 350 medical into medical engagements since FDA approval.

Priyanka Arun Grover: Of course, some practices, typically those of smaller size, will hold off until a permanent J code is issued, but overall, we are not seeing payer and reimbursement issues thanks to strong interest in the product, endorsement by NCCN, and, of course, what we feel is a fairly priced offering. We have also discussed the importance of aided and unaided awareness of Cocella in the past, and we are enthusiastic about progress we have seen in that regard since the end of March.

In addition to interactions with academic opinion leaders, our MSL team is actively engaging with community cancer clinics, where the majority of small cell lung cancer patients actually present and are treated.

The team is taking a total clinical approach with engagements with the oncologists and other allied health care professionals, especially nursing pharmacy and other clinic staff.

And the community cancer clinics and integrated delivery network key accounts.

Some of the insights we have heard from community oncologists are around the importance of education on the novel mechanism of action of <unk>.

Priyanka Arun Grover: Both awareness measures are well above baseline, but it's a little early in the launch to attach significance to them. We will provide an update in that regard on the next call.

It's a proactive multi lineage approach to protecting the bone marrow, which is new and different from what they used to.

Priyanka Arun Grover: To summarize, we are seeing good early metrics of engagement and ordering from priority orgs. Our demand sales came in line with our expectations for the first month of availability. We are making good progress with key large community GPO counts, though the process to progress each one will take some time. And from a market access perspective, we have seen no issues with coverage and expect our permanent codes to issue in the second half of the year.

Most of them colleges immediately think of neutropenia when it comes from all of suppression.

But when we discuss the other lineages red blood cells and platelets that begin to understand the novel mechanism.

They are also used to thinking about oral CDK <unk> inhibitors that are administered chronically.

However, what makes casella unique is that it's administered IV.

Cleared rapidly and only administered on days that chemo is given in order to provide a transient G. One of the last four mile of protection.

Priyanka Arun Grover: So, we are off to a solid start, and we believe we are well positioned to build on the momentum we've generated in these first four weeks. Thanks to the preparedness of our teams, we've been able to meet every request for product and support. It is a very exciting time for the commercial team at G1 and at BI. And I'll now turn the call over to Raj Malik.

The nursing community is on the Frontlines of dealing with patients on managing chemo related side effects and the feedback from them husband resoundingly positive regarding the reduction of myeloid suppressive chemo consequences by herself.

Many of the questions from nurses, so far have been very practical and pragmatic in nature.

Rajesh K. Malik: Thanks, Soma, and good afternoon, everyone. I'm going to cover three topics. First, I'll highlight some of our medical efforts during the quarter, including Cosella's addition to the NCCN guidelines and how our interactions with HCPs are progressing. Second, I will describe some compelling budget impact model data that were recently presented at the Academy of Managed Care Pharmacy, or AMCP, meeting in April. Finally, I'll provide an overview of our recently initiated pivotal trial in triple negative breast cancer, or TNBC.

Mostly around choice of IV infusion sets like which tubing and filters are compatible with IV administration of Casella.

This is important since it indicates that they are interested and preparing to use casella in their practice.

Our field medical team has also received a lot of practical questions from pharmacists and addition to requests for pharma co economic information to inform their PMT and formulary decisions.

Like the data we presented at the <unk> meeting.

Our <unk> have also seen a strong uptick and interest in the G. One scientific platform.

Rajesh K. Malik: Our medical science team has held over 350 medical-to-medical engagements since FDA approval. In addition to interactions with academic opinion leaders, our MSL team is actively engaging with community cancer clinics where the majority of small cell lung cancer patients actually present and are treated. The team is taking a total clinic approach with engagements with the oncologist and other allied healthcare professionals, especially nursing, pharmacy, and other clinic staff in the community cancer clinics and integrated delivery network key accounts.

And this not only helps to drive interest from additional investigators or our lifecycle management clinical trials, but also translates into new proposals for investigator sponsored studies.

Our medical team was instrumental in having to sell on added to two updated national comprehensive cancer network clinical practice guidelines in oncology in late March.

The treatment guidelines for small cell lung cancer, and the supportive care guidelines for hematopoietic growth factors.

This type of simultaneous update of two MCC on guidelines.

Rajesh K. Malik: Some of the insights we've heard from community oncologists are around the importance of education on the novel mechanism of action of Casel. It's a proactive, multilineage approach to protecting the bone marrow, which is new and different from what they're used to. Most oncologists immediately think of neutropenia when it comes to myelosuppression. However, when we discuss the other lineages, red blood cells, and platelets, they begin to understand the novel mechanism.

Is not only rare, but also a testament to the multi disciplinary importance of this breakthrough therapy.

Gaining inclusion into relevant guidelines also drives inclusion into oncology care pathways, which is a vital part of our strategy to ensuring appropriate patient access as these recommendations facilitate reimbursement and patient access.

We have submitted data packages to the oncology care pathway committees via their formal submission processes.

Rajesh K. Malik: They're also used to thinking about oral CDK4-6 inhibitors that are administered chronically. However, what makes Costella unique is that it's administered IV, cleared rapidly, and only administered on days that chemo is given in order to provide a transient G1 arrest for myeloprotection. The nursing community is on the front lines of dealing with patients and managing chemo-related side effects, and the feedback from them has been resoundingly positive regarding the reduction of myelosuppressive chemoconsequences by Costella.

G. One has a very robust publications plan on which we are executing.

For example, 18 trial cyclist peer reviewed manuscripts have been published to date eight of which were in 'twenty 'twenty or 2021 and.

And several others have been submitted and are under review.

In addition, we have submitted abstracts for presentation at eight different medical meetings in 2021.

At the <unk> meeting, we presented the budget impact of prescribing casella to decrease the incidence of chemotherapy induced model suppression in adult patients with extensive stage small cell lung cancer from the perspective of a third party payer.

Rajesh K. Malik: Many of the questions from nurses so far have been very practical and pragmatic in nature, mostly around the choice of IV infusion cells, like which tubing and filters are compatible with the IV administration of Casal. This is important since it indicates that nurses are interested in and preparing to use Cocella in their practice. The field medical team has also received a lot of practical questions from pharmacists, in addition to requests for pharmacoeconomic information to inform their P&T and formulary decisions, like the data we presented at the AMCP meeting. Our MSLs have also seen a strong uptick in interest in the G1 scientific platform.

The model created uncompetitive two scenarios for this analysis over a five year time horizon in a hypothetical plan with 1 million members in total.

The first which was a prelaunch scenario outlined the economics and outcomes associated with standard extensive stage small cell lung cancer treatments for casella was available.

The second which was the post launch scenario.

Displayed the economics on outcomes projected to evolve when those same standard treatments are needed with cross sell on being given.

The results are compelling.

<unk> therapy induced adverse events in patients treated with extensive stage small cell lung cancer are estimated to be fewer over five years in the scenario, where casella is available.

Rajesh K. Malik: And this not only helps to drive interest from additional investigators for our lifecycle management clinical trials but also translates into new proposals for investigator-sponsored studies. Our medical team was instrumental in having Cosella added to two updated National Comprehensive Cancer Network clinical practice guidelines in oncology in late March. The treatment guidelines for small cell lung cancer and the supportive care guidelines for hematopoietic growth factors.

<unk> in the net financial impact of Casella, which is estimated to be a budgetary cost saving.

The presentation is available on the publications page of our corporate website.

Next regarding our clinical development progress our first line colorectal phase III trial is continuing to enroll patients.

In late April we initiated preserved to our second pivotal phase III trial, which is a randomized double blind placebo controlled study of casella in patients receiving first or second line jumped side of being and Carboplatin chemotherapy.

Rajesh K. Malik: This type of simultaneous update of two NCCN guidelines is not only rare but also a testament to the multidisciplinary importance of this breakthrough therapy. Gaining inclusion into relevant guidelines also drives inclusion into oncology care pathways, which is a vital part of our strategy to ensure appropriate patient access, as these recommendations facilitate payer reimbursement and patient access. We have submitted data packages to the Oncology Care Pathway Committees via their formal submission process.

For locally advanced Unresectable or metastatic triple negative breast cancer.

This cancer comprises up to 20% of all breast cancers and is an aggressive disease with poor outcomes.

Because the tumor is negative for estrogen progesterone on her two receptors. Thus the term triple negative.

Patients do not respond well to carbon medications block hormone or her two receptors.

Instead treating T M. B C. Typically consists of using chemotherapy combinations in addition to radiation and surgery.

Therefore, there is a significant medical need for well tolerated and efficacious therapies with novel mechanisms of action.

Rajesh K. Malik: G1 has a very robust publication plan on which we are. For example, 18 trialocyclic peer-reviewed manuscripts have been published to date, eight of which were in 2020 or 2021, and several others have been submitted and are under review. In addition, we have submitted abstracts for presentation at eight different medical meetings in 2021. At the AMCT meeting, we presented the budget impact of prescribing Cocella to decrease the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small cell lung cancer from the perspective of a third-party payer. The model created and compared two scenarios for this analysis, over a five-year time horizon in a hypothetical plan with one million members in total.

The study is enrolling two cohorts of patients cohort one will enroll 170 patients receiving first line therapy, regardless of tumor PDL, one status, who have not been previously treated with a PD one or PDL one inhibitor.

Cohort two will enroll 80 patients with a PD lone positive tumor receiving second line therapy. Following prior PD, one or PDL, one inhibitor therapy.

These two cohorts are adequately powered and considered independent of each other.

Within each cohort enrolled patients will be randomized one to one to receive either <unk> or placebo prior to Jim side of being on Carboplatin therapy administered intravenously on days, one and eight in 21 day cycles, which is the same dosing regimen used in group two of our positive.

Rajesh K. Malik: The first, which was a pre-launch scenario, outlined the economics and outcomes associated with standard extensive stage small cell lung cancer treatments before Cothela was available. The second, which was the post-launch scenario, displayed the economics and outcomes projected to evolve when those same standard treatments are needed with Cocella being given. The results are compelling. Chemotherapy-induced adverse events in patients treated with extensive-state small-cell lung cancer were estimated to be fewer over five years in the scenario where Clothela is available, resulting in a net financial impact of Cosella, which is estimated to be a budgetary cost-saver.

Phase II study.

Treatment will continue until progressive disease unacceptable toxicity withdrawal of consent investigator decision on the end of the study whichever occurs first.

The primary endpoint in both cohorts is to evaluate the effect of casella on overall survival compared with placebo.

Secondary objectives in cohort one include assessments of Casella has impact on overall survival and PD lone positive and PD, one negative groups and on progression free survival compared to placebo.

Rajesh K. Malik: The presentation is available on the publications page of our corporate website. Next, regarding our clinical development progress, our first-line colorectal phase 3 trial is continuing to enroll patients. In late April, we initiated PRESERVE-2, our second pivotal Phase 3 trial, which is a randomized double-blind placebo-controlled study of Cocella in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple negative breast cancer. This cancer comprises up to 20% of all breast cancers and is an aggressive disease with poor outcomes. Because the tumor is negative for estrogen, progesterone, and HER2 receptors, thus the term triple negative.

Cohort two on progression free survival compared to placebo.

The key secondary objective in both arms includes assessment of the effect of Casella on patients' quality of life as measured by time to first two from deterioration of T compared with placebo.

Other secondary endpoints in both arms will evaluate the effect of casella on measures of antitumor activity, including overall response rate clinical benefit rate and duration of response.

And the model of protection effect of Casella on.

Multiple measures of multi lineage motto suppression, Inc.

<unk> neutrophils red blood cells and platelets.

Rajesh K. Malik: Patients do not respond well to common medications that block hormone or HER2 receptors. Instead, treating TMBC typically consists of using chemotherapy combinations, in addition to radiation and surgery. Therefore, there is a significant medical need for well-tolerated and efficacious treatments with novel mechanisms of action. The study is enrolling two cohorts of patients. Cohort 1 will enroll 170 patients receiving first-line therapy, regardless of tumor PD-L1 status, who have not been previously treated with a PD-1 or PD-L1 inhibitor. Cohort 2 will enroll 80 patients with a PD-L1 positive tumor receiving second-line therapy following prior PD-L1 or PD-L1 inhibitor therapy. These two cohorts are adequately powered and considered independent of each other.

We expect these pivotal data to readout in the second half of 2023.

We also remain on track to initiate two additional phase II trials of <unk> this quarter.

One in second and third line treatment on non small cell lung cancer.

And the other in first line treatment of locally advanced or metastatic bladder cancer bladder cancer or metastatic <unk> carcinoma.

Finally, turning to rental desk strength, our oral surgery.

We will present phase two data from a combination of rental desktop with Alba cyclists and 40 patients with ER positive <unk> negative breast cancer at ESMO later on this quarter on our press release will coincide.

We will provide the details of the presentation as soon as the embargo policy allows.

With that I'll turn the call over to Jenn for her to review the results of the first quarter.

Rajesh K. Malik: Within each cohort, enrolled patients will be randomized one-to-one to receive either casella or placebo prior to gemcitabine and carboplatin therapy administered intravenously on days 1 and 8 in a 21-day cycle, which is the same dosing regimen used in group 2 of our positive phase 2 study. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, investigator decision, or the end of the study, whichever occurs first The primary end point in both cohorts was to evaluate the effect of Casella on overall survival compared with placebo.

Jeff.

Thanks, Raj and good afternoon, everyone as Lou mentioned full financial results for the first quarter of 2021.

Available on our press release.

Q.

Today I'd like to focus on a few key points from our disclosures.

Our total revenue for the first quarter of 2021, $14 2 million comprised of net product revenue of $1 6 million and license revenue of $13 6 million.

We recognize product revenue upon delivery of cross sell it to our specialty distributors first quarter product revenue includes net product sales from our first shipments in March following FDA approval.

Our license revenue was primarily related to development milestone payments from our license agreement with <unk>, which provides them with development and commercialization rights for trailers cyclin across all indications in greater China.

Rajesh K. Malik: Secondary objectives in Cohort 1 include assessments of Cosella's impact on overall survival in PD-L1 positive and PD-L1 negative patients and on progression-free survival compared to placebo, and for Cohort 2 on progression-free survival compared to... The key secondary objective in both arms is the assessment of the effect of Casella on patients' quality of life as measured by time to first-to-firm deterioration of fatigue compared with

And revenue from AQR acts with whom we have a license agreement from <unk> cyclists.

The revenue from each of our ex relates to delivery of clinical drug supply and manufacturing services and reimbursement on clinical trial costs.

In addition, we recognized revenue related to achievement of a development milestone budget norm.

It's worth noting that while we do expect to continue to receive modest expense reimbursements and payments under our supply agreements from our partners. We do not expect to receive this amount of license revenue in any one quarter or for the remainder of this year.

Rajesh K. Malik: Other secondary endpoints in both arms will evaluate the effect of Cosella on measures of anti-tumor activity, including overall response rate, clinical benefit rate, and duration of response, and the Mahler protection effect of Cosella, and multiple measures of multilineage model suppression, including neutrophils, red blood cells, and platelets. We expect these pivotal data to read out in the second half of 2020. We also remain on track to initiate two additional Phase II trials of Cothela this quarter, one in second and third line treatment of non-small cell lung cancer and the other in first-line treatment of locally advanced or metastatic bladder cancer or metastatic urofilial carcinoma.

Cost of goods sold for the three months ended March 31, 2021 with minimal as the majority of the manufacturing costs related to the first quarter <unk> sales were incurred prior to FDA approval and therefore were recorded as R&D expense in prior periods.

The prior expensing of these costs will continue to impact presentation on cost of goods sold in future period until initial prelaunch inventory is depleted and additional inventory manufactured installed.

G. Once research and development expenses for the first quarter of 2021 was $16 5 million compared to $20 4 million for the first quarter of 2020.

Rajesh K. Malik: Finally, turning to Rinto Deshchand, our oral surge. We will present phase two data from our combination of RintoDestrant with PalvoCyclid in 40 patients with ER-positive, HER2-negative breast cancer at ASCO later this quarter, and a press release will accompany it.

The decrease was primarily due to a decrease in costs from manufacturer of active pharmaceutical ingredient that drug product to support clinical trials as well as a decrease in external costs related to discovery and preclinical development.

Rajesh K. Malik: We will provide the details of the presentation as soon as embargo policy allows. With that, I'll turn the call over to Jen for her to review the results of the first quarter.

Our selling general and administrative expenses for the first quarter of 2021 or $23 million compared to 11 4 million for the first quarter of 2020.

Jen Moses: Thanks, Raj. And good afternoon, everyone. As Will mentioned, full financial results for the first quarter of 2021 are available in our press release and in. Today, I'd like to focus on a few key points from our disclosure. Our total revenue for the first quarter of 2021 was $14.2 million, comprising net product revenue of $0.6 million and license revenue of $13.6 million. We recognize product revenue upon delivery of Cosella to our specialty distributors.

The increase was largely due to an increase in compensation costs due to increased head count and increased commercialization activity.

We ended the first quarter with cash and cash equivalents of 279 million, which included $86 4 million net proceeds from our at the market offering with Cowen.

As a reminder, this activity utilized all remaining capacity under the sales agreement. So this ATM offering is now closed.

We also drew an additional $10 million on the debt financing facility with Hercules capital and entered into an amendment to the agreement, which provided slightly lower interest charges and additional covenant relief on our future tranche of debt.

Jen Moses: First quarter product revenue includes net product sales from our first shipments in March following FDA approval. Our license revenue was primarily related to development milestone payments from our license agreement with Concierge, which provides them with development and commercialization rights for trial recyclables across all indications in Greater China, and revenue from eQRX, with whom we have a license agreement for Lerocyte. The revenue from EQRx relates to the delivery of clinical drug supply and manufacturing services and reimbursement of clinical trial costs.

There is currently $70 million of capacity remaining on the Hercules facility.

We expect our current financial position to be sufficient to fund operations into 2023.

With that I'll turn the call back over to Jack Jack.

Thank you Jim Rusche Soma well before we conclude this portion of the call go to Q&A I want to thank the people living with cancer and their health care professionals for their inspiration.

Jen Moses: In addition, we recognize revenue related to the achievement of a development milestone by Junor. It's worth noting that while we do expect to continue to receive modest expense reimbursements and payments under our supply agreements from our partners, we do not expect to receive this amount of license revenue in any one quarter for the remainder of this year. Cost of goods sold for the three months ended March 31st, 2021 was minimal as the majority of the manufacturing costs related to the first quarter of Cosella sales were incurred prior to FDA approval and, therefore, were recorded as R&D expense in prior periods.

Particular, given that May is oncology nurse nurse month I'd like to personally. Thank these nursing professionals for the incredible work. They do you are truly the frontline of care for people living with cancer and work with them every step of the way from diagnosis on.

We appreciate the opportunity to be part of and helped support Europe too.

I would also like to thank the <unk> for your continued dedication to improving the lives.

Cancer patients as we execute on our clinical and commercial programs, we will have the opportunity to impact a lot of lives your dedication and drive matters.

Jen Moses: The prior expensing of these costs will continue to impact presentation of cost of goods sold in future periods until initial pre-launch inventory is depleted and additional inventory is manufactured and sold. G1's research and development expenses for the first quarter of 2021 were $16.5 million, compared to $20.4 million for the first quarter of 2020. The decrease was primarily due to a decrease in costs for the manufacture of active pharmaceutical ingredients and drug products to support clinical trials, as well as a decrease in external costs related to discovery and preclinical development. Selling general and administrative expenses for the first quarter of 2021, or $23 million, compared to $11.4 million for the first quarter of 2020. The increase was largely due to an increase in compensation costs due to increased headcount and increased commercialization activity.

As I mentioned on the last call. The first quarter of 2021 was transformational for Q1 and I'm happy to report that we are well along in turning the corner on becoming a commercial organization without losing focus on our clinical endeavors.

We will keep you up to date as possible on our commercial rollout of casella to these leading and lagging indicators of both interest and uptake, which we intend to provide every quarter along with our revenue results. However on this call. We described some patient numbers to help you understand our early trajectory we do.

Not new tend to provide them every quarter as we start to get into our revenue generation.

Again before we move to Q&A, let me just recap what you've heard today.

The combined sales team is executing on its launch program and achieving good early metrics of engagement and adoption of cross sell.

We see no issues on coverage and expect to hear about our permanent J C. <unk> codes in the second half of this year.

Jen Moses: We ended the first quarter with cash and cash equivalents of $279 million, which included $86.4 million in net proceeds from our at-the-market offering with Cowen. As a reminder, this activity utilized all remaining capacity under the sales agreement, so this ATM offering is now closed. We also drew an additional $10 million on the Debt Financing Facility with Hercules Capital and entered into an amendment to the agreement which provided slightly lower interest charges and additional covenant relief on a future tranche of debt.

Our medical affairs team to sell over 350 medical to medical engagements across the MSL team since FDA approval driving education on Casella and interest in the G. One scientific platform.

We have a strong publications program on which the medical team is executing including the recent presentation of data showing that the net financial impact of co seller is estimated to be cost savings from a budget standpoint.

<unk> was added to two different mtc and guidelines in late March, which we expect to facilitate timely payer reimbursement and ongoing patient access.

Jen Moses: There is currently 70 million of capacity remaining on the Herculean facility. We expect our current financial position to be sufficient to fund operations into 2020. With that, I'll turn the call back over to Jack.

We recently initiated our pivotal trials in TWC with data expected in 2023.

We also expect to initiate our phase III programs in non small cell lung cancer and bladder cancer later this quarter, giving us five ongoing late stage trials and numerous readouts coming over the next 24 months and finally, we have a cash runway that takes us into 2023 with options.

John E. Bailey: Thank you, Jen, Raj, Sam, and Will. Before we conclude this portion of the call and go to Q&A, I want to thank the people living with cancer and their healthcare professionals for their inspiration. In particular, given that May is Oncology Nurse Month, I'd like to personally thank these nursing professionals for the incredible work they do. You are truly the front line of care for people living with cancer. And walk with them every step of the way from diagnosis onward.

To extend that further.

Thank you for your time. This afternoon, we will speak again in this format in the August call for Q2 earnings but between now and then we look forward to connecting with many of you at the upcoming virtual health care conferences and non deal Roadshows in the weeks ahead.

With that I'll close the call and turn it over to Q&A. Operator would you. Please remind our listeners how to ask a question.

John E. Bailey: We appreciate the opportunity to be part of and help support your community. I would also like to thank the G1 team for your continued dedication to improving the lives of cancer patients. As we execute on our clinical and commercial programs, we will have the opportunity to impact a lot of lives. Your dedication and drive matter.

As a reminder to ask a question you will need to press star one on your telephone keypad to withdraw your question. Please press the pound key.

Standby, while we compile the Q&A roster.

John E. Bailey: Now, as I mentioned on the last call, the first quarter of 2021 was transformational for G1. And I'm happy to report that we are well along in turning the corner on becoming a commercial organization without losing focus on our clinical endeavors. We will keep you up-to-date, as possible, on our commercial rollout of Cosella through these leading and lagging indicators of both interest and uptake, which we intend to provide every quarter, along with our revenue results. However, on this call, we describe some patient numbers to help you understand our early trajectory. We do not intend to provide them every quarter as we start to get into revenue generation.

Our first question comes from the line of Mr. Thumps leader from BTG. Please go ahead.

Hi, This is Kelly on for Tom Thanks for taking our question I just have one on the Oh sorry.

With all the update from the other three programs like Sanofi than Genentech has the bar.

Or what has to be seen for them into desk from changed.

Yes. Thanks for the question really appreciate it I would say our internal measure that we.

We've communicated of CBR 24 between 60, and 65% really remains to your point as more data comes out in the <unk> class both on the efficacy and the Tolerability and side effect standpoint, we will continue to monitor that but we believe if we can match the profile and strong tolerability.

John E. Bailey: Again, before we move to Q&A, let me just recap what you've heard today. The Combined Sales Team is executing on its launch program and achieving good early metrics of engagement and adoption of Coacella. We see no issues in coverage and expect to hear about our permanent J, C, and NTAP codes in the second half of this year.

And fifth a CVR in that range.

We will consider that.

Good a good result.

Great. Thank you and congrats on the progress.

Thank you very much I appreciate it.

Our next question comes from the line of consistently but Theyre from Roth capital. Please go ahead.

John E. Bailey: Our medical affairs team has held over 350 meetings with doctors across the MSL team since FDA approval, driving education on Cocella and interest in the G1 scientific platform. We have a strong publications program on which the medical team is executing, including the recent presentation of data showing that the net financial impact of Cocella is estimated to be cost savings from a budget standpoint. Cocella was added to two different NCCN guidelines in late March, which we expect to facilitate timely payer reimbursement and ongoing patient access.

Thanks, very much Soma.

I appreciate the presentation on the color, but I have to ask.

Can you describe.

Any payers that had a pushback, but importantly, how old it Howard.

How are the field agents able to actually deal with that pushed back I think it's important.

There's a lesson to be learned.

And then the second question involves around it.

The discussions that you've been having with payors, who have yet to sign.

John E. Bailey: We've recently initiated our pivotal trial in TMBC, with data expected in 2023. We also expect to initiate our Phase II programs in non-small cell lung cancer and bladder cancer later this quarter, giving us five ongoing late-stage trials and numerous readouts coming over the next 24 months. And finally, we have Cash Runway that takes us into 2023 with options to extend that further. Thank you for your time this afternoon.

Contracts or incorporate.

Portola within their reimbursement.

Again can you can you discuss.

Where the.

Any rate limiting steps that may be occurring at least today, thanks very much.

Sure Tony.

Here from me so on both points.

No.

As I said in my comments, we have had very little pushback from Payors.

At this stage and so at this point what's happening is.

Operator: We will speak again in this format on the August call for Q2 earnings, but between now and then, we look forward to connecting with many of you at the upcoming virtual healthcare conferences and non-deal roadshows in the weeks ahead. With that, I'll close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask a question? As a reminder, to ask a question, you will need to press star 1 on your telephone keypad. To withdraw your question, please press the ground key.

Physicians are choosing to write that theyre, putting it in.

And theyre not having issues and in fact as you know we have this one to one service.

So the cases had to come through there same thing no problems I think at this stage.

The label and so to answer your second question.

The second question around the policies is that the process. There's presentations that are given we've done those presentations that cover about 80% of lives at this stage they.

They are well underway.

And then they all take their time to.

The data understand the data understand the benefit and then.

Operator: Stand by while we compile the Q&A. Our first question comes from the line of Mr. Tom Schrader from DTIG. Please go ahead. Hi, this is Kaveri for Tom.

And then write the policy and so as I said.

We got the first policy from anthem at the end of March. So we were very happy about that I think different.

Different insurance companies basically handle that in different ways on take time on different timelines. So we think that might take anywhere between could take six months for all of them to come on board on right. Their individual policies. Some of them came on anthem came on very early on the progress on the progress.

Kaveri Pohlman: Thanks for taking our call. I just have one question: with all the updates from the other third programs, like Sanofi and Genentech, there is a bar for what has, for Winter Deaf Friendship. Yeah, thanks for the question. I really appreciate it. I would say our internal measure that we communicated of CBR 24 between 60 and 65 percent really remains. To your point, as more data comes out in the CERT class, both on the efficacy and the tolerability and side effects, we'll continue to monitor that.

I would say overall.

This is not on the area with the payers, where we're seeing a lot of pushback on issue.

And so even to answer your question about how the reps are handling at the.

The rates aren't really having to handle it because it hasn't really been that much of an issue to date again, we think we've fairly price that we.

We think people understand multi lineage that theyre getting the benefit of not just what they got with G CSF or others, but theyre cutting on the other pieces and I think that that goes a long way in terms of the value proposition on cross all of it but we're very encouraged by.

Kaveri Pohlman: But we believe if we can match the state's profile and strong tolerance and hit a CBR in that range, we'll consider this a good result. Thank you, and congratulations on the project. Thank you very much; I appreciate it. Our next question comes from the line of Mr. Tony Butler from Roth Capital; please go ahead. Thanks very much. Soma, I appreciate the presentation and the color, but I have to ask, can you describe any payers that had a pushback, but importantly, how did, and how are the field agents able to actually deal with that pushback? I think it's important as a lesson to be learned.

By the progress on the payer front today.

Thank you very much.

Our next question comes from the line of Mr. Chad message Union from Needham. Please go ahead.

Okay.

Great. Thanks for taking my question and.

Thanks to the whole team for.

All the added color today and.

Yes.

My.

Credit.

Analyst a special thanks, so much for all of her color.

John E. Bailey: And then the second question involves around... the discussions that you've been having with payers who have yet to sign contracts or incorporate. Again, can you discuss any rate-limiting steps that may be occurring, at least to date? Thanks very much.

So am I may need to.

Replay parts of your.

Prepared remarks today at two thirds speed so I can.

Absorb it all.

On an inferior.

Priyanka Arun Grover: Yes, sure, Tony. It's nice to hear from you. So on both points, as I said in my comments, we have had very little pushback from payers at this stage. And so, at this point, what's happening is physicians are choosing to write them, they're putting them in, and they're not having issues. And in fact, as you know, we have this G1 to 1 service, so the cases that have come through there, same thing, no problems.

Our ability to process.

Information.

Clearly, Florida in years, but if we could just dive into.

A couple of things I'm trying to get a hold on.

And I get it so we're talking about the very earliest days, it's a very flash time point in the launch things do sound like theyre going well, but $600000 in sales.

Priyanka Arun Grover: I think at this stage, it's PA to label. And so to answer your second question, you know, the second question around the policies is that the process is there are presentations that are given. We've done those presentations that cover about 80% of lives at this stage. They are well underway.

Through that very end of March I believe if I have my notes down correct. You guys are estimating that's about 30 patients that you treated maybe some context on that number I know it's.

Priyanka Arun Grover: And, you know, they all take their time to, you know, review the data, understand the data, understand the benefits, and then write the policy. And so, as I said, we got the first policy from Anthem at the end of March, so we were very happy about that. I think different insurance companies basically handle that in different ways and take time on different timelines.

A months.

Early data, but like are we 2%, 20%, 40% and then you also I believe again I've got to read my own.

Notes, but 60 40 on the community academic breakdown and 60 <unk> 10 on the net be commercial and government breakdown.

Priyanka Arun Grover: So we think that might take, you know, anywhere between, it could take six months for all of them to come on board and write their individual policies. Again, we think we've fairly priced it. We think people understand the multilineage, that they're getting the benefit of not just what they get with GCSF or others, but they're getting the other pieces. And I think that that goes a long way in terms of the value proposition of COSELLA.

Can you give us some context on where those.

Or and where we think they need to be like.

Again, it's.

It's just the first few weeks, we're all going to over analyze it that's what we do.

But sort of where where are we on those if you could give us come from.

Priyanka Arun Grover: But we're very encouraged by the progress on the payer front. Thank you very much. Our next question comes from the line of Mr. Chad Messer Jr. from Needham, please go ahead. Great, thanks for taking my question and thanks to the whole team for... We'll be at color today and, Analyst, a special thank you so much for all of her color. Some of my may need to replay parts.

Yeah, absolutely yeah.

Yes.

I tend to be a fast talking to Europe as you may know.

So I appreciate that but interestingly you've got all the numbers correct.

So that's the first thing so on the 30 patient so what I can tell you about a 30 patient. It is an estimate because it's the way that the data comes in to us as we see.

Different accounts with first of all we see accounts and so accounts will order and we'll be able to see okay. That's person. They ordered five miles that's probably a second line patient person. They ordered six filed that's probably as a first line patient so we're doing a little bit.

Priyanka Arun Grover: I'd like to make a couple of remarks today at two-thirds speed, absorb it all, um, and hear your... A couple of things I'm trying. And I get it, so we're... very flash time point in the long do sound like they're going. $600,000 in sales, through that very end. I believe if I have, you guys are...?? www.youtube.com or the link in the video description of early data, but like www.youtube.com 60-40 on, [inaudible] 60-30-10 on the meds.

Math together, our best estimate around the patient, but we didn't think it was important to be able to give a perspective on how many patients. We think went on track on we think it's about 30 other that 30, we think.

We think about half of those are definitely first line patients. We think about 25% on those might be second line and then about 25% of simple. We're just not sure based on the way the order and came in so that's a little bit of color at least on the patient peaks in terms on where we think on it.

We think that's very positive we think Directionally 30 patients was great.

This is a this is a disease when you think about it.

Priyanka Arun Grover: Can you give us some context on where those are and where they are? Like, you know, I again... For the first few weeks, we're all going to overanalyze it. Um, but sort of where, where, Yeah, absolutely. So, yes, I tend to be a fast-talking New Yorker, as you may know, so I appreciate that. But interestingly, you got all the numbers correct, so that's the first thing. So on the 30 patients, what I can tell you about the 30 patients is that it is an estimate because the way that the data comes into us is we see different accounts.

There is only 30000 patients that present in a given year all of those 17 to 18000 are first line about 10000 are second line on the kind of the remainder are third party inspections don't really make it through multiple lines of therapy. So when you think about that on them. So you take that number that you can kind of do it on a monthly basis, the number of patients walking and every month.

Not that big.

And so for US we thought 30 patients with a good buffer for the first month of launch that's the first thing.

The other numbers that you mentioned the 60 40 communities, but we actually think that's going to move closer to 70 30 over time.

What might have happened in this instance community sometimes the community institutions, the larger practices they have longer processes to kind of pull it through.

The whole process I talked to you about cutting piceance team on opening it up from the top sometimes that perhaps is a little bit longer and some other community accounts and then some of the academic accounts such as it goes faster because they can get access to the things they need to that might be why wait a little bit heavier on academic.

Priyanka Arun Grover: First of all, we see accounts, and so accounts will order vials, and we'll be able to see, okay, that person ordered five vials, that's probably a second-line patient; that person ordered six vials, that's probably a first-line patient. So we do a little bit of math to get at our best estimate around the patient. But we did think it was important to be able to give a perspective on how many patients we think went on drugs, and I think it's about 30.

I think what we expect to see a steady state, which in my mind would be more like 70 30 on the payer mix on 63 10.

That is that's actually what we expect to see so that was actually right in line with exactly how we expected to come in again on these patients average weighted 65 and.

65, so we know that's a heavily on Medicare population so to assume it's about 60% is a reasonable 31st on commercial and then 10% kind of <unk> and others. So I think.

Priyanka Arun Grover: Of those 30, we think, you know, we think about half of those are definitely first-line patients. We think about 25% of those might be second-line, and then about 25% of them were just not sure, based on the way the orders came in. So that's a little bit of coloring, at least on the patient piece.

In General we think this is actually the patient count again instead of estimates.

We feel very good about what the patient count is.

And where we were able to get to on the first month on as I said the other two metrics ideal arent very in line with what we expected.

Yes.

Alright, well really.

Priyanka Arun Grover: And, you know, in terms of where we think that is, I mean, we think that's very positive. We think directionally, 30 patients were great for four weeks. This is a disease, when you think about it, you know, there are only 30,000 patients that present in a given year. Of those, 17,000 to 18,000 are first-line, about 10,000 are second-line, and then kind of the remainder are third-line.

And in fleet debt.

My permission to take a breath. Thank you.

Yeah.

Yes.

Yeah.

[laughter].

Our next question comes from the line of Mr. Joe Thome from Cowen and company. Please go ahead.

Hi, there. Thank you for taking my questions first one just on the PNT approval process.

Process.

Given kind of the COVID-19 pandemic timeframe on what's the average time from sort of initial presentation to the hospital for.

Priyanka Arun Grover: These patients don't really make it through multiple lines of therapy. So when you think about that, and you take that number that you kind of do it on a monthly basis, the number of patients walking in every month is not that big. And so, for us, we thought 30 patients was a good number for the first month of launch. That's the first thing.

For it to get through the PMT Committee and then.

Second is it possible to use casella concomitantly with other.

GM CSF products in clinical practice I know on clinical study, we saw obviously reduce need but is it still reimbursable after lunch. Thank you.

Priyanka Arun Grover: The other numbers that you mentioned, the 60-40 community split, we actually think that's going to move closer to 70-30 over time. We think that what might have happened in this instance is that the community, sometimes the community institutions, the larger practices, they have longer processes to kind of pull it through. And, you know, the whole process I talked through about getting PNT and opening it up from the top, sometimes that process is a little bit longer on some of the community accounts.

Great. Thanks, Joe.

I'll quickly address the first one then I'll flip the second one over to Raj.

Terms. So what is your typical PUC timeline, just almost point this is really.

Very individualized its on an account by account basis, depending on either the institutional large hospital institution versus a large practice. So the team is monitoring. This we've got a good sense for a lot of them of when they will occur but to be honest with you the picture really the duration of.

Priyanka Arun Grover: And in some of the academic accounts, that just goes faster because they can get access to the things they need. So that might be why it weighed a little bit heavier on academics than we, I think, what we expect to see at SteadyState, which in my mind would be more like 70-30. On the payer mix of 60-30-10, you know, that's actually what we expect to see.

When they start on how long it takes really does vary account by account, but the team is heads down executing on this and making sure. They have the information they need to be able to hopefully move through that process as quickly as possible rush.

Yeah happy to so in our in our trials, which allows the use of gcs.

Priyanka Arun Grover: So that was actually right in line with exactly how we expected to come in. Again, these patients, the average age is 65, so we know that the Medicare population is heavily composed of seniors, so to assume it's about 60% is reasonable, 30% commercial, and then 10% kind of VA, DOD, and others. So I think that in general, we think this is actually, the patient count, again, it's an estimate, but we feel very good about what the patient count is and where we were able to get to in the first month. As I said, the other two metrics are very in line with what we were expecting. All right, well, I really appreciate the extra color.

And what we have.

<unk> found it was a substantial decrease in the need for G. CSF when when Costello is Kevin.

There were no safety issues with giving both.

Casella and G CSF.

So we think in process because of the proactive approach with casella.

Ascribe hours will initially use casella and also having a multi lineage benefit.

And could have the option of using G. CSF it needed down the road.

Okay perfect. Thank you very much.

Thanks, Joe.

Priyanka Arun Grover: Please accept my permission to take a breath. [inaudible] Our next question comes from the line of Mr. Joe Thomp from Cohen and Company. Please go ahead. Hi there.

Our last question comes from the line of Mr. Ed White from H C. Wainwright. Please go ahead.

Okay.

Good evening, Thanks for taking my questions.

Joseph John: Thank you for taking my questions. First one, just on the P&T approval process, given kind of the COVID pandemic timeframe, what's the average time from sort of initial presentation to the hospital for it to get through the P&T committee? And then second, is it possible to use Casella concomitantly with other GM-CSF products in clinical practice?

Thanks for the update on rental.

Just wondering if you can.

Briefly review your strategy, there again and has there been interest from partners.

For that product and then a quick question on for Jim.

Just that.

The.

Cash.

John E. Bailey: I know in the clinical study, we saw obviously reduced need, but is it still reimbursable after launch? Great, thanks Joe. I'll quickly address the first one, then I'll flip the second one over to Raj. In terms of what is your quote typical PFT timeline, to Soma's point, this is really very individualized. It's on an account-by-account basis, depending on either the institution, a large hospital institution versus a large community practice.

Runway into 2023 does that include the $70 million left from the Hercules.

Deal. Thanks.

Good to hear from you Ed I'll answer the first one is enough flip it over to Jim to hit your second question in terms of printer debt strength, we are still on.

The same path that we communicated last year, we believe given the competitive nature.

Rajesh K. Malik: So the team is monitoring this. We've got a good sense for a lot of them about when they will occur. But to be honest with you, the dates really, the duration of A, when they start, and how long it takes, really does vary account-by-account. But the team is heads down, executing on this, and making sure they have the information they need to be able to, hopefully, move through that process as quickly as possible.

The class the cash.

Cost of the phase III development programs, let alone.

The significant investment to commercialize we think the best use of shareholder capital just a partner that to your point, we have had interest in it and have had discussions obviously as we released the data at Astro that'll be the next logical milestone here, where we'll follow up on a lot of those discussions, but we're still on on path to.

Rajesh K. Malik: Raj, you want to grab the second question? Yeah, happy to. In our trials, we allowed the use of GCSF. And what we actually found was a substantial decrease in the need for GCSF when Cosella was given, but there were no safety issues with giving both Cosella and GCSF.

From a partner that is really <unk>.

Fully deploy our capital behind on trials Cypress development plan, Jim on Pik.

Sure.

When were giving guidance, we run at a number of different ways and for early stages of revenue looking at a bunch of different options, but we are not utilizing the full $70 million to get to 2023.

Rajesh K. Malik: So we think in practice, because of the proactive approach with Cocella, prescribers will initially use Cocella and also have that multi-lineage benefit and could have the option of using GCSF if needed down the road. Perfect. Thank you very much. Thank you, Joe. Our last question comes from the line of Mr. Ed White from H.C. Wainwright. Good evening.

So I hope that answers your question.

That does guidance. Thank you.

Thanks, Ed.

Yes.

Okay. It looks like its the last question.

So let me just conclude by saying we are very excited to be bringing <unk> to patients with extensive stage small cell lung cancer and to our clinical teams to many more patients with a variety of different cancers as always I look forward to keeping you all updated as we move forward and certainly we will continue to be as transparent and proactive as possible in this regard so.

Edward Patrick White: Thanks for taking my questions. Thanks for the update on Rinto. Just wondering, you know, if you...

John E. Bailey: Briefly review your strategy there again, and has there been interest from partners for that product? And then a quick question for Jen, just that... The cash runway into 2023, does that include the $70 million left from... Thank you. It's good to hear from you, Ed. I'll answer the first one and then flip it over to Jim to hit your second question. In terms of rent-to-vest rent, we are still on the same path that we communicated last year. We believe, given the competitive nature of the class, the cost of the Phase 3 development programs, let alone the significant investment to commercialize it, the best use of shareholder capital is to partner with that.

To everyone listening. Thank you for joining us today, please stay healthy and well look forward to talking soon thank you.

Yes.

This concludes today's conference you may now disconnect.

Okay.

Yes.

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John E. Bailey: To your point, we have had interest in it and have had discussions. Obviously, as we release the data at ASCO, that will be the next logical milestone here where we'll follow up on a lot of those discussions. But we're still on the path to be able to partner with that and really fully deploy our capital behind the Try the Cycles development plan. Jen, do you want to take the second one?

Jen Moses: Sure. So, Ed, when we're giving guidance, we run it a number of different ways. For the early stages of revenue, we look at a bunch of different options, but we are not utilizing the full $70 million to get to 2023. So, I hope that answers your question.

Jen Moses: Thanks, Ed. Okay, that looks like it's the last question, so let me just conclude by saying we are very excited to be bringing Cocella to patients with extensive stage small cell lung cancer and to our clinical teams to many more patients with a variety of different cancers. As always, I look forward to keeping you all updated as we move forward, and certainly, we will continue to be as transparent and proactive as possible in this regard. So, to everyone listening, thank you for joining us today. Please stay healthy and well. We look forward to talking to you soon. Thank you. This concludes today's conference.

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Yes.

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