Q2 2020 G1 Therapeutics Inc Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to be G. One therapeutics second quarter 2020 fiscal results conference call. At this time, all participants' lines or any listen only mode. After the speakers presentation. There will be a question and answer session to ask a question. During the session you want me to press Star.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to G1 Therapeutics' 2nd Quarter 2020 Fiscal Results. At this time, all participants' lines are in a listen-only mode. After the speaker's presentation, there will be a question... To ask a question during the session, you will need to press star 1 on your remote control. If you require any further assistance, please press star. I would now like to hand the conference over to your speaker today, Mr. Jeff McDonald. Thank you. Please go ahead.
One on your telephone if you require any further assistance please press star zero.
Alan I'll highlight and the conference over to your speakers today Mr., Jeff Mcdonald. Thank you. Please go ahead Sir.
Jeff McDonald: Thank you, Operator. Good afternoon, everyone, and welcome to the G1 Therapeutics second quarter of 2020 Corporate Financial Update. On today's call, Mark Beleka, Chief Executive Officer, Soma Gupta, Chief Commercial Officer, Raj Malik, Chief Medical Officer and Senior Vice President, R&D, and Jen Moses, Chief Financial Officer, will provide an update on the quarter with Q&A to follow. Before we begin, I would like to remind you that this call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from expected results.
Thank you operator.
Afternoon, everyone and welcome everyone Therapeutics second quarter 2020, corporate financial update on today's call Mark Bullock, Chief Executive Officer, Soma Gupta, Chief Commercial officer Broad Malek, Chief Medical Officer, and senior Vice President R&D engine, those as Chief Financial Officer will provide an update of the quarter accumulate to follow.
Before we begin I'd like to remind you of this call will include forward looking statements based on current expectations such statements represent management's judgment as of today and they involve risks and uncertainties.
Actual results to differ materially from expected results. Please refer to our buys with the FCC, which are available from the FCC on our corporate website for information concerning risk factors that could affect the company now I'll turn the call on remark.
Thanks, Jeff Good afternoon, everyone and thank you for joining US we hope that you and your families are well.
On today's call, Jim and I will discuss how our recently announced financing and partnering agreements have enabled us to sharpen our focus on maximizing the potential of trial sites the benefit patients across multiple indications.
So Bob will provide an overview of the trial sites with launch strategy, including our partnership with Barrington behind.
Raj will comment on how our medical team is supporting trial and also review the robust development plans, we are implementing to evaluate try less likely to potential beyond small cell lung cancer.
After our prepared remarks, well open the call for questions.
Jeff McDonald: Please refer to our plans with the SEC, which are available from the SEC or on our corporate website, for information concerning risk factors that could affect the company. Now, I'll turn the call over to Mark. Thanks, Jeff.
At the beginning of the year, we outlined our corporate strategy to focus on the development and commercialization of trials cyclists, along with continuing to advance rate pedestrian has the best way to serve patients and create value for shareholders.
To that end our goals in 2020 included one completing our first new drug application or NVCA.
Mark: Good afternoon, everyone, and thank you for joining us. We hope that you and your families are doing well. On today's call, Jen and I will discuss how our recently announced financing and partnering agreements have enabled us to sharpen our focus on maximizing the potential of trilocytes to benefit patients across multiple indications. Selma will provide an overview of the Trilocyclic launch strategy, including our partnership with Barringer Ingleheight. Raj will comment on how our medical team is supporting TRILA and also review the robust development plans we are implementing to evaluate TRILA-Cyclib's potential beyond small cell lung cancer. After our prepared remarks, we'll open the call for questions.
To establishing a commercial infrastructure to execute the trial sites with larger strategy three initiating a combination trial of rental debts, Trent and pelvis cycling and for identifying non dilutive funding to support the launch and continued development of trial.
I'm pleased to report today that we have delivered on all of those goals.
We have completed the trial and the filing and initiated the rental Palbo combination trial in June as scheduled we closed four strategic partnerships that collectively brought in $40 million in upfront payments up to $486 million in milestone payments plus royalties and.
Bolstered the launch of trial of cycling in the U.S.
In addition, we secure access to a 100 million dollar flexible credit facility.
Collectively these accomplishments have enabled us to advance several critical business objectives, including.
Positioned you wanted to focus on the development and commercialization of trials cyclists, which is where we can deliver the most value chip patients the healthcare system and our investors.
Continuing to advance rate to test ramp to a significant value inflection point in 2021, enabling a potential partnership.
And realizing meaningful value for our development of lever up cycle and partner with companies that have the resources to advance this therapy and make it available to patients.
Moreover, we've significantly strengthened our balance sheet with non dilutive capital limited our exposure to future expenses and had expected our cash runway.
Mark: At the beginning of the year, we outlined our corporate strategy to focus on the development and commercialization of trial cyclists, along with continuing to advance rent-to-desk rent as the best way to serve patients and create value for shelter. To that end, our goals in 2020 included one, completing our first new drug application or NDA, and 2. Establishing a commercial infrastructure to execute the trilocytic launch strategy.
Our highest priority is to make travel cycle of available to patients as quickly as possible last year. We received breakthrough therapy designation and June of this year, we submitted a new drug application for small cell lung cancer.
We expect that the FDA will respond to our submission later this month and assign a PDUFA date.
A priority review would put us on track for a potential approval in the first quarter 2021.
A key component of our launch strategy is our recently announced co promotion agreement with Beringer in July.
Mark: Initiating a combination trial of rintodestrin and palvocyte, and four, identifying non-dilutive funding to support the launch and continued development of trials. I am pleased to report today that we have delivered on all of those goals. We have completed the Trila-NDA filing and initiated the RENTO-PALBO combination trial in June as scheduled. We closed four strategic partnerships that collectively brought in $40 million in upfront payments, up to $486 million in milestone payments, plus royalties, and bolstered the launch of Trila-Cyclib in the U.S. In addition, we secured access to a $100 million flexible credit facility.
This agreement is a great outcome for all stakeholders as it de risks our initial launch limits our expense liability during this critical timeframe and maintaining optionality by avoiding any long term lockup.
We explored a range of attractive options for sales or.
And our decision to collaborate with VI was based on several factors, including a shared vision for what trials cyclist due for patients.
In addition to the benefits of working with a partner with the right expertise that can hit the ground running this approach is much more capital efficient and creating our own sales team from scratch.
Another key element is that this is a three year agreement limited to support for the small cell lung cancer indication.
We ended the agreement coincides with the timing of data Readouts from the colorectal and identified two trials.
While we are looking forward to a successful partnership with fee.
This timeframe provides us with flexibility.
As we evaluate options for launching trial of cyclic in additional indications that have significantly larger patient populations.
Mark: Collectively, these accomplishments have enabled us to advance several critical business objectives, including positioning G1 to focus on the development and commercialization of tricyclics, which is where we can deliver the most value to patients, the healthcare system, and our investors. Continuing to advance RintoDestrant to a significant value inflection point in 2021, enabling a potential partnership, and realizing meaningful value for our development of lerocyclic and partnering with companies that have the resources to advance this therapy and make it available to patients. Moreover, we've significantly strengthened our balance sheet with non-dilutive capital, limited our exposure to future expenses, and have extended our cash runway.
Some of the will provide additional color on the collaboration later in the call shall Raj will also discuss our commercial and medical affairs teams efforts to prepare for a successful launch and use including outreach to health care providers oncology practice centers payers guideline committees and other red.
Stakeholders.
Raj will also provide comments on our development strategy to evaluate additional tumor types in chemo regimens, we're trying to size that may benefit patients and unlocked significant value for our company.
Related to our development plans for trials cyclists, we're excited about our recently announced partnership with sincere Pharmaceuticals group in China.
In addition to being a well established commercial player in China, We will collaborate with since the are unclear nickel trials evaluating trial of cycling in additional tumor types and look forward to benefiting from their experience in executing trials in China.
Turning to the development of our oral surgery rents are desperate findings from our ongoing phase one two trials have led us to select 800 milligrams has to go forward jumps in future trials.
Last quarter, we began recruitment for arm of the trial that will evaluate rented debt strength in combination with CDK, where six inhibitor public cycling.
Which is being provided by Pfizer under a nonexclusive supply agreement.
Before I turn the call over to Soma, a brief comment on our operations relative to the coated 19 pandemic today, we have not seen any significant interruptions to our business. While we expect some initial impact on clinical trial enrollment our overall recruitment timelines remain on track.
Mark: Our highest priority is to make trial cycles available to patients as quickly as possible. Last year, we received breakthrough therapy designation, and in June of this year, we submitted a new drug application for small cell lung cancer. We expect that the FDA will respond to our submission later this month and assign a PDUFA. A priority review would put us on track for a potential approval in the first quarter of 2021.
Similarly, we do not anticipate supply chain or production delays.
I'd now like to turn the call over to Salt life to discuss our commercial strategy for trials cycle summer.
Thanks, Mark since this is my first earnings call at key line I wanted to start by providing a bit of my background and then get into the commercial strategy. We are advancing for trial Cyclades.
Before joining Q1 this spring I spent 15 years at side there. Most recently I led the global commercial launch of been Macau prior to that I was the global commercial leader for the accompanying oncology portfolio and with part of the oncology team advisor that launch seven products in seven years, what attracted me to GE one.
Mark: A key component of our launch strategy is our recently announced co-promotion agreement with Beringer Ingelheim. This agreement is a great outcome for all stakeholders as it de-risks our initial launch, limits our expense liability during this critical time frame, and maintains optionality by avoiding any long-term loss. We explored a range of attractive options for sales support, and our decision to collaborate with DI was based on several factors, including a shared vision for what trilocyclic acid could do for patients. In addition to the benefits of working with a partner with the right expertise that can hit the ground running, this approach is much more capital efficient than creating our own sales team from scratch.
With the potential of trial is likely to really transformed the treatment experience for patients receiving chemotherapy not only in the initial indication how small cell lung cancer, but also in multiple other tumors, where we think it will help transform that chemotherapy experience.
As a supportive care agent, though long term trial would be different than a typical therapeutic it would require both a top down account based approach working with payers to ensure trial is available to prescribers as well the bottle of approach of marketing and sales efforts to pull through demand.
Mark: Another key element is that this is a three-year agreement limited to support for the small cell lung cancer indication, and the end of the agreement coincides with the timing of data readouts from the colorectal and ISPI-2 trials. While we are looking forward to a successful partnership with DI, this time frame provides us with flexibility as we evaluate options for launching trilocyclet in additional indications that have significantly larger patient populations. Thoma will provide additional color on the collaboration later in the call.
We have put together a comprehensive integrated launch strategy that is informed by the various launches our commercial team has been part of including South Cory Hi brands eccentric Tagrisso when part is that the families and the mens all tailored to what we need for travel cycling.
Mark: She and Raj will also discuss our commercial and medical affairs team's efforts to prepare for a successful launch in the U.S., including outreach to health care providers, oncology practice centers, payers, guideline committees, and other relevant stakeholders. Raj will also provide comment on our development strategy to evaluate additional tumor types and chemo regimens where tricyclic may benefit patients and unlock significant value for our company. Related to our development plans for Triacycline, we are excited about our recently announced partnership with Sincere Pharmaceuticals Group in China. In addition to being a well-established commercial player in China, we will collaborate with Sincere on clinical trials, evaluating trials likely of an additional tumor type, and look forward to benefiting from their experience in executing trials in China. Turning to the development of our oral CERD rent-a-destrin, findings from our ongoing Phase 1-2 trial have led us to select 800 mg as the go-forward dose in future trials.
Dennis on the optimal way to do that is a big part of my remarks.
Our launch priorities are to first increase awareness of the impact of chemo induced myelosuppression on the patient experience.
Second so I was trying to site multi lineage Milo preservation benefit as the new standard of care.
Good to optimize the early launch experience to this and one of my first priority, what's determine how we would build out our commercial infrastructure to support this launch strategy.
Gee why it hits are working on trial for years and knows whats therapy better than anyone. So we concluded that it would be important for us to maintain control leadership of marketing market access and medical engagement efforts, which enable that prescriber access to therapy, we had the foundations I'm a strong commercial.
Team when I arrived and I've been really impressed with the top level, you've been able to attract we have hired seller leads for market access, which that from Germany, and medical affairs, which sits under rise to help us again to engage the large integrated delivery networks and group purchasing organization, which are.
Mark: Last quarter, we began recruitment for an arm of the trial that will evaluate RNTG in combination with the CDK4-6 inhibitor, Pelviciclin, which is being provided by Pfizer under a non-exclusive supply agreement. Before I turn the call over to Soma, a brief comment on our operations relative to the COVID-19 pandemic. To date, we have not seen any significant interruptions to our business. While we expect some initial impact on clinical trial enrollment, our overall recruitment timelines remain on track. Similarly, we do not anticipate the supply chain or production.
Critical to access in the community treatment settings, which is where we think the vast majority prescribing will occur.
With that component of the launch strategies that we then assess the most effective way to pull through demand by a sales force.
We looked at a number of different structures, including building our own salesforce working with a contract sales organization or collaborating with a partner.
After discussions with multiple interested parties and a thorough review of our options. We determined the most effective solution was the Copromotion agreement with Boehringer Ingelheim, there were a number of factors that weighed in favor of the B. I co promote.
Soma: I now have to turn the call over to Selma to discuss our commercial strategy for the trial cycle. Soma, Hi, this is Mark. Since this is my first earnings call at G1, I wanted to start by providing a bit of my background and then get into the commercial strategy we are advancing for Trilocyclib. Before joining G1 this spring, I spent 15 years at Pfizer. Most recently, I led the global commercial launch of Vindical. Prior to that, I was the global commercial leader for the company's oncology portfolio and was part of the oncology team at Pfizer that launched seven products in seven years. What attracted me to G1 was the potential of trilocycline to really transform the treatment experience for patients receiving chemotherapy, not only in the initial indication of small cell lung cancer but also in multiple other tumors where we think it will help transform that chemotherapy experience.
First we are working with the lung cancer community supporting their therapy Jilla trust for more than seven years. When we looked at the oncologists, we would target for travel cyclic there was a 90% overlap with the hours per its footprint so lot of synergies there.
Second the long term relationships with these oncology practices will be especially critical in the cobot Arrow, we anticipate that actually to the oncology centers will be limited for the foreseeable future ended the year Salesforce will be able to virtually call on oncology practices based on their pre existing relationships.
As Mark mentioned from our first meeting with the VR team. We were on the same page our discussions were highly collaborative and they shared our vision and excitement for trials cyclists and the potential benefits it would provide gestation.
Lastly, when working with an established feels worse available to partner today.
So if you still consideration it would accelerate our launch preparations for 2021.
Soma: As a supportive care agent, though, launching trial cycles would be different than for a typical therapeutic. It would require both a top-down, account-based approach, working with payers to ensure the trial is available to prescribers, as well as a bottom-up approach of marketing and sales efforts to pull through demand. We have put together a comprehensive, integrated launch strategy that is informed by the various launches our commercial team has been part of, including Salcori, Ibram, Texentric, Tegriso, Limparza, Tefaminis, and Amend, all tailored to what we need for tricyclists. Identifying the optimal way to do that is a big part of my remit.
Building on our own Salesforce and the care in seating of that sales force would've occupied significant organizational time and resource in the midst of this critical prelaunch period, we have already begun working with the B. I sales team and are very excited about their insights and contributions we know will only strengthen our prospects.
For a successful launch.
I look forward to provide an update on our progress across these initiatives on our next quarterly update call and now I'd like to turn it over to rise Raj.
Thanks, and good afternoon, everyone I'd like to start with an update on the progress our medical and technical teams have made supporting trial site.
As our work to highlight the negative impact that Myelosuppression has on patients findings from one of our patient experience studies were published in July.
Soma: Our launch priorities are two. First, increase awareness of the impact of chemo-induced myosuppression on the patient experience. Second, to establish trilocyclic multilineage myelopreservation benefits as the new standard of care. And third, to optimize that early launch experience. To this end, one of my first priorities was to determine how we would build out our commercial infrastructure to support this launch strategy.
This study puts concrete research around what patients really feel when they are undergoing chemotherapy and develop myelosuppression.
910, respondents noted that chemotherapy induced myelosuppression at a moderate to major impact on their lights and at least a third felt that they're treating physician did not understand how uncomfortable up an experienced it was.
This reflects the need for continued education around how myelosuppression impacts patients.
I will better communication between the physician and patient so thats a patients experiencing chemotherapy can be improved.
Soma: The team at G1 has been working on TRILA for years and knows this therapy better than anyone, so we concluded that it would be important for us to maintain control and leadership of marketing, market access, and medical engagement efforts which enable prescriber access to therapy. We had the foundations of a strong commercial team when I arrived, and I've been really impressed with the top-level talent we've been able to attract. We have hired stellar leads for market access, which sits under me, and medical affairs, which sits under Raj. They will help us begin to engage the large integrated delivery networks and group purchasing organizations, which are critical to access in the community treatment setting, which is where we think the vast majority of prescribing will occur. With that component of the launch strategy set, we then assessed the most effective way to pull through demand via a sales course. We looked at a number of different structures, including building our own sales force, working with a contract sales organization, or collaborating with a partner.
We are also continuing our work and the fields.
Our medical science liaison MSL are having regular engagements with academic AOL and community oncologists as well as pharmacists and nurse.
Complication, some modest suppression have been a longstanding issue when treating cancer patients.
And as someone noted cobot 19 has brought these into sharper focus.
Recent covert 19 guidance from the NCCN as highlighted the broader strains on the healthcare system caused by the pandemic.
Such as limited lot supply and higher infection rates.
Our MSL are learning more about how oncology centers are adapting patient care to account for the additional risks presented by coven 90, with an important goal of reducing complications after chemotherapy that could result in additional clinical or hospital visits.
Our discussions with healthcare professionals are helping us better understand approaches to be actively managing complications from chemo induced myelosuppression.
We're finding that the current circumstances have spurred practitioners to become more cognizant of the impact a modest suppression.
And we believe that are more intentional consideration of Myelosuppression will remain even after corporate 90 is brought under control.
Soma: After discussions with multiple interested parties and a thorough review of our options, we determined the most effective solution was the co-promotion agreement with Beringer Ingelheim. There were a number of factors that weighed in favor of the BI co-promotion. First, B.I. has been working with the lung cancer community, supporting their therapy, GILATRIF, for more than seven years. When we looked at the oncologists we would target for trilocyclabs, there was a 90% overlap with B.I.'s current footprint, so there are a lot of synergies there.
These exchanges with healthcare practitioners have been critical and understanding both the opportunities and challenges atrotos cyclists those face at launch.
It is also important for China cycle. It to be included in the NCCN guidelines as soon as possible after approval.
Prior to potential approval of try to cycling.
Medical team will notify the appropriate guideline committees regarding the PDUFA date and provide data on trial site.
Immediately after approval a formal request will be submitted to NCCN to evaluate child of cycling for inclusion in the guidelines.
This submission will include the approved label supportive evidence and rationale for including travel side.
Concurrent with our medical affairs teams education, an outreach efforts on small cell lung cancer, our clinical and regulatory teams are executing a comprehensive development plan to evaluate China cyclists in a broader set of tumors as a model preservation agent and its potential anti tumor efficacy.
Soma: Second, VA's long-term relationships with these oncology practices will be especially critical in the COVID era. We anticipate that access to oncology centers will be limited for the foreseeable future, and the VA sales force will be able to call on oncology practices based on their pre-existing relationships. As Mark mentioned, from our first meeting with the BI team, we were on the same page. Our discussions were highly collaborative, and they shared our vision and excitement for Trilocyclib and the potential benefits it would provide to patients. Lastly, by working with an established field force available to partner today on executional considerations, it would accelerate our launch preparations for 2021. Building our own field force and the care and feeding of that field force would have occupied significant organizational time and resources in the midst of this critical pre-launch period.
In some tumor types.
In the fourth quarter of this year, we expect to initiate a registrational trial in metastatic colorectal cancer with primary endpoints focused on model preservation.
Earlier this year, we completed a pre phase three meeting with the FDA.
Finalize the trial design based on their feedback.
We're also moving forward in breast cancer.
Last quarter patient enrollment began in the ice by two trial with a goal of evaluating the potential for China cycling to enhance the pathological complete response rate of patients being treated with chemotherapy in the neoadjuvant setting.
Later this year, we will present, the mature less data from our phase two trial in metastatic triple negative breast cancer.
On to initiate a registrational trial in CNBC and 2021.
I'll turn now to development of our oral surgery rental industry.
In the second quarter, we began recruiting an additional arm in our phase one two trial evaluating a combination of rental desktop and the CDK for sex inhibitor of how the cycle it commercially known as Ibrance.
Soma: We have already begun working with the BI sales team and are very excited about their insights and contributions, which I know will only strengthen our prospects for a successful launch. I look forward to providing updates on our progress across these initiatives on our next quarterly update call. Now, I'd like to turn it over to Raj.
This arm will enroll approximately 40 patients with positive hertwo negative breast cancer with patients receiving an 800 milligram dose of into that strategy at 125 milligram dose of how the cyclists both one state.
We are on track to complete enrollment by the end of the year.
The monotherapy arm. If this trial is fully enrolled last year, and we anticipate reporting updated safety and efficacy data from all 67 patients in the fourth quarter.
We expect to record results from the rental desktop aside the arm, including safety findings that efficacy data in the latter part of 2021.
Raj: Thanks, Thelma, and good afternoon, everyone. I'd like to start with an update on the progress our medical and clinical teams have made supporting Traverse IT, as part of our work to highlight the negative impact that myelosuppression has on patients. Findings from one of our patient experience studies were published in July. This study puts concrete research around what patients really feel when they are undergoing chemotherapy and develop myelosuppression.
I'll now turn the call over to Jeff Jan.
Thanks Raj.
Financial results for the second quarter 2020 are available in our press release and 10-Q.
Hey, I'd like to focus on our ongoing financial management of the company.
As Mark noted earlier in the column, our corporate strategy is focused on maximizing our opportunity with trial cyclists and also advancing rented out the DRAM.
Our recent finance and business development transactions have all been directed supporting that strategy.
Basically we were able to execute agreements that include immediate nondilutive cash continues to support the trial in launch and enable completion of our winter debts trend based on two trial.
In addition, these agreements provide future revenues and access to capital to fund our robust trial site development plan.
A few specific comments on our recent trial is tight lipped Microsites agreement.
Raj: Nine out of ten respondents noted that chemotherapy-induced malice suppression had a moderate to major impact on their lives, and at least a third felt that their treating physician did not understand how uncomfortable of an experience it was. This reflects the need for continued education around how myelosuppression impacts patients and for better communication between the physician and patient so that the patient's experience during chemotherapy can be improved. We are also continuing our work in the field. Our medical science liaisons, or MSLs, have regular engagements with academic KOLs and community oncologists, as well as pharmacists and nurses. Complications for myelosuppression have been a long-standing issue when treating cancer patients, and as Soma noted, COVID-19 has brought them into sharper focus.
Earlier in the call. Some of commented on the strategic rationale approach on the type of Copromotion agreement with Pi.
From a financial perspective disagreement is significantly more capital efficient and building out our own internal sales force and allows us to invest that capital into development programs for trial in cyclists and have the potential to increase the number of patients who would benefit from therapy.
Our agreement with can see or for right to try to cycling in China, not only brings in a $14 million upfront payment and collaborator with significant commercial capability. We also gain a partner with expertise in running development program in China.
Our ability to work with MCR and global clinical trial May help us realize significant development cost savings in the future.
Our global Outlicensing, Lebron cyclists provided 26 million, an upfront payment and eliminate future development cost for that program, which frees up resources that we can then invest in trial as cyclists and advancing winter that span.
The three licensing agreements with tier two Rx into nor also have future financial benefits that we may realize over time, including clinical regulatory and commercial milestones milestone payment as well as royalty stream.
In addition to these collaboration in June we entered into a debt financing agreement for up to 100 million with Hercules capital well regarded from networks with many of our peers.
Raj: Recent COVID-19 guidance from the NCCM has highlighted the broader strains on the healthcare system caused by the pandemic, such as limited blood supply and higher infection rates. Our MSLs are learning more about how oncology centers are adapting patient care to account for the additional risks presented by COVID-19 with an important goal of reducing complications after chemotherapy that could result in additional clinic or hospital visits. Our discussions with healthcare professionals are helping us better understand approaches to reactively managing complications from chemo-induced myelosuppression. We are finding that current circumstances have spurred practitioners to become more cognizant of the impact of model suppression.
This structured debt instrument, it's a high degree of flexibility as we approach to launch a pilot cyclists and provides access to low cost capital that we can pull down is needed to support commercial and development activity.
We are not required to draw down the full 100 million and had the ability to exit the agreement under reasonable terms.
As of June 32020, we had 234.3 million in cash and cash equivalents on the balance sheet compared to 269.2 million as of December 31 to 2019.
This total includes the $20 million from our Hercules financing, but not the upfront proceeds from our agreement with sincere into Rx engine or.
In aggregate our finance into this business development transaction have enabled us to increase our 2020 cash guidance to finishing the year with 185 to 200 million up from our previous guidance of 110 to 130 million.
Raj: And we believe that a more intentional consideration of milder suppression will remain even after COVID-19 is brought under control. These exchanges with health care practitioners have been critical in understanding both the opportunities and challenges that trial-cyclists will face at launch. It is also important for talocyclists to be included in the NCCN guidelines as soon as possible after approval. Prior to potential approval of tralocycline, our medical team will notify the appropriate guideline committees regarding the PDUFA date and provide data on tralocycline. Immediately after approval, a formal request will be submitted to NCCM to evaluate Tralocyclib for inclusion in the guidelines. This submission will include the approved label, supportive evidence, and rationale for including trial psych.
We expect our current cash to support operations into 2022.
Well. This guidance includes the upfront payments, we will receive and our debt drawn down to date. It does not consider any additional proceeds of current agreements other inflows of capital that we may realize our revenue that we may generate from the sales of trial is cyclical beginning in 2021.
I'll now turn the call back to Mark Mark.
Thanks Jen.
Our accomplishments in the first half of the or have provided a strong foundation to deliver long term value to shareholders.
Our first endeared submitted for travel cyclists, we're moving towards becoming a revenue generating company.
Our recent financing business development transactions have put us in a strong financial position to execute on the US commercial launch of trial sites within 2021 and support a robust development plan to expand into additional indications.
Moving forward realizing the full potential of Charles Hartcliffe across multiple indications will be our primary focus.
We continue to view, our oral serve rental industry and as a potential best in class therapy.
Phase one two trial has generated compelling safety and Tolerability data.
Along with evidence of clinical activity in a monotherapy setting.
We expect to have data from the rental guest traffic couple of cyclic combination arm of this trial in 2021.
We believe the most efficient development path for rent ADEPS trends, despite a partnership and the combination data will be critical to those discussions.
Before we go to Q in AG I would like to take a moment to acknowledge all of the healthcare professionals and frontline workers were continuing to provide essential services through the cobot 19 pandemic.
Raj: Concurrent with our medical affairs team's education and outreach efforts on small cell lung cancer, our clinical and regulatory teams are executing a comprehensive development plan to evaluate tricyclic in a broader set of tumors as a myelopreservation agent and its potential for anti-tumor efficacy in some tumor types. In the fourth quarter of this year, we expect to initiate a registrational trial in metastatic colorectal cancer with primary Earlier this year, we completed a pre-phase 3 meeting with the FDA and have finalized the trial design based on their feedback. We are also moving forward in breast cancer. Last quarter, patient enrollment began in the ICE-V2 trial with a goal of evaluating the potential for tralocytin to enhance the pathological complete response rate for patients being treated with chemotherapy in the neoadjuvant setting.
On behalf of everyone. At Q1, Thank you for the sacrifices view and your loved ones are making for all of us during this challenging time.
That concludes our prepared remarks, operator, please open the call for questions.
Okay.
And as a reminder to ask a question you will need to press star one or your telephone keypad.
Your first question comes from a lot of Dane Leone with Raymond James.
Hi, Thank you for taking your questions and congrats on the updates I want to.
Actually touch on something that you hit during the prepared remarks, which I think it's probably a bit under appreciated.
But you did mention working to get chose the club within that NCCN guidelines.
Maybe you could just remind us how the guidelines are currently written for G. CSF utilization around severe muc 16 year related to chemotherapy.
Raj: Later this year, we will present the mature OS data from our Phase II trial in metastatic triple-negative breast cancer and plan to initiate a registrational trial in TMBC in 2021. Now, I'll turn now to the development of our oral CERD for rheumatoid arthritis. In the second quarter, we began recruiting an additional arm in our Phase 1-2 trial, evaluating a combination of Rintodastran and the CDK4-6 inhibitor Pelvacyclib, commercially known as IBRAN. This arm will enroll approximately 40 patients with ER-positive, HER2-negative breast cancer, with patients receiving an 800 milligram dose of rinted Estran and 125 milligram dose of calicycline, both once daily
And how you could envision the guidelines potentially adopting the label you'd have at hand from U.S. ft, a and potentially any other data that you could provide.
Given that there is flexibility to how that usually written for other drugs as well.
Sure. Thanks Thats Mark.
Margins rather than to that question Raj.
I think yes for before my way growth factors, which is actually now one guidelines they used to be moderate growth factors and erythroid growth factors, but speak specifically to G. CSF, which was your question.
It's really broken out by the risk of febrile neutropenia.
Where if there is a greater than 20% to risk of fair value to Kenya primary profile accesses recommended.
For intermediate risk, 10% to 20%.
Really depending on the patient characteristics.
Raj: We are on track to complete enrollment by the end of the year. The monotherapy arm of this trial was fully enrolled last year, and we anticipate reporting updated safety and efficacy data from all 67 patients in the fourth quarter. We expect to report results from the Rinto Death Strand Palpacyclib arm, including safety findings and efficacy data, in the latter part of 2021. I'll now turn the call over to Jen. Thanks Raj. Full financial results for the second quarter of 2020 are available in our press release and 10Q.
The.
I'm sure you're aware that we've covered 19 the guidelines were updated.
Where they are recommending that even patients who are at intermediate risk.
Receive primary prophylactic gcs.
So in terms of where trello sites, if could sit within the guidelines I think there are two potential places one is within small cell lung cancer.
The second is within the model like growth factor guidelines.
Where of course since our data is only in small cell lung cancer, we obviously assume that there'll be some notation off that fact in the guideline itself.
Does that help to answer your question David.
And this is the operator next question comes from a line of Chris Shibutani with Cowen.
Jen: Today, I'd like to focus on our ongoing financial management of the company. As Mark noted earlier in the call, our corporate strategy is focused on maximizing our opportunity with trial-and-error cyclists and also advancing rent-to-debt trends. Our recent finance and business development transactions have all been directed at supporting that strategy.
Great Hi, guys two questions if I could just trying to clarify and some of the additional trial opportunities. This said TNBC Registrational study is that new information.
Secondly on the colorectal opportunity is there anything further you can share with us about the trial design as you're planning to get that underway and in the deck. It talks about data in 2023 will that be both.
Jen: Specifically, we were able to execute agreements that include immediate, non-dilutive cash that can be used to support the trial of launch and enable completion of our RintoDevStrand Phase 1-2 trial. In addition, these agreements provide future revenues and access to capital to fund our robust trial and cycle development plan. A few specific comments on our recent trial of Cyclops and laryngocyclops.
Hello preservation data as well as the anti tumor efficacy endpoints that are check there should we expect both of those.
Aspects in 2023.
Yes.
Thanks, Chris I'll take the first question and I'll, let Rob answer the second on its mark.
As far as a TNBC registrational trial, we have been.
Jen: Earlier in the call, Thelma commented on the strategic rationale for our Trialocyclus co-promotion agreement with BI. From a financial perspective, this agreement is significantly more capital efficient than building out our own internal sales force and allows us to invest that capital into development programs for trial cyclists that have the potential to increase the number of patients who would benefit from therapy. Our agreement with SymSeer for rights to trial cyclin in China not only brings in a $14 million upfront payment and a collaborator with significant commercial capabilities, but we also gain a partner with expertise in running development programs in China.
Saying that we are planning to run one in 21.
That will be a registrational trial. The primary endpoints will be survival measures will provide more details on that trial. When we present the final less data from the phase two trial later this year.
But I'll, let lodge speak to the specifics of the clinical trial, starting this quarter Raj, Yes, hi, Chris the colorectal trial.
We'll be in first line setting with would still Fox theory as the Kibo backbone.
Approximately 300 patients.
The primary endpoints will be the occurrence and duration of severe neutropenia. So similar to the endpoints. So we evaluated in our small cell lung cancer study.
Our studies I should say.
We're also evaluating other molla preservation endpoints and is a study as well.
Jen: Our ability to work with SymSeer on global clinical trials may help us realize significant development cost savings in the future. Our global out-licensing of Laracyclib provided $26 million in up-front payments and eliminated future development costs for that program, which frees up resources that we can then invest in Trilocyclib and advance rentodestrin. The three licensing agreements with Sincere, EQRx, and Genore also have future financial benefits that we may realize over time, including clinical, regulatory, and commercial milestone payments, as well as royalty-free. In addition to these collaborations, in June, we entered into a debt financing agreement for up to $100 million with Hercules Capital, a well-regarded firm that works with many of our peers. This structured debt instrument gives us a high degree of flexibility as we approach the launch of Trilocyclus.
In terms of as you pointed out we're looking also at PFS and OS in terms of 2023, it's going to really be the model preservation data that will be.
Available at that time as the tumor efficacy data will follow later.
Your next question comes from the line of Tom Shrader with BT.
Okay.
Good afternoon.
Thank you for taking the questions I had a question for settlement.
Okay.
As you as you reach the field, where do you find depreciation for Truckless system is now have most people heard of it has there been enough news or.
Or do you need.
Sort of more general distribution of the data.
Yeah, Hi, so I'm happy to take that question I think right now you know there theres definitely awareness or Travis I club amongst.
Certain I'm certain academic folks I think where we will continue to do work over the next several months is really is really getting out what the community so that their understanding it I think.
Jen: It provides access to low-cost capital that we can pull down as needed to support commercial and development activities. We are not required to draw down the full $100 million and have the ability to exit the agreement under reasonable terms. As of June 30, 2020, we had $234.3 million in cash and cash equivalents on the balance sheet, compared to $269.2 million as of December 31, 2019.
We've spoken before that there are we havent seen from AMA cells, who are currently in market right now and they're working to understand these practices and have conversations throughout.
So I think over the next couple of months, we will start doing that theres been several.
Several AD boards with different different types of prescribers on and I think I do think that the word is getting out and I feel but I do think that there's more work to do over the next several months.
Jen: This total includes the $20 million from our Hercules financing but not the upfront proceeds from our agreements with Sincere, EQRx, and Genore. In aggregate, our financing and business development transactions have enabled us to increase our 2020 cash guidance to finish the year with $185 to $200 million, up from our previous guidance of $110 to $130 million. We expect our current cash to support operations into 2022. However, while this guidance includes the upfront payments we will receive and our debt drawdown to date, it does not consider any additional proceeds from current agreements, other inflows of capital that we may realize, or revenue that we may generate from the sales of Trilocyclib beginning in 2021. I'll now turn the call back to Mark. Thanks, John.
Your next question comes from them on of Chad Messer with Needham.
Great. Thanks for taking my question.
Very very excited to hopefully hearing.
Dr. Paducah date for trial later this month.
Well actually much has been.
Really important for you guys in terms of the financing in BB deals you've done I think you've created a lot of good financial flexibility going into to the launch here, but just kind of wondering what your BD priorities are now going forward I guess, there's some other regions for trial.
And you've got the euro out there with Mark Youve touched or just a little bit at the end of your.
Remarks from your thinking on that.
Maybe just sort of leave it open ended to you guys. What are your sort of BT priorities as as you look at the pipeline and get ready to launch trial in small cells.
Yes, Thanks, Chad I'll take that it's it's mark.
Mark: Our accomplishments in the first half of the year have provided a strong foundation to deliver long-term value to shareholders. With our first NDA submitted for trial recycling, we are moving toward becoming a revenue-generating company. Our recent finance and business development transactions have put us in a strong financial position to execute on the U.S. commercial launch of Trilocyclib in 2021 and support a robust development plan to expand into additional indications. Moving forward, realizing the full potential of trial cycles across multiple indications will be our primary focus. We continue to view our oral CERD rentodestrin as a potential best-in-class therapy. Our Phase I-II trial has generated compelling safety and tolerability data, along with evidence of clinical activity in a monotherapy setting.
Yeah, Weve executed several deals as you pointed out very recently and they put us.
There is strong financial footing so.
Our our view on partnerships is do some at the right time.
With with.
Terms that deliver value for shareholders. So we're not feeling.
We need to rush into any further deals at this point I.
I did allude to rent pedestrians and the combination data as something that could really push.
A potential partnership so that's a 21 event, but right now we're feeling very good about the deals we've put together and the value theyre going to deliver a shareholders.
Your next question comes from the line of added White with H.C. Wainwright.
Hi, guys. Thanks for taking my questions. So just to.
Someone Roger you, thanks for telling us about the.
Provider interactions that you've had in your strategy there.
I was just wondering if maybe you can discuss any payer discussions that you've had.
In your strategy.
With the payers and then lastly, just going back to sort of BD Mark just wanted to get your thoughts on.
Trials.
Strategy in Europe. Thank you.
Mark: We expect to have data from the rinta-destrat-albocyclic combination arm of this trial in 2021. We believe the most efficient development path for rink-to-death strength is through a partnership, and the combination data will be critical to those discussions. Before we go to Q&A, I would like to take a moment to acknowledge all of the healthcare professionals and frontline workers who are continuing to provide essential services during the COVID-19 pandemic. On behalf of everyone at G1, thank you for the sacrifices you and your loved ones are making for all of us during this challenging time.
Thanks, Ed maybe I'll answer that second question first it's Mark and then over some on pricing.
We've had several interested parties.
On trial for territories outside the us.
And again same same responses against the Chad.
Well do the right deal at the right time that delivers value for shareholders.
Somebody you want to comment on.
Price.
Sure I'm happy to do that so this program were.
The other participants on yachts, we are engaged with payer discussions we will start to engage in the pre are critical information exchange hi discussions over the coming months, but we have been doing work to understand the pairs perspective over the last few months just to kind of got a better sense of.
Where we might land on price and you know and what it's looking like right now is and what I can tell you today right is that there is definitely and enthusiasm I think that understanding for travel cycling.
Operator: That concludes our prepared remarks. Operator, please open the call for questions. And as a reminder, to ask a question...
Similarly, as regards the idea that there's this multi lineage benefit sort of a two for one if you well, but they're gonna got what trial recycling, but they would not got lucky SAP and I think that leads them to view that you know some premium to aspect is warranted.
Dane Vincent Leone: The first question comes from... Hi, thank you for taking the questions and congrats on the updates. I want to actually touch on something that you hit during the prepared remarks, which I think is probably a bit underappreciated. But you did mention working to get trilocycloid within the NCCN guidelines.
Degree of premium I think we need to understand the data better and the feedback that were to come to a final conclusion on but I think we're pretty clear that it will not be price like a therapeutic it'll be wells, well below that but but likely offering into new afton those discussions, but let us the believed that we set the.
Mark: Maybe you could just remind us how the guidelines are currently written for GCSF utilization around severe neutropenia related to chemotherapy and how you could imagine the guidelines potentially adopting the label you'd have in hand from the US FDA and potentially any other data that you could provide, given that there is flexibility to how that's usually written for other drugs as well. Thanks, Dane. It's Mark. I think Raj is ready to answer that question. Raj? Hey Dane,
A press correctly the access will be there.
Your next question comes from a line of cruise ship food Tony.
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Oh, Thanks, I was getting back into the Q a couple of quick financial ones for Gen actually congrats on the rental deal can you talk to what the implications are on the Opex as we think about maybe the balance of this year and into next year.
Raj: Yeah, for myeloid growth factors, which is actually now just one guideline. There used to be myeloid growth factors and erythroid growth factors, but specifically to GCSF, which was your question. It's really broken out by the risk of febrile neutropenia, where if there is a greater than 20% risk of febrile neutropenia, primary prophylaxis is recommended, and for intermediate risk, i.e., 10 to 20%, really depending on the patient characteristics. I'm sure you're aware that with COVID-19, the guidelines were updated to recommend that even patients who are at intermediate risk receive primary prophylactic GCSS. So, in terms of where Trelocyclib could fit within the guidelines, I think there are, you know, two potential places. One is within small cell lung cancer, and the second is within the myeloid growth factor guidelines, where, of course, since our data is only for small cell lung cancer, we assume that there will be some notation of that fact in the guideline itself.
It would be helpful to get some perspective, there, particularly.
I'm sorry in the lira deal I would hope to get some perspective, there, particularly as the cash runway that you're describing certainly seems a little bit stronger and when I do the math on sort of the incremental sources that the guidance that you've given.
I'm looking for kind of an additional 10 million here. There. So if you could provide us with that perspective that would be great.
Sure so.
Well first of all high Chris Tucker.
So I think [laughter] and but there's a couple ways that the burn has come down one is tilera deal that they are picking up development cost going forward on those deals that we have two trials that were still.
Spending on and so thats something that comes off our books and goes on to our partners.
In addition to that we're getting reimbursed for drug product and drug substance that we have on hand that we've already expensed about will realize that and then also the other benefit is on the be ideal and taking some upfront around launch readiness that now is being moved off our books the I'd part.
Our ship that's the combination of a number of things that that's helping bring our burned down.
Your next question comes from a lot of Dane Leone with Raymond James.
Hey, Thanks for follow up we've got.
Raj: Do you think that helps to answer your question, Dane? Great. Hi guys, two questions, if I could.
Kevin Ninja today.
So [laughter] I was trying to.
Follow up on that the my first question, though that guideline.
Chris: Just trying to clarify some of the additional trial opportunities. This TNBC registrational study, is that new information? Secondly, on the colorectal opportunity, is there anything further you can share with us about the trial design as you're planning to get that underway? And in the deck, it talks about data in 2023. Will that be both myelopreservation data as well as the anti-tumor efficacy endpoints that are checked there? Should we expect both of those aspects in 2023? Yeah, thanks, Chris. I'll take the first question, and I'll let Raj answer the second one. It's Mark.
Given you are expecting a broader label them, just what dcs that would be on their rates really side.
Maybe rise how how do the guidelines would incorporate.
Both aspects I guess a pro cyclical.
Yes, absolutely Dane.
Last year.
Did that this is obviously a very unique aspect of trial out right one drug that can have.
Benefits across multiple lineages and I think just to some extent, it's good but both of these guidelines will emerge because that is certainly going to be our.
We will provide the evidenced as you know we don't make the decisions on how.
Telesites it will ultimately be.
Mark: As far as a TMDC registrational trial, we have been saying that we are planning to run one in 21. That will be a registrational trial, and the primary endpoints will be survival measures.
Included in the guidelines, we just need to provide the evidence and there is certainly strong evidence for reduction in red cell transfusions improvement in EMEA and.
In addition to the strong neutrophil.
Endpoints. So that is certainly going to be will provide the evidence on the rationale for doing so.
Mark: We'll provide more details on that trial when we present the final OS data from the Phase 2 trial later this year. And I'll let Raj speak to the specifics of the colorectal trial, which is starting next quarter. Raj?
And ultimately the guideline committee, that's going to make that call.
And your next question comes from a lot of among Palm Rama with JP Morgan.
Hey, guys Hi, this is tough on the call Tonight.
Raj: Yeah. Hi, Chris. The colorectal trial will be in a first-line setting with Fulfoxiri as the chemo backbone, approximately 300 patients. The primary endpoints will be the occurrence and duration of severe neutropenia, so similar to the endpoints that we evaluated in our small cell lung cancer study, or studies, I should say.
Oh, we've been we've been juggling a few consummate guy so and I'll ask a question hopefully I have not been addressed.
But one question from the pipeline from that.
Additional data for rent Perenco as expected in the fourth quarter and how how are you thinking about differentiation here for rental and what should we be looking out for in the fourth quarter update.
Raj: We're also evaluating other myelopreservation endpoints in the study as well. In terms of, as you pointed out, we're looking also at PFS and OS. In terms of 2023, it's going to really be the myelopreservation data that will be available at that time, and the tumor efficacy data will follow later. Your next question comes from Tom Schrader. Good afternoon. Thank you for taking the questions. I had a question for Selma. As you reach the field, where do you find appreciation for Trilocyclob now? Have most people heard of it?
And maybe second question can you provide an update on how enrollment is progressing in the palbo and rental expansion arm and when we might see Dana. Thanks, So much right.
Now I'd have thought its mark I can take that another question has not been asked so.
Hi, good ones.
During the fourth quarter will be the 67 patients with monotherapy.
That we're seeing monotherapy dose escalation that expansion. So they don't be incremental to what we presented last year with a focus on safety and Tolerability.
Tom Schrader: Has there been enough news, or do you need sort of a more general distribution of the data? Yeah. Hi, it's Thoma.
As you recall that as a heavily penta refractory.
Patient population.
Most of the patients has.
All the strength.
So again, some incremental efficacy data, but it's a highly and different refractory patient population.
Thoma: I'm happy to take that question. I think right now that there's definitely awareness of Trilocyclib amongst certain academic folks. I think where we will continue to do work over the next several months is really getting out with the community folks so that they understand it. I think we've spoken before that we have a team of MSLs who are currently in market right now, and they are, you know, working to understand these practices and have conversations, you know, throughout. So I think that in the next couple of months, we will start doing that.
The combination trial.
Is enrolling very well, we're confident that we'll have those for the patient enrollment by the end of this year and therefore data next year.
That patient population is different.
Much more into consent.
In addition to wanting to sing the very good safety and Tolerability data that we've seen from Rancho contained.
We'll be looking for.
Efficacy that is at least as good as focus Trent.
In that patient population, so that'll be coming next year.
There are no other questions at this time you may continue with any closing remarks.
Thank you operator that concludes the call. Please reach out to us with any questions. We look forward to connecting with many of you at this month edgy and Wedbush virtual conferences. Thank you for joining us today. Some please stay well.
Thoma: There's been several ad boards with different types of prescribers, and I think – I do think that the word is getting out, and I think – but I do think that there is more work. Great, thanks for taking my question and, you know, very, very excited to hopefully hear from Trila later this month. The last few months have been really important for you guys in terms of the financing and BB deals you've done, creating a lot of good financial flexibility going into the launch here. Just kind of wondering what your BD priorities are now going forward. I guess there are some other regions for Trila, and you've got Lero out there, which Mark, on just a little bit at the end of your remarks and your thinking on that.
Ladies and gentlemen that concludes today's conference call. Thank you for participating you may now disconnect.
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Chad: And maybe just sort of leave it open-ended to you guys. What are your sort of... priorities as you look at the pipeline and get ready to launch trials in small, Yeah, thanks, Chad. I'll take that. It's Mark.
Mark: You know, we've executed several deals, as you pointed out, very recently, and they put us on a very strong financial footing. So our view on partnerships is to do them at the right time, with terms that deliver value for shareholders. So we're not feeling we need to rush into any further deals at this point. But I did allude to the rent-a-desk grant and the combination data as something that could really push a potential partnership. So that's a 21 event.
Mark: But right now, we're feeling very good about the deals we've put together and the value they're going to deliver to shareholders. Your next question comes from the line of Ed White. Hi guys, thanks for taking my questions. So, just to... Soma and Raj, thanks for telling us about the provider interactions that you've had in your strategy there. I was just wondering if maybe you could discuss any payer discussions that you've had in your strategy with the payers. And then, lastly, just going back to sort of BD, Mark, just wanted to get your thoughts on Trila's strategy in Europe. Thank you. Thanks, Ed. Maybe I'll answer that second question first. It's Mark, and then I'll go over to Salma on pricing.
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Mark: You know, we've had several interested parties on trial for territories outside the US. And again, the same responses I gave to Chad. We'll do the right deal at the right time that delivers value for shareholders. Does somebody want to comment on Fred's? Sure, I'm happy to do that. So, this is Thelma.
Thelma: So on the pricing side, yes, we are engaged in payer discussions. We will start to engage in the pre-approval information exchange, these high-level discussions over the coming months. But we have been doing work to understand the payers' perspective over the last few months, just to kind of get a better sense of where we might land on price. And, you know, and what it's looking like right now, and what I can tell you today, is that there is definitely an enthusiasm, I think, and an understanding for trilocycloids, particularly as regards the idea that there is this multilineage benefit, sort of a two- And I think that leads them to a view that, you know, some premium to the new AFSA is warranted. But that degree of premium, I think we need to understand the data better and the feedback better to come to a final conclusion on. But I think we're pretty clear that it will not be priced like a therapeutic. It will be well below that.
Thelma: But likely at a premium to new AFSA. And those discussions have led us to believe that if we set the price correctly, access will be better. Douglas Goldstein, CFP®, is the director of Profile Investment Services and the host of the Goldstein on Gelt radio show. He is a licensed financial professional in both the U.S. and Israel. His book Building Wealth in Israel is available in bookstores, on the web, or can be ordered at www.goldsteinradioshows.com.
Douglas Goldstein: Thank you. Thank you. Thank you. Well, first of all, hi, Chris. It's nice to talk to you. So I think there are a couple ways that the burn has come down. One is the LARO deal.
Jen: So that's, they're picking up development costs going forward on those deals. So we have two trials that we're still spending on. And so that's something that comes off of our books and goes to our partners. In addition to that, we're getting reimbursed for drug products and drug substances that we have on hand that we've already expensed. So we'll realize that. And also, the other benefit is the BI deal, taking some upfront costs around launch readiness that are now being moved off our books with the BI partnership. That's a combination of a number of things that's helping bring our burn rate down.
Jen: Your next question comes from the line of Dane Leone with... Hey, thanks for the follow up. We got the operators kind of a ninja today. So I was trying to follow up on that. My first question about the NCCI and guidelines. Given you are expecting a broader label than just what GCSF would be on the erythroid side, maybe Raj, how would the guidelines, would incorporate both aspects, I guess, of trialism. Yeah, absolutely, Dane. Raj here. You know, this is obviously a very unique aspect of trila, right?
Raj: One drug that can have benefits across multiple lineages. And I think to some extent it's good that both of these guidelines were merged because that is certainly going to be our, you know; we will provide the evidence. As you know, we don't make the decisions on how trilocyclic will ultimately be included in the guidelines. We just need to provide the evidence. And there is certainly strong evidence for reduction in red cell transfusions, improvement in anemia, in addition to the strong neutrophil endpoints. So that is certainly going to be, we'll provide the evidence and the rationale for doing so, and ultimately, it's the guideline committee that's going to make that call. Hey guys, this is Tess on the call tonight for Anupam. We've been juggling a few calls tonight, guys, so I'll ask you a question.
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Tess: Hopefully, it has not been addressed. But one question from the pipeline from us. Additional data for Rinto is expected in the fourth quarter. How are you thinking about differentiation here for Rinto, and what should we be looking out for in the fourth quarter update? And maybe a second question: can you provide an update on how enrollment is progressing in the Palo Alto and Rinto expansion arms and when we might see data? Thanks so much, guys. Hi Seth, it's Mark. I can take that. And no, the question has not been asked before, so it's a good one.
Mark: The data in the fourth quarter will be the 67 patients who received monotherapy, the dose escalation and expansion. So it'll be incremental to what we presented last year with a focus on safety and tolerability. As you recall, that is a heavily endocrine refractory patient population. Most of the patients have seen all the strength. So again, some incremental efficacy data, but this is a highly endocrine refractory patient population. The combination trial is enrolling very well. We're confident that we'll have those 40 patients enrolled by the end of this year and, therefore, data next year. But that patient population is different. They are much more endocrine sensitive.
Mark: So, in addition to wanting to see the very good safety and tolerability data that we've seen from RENTO to date, we'll be looking for efficacy that is at least as good as full restraint in that patient population. So that'll be coming next week. Thank you, Operator. That concludes the call. Please reach out to us with any questions. We look forward to connecting with many of you at this month's BTIG and Wedbush Virtual Conferences. Thank you for joining us today, and please stay well. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. [inaudible] No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.
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