Q3 2020 ADC Therapeutics SA Earnings Call
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Thank you Paolo good morning, welcome to Cara Therapeutics third quarter, South Atlantic and that's and then breaking with Cowen.
Operator: Thank you for holding. Good morning and welcome to Therapeutics' 3rd Quarter 2020 Financial and Operating Results. At this time, all participants are in a listen-only mode.
This time all participants are in that it's not only about.
Following the formal remarks, we will open the call up for your questions.
Operator: Following the formal remarks, we will open the call-out for your questions. Please be advised that this call is being recorded at the company. At this time, I'd like to turn it over to Amanda Hamilton, Investor Relations Manager at ADC Therapeutics.
Yeah advise that this call is being recorded at the company's request.
At this time I'd like to turn it over to Amanda Hamilton Investor Relations manager at 80 C. Therapeutics. Please proceed.
Amanda Loshbaugh: Thank you, Operator. This morning, we issued a press release announcing our third quarter 2020 financial results and business updates. This release is available on the ADCT website at ir.adctherapeutics.com under the press releases section. On today's call, Chris Martin, Chief Executive Officer, Jay Feingold, Chief Medical Officer, and Jen Creel, Chief Financial Officer, will discuss recent business highlights and review our third quarter 2020 financial results. In addition, Jennifer Heron, our Chief Commercial Officer, will be available for questions. As a reminder, this conference call may contain statements that constitute forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors.
Thank you operator.
Good morning, we issued a press release announcing our third quarter 2020 financial results and business update that's really that's available on the website at IR ATP Therapeutics dotcom under at the press release, the section of todays call, Chris Martin Chief Executive Officer, Jay Fine gone.
<unk> Chief Medical Officer, and 10, Creel, Chief Financial Officer will discuss recent business highlights and review our third quarter 2020 financial result.
In addition to Jennifer Herron, our Chief commercial officer will be available for questions.
As a reminder, this call.
This call may contain right there.
Constitute forward.
Yeah.
All statements other than statements of historical fact are forward looking statements.
Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied in the forward looking statements due to various factors.
We refer you to the section titled cautionary statement.
Amanda Loshbaugh: We refer you to the section titled Cautionary Statements Regarding Forward-Looking Statements in Exhibit 99.2 of our report on Form 6K filed with the U.S. Securities and Exchange Commission earlier today for further information on forward-looking statements, which speak only as of the date of this conference call. In addition, during today's call, we will be presenting certain non-IFRS financial information that management uses when monitoring and evaluating operational performance, generating future operating plans, and making strategic decisions regarding the allocation of capital. These non-IFRS measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with IFRS.
Regarding forward looking statements and it's like 9.2 of our report on form 6K filed with the U.S. Securities and Exchange Commission earlier today.
Further information on forward looking statements.
Such statements speak only as of the date of this conference call, we expressly disclaim any obligation or.
Speaking to update these forward looking statements unless required to do so by applicable law. In addition, during today's call we will be presenting certain non I ask our EPS financial information management uses when monitoring and evaluating operational performance generating future operating plan and making.
Making strategic decisions regarding the allocation of capital.
These non I asked our EPS measure have limitations of financial measures and should be considered in addition to and not in isolation or as a substitute for information prepared in accordance with our.
Our EPS.
We refer you to the section titled.
Chris Martin: We refer you to the section titled Use of Non-IFRS Financial Measures in Exhibit 99.3 of our report on Form 6K filed with the U.S. Securities and Exchange Commission earlier today for further information on non-IFRS financial measures, including reconciliation of IFRS to non-IFRS financial measures. It is now my pleasure to pass the call over to our CEO, Chris Martin.
News of nine I asked our financial measure in exhibit 99.3 of our report on form 6K filed with the US Securities and Exchange Commission earlier today for further information on non I ask our EPS financial measures, including reconciliation of I.
Our EPS.
Tonight I ask our EPS financial measures. It is now my pleasure to pass the call over to our CEO Chris Martin.
Chris Martin: Thanks, Amanda, and thank you all for joining us this morning. I'm pleased to be here today to share our recent corporate and clinical accomplishments. Our team has made tremendous progress over the past quarter as we prepare for the launch of our first drug and continue to build out and advance our deep pipeline of highly potent and targeted antibody drug conjugates. I would like to thank our teams for their resilience and dedication over the past month.
Thank you Amanda and thank you for joining us this morning.
I'm pleased to be here today to share a recent corporate controller.
Well treatments by tremendous progress already.
As we prepared for the loan to offer strong continued to build out the gold sold the outgoing quality poke gyms told gig.
Good.
I would like to turn adult seeds for them really dedication holzman.
In two weeks.
Chris Martin: In September, we reached a major milestone for our organization, announcing the submission of our BLA to the FDA for our LEAD program, Long-Term Care, for the treatment of relapsed and refractory diffuse large T-cell lymphoma. As we have previously discussed, this submission is based on data from our Pivotal Phase II LOTUS-II trial, which evaluated efficacy and safety in patients with relapsed or refractory DLBTL following two or more lines of prior systemic therapy and demonstrated important anti-tumor activity and durability, as well as manageable toxicity across patients with difficult-to-treat disease. We are expecting to receive FDA feedback on this submission later this month. And in anticipation of our pending PDUPA date, we are currently preparing to launch Lonca in 2021. In order to prepare for launch, we have recruited highly experienced and focused oncology, commercial, and medical affairs talent. Based out of New Jersey and Oklahoma.
We reached a major milestone pro.
Announcing this mission with healthier like you for our lead program longer.
For the treatment of relapsed and refractory diffuse large b cell lymphoma.
But do we get previously discussed this submission is based on data from our pivotal phase two Lotus two trial, which are backend weighted.
Safety.
Okay in patients with relapsed or refractory DLP scale, following two or more lines of cross systemic therapy.
And demonstrated important anti tumor activity and durability as well as manageable toxicity across.
Across patients with difficult to treat disease.
We are expecting to receive that feedback.
Like small.
And in anticipation of all pending due to date. We are currently prepared York smoker toward you toward you more.
Well just to prepare can do we have recruited quality experienced and focused on quality commercial medical affairs.
I used to talk about New Jersey offers.
Despite coverage restrictions. This team is collaborating seamlessly on engaging key Dl bcl stakeholders.
Chris Martin: Despite COVID restrictions, this team is collaborating seamlessly and engaging key ELVCL stakeholders. As we anticipate the FDA acceptance of our BLA later this month, we have continued our efforts to ensure a quick sales team build in 2021, comprising predominantly haematology oncologist specialists with knowledge and networks to effectively communicate the long-term value proposition to kids to stay told. The sales force will cover more than 90% of the DLBCL opportunity, and we anticipate a hybrid approach at launch due to COVID-19. Therefore, we are staffing and training all members of our commercial and medical organizations to be prepared to pivot between face-to-face and virtual launch activities. We have to look at multi-channel engagement plans to ensure that all key audiences... Physicians, Nurses, Office Managers, Payers, and Patients... receive the necessary information and support to ensure rapid and easy access to, and safe administration of, long-distance. As part of our launch preparations, we have had the opportunity to engage with healthcare professionals on advisory boards and market research regarding Lonca's maturing profile, and I'm pleased to report that the profile resonates really well.
As we anticipate yet acceptance of albeit later this month.
We have continued our efforts to ensure a quick sales team building Twentytwenty block.
Comprising.
Predominantly hematology oncologists specialists with knowledge network to effectively communicate the long 'cause value proposition can stay total.
The Salesforce will cover more than 90% of the deal PCL opportunity.
We anticipate a hybrid approach launch due to COVID-19.
Therefore, we are stopping and tried to be members of all commercial medical cost ratio.
To be prepared if it between posted footage virtual activities.
We have to multichannel engagement to ensure that we see audiences physicians nurses opus managers payers and patients.
Received the necessary information and support to ensure rapid and easy access to.
Like administration, all long that.
As part of our launch preparations we have had the opportunity to engage with health care professionals and advisory boards and market research regarding loan because maturing profile.
'cause I'm pleased to report that the protocol resonates really well.
Hematology and oncology EPS of shared with US their challenge is to find an agent and the third line in relapse refractory DLP CEO.
Chris Martin: Hematologists oncologists have shared with us their challenges to find an agent in the third line in relapsed refractory DLBCL that can potentially address the majority of their patients, be they transplant eligible or ineligible, high risk disease, heavily pre-treated or refractory population. Based on feedback from physicians on LONC's efficacy, tolerability profile, and needs for administration, we believe LONC has the opportunity to become the standard of care in the third line, based on our competitor's profile versus other available options. In addition to our longer commercial preparations, we have continued to develop and expand our partnerships. I'm pleased to hand the call over to Chief Medical Officer Jay Feingold, who will now discuss those programs with you in more detail. Jay
That can potentially address the majority of the patients either.
Maybe they transplant eligible or in any trouble.
Hi, Rich degree.
Heavily pre treated or refractory populations.
Based on feedback from physicians, but one could efficacy tolerability profile needs of administration, we believe long had an opportunity to become the standard of care.
Line based on our competitive profile versus other available options.
In addition to our longer commercial preparations we have continued to the grit and expand our pipeline.
I'm pleased to hand, the call over to.
Our Chief Medical Officer, Jay bundled who will now discuss those programs with you in more detail.
Great. Thank.
Jay Feingold: Thank you, Chris, and good morning. I am pleased to present an update today on both our clinical and preclinical programs, in addition to providing some additional information regarding our upcoming ASH presentations. Overall, we continue our plan to expand the use of LUNCA to earlier lines of therapy for patients with BLBTL with both our pivotal phase 2 combination study with ibrutinib and the opening of sites for our confirmatory phase 3 study in combination with lutexin, and to expand the use of Milankov into other cancer types with a pivotal phase 2 trial in follicular lymphoma. For Kami, we continue enrollment in I will also provide a brief update on the Phase I-II studies for ADCT-602 and the Phase I study for ADCT-601, moving into a combination with a checkpoint inhibitor. But first, let me give you an update on LARPA and our continuing lifecycle development plan. As we approach the anticipated approval of WACA next year, we are broadening our lifecycle development program.
Thank you, Chris and good morning.
I'm pleased to present an update today.
And both our clinical and preclinical programs. In addition to providing some additional information regarding our upcoming ash presentations.
Overall, we continue our plan to expand the use of longer term earlier lines of therapy for patients with deal Bcl for both our pivotal phase two combination study with identity and the opening of sites.
Welcome. Some chase me study in combination with some tax net interest.
And to expand the using local into other cancer types for the pivotal phase two trial in filmmaking lymphoma.
Kennedy, we continue enrollment in our pivotal phase two trial in patients with relapsed or refractory Hodgkin lymphoma controlling asixty, 5% symbol.
And recently extend chemists phase Oneb study in solid tumors to add a combination arm will enroll and dose our first patient.
I will also provide a brief update in the phase one two study for ADC six searching and the phase one study ADCC six or one moving into combination with a checkpoint inhibitor.
First let me give you an update on level and our continuing lifecycle development plan.
As we approach the anticipated approval will come next year.
Broadening our lifecycle development program.
First we are investigating its potential and only line of treatment in relapsed and refractory deal Bcl.
Jay Feingold: First, we are investigating its potential as an early line of treatment for relapsing refractory DLBCL. Our Lotus 5 trial, a Phase III confirmatory clinical trial evaluating the safety and efficacy of Lanca in combination with Detoximab versus standard immunochemotherapy in patients with redox to refractory DLVCL who are not eligible for an autologous stem cell transplant, is now open for enrollment. This study is designed to support a supplemental biologics license application for long-term and second-line therapy and to fulfill a post-marketing requirement to the FDA for full approval, or, if accelerated approval is granted, to relapse the retracted DLPCL.
Our lone Star trial, the phase three component.
Inventory clinical trial evaluating the safety and efficacy of local in combination with the tux map versus standard immuno chemotherapy in patients with relapsed or refractory B OVC out were not eligible for told the stem cell transplant is now opened for enrollment.
The study is designed to support a supplemental.
Hi, logics license application for longer as a second line therapy and to fill our post marketing requirement to the FDA for full approval if.
Accelerated approvals granted to relapse and refractory DLP.
We continue to enroll patients in our pivotal phase two trial of Walker in combination with Ibrutinib and you'd have to.
Jay Feingold: We continue to enroll patients in our Pivotal Phase II trial of bronchia in combination with ibrutinib in relapse of refractory DLBCL and mantle cell lymphoma, which in phase 1b showed a promising effect on overall and complete response rates along with manageable toxicity. In addition, we are planning to initiate a dose finding study of long-cut in combination with R-CHOP in previously untreated DLDCL patients in the first half of 2021. Finally, we are expanding to new histologies where LACA has demonstrated encouraging activity, including follicular lymphoma, and we plan to initiate a phase two trial of relapsed refractory follicular lymphoma in the first half of 2021. With regard to our second lead program, CAMI, the Pivotal Phase II clinical trial in patients with relapse to refractory Hodgkin lymphoma who have failed at least three power lines in therapy, continues to enroll patients.
Factory, DLP, CLL and mantle cell lymphoma.
Which in a phase one b showed a promising effect on overall and complete response rate along with manageable toxicity.
In addition, we are planning to initiate a dose finding study of long haul in combination with R. Chop previously untreated DLP CLL patients.
In first half of 2021.
Finally, we are spending to meet Histologies that locker has demonstrated encouraging activity, including significant lymphoma, we plan to initiate a phase two trial in relapsed refractory shortly lymphoma in the first half of 2021.
With regard to our secondly.
Tammy pivotal phase two clinical trial in patients with relapsed or refractory Hodgkin lymphoma or failed at least keep four lines of therapy continues to evolve.
Jay Feingold: There were 65 patients enrolled as of November 6th, and we remain on track to announce further data in the first half of 2021. Data from this trial is intended to support the submission of the BLA to the FDA. In addition to our Hodgkin Employment Program, we continue to advance our FAME 1B clinical trial of PAMI, a solid two-month program. In September, we presented preliminary data in the ongoing Phase 1b trial in patients with selected advanced locally or monostatic solid tumors as an e-poster at the European Society for Medical Oncology Virtual Congress 2020. Data presented, which included pharmacokinetics and biomarker evaluations, showed that treatment of CAMI is associated in some patients with clinically relevant modulation of new immune cells, including an increase in CD4 positive and CD8 positive T cells, an increase in soluble CD25, and cytokines in serum post-dosing, and a dose-related increase in the effector T cell to regulatory T cell ratio.
65 patients enrolled as of November six and remain on track to announce for the data in the first half of 2021.
Data from this trial intended.
Troubled submission of the BLA to the FDA.
In addition to our Hodgkin lymphoma program, we continue to advance our phase one b clinical trial currently solid too.
In September we presented preliminary data the ongoing phase Oneb trial in patients with selected advanced locally or metastatic solid tumors.
In posters at the European Society for medical Oncology Virtual Congress 2020.
Data presented which include a pharmacokinetics and Biomarkers evaluations showed that should move county.
As associated in some patients with clinically relevant modulation of immune cells, including an increase in CD.
Before positive and Cdeight positive T cells increase insoluble CD 25, and cytokine concerning post dosing.
Yesterday it increased in the effector T cell to regulatory T cell ratio.
This presentation.
Jay Feingold: This presentation follows the publication of preclinical data related to CAMI in the Journal for Immunotherapy of Cancer, which demonstrated that single low-doses of the CD25 targeted ADCs resulted in potent and durable anti-tumor activity against established CD25 negative solid tumors with infiltrating Tregs, both as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor. Based on these data, we expanded the Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of Kami, in combination with Pembrolizumab, the chef's point inhibitor, in patients with selected advanced-style tumors. We recently announced that we have diagnosed the first patient in the Phase 1b expansion, and we look forward to sharing the data in the future. In our earlier stage pipeline, we have a presentation at ASH analyzing the preclinical activity in B-cell lymphoma models and potential biomarkers for ADCT602, targeting CT22, which is currently in phase 1, 2 development for patients with relapsed or refractory acute lymphoblastic leukemia.
The publication of preclinical data.
Academy in the journal.
For immunotherapy of cancer, which demonstrated that single low dose to implement CD 25 target. The ADCC resulted in potent durable anti tumor activity against established CD 25 negative solid tumors.
With infiltrating T regs, both as a monotherapy and in combination with anti PD.
PD one checkpoint inhibitor.
Based on these data we have experienced in phase one b trial to evaluate safety Tolerability pharmacokinetics and anti tumor activity Academy in combination with Pembrolizumab checkpoint inhibitor in patients with selected advanced solid tumors.
We recently announced that.
As the first patient in the phase one being expansion.
Turning to sharing the data in the future.
In our early stage pipeline, we have a presentation at ash analyzing the preclinical activity in B cell lymphoma models and potential biomarkers for ADC, so to targeting CD 22, which is currently.
In phase one two development in patients with relapsed or refractory acute lymphoblastic leukemia.
We are also preparing to initiate a phase oneb combination trial with ADCC six on one targeting axle in patients with certain solid tumors. The second half of 2021.
Jay Feingold: We're also preparing to initiate a Phase 1b combination trial with ADCP 601, targeting AXL in patients with certain solid tumors in the second half of 2021. We continue to advance our preclinical programs towards IND submissions and look forward to providing further updates as these programs advance. We are pleased that eight of our abstracts were accepted for presentation at the American Society of Hematology Annual Meeting, which is being held virtually from December 5th to 8th. Presentations will feature data on three of the company's ABCs, Lancope, Kami, and ABCP602. I'd like to highlight two of the longer excerpts.
We continue to advance our precast.
Clinical programs towards high end. These submissions look forward to providing further updates as these programs advance.
We are pleased that eight of our abstracts were accepted for presentation at the American Society of Hematology annual meeting, which is being held virtually in December fiveth to eightth.
Presentations will feature data on three of the Companys.
C.'s wont county, and ABC so too.
I'd like to highlight to unlock and checks the.
The first dose that provides additional subgroup data will notice two pivotal phase one b trial in relapsed or refractory LTC up.
Jay Feingold: The first poster provides additional subgroup data from the LOTUS 2 Pivotal Phase 1b trial and relapse of refractory DLPCL. This dataset, a more mature dataset than previously shared, will include efficacy and duration of response data, patient subgroups with high-risk characteristics, as well as patients who were refractory to first-line therapy, patients who are refractory to any line of therapy, patients who received prior The second poster will highlight interim results from the ongoing Phase 1b trial of Blanca combined with adjuvant and relapser of factory DLBCL or MCL and will also provide more mature data on the efficacy and safety for the combination. There will also be three CAMI presentations.
This dataset the more mature data set than previously shared.
Efficacy and duration of response data patient subgroups with high risk characteristics of those patients who are refractory to first line therapy patients refractory to any line of therapy patients who received prior carty or patients who received prior stem cell transplants.
Second poster highlight interim results.
From the ongoing phase one b trial of local combined about Britain, and relapse and refractory PMBCL mcl.
The profit will provide more mature data on the efficacy and safety for combination.
We'll also be three chemicals and stations, we have an oral presentation and the interim results in phase two trial Academy in relapse refractory.
Jay Feingold: We have an oral presentation and the interview results for the phase two trial of CAMI and relapse of refractory Hodgkin-Thompson. The oral presentation will highlight efficacy and safety data for the first 47 patients enrolled at the end of August 2020. In addition, we will have a poster presentation of PK-PD data from the Phase I study in relapse of refractory Hodgkin and non-Hod
The contribution from.
Our presentation will highlight efficacy and safety data.
First 47 patients enrolled as of August 2020.
In addition, we will have a poster presentation of PK PD data from the phase one study in relapsed or refractory Hodgkin and non Hodgkin lymphoma.
Jay Feingold: Preclinical Data Showing Anti-Tumor Activated Chemie in Combination with Genocidabine, Now, I will turn the call over to Jen to give a financial update. Thank you, Jay, and good morning, everyone. In September, we completed an upsized public offering of 6 million common shares at a price of $34 per share.
In preclinical data.
Showing anti tumor activity of cammy in combination with inside of me.
With that I will turn the call over to Jen to give a financial update.
Thank you Tony and good morning, everyone.
Timber, we completed an upsized public offering of 6 million common shares at a price.
$334 per share.
Gross proceeds from the public offering were approximately $204 million on the funds are on target to support the acceleration market development activities.
Jen Creel: Gross proceeds from the public offering were approximately $204 million, and the funds are intended to support the acceleration of Lanka development activities, advance our early pipeline, and the commercialization of Lanka. These funds position the company to deliver on the many opportunities discussed in today's call. And now, turning to our financials. As we reported in our press release, we ended the third quarter with cash and cash equivalents of approximately $494 million, as compared to approximately $116 million as of December 31, 2019. We used approximately $44 million in net cash for operating activities in the third quarter and $117 million in net cash year-to-date.
Advancing our early pipeline on the commercialization and Atlanta.
Funds position the company to deliver.
On the many opportunities discussed in today's call.
And now turning to our financials.
As we reported in our press release, we ended the third quarter with cash on cash equivalents, approximately $494 million as compared to approximately 100.
16 million as of December 31st 2019.
We used approximately 24 million im not cash for operating activities in the third quarter.
117 million Im not cash year to date.
We expect our stand to continue to increase over the next few quarters as.
Jen Creel: We expect our spend to continue to increase over the next few quarters as we prepare for the anticipated launch of Lanka and continue to invest in our broad pipeline. R&D expense was $32.2 million for the third quarter, compared to $30.5 million for the same quarter last year. The increase was primarily due to increased headcount to support the LUNCA BLA submission and multiple LUNCA and CAMI clinical programs, as well as increased share-based compensation expense. P&A expense was $20.3 million for the third quarter compared to $2.3 million for the same quarter in 2019. The increase was primarily due to increased share-based compensation expense and an enhanced commercial team as we prepare for the anticipated launch of Lanka. We also saw an increase in investment in our commercial preparations and the costs associated with being a public company.
Good luck prepare for the anticipated launch of Blanca and continue to invest in our broad pipeline.
R&D expense was $32.2 million for the third quarter compared to 30.5 million, how the same quarter in 2019.
The increase was primarily due to increased headcount.
As we point amongst the BLE submission on multiple mom Clinton County clinical programs as well as increased share based compensation expense.
GNS expense was $20.3 million for the third quarter compared to 2.3 million for the same quarter in 2019.
Increase was primarily due.
To increase share based compensation expense on an enhanced commercial team as we prepare for the anticipated launch Atlanta.
We also saw an increase in investment in our commercial preparations and the costs associated with being a public company.
Our net loss was 20.3 million for the third quarter of 20.
Jen Creel: Our net loss was $20.3 million for the third quarter of 2020 compared to $31.3 million in the same quarter of 2019. The net loss for the quarter includes a $33.9 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the facility agreement with Deerfield. The net loss for the quarter was also impacted by share-based compensation expense of $11 million.
20, compared to 31.3 million in the same quarter of 2019.
Net loss for the quarter, including $33.9 million noncash gain related to the changes in fair value of derivatives associated with the convertible loans under the facility agreement with Deerfield.
Net loss for the quarter was also impacted our share based compensation expense of $11 million.
Finally, our adjusted net loss, which excludes certain items, including the Deerfield convertible loan and share based compensation for the third quarter of 2020 with 41.39.
Jen Creel: And finally, our just-did-not-lose... Included certain items, including the Deerfield Convertible Loan and share-based compensation, for the third quarter of 2020 was $41.3 million compared to $31.1 million in the same quarter of 2019. The adjusted diluted net loss per share was 58 cents in the quarter ending September 30, 2020, compared to 62 cents for the same quarter in 2019.
Dollars compared to $31.1 million in the same quarter of 2019 the.
The adjusted diluted net loss per share was 15 cents in the quarter ending September Thirtyth 2020, compared to 62 cents for the same quarter in 2019.
With that I will turn the call.
Chris Martin: With that, I will turn the call back to Chris for closing remarks. Chris? Thank you. As you can see from today's call, we have several important upcoming milestones, and it's certainly an exciting time at ADC Therapeutics. As we await feedback from the FDA on our BLA submission, our highly experienced commercial, market access, and medical affairs teams are actively preparing for a successful commercial launch next year. Looking forward to the first half of next year, we are eager to expand our longer development program with the start of the pivotal phase 2 trial in funicular lymphocytes and to review interim results for the CAMI Pivotal Phase 2 trial in relap to a primary Hodg We continue to build the long-term value of the company and its assets through investment in Lonka and Kami and our promising earlier-stage pipeline program. We look forward to presenting a number of key datasets during the upcoming ASH meeting in December, further showcasing the value and potential of our productive ADC platform and development.
Yes, Chris for closing remarks, Chris.
Thank you.
As you can see from today's call, we got several important upcoming milestones certainly.
Certainly an exciting kilometer agency therapeutics.
As we breed feedback from year to year, you will not be a nice admission R&D experienced commercial market access metric.
The Clippers teams are actively preparing for a successful commercial launch next year.
Looking forward to the first half of next year.
To expand or longer development program with the scope of the pivotal phase two in particular that book.
To review interim results could academy pivotal phase two trial in relapse.
Up to attract critical.
We continue to build long term value.
And the taxes through investment Yunker cabin, and our promising earlier stage partner programs.
We look forward to presenting a number of key data sets during the upcoming ash meeting in December.
Further showcase.
And the value and potential of our productive hdc platform and development team.
We plan to host a conference call. We took time Adobe Professor internal medicine, and scientific director of the division of Hematology and oncology Medical College of Wisconsin on Monday December.
Chris Martin: We plan to host a conference call with Dr. Ahmed Ghani, Professor of Internal Medicine and Scientific Director of the Division of Hematology and Oncology at the Medical College of Wisconsin, on Monday, December 7th at 8 a.m. Eastern time. I look forward to updating you on our programs in the future and will now open the call to your questions. We will now take any questions you may have. If you have a question, press 01, and we will put it into the queue.
What are your needs to go.
Commodore shop spreads.
I look forward to updating you on our programs in the future and we will now open the call to your questions.
Operator.
We will now take any questions. You may have if you have a question past several one and you would put in.
Into the Q, if you would like to capital. Your question. Please press the other two.
Operator: If you would like to cancel your question, please press 02. The first question comes from Matthew Harrison from Morgan Stanley. Please go ahead; your line is open.
The first question comes from Matthew Harrison from Morgan Stanley. Please go ahead. Your line is open.
Great.
Matthew Harrison: Great. Good morning. Good afternoon. Thanks for taking the questions. I guess maybe one question for Jay and one for Chris.
Good morning, good afternoon. Thanks for thanks for taking the questions I guess, maybe maybe one for Jay and.
One for Chris.
Okay could you just comment briefly I guess and I get the question is more broadly on earlier lines of therapy and in NHL. I mean, I think a lot of investors are trying to figure out the competitiveness of that landscape and how to view the early data.
Jay Feingold: Jay, could you just comment briefly, I guess, and I guess the question is more broadly on earlier lines of therapy in NHL. I think a lot of investors are trying to figure out the competitiveness of that landscape and how to view the early data that you have from the Ibrutinib combination, how that fits in, and how much data you think you need to have from that combination before you feel confident that you have a signal there that is significantly better than competitors. And then Chris, or maybe it's for Chris and Jen, but can you just comment broadly on how we should think about commercial spend ramping up over the course of the next few quarters as you get ready for launch? I'll answer the question first. I agree with you that the landscape is very competitive.
That you have from the aggregate combination how that fits in and how much data do you think you need to have from that combination before you feel confident that you have a signal there that is.
Significantly better than than competitors, and then and then Chris or maybe for Chris Amgen, but could you just comment.
Broadly on how we should think about commercial spend ramping up.
Over the course of the next few quarters and as you get ready for launch thanks.
Sumo answer the clinical question first.
I agree with you that landscape is very competitive and on the settlement.
Jay Feingold: Salman, Hodgkin, and Palmer, and even in for both DLBCL and follicular lymphoma, as well as NAMPYL. Focusing on DL-BCL, you know, with the introduction of rituximab about 20 years ago, As you know, about 30% to 40% or slightly lower, depending on studies. Our patients are not cured in their first line, so we believe that welcome because Dr. Hung, Gregory Renza, Ameet Mallik, Eugenia Litz, Jose Carmona, Brian Cheng, Michail Paraskevopoulos, particularly in non-GCBD LBCL patients, which is where most of the data is.
The lymphoma and even in.
You know to book deal Bcl influencing lymphoma, as well as mantle cell lymphoma.
Focusing on PMBCL, you know with the introduction of the traction that 20 years ago Lee.
Purely to a deal Bcl increase significantly.
But since that time, there's been little change and that remains a very very difficult to treat disease with the patients are not cured and the first line and as you know about 30% to 40% owner start no. Some cases, some studies and patients are not killed my first line. So we believe that market because it is something that activism as a model.
The has a role in the treatment of relapsed refractory b cell in terms of moving up into earlier lines of therapy. The only data that weve shared so far and what you'll see at Ash I think is good it's very interesting the combination of local cost improvement, particularly in language can be lumpy cell patients, which is where most of the data is at this time so.
Jay Feingold: So we'll just have to wait and see how it works out. I don't have a number in mind that would say to me, oh yeah, this is so great. We have to go into a second line or whatever with this combination.
Well just have to wait and see how it works out I don't have a number in mind that would say to me earlier. This is so great. We have to go into our second line or whatever it is combination I think we need to see more data we need a few more rapid durability, but the early indications are very positive.
Jay Feingold: I think we need to see more data. We need to see more about durability, but the early indications are very positive. Thank you, Joe. Matthew, in terms of commercial spend, I'll let Jen answer that in detail. I will say that Jennifer and Joe Camargo in commercial and medical affairs have made tremendous progress this quarter in building their teams and interacting, as I mentioned earlier, with the healthcare professionals and the healthcare infrastructure more broadly. And they've received very encouraging feedback from those they interact with, and we continue to recruit the commercial and medical affairs field forces ready for deployment. But Jen, perhaps you'd like to address the financial part. Sure.
Thank you Joe.
Back in terms of.
Social spend on old Gen on stuff in detail Bill.
Jennifer and check them out or in commercial and medical affairs, but made tremendous progress in this quarter in building their teams.
Interacting bazaarvoice as I mentioned in the earlier.
Earlier with the healthcare professionals.
And the healthcare infrastructure more broadly.
And they've received very encouraging feedback from those interactions and.
We continue to recruit the commercial and medical Affairs field forces ready for deployment, but in a country like to address the financial part of that question.
Sorry, Thanks, Chris and Thanks, Matthew and then had the question ads and the teams have been building out next Chris mentioned, we've had a lot of progress this year in the commercial and medical affairs team building throughout this year.
Chris Martin: Thanks, Chris. And thanks, Matthew, for the question. As the teams have been building out, and as Chris mentioned, we've had a lot of progress this year in the commercial and medical affairs team building throughout this year, so we have seen our spend increasing steadily throughout this year with that preparation, and we'll continue to see an uptick each quarter as we head towards the launch of LANCA. In the middle of next year, so I would say that we're seeing that increase in year-to-date spend, and it'll continue to tick upwards as we head towards the middle of next year.
So we have seen our spend increasing steadily.
Throughout this year with that preparation and we'll continue to see an uptick.
Each quarter as we head towards the launch.
The launch of long path in the middle of next year. So I would I would say that we're seeing that increase in the year to date spend and it'll continue to tick upwards as we head towards the middle of next year. Thank.
I remind you that if you want to ask a question. Please press star one on your telephone keypad now.
Jen Creel: Thank you. I remind you that if you want to ask a question, please press 01 on your telephone keypad now. Ladies and gentlemen, this does conclude your program, and you may now disconnect. And everyone, have a great day.
Ladies and gentlemen, thank you for parties.
Okay dissipating in today's conference. This does conclude your program and you may now disconnect everyone have a great day.
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