Q4 2021 ADC Therapeutics SA Earnings Call
[music].
Operator: Welcome to the ADC Therapeutics fourth quarter and year-end 2021 Financial Results Conference call. My name is Josh, and I will be your operator for today's call. At this time, all participants are in a listen-only mode.
Welcome to the ADC Therapeutics fourth quarter and year end 2021 financial results Conference call. My name is Josh and I will be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session. During the question and answer session.
Operator: Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press star, then one on your touch-tone telephone. I will now turn the call over to Amanda Hamilton, Investor Relations Manager. Amanda, you may begin. Thank you. Thank you, Operator. This morning, we issued a press release announcing our fourth quarter and year-end 2021 financial results and business updates. This release is available on the ADCT website at ir.adctherapeutics.com under the Press Releases section.
Operator: On today's call, Chris Martin, Chief Executive Officer, Jennifer Herring, Chief Commercial Officer, Joe Camarto, Chief Medical Officer, and Jen Creel, Chief Financial Officer, will discuss recent business highlights and review our fourth quarter and full year 2021 financial results before opening the call for questions. As a reminder, this conference call may contain forward-looking statements. Such statements are subject to risks and uncertainties.
Amanda Hamilton: For additional information concerning forward-looking statements and factors that could cause actual results to differ materially from those expressed or implied in the statement, we refer you to the section titled Cautionary Statement Regarding Forward-Looking Statements in Exhibit 99.3 of our report on Form 6K filed with the U.S. Securities and Exchange Commission earlier today. Such statements speak only as of the date of this conference call, and we expressly disclaim any obligation or undertaking to update these forward-looking statements unless required to do so by applicable law.
Amanda Hamilton: Today's presentation also includes non-IFRS financial measures. 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.
Amanda Hamilton: You should refer to the information contained in the company's fourth-quarter earnings release for definitional information and reconciliation of historical non-IFRS measures to comparable IFRS financial measures. It is now my pleasure to pass the call over to our CEO, Chris Martin. Chris?
Chris Martin: Thanks, Amanda, and thank you, everyone, for joining us today. I'm very pleased to share our fourth quarter and full year results as we executed on our key objectives and closed out a pivotal year for ADC Therapeutics. I'm also looking forward to sharing our 2022 milestones. The Zenod Talon remains a top priority, and my very encouraged by what we have been able to accomplish so far. In addition, we have advanced our clinical development portfolio and research pipeline, and we are entering the year with a healthy cash balance. Starting with the launch, we delivered $17 million in net sales during the fourth quarter and approximately $34 million for the eight months of sales in 2021.
If you have a question. Please press Star then one on your Touchtone telephone I will now turn the call over to Amanda Hamilton Investor Relations manager Amanda you may begin.
Thank you operator. This morning, we issued a press release announcing our fourth quarter and year end 2021 financial results and update.
This release is available on <unk> website.
Alright that ADC therapeutics Dot com under the press releases section.
On today's call, Chris Murray, Chief Executive Officer, Jennifer hearing Chief Commercial Officer, Joe <unk>, Chief Medical Officer, and Jen Creel, Chief Financial Officer will discuss recent business highlights and review, our fourth quarter and full year 2021.
Before opening the call for questions.
As a reminder, this conference call may contain forward looking statements.
Statements are subject to risks and uncertainties for additional information concerning forward looking statements and factors that could cause actual results to differ materially from those expressed or implied in these statements.
Refer you to the sections titled cautionary statement regarding forward looking statements and exhibit 99 three of our report on form 6K filed with the U S Securities and Exchange Commission earlier today.
These statements speak only as of the date of this conference call and we expressly disclaim any obligation or undertaking to update these forward looking statements unless required to do so by applicable law.
Today's presentation also includes non <unk> financial measures. These non <unk> measures have limitations as financial measures and should be considered any additional steel and not in isolation or as a substitute for the information prepared in accordance with IRS you should refer to the information contained in the company's fourth quarter.
Earnings release for Definitional information and reconciliations of historical non <unk> measures to the comparable <unk>.
Financial measures.
It is now my pleasure to pass the call over to our CEO , Chris Martin Chris.
Thanks, Amanda and thank you everyone for joining us today.
I'm very pleased to share our fourth quarter and full year results as we executed on all key objectives and closed out a pivotal year for ADC therapeutics.
Im also looking forward to sharing our 2022 milestones with you.
So is the multiple remains a top priority and we're very encouraged by what we have been able to accomplish so far.
In addition, we have advanced our clinical development portfolio and research pipeline and we are entering the year with a healthy cash balance.
Starting with the launch we delivered 17 <unk> net sales during the fourth quarter on approximately $34 million for the eight months sales in 2021.
Chris Martin: The differentiated product profile of Dinlanta continues to serve an unmet need in the third line plus DL-BCL market, and is resonating with physicians both at major academic centers and in the community as they consider treatment options for their patients. The positive launch dynamics are also a testament to our experienced commercial team which has been able to navigate the challenges of the evolving COVID landscape. Jennifer Herron, our Chief Commercial Officer, will share more details on our Q4 and 2021 performance a little later in this call.
The differentiated product profile of the mantra continues to serve an unmet need in the third line plus <unk> market and.
And is resonating with physicians, both with major academic centers and in the community as they consider treatment options for their patients.
The positive launch dynamics are also a testament to our experienced commercial team, which has been able to navigate the challenges of the evolving COVID-19 landscape.
Jennifer Herron, our chief commercial officer will share more details on our Q4 2021 performance a little later in this call.
Chris Martin: Next, we remain committed to expanding worldwide access for any relapsed refractory DLBCL patient who may benefit from Zinlomta, and we are working to expand our geographic footprint. During the fourth quarter, the EMA validated our marketing authorization application.
Next we remain committed to expanding worldwide access for any relapse refractory <unk> patients who may benefit from <unk>.
And we are working to expand our geographic footprint.
During the fourth quarter.
M&A validated our marketing authorization application.
Chris Martin: And in January, we announced an exclusive license with Mitsubishi Tenabe for the development and commercialization of Zinlonter in Japan. The Overland ADCT BioPharm Joint Venture continues to enroll patients in the Pivotal Phase 2 Bridging Study in China, which is intended to serve as the basis for regulatory filing. The joint venture is making rapid progress towards bringing Zinlanta to patients in China. We will continue to focus on moving Zinlantra into first and second line DLBCL therapy with promising combinations that may offer a path to registration, including our ongoing confirmatory Phase III study of Zinlantra in combination with Rituximab, as well as our frontline study in the same combination in unfit or frail patients.
In January we announced an exclusive license with Mitsubishi Tanabe for the development and commercialization of <unk> in Japan.
The overland ADT Biopharma joint venture continues to enroll patients in the pivotal phase III bridging study in China, which.
Which is intended to serve as the basis for regulatory filings.
The joint venture is making rapid progress towards bringing <unk> to patients in China.
We will continue to focus on moving <unk> into <unk>.
First and second line <unk> therapy, with promising combinations that may offer a path to registration, including our ongoing confirmatory phase III study of <unk> in combination with Rituximab as well as a frontline study in the same combination and unsafe or frail patients.
Chris Martin: We have refined our Zinmonta development strategy, prioritizing areas where we can bring the most differentiated benefits to patients and healthcare providers, which would also result in increased value for all stakeholders. Joe Camado, our Chief Medical Officer, will elaborate on this in a moment. In addition to Zinn Lanter, we continue to advance the programs in our robust clinical developments and research pike, which will ensure long-term growth and value creation for the company.
We have refined also involves the development strategy prioritizing areas, where we can bring the most differentiated benefits to patients and healthcare providers, which would also result in increased value for all stakeholders.
Joe <unk>, our Chief Medical Officer will elaborate on this in a moment.
Yes.
In addition to the Monza, we continue to advance the programs and a robust clinical development and research pipeline, which will ensure long term growth and value creation for the company.
Chris Martin: At Cammie, we have completed the 12-month follow-up of the pivotal phase 2 trial in relapse refractory hog pins and lymphoma, and we have submitted the data to an upcoming meeting, as we highlighted on our Solid Tumor Pipeline Webcast in February. We see significant potential for our pipeline of solid-tumor programs, which includes three clinical programs in CAMI, ABCT901 targeting CAG1, and ABCT601 targeting AX1. We also have two preclinical programs with ADCT701 targeting DLK1 and ADCT212 targeting PSMA. This exciting pipeline demonstrates the impact of our expanding ADC platform and the productivity of our experienced team of industry experts.
For <unk>, we have completed the 12 month follow up of the pivotal phase III trial in relapsed refractory Hodgkin lymphoma.
And we have submitted the data to an upcoming meeting.
As we highlighted on our solid tumor pipeline webcast in February .
We see significant potential for our pipeline of solid tumor programs, which includes three clinical programs and Kennedy <unk> 901, targeting <unk>, one and <unk> 601 targeting Axel.
We also have two preclinical programs with <unk> 701, targeting <unk>, one and <unk> targeting <unk>.
This exciting pipeline demonstrates the impact of our expanding the ADC platform and the productivity of our experienced team of industry experts.
Chris Martin: Joe will tell you more about the Solid Tumor Program, sure. I would now like to turn the call over to Jennifer to report on the launch and provide insights on our progress in establishing Xen Lonter as a 3rd line plus standard of care in DL-BCL. Jennifer.
Joe will tell you more about our solid tumor program shortly.
I would now like to turn the call over to Jennifer to report on the launch and provide insights on our progress in establishing <unk> as a third line plus standard of care in <unk> Bcl.
Jennifer.
Jennifer Herron: Thank you, Chris, and good morning, everyone. With our second full quarter into the Zalanta launch, I'm very happy to share an update on our progress. As Chris mentioned, we are pleased to report Xelantha net sales of $17 million in the fourth quarter of 2021, representing quarter-over-quarter growth of 30% , and 2021 total net sales of 34 million for the first eight months of launch. This steady progress has been driven by a seasoned and focused U.S. commercial and medical organization supported by all of ADC Therapeutics.
Thank you, Chris and good morning, everyone.
With our second full quarter into this and want to launch them.
Very happy to hear an update on our progress.
As Chris mentioned, we are pleased to report the launch of net sales of $17 million in the fourth quarter of 2021.
Presenting quarter over quarter growth of 30%.
And 2021 total net sales of $34 million for the first eight months of launch.
This steady progress has been driven by season's end focused U S commercial and medical organization supported by all of ADC Therapeutics.
Jennifer Herron: This effort ensures that U.S. health care providers appreciate Denlaunce's differentiated product profile, its robust single-agent efficacy. Tolerability and Ease of Administration across all, and its broader applicability in the 3rdLinePlus DLBCL market. Through 2021, the commercial and medical teams have been successful in driving their respective initiatives, resulting in both P-Account Depth and Breath in terms of demand. We have seen significant increases in Zanlanta awareness, familiarity, and share of voice with an increasing proportion of Zanlanta use in the third line setting as compared to later lines.
This effort ensures that U S healthcare providers I appreciate lots of differentiated product profile, it's robust single agent efficacy tolerability and ease of administration across all patients and its broad applicability and the third line plus <unk> market.
Through 2021, the commercial and medical teams have been successful in driving their respective initiatives, resulting in the key account depth and breadth in terms of demand.
We have seen significant increases in Finland to awareness familiarity and share of voice with an increasing proportion of deadline to us in the third line setting as compared to later lines.
Jennifer Herron: As Chris mentioned in his initial remarks, the differentiated Zalanta product profile continues to resonate with both academic and community-based physicians. During the fourth quarter, academic centers still represented over 50% of total volume with an equal proportion of ordering accounts coming from academia and the community.
As Chris mentioned in his initial remarks, the differentiations and launch a product profile continues to resonate with both academic and community based physicians.
During the fourth quarter academic centers still represented over 50% of total volume with an equal proportion of ordering accounts coming from academia and the community.
Jennifer Herron: In terms of patient access, our payer and medical teams have achieved broad access, with no significant barriers encountered so far. As we examined ordering patterns in Q4, we believe there was some modest year-end inventory build in both the community and academic settings reflective of future prescribing intent in anticipation of early 2022 infusions. In the fourth quarter, COVID impacted our launch landscape with some restrictions on face-to-face interaction.
In terms of patient access our payer and medical teams have achieved broad access for patients with no significant barriers encountered so far.
As we examine ordering patterns in Q4, we believe there was some modest year end inventory build in both the community and academic settings reflective of future prescribing intent in anticipation of early 2022 infusions.
In the fourth quarter Covid impacted our launch landscape with some restrictions on face to face interactions.
Jennifer Herron: We will continue to carefully monitor the changing landscape and be ready to pivot to maximize our efforts just as we have done since our approval last year, with our Strong Zin Lonsa Launch in 2021. This year, we have the opportunity to establish Zin Lonsa as the third line plus standard of care through increases in account breath, New Commercial Initiatives, and Increased Effectiveness as we sharpen even further our multi-channel execution. We continue to ensure patient access through our patient hub, advancing patient support.
We will continue to carefully monitor the changing landscape and be ready to pivot to maximize our efforts just as we have done since our approval last year.
With our strong <unk> launch in 2021. This year, we have the opportunity to establish <unk> as the third line plus standard of care through increases in account breadth and depth.
New commercial initiatives and increased effectiveness as we sharpen even further our multichannel execution.
<unk> continued to ensure patient access through our patient hub advancing patient support, which importantly helps patients and physicians offices during the benefit re verification process and with co pay support.
Jennifer Herron: With importantly, helps patients and sedition officers, during the Benefit Reverification Process and with co-paste support. And even as we have seen increasing volume to date coming from the community, we expect community demand to increase even more once we receive our permanent J code, which is expected in April of 2022.
And even as we have seen increasing volume to date coming from the community.
Expect community demands to increase even more once we receive our permanent J code, which is expected in April of 2022.
Joe Camardo: In summary, we are encouraged by the in-market performance of DynLaunch's differentiated product profile, the anecdotal feedback from our customers and patients, and the resulting launch trajectory to date. While we recognize there are uncertainties associated with the progression of the pandemic, we believe in our ability to establish and launch it as a third-line plus standard of care. In addition, we are optimistic about Zinlaunt's long-term potential as a cornerstone of DLBCL therapy in first and second line. We look forward to keeping you updated on our launch progress. Now I'll turn the call over to Joe to provide an update on our clinical development portfolio and research pipeline. Joe?
In summary, we are encouraged by the end market performance of the launch its differentiated product profile.
Feedback from our customers and patients and the resulting launch trajectory to date.
While we recognize there are uncertainties associated with the progression of the pandemic, we believe in our ability to established and launch it as a third line plus standard of care.
In addition, we are optimistic about <unk> long term potential as a cornerstone of DLP steel therapy in first and second line. We look forward to keeping you updated on our launch progress now.
Now I will turn the call over to Joe to provide an update on our clinical development portfolio and research pipeline.
No.
Thank you Jennifer.
Joe Camardo: Thank you, Jennifer. First, I'd like to share some updates for our Zenmanta development program, and then I will provide a progress report on the pipeline. We continue to see a great opportunity with Sonlanta in combinations in earlier lines of therapy in DLBCL. Based on emerging Sonlanta data, we have refined our strategy to execute a highly focused program for clinical trials, where Sonlanta can deliver the most value for patients in first and second lines.
First I'd like to share some updates quarters and lots of development program and then I will provide a progress report on the pipeline.
We continued to see a great opportunity with <unk> combinations in earlier lines of therapy in <unk> based on emerging and lots of data we have refined our strategy to execute a highly focused program for clinical trials, where you didn't want that can deliver the most value for patients in first and second line.
Joe Camardo: First, we are focused on the combination with Zinlantra and Rituximab. We are encouraged by the results from the safety meeting of the Lotus 5 Phase 3 confirmatory trial of Zinlantra combined with Rituximab. This trial includes second and later line patients who are not eligible for stem cell trans [inaudible] Safety running is complete, and the randomized portion of the trial is enrolled. The combination of Xenlanta and Rituximab is well-tolerated, there are no new safety events, and the initial data suggests the combination is adequate.
First we are focused on the combination with <unk> and Rituximab. We are encouraged by the results from the safety meeting of the Lotus five phase III confirmatory trial of <unk> combined with your talks about.
This trial includes second and later line patients who are not eligible for stem cell transplant.
Thank you running is complete and the randomized portion of the trial is enrolling.
Combination of the Atlanta, and Rituximab as well tolerated there are no new safety events and the initial data suggests the combination is additive.
Joe Camardo: Another combination in development was Lotus III, the Phase II trial of Zanlanta in combination with Abrudnid in Relapse Free Fractory DLBCL. With the latest results of the Lotus 5 Safety run-in, we have decided to discontinue Lotus III.
Another combination in development with <unk> III, the phase II trial of <unk> in combination with Ibrutinib in relapsed refractory <unk>.
With the latest results of the Lotus flight safety running we have decided to discontinue lotus great.
Joe Camardo: We will focus our efforts on the Lotus 5 trial, which is potentially a fast and direct potential pair to market in second line. In the front line setting, a significant area of high unmet medical need is with unfit and for L.P. This patient subgroup is addressed by our LOTUS 9 trial, a study to evaluate SINLASA in combination with rituximab in the first. Unfit and frail means patients who are either because of age or other concurrent illness cannot be given a full course of the R-CHOP regimen or even the low-dose R-mini-CHOP due to toxicity.
We will focus our efforts on the Lotus five trial, which is potentially a fast and direct potential path to market in second line.
In the frontline setting a significant area of high unmet medical need is with unsafe and frail patients. This patient subgroup is addressed by our Lotus nine trial, a study to evaluate <unk> in combination with Rituximab in the first line.
Unfit and fail means patients who are either because of age or other concurrent illness cannot be given a full course of the art Chop regiment or even the low dose are many job due to toxicity. These patients are often excluded from first line studies or new combinations and some studies exclude patients over 80, regardless of medical status.
Joe Camardo: These patients are often excluded from first-line studies or new combinations, and some studies exclude patients over 80 regardless of medical status. These patients represent a meaningful and growing subset of frontline patients for whom new treatments are lacking. So the LOTUS 9 protocol serves a significant unmet medical need and also leverages the differentiated profile of SINLANTA. That is the single agent efficacy and the tolerability and safety.
These patients represent a meaningful and growing subset of frontline patients for whom new treatments are lacking.
So the Lotus nine protocol serves a significant unmet medical need and also leverages. The differentiated profile of <unk> that is the single agent efficacy and Tolerability and safety. Moreover, with the Lotus valve safety run in showing the Tolerability of the <unk> combination. We now have the data needed to initiate this study in the second half.
Joe Camardo: Moreover, with the LOTUS-5 safety run-in showing the tolerability of the Zinlantra-Rituximab combination, we now have the data needed to initiate the study in the second half of this year. We will focus our frontline program on LOTUS-9, and therefore, we will not initiate LOTUS-8, which was the dose-finding trial of Zinlantra in combination with our CHOP in frontline DLV-CL. Beyond rituximab, we will also explore other novel combinations in the LOTUS-7 trial, with regard to the phase two loaded six trial in relapse or refractory follicular lymphoma. The comparator idealilisted was withdrawn from the follicular lymphoma.
This year, we will focus our frontline program on Lotus nine and therefore, we will not initiate motors eight which was the dose finding trial of Zimmer and.
In combination with R chop in frontline <unk>.
Beyond Rituximab, we will also explore other novel combinations in the low to seven trial.
With regards to the phase III <unk> trial in relapsed or refractory Follicular lymphoma.
The comparator ideal Elisa was withdrawn from the Follicular lymphoma market.
Joe Camardo: Therefore, we have paused the LOTUS-6 study while we work with our advisors and the FDA on potential next steps. We will update you in the future on our plans in follicular lymphoma. We remain highly positive about the opportunity to expand the potential of Jinlantha in first and second lines and look forward to keeping you updated on our progress.
Therefore, we have caused <unk> to six study, while we worked with our advisors and the FDA on potential next steps, we will update you in the future on our plans in Follicular lymphoma.
We remain highly positive about the opportunity to expand the potential of and launch it in first and second lines and look forward to keeping you updated on our progress.
Joe Camardo: Moving on to CAMI and Hodgkin lymphoma, we plan to report results for the Phase 2 trial at a medical meeting in the first half of 2022. The one-year follow-up is now complete, and we are in the process of compiling data in advance of our meeting with the FDA. We will share our plans for the regulatory submission later this year. As we recently highlighted in our Solid Tumor and Pipeline webcast, our solid tumor portfolio includes three clinical and two preclinical programs. Our ongoing CAMI Phase 1b dose escalation trial in combination with Pembrolizumab in patients with advanced solid tumors shows the combination to be safe and tolerable so far.
Moving on to <unk> in Hodgkin lymphoma, we plan to report results for the Phase II trial at a medical meeting in the first half of 2022.
One year follow up is now complete and we are in the process of compiling data in advance of our meeting with the FDA.
We will share our plans for the regulatory submission later this year.
As we recently highlighted in our solid tumor pipeline webcast. Our solid tumor portfolio includes three clinical and two preclinical programs our ongoing <unk> phase <unk> dose escalation trial in combination with <unk> in patients with advanced solid tumors shows the combination to be safe and tolerable so far.
Joe Camardo: This has allowed for continued dose escalation of CAMI to assure the optimal dose for evaluation of anti-tumor activity. The protocol allows for small dose expansions if warranted by the scan results, if there is stable disease or tumor regression, and we have done so at the 60 microgram per kilogram dosing level. In parallel, dose escalation continues, and we are now at 80 micrograms per kilogram combined with the usual dose of Pembrolizumab. The combination of Pembro and Cammy is highly synergistic in models, and our trials are designed to take advantage of this in cancers that are not highly responsive to Pembro losing that alone. ADC T901 targeting TAG1 is a novel first-in-class candidate for the treatment of patients with advanced solid tumors.
This has allowed for continued dose escalation of <unk> to assure the optimal dose for evaluation of anti tumor activity.
Total allows for small dose expansions if warranted by the scan results. If they are stable disease or tumor regression and we have done so at the 60 microgram per kilogram dosing level in parallel dose escalation continues and we are now at 80 micrograms per kilogram combined with usual dose of temporal isn't that big.
The combination of <unk> and <unk> is highly synergistic and models and our trials are designed to take advantage of this and cancers that are not highly responsive September with some avalon.
<unk> hundred one targeting tag one is a novel first in class candidate for the treatment of patients with advanced solid tumors. This includes platinum resistant ovarian cancer fallopian tube cancer prostate cancer, cholangiocarcinoma renal cell carcinoma, and triple negative breast cancer and our lab.
Joe Camardo: This includes platinum-resistant ovarian cancer, fallopian tube cancer, prostate cancer, cholangiocarcinoma, renal cell carcinoma, and triple negative breast cancer. In our labs, we have shown that CAG1 is differentially expressed on these cancers. The dose escalation of the Phase 1 study is ongoing. ADCT-601, Mificedum abuzopterine, targets AXA. This protein is overexpressed in many solid tumors, such as lung, breast, prostate, pancreas, glioma, and esophageal cancers, and is highly prevalent in sarcoma. We expect to initiate the phase 1B in the first half of this year.
<unk>, we have shown that <unk>. One is differentially expressed on these cancers the dose escalation of the phase one study is ongoing.
<unk> 601, <unk> targets axle. This protein is over expressed in many solid tumors, such as lung breast prostate pancreas, glioma and esophageal cancers and is highly prevalent in sarcoma, we expect to initiate the phase <unk> in the first half of this year.
Joe Camardo: The planned study will include a dose escalation, followed by dose expansion in sarcoma patients in combination with gemcitabine and ADCT601 monotherapy in patients in whom axial gene amplification is detected. In addition to our clinical programs, we have two advanced preclinical solid tumor programs. ADCT701 targets DLK1.
The planned study will include a dose escalation followed by dose expansion in sarcoma patients in combination with Gemcitabine and <unk> 601 monotherapy in patients in whom axle gene amplification is detected.
In addition to our clinical programs, we have two advanced preclinical solid tumor programs.
Joe Camardo: We are developing this in neuroendocrine malignancies in collaboration with the National Cancer Institute, are recently announced ADCT212 program is our optimized second-generation, TBD-based ADC. This targets PSMA, a validated target in metastatic prostate cancer. We are currently completing I&D enabling work for both of these programs. With that, I will turn the call over to Jen to give a financial update. Thank you, Joe, and good morning, everyone. As we've reported in the press release issued earlier today, Zalanthem Net sales were $17 million for the fourth quarter, and approximately $34 million for eight months in 2021.
<unk> 701 targets <unk>, we are developing this in euro independent malignancies in collaboration with the National Cancer Institute.
Our recently announced a DCT <unk> program is our optimized second generation.
TBD based ADC this targets PSM.
Validated target in metastatic prostate cancer. We are currently completing IND, enabling work for both of these programs.
With that I will turn the call over to Jim to give a financial update.
Jen Creel: As of December 31st, we had cash and cash equivalents of $467 million as compared to $530 million as of September 30th, 2021. We used approximately $62 million in net cash for operating activities in the fourth quarter and $233 million in net cash for the full year 2021. R&D expenses were 42 million for the fourth quarter and 158 million for the four-year 2021 compared to 49 million and 142 million for the same quarter and four-year 2020.
Thank you Joe and good morning, everyone.
As we reported in the press release issued earlier today and lines of net sales were $17 million for the fourth quarter and.
And approximately $34 million for eight months in 2021.
As of December 31, we had cash and cash equivalents of $467 million as compared to $530 million as of September 32021.
Used approximately $62 million in net cash for operating activities in the fourth quarter and $233 million in net cash for the full year 2021.
R&D expenses were $42 million for the fourth quarter and $158 million for the full year 2021, compared to $49 million and $142 million for the same quarter and full year 2020 R&D.
Jen Creel: R&D expense decreased for the quarter ended December 31, 2021 as compared with the same quarter in 2020 as a result of lower CMC activities following business and lots of DLA submission and subsequent approval. R&D expenses increased for the full year 2021 as compared to the same period in 2020 due to investments in Zinlanza trials and earlier lines of treatment and advancing our broad portfolio. As a result of these initiatives, employee headcount and share-based compensation expense increased.
R&D expense decreased for the quarter ended December 31, 2021, as compared to the same quarter in 2020 as a result of lower CMC activities. Following there's been lots of BLA submission and subsequent approval.
R&D expenses increased for the full year 2021, as compared to the same period in 2020 due to investments in lines of trials in earlier lines of treatment and advancing our broad portfolio.
As a result of these initiatives employee headcount and share based compensation expense increased.
Jen Creel: Selling and marketing expenses were $19 million for the fourth quarter and $65 million for the full year 2021, compared to $9 million and $22 million for the same quarter and full year 2020. The increase in selling and marketing for the quarter and for the full year reflects the expenses for the Zenlanta launch and ongoing commercial efforts. TNA expenses were 18 million for the quarter and 71 million for the 4-year 2021, compared to 20 million and 55 million for the same quarter and 4-year 2020.
Selling and marketing expenses were $19 million for the fourth quarter and $65 million for the full year 2021, compared to $9 million and $22 million for the same quarter and full year 2020, the increase in selling and marketing for the quarter and for the full year reflects the expenses for the <unk> launch and ongoing.
And commercial efforts.
G&A expenses were $18 million for the quarter and $71 million for the full year 2021, compared to $20 million and $55 million for the same quarter in full year 2020.
<unk> expenses decreased for the fourth quarter of 2021 as compared to the same quarter in 2020, primarily due to a decrease in share based compensation expense that was partially offset by higher cost of being a public company.
<unk> expenses for the full year 2021, as compared to full year 2020 increased due to higher cost of being a commercial stage public company.
Jen Creel: TNA expenses decreased for the fourth quarter of 2021 as compared to the same quarter in 2020, primarily due to a decrease in share-based compensation expense that was partially offset by higher cost of being a public company. G&A expenses for the full year 2021 as compared to full year 2020 increased due to higher costs of being a commercial stage public company. Netloss was $34 million to the fourth quarter and $230 million to the four-year 2021, compared to a net loss of $56 million and $246 million for the same quarter and four-year 2020.
Net loss was $34 million for the fourth quarter and $230 million for the full year 2021, compared to a net loss of $56 million and $246 million for the same quarter and full year 2020, our diluted net loss per share was <unk> 45 in the fourth quarter and $3 for the full year.
Jen Creel: Our diluted netloss for share was $0.45 in the fourth quarter and $3 for the four-year 2021, compared to a net loss of 73 cents for the same quarter and $3.77 for the four-year 2020. Finally, adjusted net loss, a measure that excludes certain items, as described in our press release issued earlier today, was $30 million for the fourth quarter and $186 million for the full year 2021, compared to an adjusted net loss of $63 million and $176 million in the same quarter and full year 2020.
'twenty, one compared to a net loss of <unk> 73 for the.
The same quarter and $3 77 for the full year 2020.
Jen Creel: The decrease in adjusted net loss for the fourth quarter 2021, as compared to the same quarter 2020, was primarily due to the recognition of an income tax benefit as a result of recording a deferred tax asset primarily related to U.S. R&D tax credits. The increase in adjusted net loss for full-year 2021 over full-year 2020 was primarily driven by the investment in Ms. Nilanthalonch and our broad clinical portfolio. The adjusted diluted net loss per share was $0.39 for the fourth quarter and $2.42 for the full year 2021 compared to a loss of $0.82 and $2.69 for the same quarter and full year 2020.
Finally, adjusted net loss a measure that excludes certain items as described in our press release issued earlier today was $30 million for the fourth quarter and $186 million for the full year 2021, compared to an adjusted net loss of $63 million and $176 million.
And the same quarter in full year 2020.
The decrease in adjusted net loss for the fourth quarter 2021, as compared to the same quarter of 2020 was primarily due to the recognition of an income tax benefit as a result of recording a deferred tax assets primarily related to U S. R&D tax credits.
The increase in adjusted net loss for full year 2021 over full year 2020 was primarily driven by the investment and is in line for launch and our broad clinical portfolio.
The adjusted diluted net loss per share was 39 for the fourth quarter and $2 42 for the full year 2021.
To a loss of <unk> 82.
And $2 69 for the same quarter and full year 2020.
Chris Martin: With that, I will turn the call back to Chris for closing remarks. Thank you, Jen, Joe and Jennifer. To conclude, in the fourth quarter we made significant progress in all areas of our business, and we are well positioned to execute on our key objectives in the year ahead. This includes driving the Zinlon to launch forward.
With that I will turn the call back to Chris for closing remarks, Chris.
Thank you Jen Joe and Jennifer.
To conclude in the fourth quarter, we made significant progress in all areas of our business and we are well positioned to execute on our key objectives in the year ahead.
This includes driving does it want to launch food.
Operator: Working to develop SynLauncer and Early Alliance of Therapy. Continuing to expand our geographic reach, and Advancing Our Pipeline of Differentiated Haematological and Solid Tumor Programs. I'm pleased now to open the call for your questions. Thank you. We will now begin the question and answer session. If you have a question, please press star, then 1 on your touchtone telephone. If you wish to be removed from the queue, please press the pound sign or the hash key. If you are using a speakerphone, you may need to pick up the handset first before pressing the numbers.
Working to develop and launch it in earlier lines of therapy.
Continuing to expand our geographic reach.
Advancing our pipeline of differentiated hematological and solid tumor programs.
I am pleased now to open the call for your questions.
Operator.
Operator: Once again, if you have a question, please press star, then 1 on your touchtone. Our first question comes from... Brian Cheng with Canter, you may proceed with your. Hey guys, thanks for taking my questions. First for Jennifer, on the sales number, can you talk about how much of an inventory bill that's there?
Thank you we will now begin the question and answer session. If you have a question. Please press Star then one on your Touchtone telephone you wish to be removed from the queue. Please press the pound sign or the ask you if youre using a speakerphone you may need to pick up the handset first before.
Pressing the numbers once again, if you have a question. Please press Star then one on your Touchstone.
Our first question comes from.
Jennifer Herron: And can you talk about how benefit reauthorization as a factor on OneCube sales? And I have a couple of follow-up. Yeah, sure. Brian, thanks for the question. So, in terms of the inventory build, as I mentioned, we did see some modest inventory build towards the end of the year, both in the academic institutions and the communities. The issue is, or I should say, it's hard to further characterize that because we don't have access to patient-level data. But when we took a look at the ordering patterns for some of our key accounts, we did see greater than expected orders.
Bryan <unk> with Cantor you May proceed with your question.
Jennifer Herron: So, it's not possible at this point to quantify it, but we do believe there was some modest build towards the end of the year. In terms of benefit verification, we think that oftentimes with Part B drugs that sometimes the benefit verification that happens for all patients, government patients, can sometimes result in a delay in getting treatment. We're watching it carefully, particularly in the context of COVID and some of the healthcare workers shortage, but we'll have to report on that when we report out to one.
Hey, guys. Thanks for taking my questions.
First part Jennifer on the sales number can you talk about how much of an inventory buildup there.
And can you talk about how benefit reauthorization that factor on <unk> sales and I have a couple of follow ups. Thank you.
Yes sure Brian Thanks for the question.
So in terms of the inventory build as I mentioned we.
Did see some modest inventory build towards the end of the year, both in the academic institutions and the community.
The issue is our I guess I'd say its hard to further characterize that because we don't have access to patient level data.
But when we took a look at the ordering patterns for some of our key accounts, we did see greater than expected orders. So it's not possible at this point to quantify it but we do believe there was some modest build towards the end of the year.
In terms of benefit for clarification.
We think that often times with part D drug that sometimes the benefit verification that happens for all patients government patients Ken.
Can sometimes result in a delay in getting treatment.
We're watching it carefully, particularly in the context of Covid and some of the healthcare worker shortage.
But that we'll have to report on that when we put out in Q1.
Jennifer Herron: Okay. And then on pricing, we noticed that you took a 1.1% increase last month. I'm just curious, any guidance on how we should think about your price increase moving forward? Is that the number that we should be projecting for out years?
Okay, and then on pricing we noticed that you took a one 1% increase last month.
Just curious any guidance on how we should think about your price increase moving forward.
A number that we should be projecting for out years, and then I have one more follow up for Joe. Thanks.
Jennifer Herron: And then I have one more follow-up for Joe. Thanks. So when you think about new product pricing and price increase recommendations, there are a lot of considerations, as I'm sure you're aware of. We take into account the overall political and policy environment, the competitive context, and also the impacts on reimbursement and physician cost recovery. So as we come into the year, we've been considering carefully all of these factors, each of them and all together, and all of the downstream implications. As well as the fact we just launched in May of 2021.
Sure.
When you think about new product pricing and price increase recommendation there are a lot of considerations as im sure Youre aware of.
We take into account the overall political and policy environment, the competitive context, and also the impact impacts on reimbursement and physician cost recovery.
So as we come into the year, we've been considering carefully all of these factors each of them and altogether and all of the downstream applications in.
Joe Camardo: So it's been less than a year and felt that, you know, a modest price increase was was most appropriate at this, Okay, and then quick question for Joe. On the discontinuation for LOTUS-8, I'm just curious, are you still looking into frontline combination potential? And if the decision is partly based on the Polaris data and from your conversation with doctors, how important is it to have an R-CHOP backbone in the frontline? Thanks, Brian. The decision is partly related to the landscape, but it's also partly related to the data we have from our lead-in on Lotus 5.
As well as the fact, we just launched in May of 2021, so it's been less than a year and felt that a modest price increase was most appropriate at this time.
Okay, and then quick question for Joe.
Okay.
Okay.
Okay.
Okay.
Okay.
Okay.
Okay.
Okay.
Okay.
How are you.
Finance it.
Are you talking about.
Thanks, Brian .
Thanks, Brian .
The decision is partly related to the landscape, but it's also partly related to the data we have from our lead in <unk> five.
I hesitate to use the term but are some of our advisors are telling us that the Christmas tree approach, adding new drugs to R. Chop.
Joe Camardo: You know, I hesitate to use the term, but some of our advisors are telling us that the Christmas tree approach, adding new drugs to our chop, is probably... Not what you would consider a modern approach. It could be incremental. And we're looking for a transformative approach to Frontline. We're looking for a way to try to use the strength of Lonca in combination with rituximab, to really change the landscape for first line and get rid of many of these old toxic drugs that have been around since I was an intern, and Provide new ways to, get a long-term remission in patients when they have their first chance at a long-term remission.
Is probably.
Sure.
Not not what you would consider modern approach.
It could be incremental and we're looking for a transformative approach to frontline, which you're looking for a way to try to use the strength of <unk>.
In combination with Rituximab.
True to really change the landscape for first line and get rid of many of these old toxic drugs that have been around since I was an intern.
<unk>.
Provide new ways to.
Get a long term remission in patients when they have their first chance that a long term remission. So it's really a difference between.
Joe Camardo: So, it's really a difference between, you know, adding something and trying to get a small benefit, which is what I think you've seen with Polarix, versus trying to have a transformative approach to first line. I really prefer the later.
Adding something in trying to get a small benefit which is what I think <unk> seen with <unk>.
Versus trying to have a transformative approach to first line I really prefer the later thats, how you make advances in medicine, and we have a lot of support from our advisers, who are doing that and we actually grew.
Joe Camardo: That's how you make advances in medicine. And we have a lot of support from our advisors for doing that. We actually... We're able to find a patient population that just about exactly suits what are the strengths of Xen Lanka, which is the tolerability and the activity. And with the combination data that we now have from our lead-in, we're really confident that this could be a big improvement for a group of patients who really don't get quite the kinds of treatments that they deserve. Great. Thanks, Jeff. You're welcome, Brian. Thank you. Our next question comes from Boris Pieker with Cowen.
We're able to find a patient population that just about exactly suits what.
Are the strengths of Saint <unk>, which is the tolerability and the and the.
Activity.
And with the combination data that we now have from our lead and we're really confident that this could be a big improvement for a group of patients who really don't get quite the kinds of treatments that they deserve.
Great. Thanks Chuck.
You're welcome Brian .
Okay.
Thank you. Our next question comes from Boris <unk> with Cowen You May proceed with your question.
Joe Camardo: You may proceed with your question. Great. I'd just like to continue the same line of questioning. So, in the frail DLBCL patients that you're targeting in Lotus 9, can you comment on how big this patient population is today or where it's projected to be in the next several years and kind of what the standard of care is for these specific patients? I was going to answer the last part of it, which there really is not a standard of care. That's one of the things we learned, that the doctors sometimes give nothing, sometimes they give rituximab, sometimes they give a course or two of something and they have to stop.
Greg I'd just like to continue the same line of questioning so in the framework deal Bcl patients that you're targeting Lotus nine can you comment on how big this patient population is today, where it's projected to be in the next several years and kind of what the standard of care is for these specific patients.
Joe Camardo: Sorry, but I can't answer that part of it. So we're really in a place where, you know, we can have a transformative outcome. Sorry, Chris, I guess Jennifer, I'd like to defer to Jennifer on the others, as you said.
Jonathan can you take that first.
Temperature.
I was going to answer the last part of it which there really is not a standard of care. That's one of the things we learned that the doctors, sometimes give nothing sometimes they gave rituximab, sometimes they gave a course or two if something that they have to stop sorry.
But to answer that part of it so we're really in a place where.
We can have a transformative outcome sorry.
Sorry, Chris I guess, Jennifer I'd like to defer to Jennifer on the other side as you.
As you said.
Jennifer Herron: Yeah, certainly. So, Boris, you know, it's this frail and unfit opportunity. I've been really impressed with the enthusiasm from our thought leaders about this, and largely because, as Joe said, there aren't a lot of clinical trials that include this population. As we've engaged them in really optimizing the program, they've anecdotally reported a range of anywhere between 15 and 30 percent of the first-line population, which could be considered frail or unfit and not eligible for R-CHOP or R-mini-CHOP, just based on, you know, comorbidities potentially.
Yes, certainly so forth.
The frown on fit opportunity I've been really impressed with the enthusiasm from our thought leaders about this.
Largely because as Joe said, there aren't a lot of clinical trials that include this population as.
As we've engaged them and really optimizing the program.
Dave Anecdotally reported a range of anywhere between 15% and 30% of the first line population.
Could be considered kraeutler on fit and not eligible for our top of our many shop.
Based on.
No.
Jennifer Herron: And, you know, recall the first-line population is approximately 60,000 patients in the U.S. and EU5. So, at this point, you know, we're engaging with the thought leaders. From a commercial perspective, I'm very excited about it, and mostly for the patients, because this is going to address an area of unmet medical need where I think DINMANTA is uniquely positioned to support our patients. Great and late. My last question is on the so on the European Strategy.
Comorbidities potentially.
Recall the first line population approximately 60000 patients in the U S and EU five so at this point, we're engaging with the thought leaders from a commercial perspective I'm very excited about it.
And mostly for the patients because this is going to address an area of unmet medical need where I think the market is huge.
And equally positioned to support our patients.
Alright.
My last question is on the.
So onto the European strategy can you comment on how you're thinking of approaching that.
Chris Martin: Can you comment how you're thinking of approach? Yes, as you know, we're committed to developing longer into the global markets. We were very pleased to make the agreement with Mitsubishi, Tanabe in Japan.
Yes.
Sure Doug.
Committed too.
Developing long code into the global markets.
Chris Martin: In Europe, we're progressing well on the regulatory pathway, and we're still looking at our alternative options for commercialization in Europe. So as those develop, we will keep you updated. Great, thank you for taking my question. Thank you. Our next question comes from Kelly Sheebly.
Very pleased to do the.
Might be agreement with Mitsubishi Tanabe in Japan and Europe .
Well on the regulatory pulpwood.
We're still looking at alternative options for commercialization in Europe , so as those develop.
We'll keep you updated.
Great. Thanks for taking my questions.
Operator: Jeff, please, you may proceed with your question. Thank you for taking my question. There have been uses to a quarter since the launch.
Thank you. Our next question comes from Kelly <unk> with Jefferies. You May proceed with your question.
And thank you for taking my question.
Thank you just two quarters into the launch and launch I Wonder if you're able to share some color on the patient profile cost Us Airlines spectrum.
Jennifer Herron: I wonder if you're able to share some color on the patient profile across the salon spectrum. Specifically, what is the slate of the patient taking the Lanta in Surla and the Falsland beyond it? Also, what percentage of patients could it was the Lanta primary refactor rate and post-19 card T? And lastly, any feedback regarding the safety profile from physicians regarding their real world experience.
Specifically what is this mainly comes from patients taking your line is now in third line and the false on beyond also.
What percentage of what percentage of patients treated who is your line's primary refractory.
And post COVID-19 car T.
And then lastly, any feedback regarding the safety profile from utilization regarding their real world peering. Thank you.
Jennifer Herron: Thank you. Thank you. Jennifer, do you want to take the first part of that, and then maybe Joe can ask just the safety protocol part? Yes, certainly. Thanks, Chris. So we're pleased with now, I guess we're now 10 months into the market, with how the real-world profile is consistent with the loaded-to-pivotal data, and we're hearing that through market research, through advisory boards, through engagements with our customers. And we are seeing broad use of Zinlansa across the entire spectrum of its indication in ThirdLinePlus, supported by the NCCN guidelines.
Okay. Thanks, Jennifer do you want to take the first part of that and then maybe Joe can also just.
Safety protocols.
Yes, certainly thank you Chris.
So we are pleased with now I guess, we're now 10 months into the into the market with how the real world profile is consistent with the two pivotal data and we're hearing that through market research advisory boards their engagements with our customers and we are seeing broad use of the monza across the entire spectrum of its indication in third line.
Yes.
Supported by the <unk> guidelines.
Jennifer Herron: In the early days of the launch, and not unexpected, we did season launch to use predominantly in the later line setting, but importantly since launch now, we have seen a nice evolution in the business with an increase in proportion of third line patients receiving in launch a versus later line, and we believe that's important for the patient because earlier line use will likely translate into even more benefit for our patients. So, you know, again, we're very excited about the opportunity and how the business is evolving and continue to believe that this is our year for establishing the launch as the third line plus standard of care. Your question specifically with regard to subsets is very difficult to answer because as I mentioned earlier, we don't necessarily have patient level data and the data that we do receive does not rarely have complete demographic.
The early days of the launch and not unexpected we did season launch used predominantly in the later line setting, but importantly since launch now we have seen a nice evolution in the business with an increasing proportion of third line patients receiving <unk> versus later lines and we believe that's important for the payer.
<unk>.
Earlier line use will likely translate into even more benefit for our patients.
So again, we're very excited about the opportunity and how the business is evolving and continue to believe that this is our year for establishing us in Lhasa as a third line plus standard of care. Your question, specifically with regard to subset is.
Very difficult to answer because as I mentioned earlier, we don't necessarily have patient level data and the data that we do receive.
It does not rarely has complete demographics. So it's hard for me to say that I mean, what I am thrilled about though that based on the loaded two data we do see consistent benefit.
Jennifer Herron: So, it's hard for me to say that. I mean, what I am thrilled about though that, based on the Lotus 2 data, we do see consistent benefits across the subsets and that has held up as we've gotten into the market. Thank you. Thank you. Thank you. The safety profile is for me to answer. Our surveillance is showing reports consistent with what we already knew and that, you know, nothing new, nothing unexpected, nothing more severe in general based on what we know from LOTUS 2.
Across the subset and that has held up as we've gotten into the market.
Thank you.
As you will see profile.
The safety profile is for me to answer.
Surveillance is showing reports consistent with what we already knew.
And that nothing to.
Nothing unexpected nothing more severe in general based on what we know from Lotus too.
Jennifer Herron: We don't have quantitative data on how every doctor is treating, you know, and using, you know, managing the side effect profile, but in general when we talk to our advisors or hears the advice we're giving and the label is working and we're not seeing, you know, more, you know, dose delays or discontinuations than we anticipated from the LOTUS 2 profile.
We don't have quantitative data on how every doctors treating.
Using this managing the side effect profile, but in general when we talk to our advisers or.
Here's your advice for giving in the label.
Is working and we're not seeing more.
Dose delays or discontinuation than we anticipated from the Lotus to profile. So so far.
Joe Camardo: So, so far what we're seeing in the clinical practice is consistent with what we saw in the clinical trial database. Great, thank you. You're welcome. Thank you. Our next question comes from Matthew Harrison of Morgan Stanley. You may proceed with your question. Hi, I'm Espa, taking my question. This is Steve Asman from Matthew Harrison.
What we're seeing in the clinical practice is consistent with what we saw in the clinical trial database.
Great. Thank you.
Youre welcome.
Thank you. Our next question comes from Matthew Harrison with Morgan Stanley You May proceed with your question.
Hi, Thanks for taking my question. This is Steve asking for Matthew Harrison.
Operator: Oh, I have a question for Longka. I want to ask about your view on the penetration into the T centers and what is the opportunity in community centers? Thanks. Thank you, Jennifer. So, as I've reported, our volume to date, or at least through 2021, is predominantly driven by the academic institutions, but we've also had some early community uptake.
I have a question for long time.
Ask about your view on the penetration into the key centers and what is the opportunity in committed community centers. Thanks.
Yes.
Thank you Jennifer.
Yes, I can take that.
So as I reported our volume to date or at least through 2021 is predominantly driven by the academic institutions, but we've also had some early community uptake.
As we think about.
The evolution of the business and with our permanent J code, which we now have confirmation will be receiving.
Jennifer Herron: As we think about the evolution of the business and with our permanent J-code, which we now have confirmation will be receiving, will be effective on April 1st, we're excited about the opportunity to move into the community. As you may be aware, in the community, the permanent J-code can be a point of pivot for physicians being willing to try a new product because it does provide greater confidence around their timing to reimbursement, which is important for their practices.
It will be effective on April one.
We're excited about the opportunity to move into the community as you may be aware in the community.
The permanent J code can be.
<unk> of a pivot for physicians being willing to try new products because it does provide greater confidence around their timing to reimbursement which is important.
Jennifer Herron: So, in terms of penetration, we've seen, you know, an equal number of, an equal proportion, I should say, of accounts on the community and the academic settings, orderings, and LONSA, with a greater volume coming from the academic institutions, but we do believe that that will evolve as we have that opportunity with the permanent J-code.
For their practices so.
In terms of penetration, we've seen an equal number of equal proportion I should say of account on the community and the academic setting orderings and launch.
With a greater volume coming from the academic institutions, but we do believe that.
That will evolve as we have that opportunity with the permanent J code.
Jennifer Herron: Thanks. That's helpful. Thank you. And as a reminder, to ask a question, you'll need to press star 1 on your telephone.
That's helpful.
Thank you and as a reminder to ask a question you will need to press star one on your telephone.
Operator: Our next question comes from Kenny McKay with RBC. You may proceed with your call. Hi, congrats on the progress, and thanks for taking the question. Maybe thinking about yours and Lanta's strategy, can you help us with the size of the newly incident frontline DLBCL market that's unfit for our trials? Just thinking about the potential market that could be indicated by the LOTUS-9 trial, and curious what percent of newly incident patients that could represent.
Next question comes from Kennan Mackay with RBC.
You May proceed with your question.
Hi, Congrats on the progress and thanks for taking the question maybe.
Maybe thinking about yours when lots of strategy can you help us with the size of the newly incident frontline <unk> market that's untapped.
Or.
Just thinking about the potential market.
As indicated by the Lotus nine trial I'm curious what percent of newly incident patients that could represent.
Operator: And then second, for Dr. Camardo, could you speak a little bit more to the LOTUS-3 trial, and what led to the decision-making to refocus on rituximab combos versus the abrutinib combo? Was there some overlapping toxicity concern or other safety events in that combination with abrutinib, or was the decision more just related to lack of sufficiently additive efficacy?
Second for Dr. Tomorrow could you speak a little bit more to the Lotus three trial and what led to the decision making to refocus on Rituxan combos.
Combos versus the Ibrutinib combo wolfberry, some overlapping toxicity concern or other safety events in that combination where the number was the decision more just related to lack of sufficiently additive efficacy. Thanks.
Jennifer Herron: Thanks. Thank you, Kennan. Jennifer, do you want to take the first part?
Thank you Jennifer.
Postpone.
Jennifer Herron: Yes, certainly. Thanks. And Ken, thanks for the question. So qualitatively, we've had a lot of enthusiasm from thought leaders, as I mentioned, because this is an under, maybe underserved population by current clinical trials. And, you know, anecdotally, they have given us a range, it really depends on the treatment setting, quite frankly, what the percentage of frail and unfit patients that they may have. But it does range somewhere between 15 and 30%.
Yes, certainly.
And Ken Thanks for the question.
So qualitatively we had.
A lot of enthusiasm from thought leaders is as I mentioned, because this is a under maybe underserved population by current clinical trials.
And anecdotally they have.
Given us a range it really depends on the treatment setting.
Quite frankly, what the percentage of rail onset patients that they may have.
But it does range somewhere between 15 and 30%.
Jennifer Herron: We're going to be doing some more work to really understand the footprint of these patients. But you think about the first-line opportunity is approximately 60,000 patients for the U.S. and EU-5. It is a significant commercial opportunity. And given the fact that it would be an area of high medical need and leveraging the strength of our single-agent profile, then in combination with a Tuxmed, I'm excited about the opportunity to do that. So that's the opportunity from a commercial perspective, for sure.
Going to be doing some more work to really understand.
The footprint of these patients, but you think about the first line opportunity is approximately 60000 patients for the U S and EU five is a significant commercial opportunity and given the fact that it would be an area of high unmet medical need and leveraging the <unk>.
Strength of our single agent profile, then in combination with Rituximab I'm excited about the opportunity from a commercial perspective for sure.
Jennifer Herron: And the answer to your question is no, this was not a decision based on observation of overlapping toxicity. Rather, it was a decision based on the observation that this combination might provide a modest additional benefit perhaps in later line treatments using a drug, a brutinib, which does not have an indication for a large cell and isn't very widely used versus a transformation for a first line indication using a drug that is widely used.
And the answer to your question is no. This was not a decision based on observation.
Observation of overlapping toxicity, rather it was a decision based on.
The arbitration that this combination will provide a modest additional benefit perhaps in later line treatment using a drug ibrutinib, which does not have an indication for large sell in isn't very widely used versus.
A transformation for first line indication using a drug that is widely used.
Joe Camardo: And I mentioned in a population that in our view is underserved and allowing us a chance to have an impact in patients at their first possible chance of cure. And also, you know, as a corollary, the long-carried Tuxmed combination is also helpful as a baseline for us to add some new drugs once we can prove benefit with that combination in the first line. That becomes a way of, you know, improving, changing, transforming the first line treatment, eliminating the old drugs and adding some of the new ones.
And I mentioned in a population that.
And our view is underserved.
And allowing us a chance to have an impact in patients. If they are first possible chance of cure and also.
As a corollary to longer Rituximab combination is also helpful. As a as a baseline for us to add some new drugs. Once we can prove benefit with that combination in the first line.
It becomes a way of.
Improving changing transforming the first line treatment, eliminating the old drugs and adding some of the new ones.
Joe Camardo: That answer your question, I hope. Yeah, definitely. Thank you very much, Jeff. And maybe just going back to your comments around the additive talk, I'm sorry, the additive efficacy with Texamab. Can you maybe help sort of set some goalposts there, House? Is that truly additive? Should we be thinking about the potential frontline, we're talking about efficacy there with some of the native response rates we've seen from denoting the third line, or how should we think about that? Think about it as better than what we're seeing in the third line, which is actually very good.
Does that answer your question I hope.
Yes.
Yes, definitely thank you very much.
Maybe just going back to your.
Your comments around the additive talk I'm, sorry, the additive efficacy.
Rituximab.
Maybe help sort of custom.
Some goalposts their house.
Is that true.
Should we be thinking about the potential worldwide.
Talk to map just as they're with.
With some of the maybe response rates we've seen from.
Lots of it in the third line or how should we think about that.
Yes think about it as better than what we're seeing in the what we what we were seeing in the third line, which is actually very good 25% complete response rate in third line is actually very good as a single agent and Thats not just third line that fourth and fifth line.
Joe Camardo: I mean our 25% complete response rate in third line is actually very good as a single agent, that's not just third line, that's fourth line, fifth line. We're adding with Texamab and seeing an improvement. I can't exactly tie what it is because at this point in time we have a pretty small sample, but there's also evidence from our labs on this combination. And it's interesting, there's a large body of evidence that shows that Texamab in general will add to the effectiveness of most of the side toxic drugs.
We're adding rituximab and seeing an improvement I can't exactly tell you what it is because we.
At this point in time, we have a pretty small sample but.
There is also evidence from our labs.
On this combination and it's interesting there is a large body of evidence that shows rituximab in general.
<unk> will add to the effectiveness of most of decided the cytotoxic drugs. So we're sort of building on something thats almost a biologic principle here and we're seeing pretty good confirmation in our early load is fine, but just a number just doesn't at this point.
Joe Camardo: So we're sort of building on something that's almost a biological principle here, and we're seeing pretty good confirmation in our early load as five, but a number just doesn't at this point, it's a little too early to come out with a number, but we are seeing what it looks like if the combination is an improvement over what we're seeing in the third line, as I said, which is pretty good, actually 25%, very good. So, okay. Thank you. And I'm not showing any further questions at this time. I would now like to turn the call back over to Chris Martin for any further remarks.
It's a little too early to come out with a number but we are seeing what looks like it's a combination is is an improvement over what we're seeing in the third line as I said, which is pretty good actually 25% very good.
Okay got it.
Okay.
Thank you.
And I'm not showing any further questions at this time I would now like to turn the call back over to Chris Martin for any further remarks.
Chris Martin: Thank you, Operator. And thank you very much for joining our call today, everyone. We look forward to keeping you updated on our progress.
Well. Thank you operator, and thank you very much for joining our call today, everyone and we look forward to keeping you updated on our progress.
Operator: And with that, I wish you all a good day. Thank you. Bye. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
And with that I'll wish you all a good day. Thank.
Thank you.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
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