Q1 2021 TG Therapeutics Inc Earnings Call

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Greetings and welcome to the TG Therapeutics Q1, 2021 earnings conference call and business update at.

Operator: Greetings and welcome to TG Therapeutics' Q1, 2021 Earnings Conference Call and Business Update. At this time, our participants are in a listen-only mode. A brief question and answer session will follow the form of the presentation. If anyone should require operator assistance during the conference, please press Star Zero on your telephone keypad. As a reminder, this concert is being recorded. I will now like to turn the conference over to Jenna Bosco, Senior VP of Corporate Communications. Please proceed.

At this time all participants are in a listen only mode.

A brief question answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded I would now like to turn the conference over to the Jenna Bosco Senior VP of corporate Communications. Please proceed.

Thank you welcome everyone and thanks for joining us this morning, I'm, Jenna Bosco and with me today to discuss the first quarter 2021 financial results and provide a business update are Michael Weiss, our executive Chairman and Chief Executive Officer, Adam Waldman, Our Chief commercialization Officer, and Sean power of our Chief Financial Officer.

Jenna Bosco: Thank you. Welcome everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the first quarter 2021 financial results and provide a business update are Michael Weiss, our executive chairman and chief executive officer, Adam Waldman, our chief commercialization officer, and Sean Power, our chief financial officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate developments, as well as an update on our current pivotal programs and key goals for 2021.

Sure.

Following our safe Harbor statement, Mike will provide an overview of our of our recent corporate developments as well as an update on our current pivotal programs and key goals for 2021.

Adam will provide an update on our commercialization efforts and Shawn will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session.

Jenna Bosco: Adam will provide an update on our commercialization efforts, and Sean will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I would like to remind everyone that various remarks that we make about our future expectations, plans, and prospects constitute forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995. Pitchy cautions that these forward-looking statements are subject to risks that may cause our actual results to differ materially from those indicated.

Okay.

Before we begin I would like to remind everyone that various remarks that we make about our future expectations plans and prospects constitute forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.

TG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated.

Jenna Bosco: Factors that may affect TG Therapeutics' operations include various risk factors that can be found in our filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10Q. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements.

Factors that may affect TG therapeutics operations include various risk factors that can be found in our filings with the securities and Exchange Commission, including our most recent quarterly report on form 10-Q.

In addition, any forward looking statements made on this call represent our views only as of today and should be and should not be relied upon as representing our views as of any subsequent date.

We specifically disclaim any obligation to update or revise any forward looking statements.

This conference call is being recorded for audio rebroadcast on Tg's web site Www Dot TG therapeutics Dot com, where it will be available for the next 30 days.

Jenna Bosco: This conference call is being recorded for audio rebroadcast on TG's website, www.gtherapeutics.com, where it will be available for the next 30 days. All participants on this call will be in a listen-only mode. Now, I'd like to turn the call over to Mike Weiss, our CEO.

All participants on this call will be on a listen only mode now I'd like to turn the call over to Mike Weiss Our C E O.

Michael S. Weiss: Thank you, Jenna, and thanks to everyone for joining us this morning. With the recent accelerated approval of Eukonic for the treatment of relaps or refractory marginal zone lymphoma and follicular lymphoma, TG has transitioned into a fully integrated commercial organization. We are extremely pleased to now have Eukonic, the first and only dual inhibitor of PI3K Delta and K1 Epsilon available to patients. We see the approval of Econic as the first step in our broader mission of developing novel treatments for patients with B-cell diseases.

Thank you Janet and thanks to everyone for joining us this morning.

With the recent accelerated approval of the iconic for the treatment of relapsed or refractory marginal zone lymphoma, and Follicular lymphoma, TG has transitioned into a fully integrated commercial organization. We are extremely pleased to now have you kind of the first and only dual inhibitor of <unk> Delta.

The one of Epsilon available to patients.

We see the approval of the economy as the first step in our broader mission of developing novel treatments for patients with B cell diseases.

With the successful phase III studies in chronic lymphocytic leukemia referred to the C O L and multiple sclerosis, MFS already completed and reported we see the potential to positively impact significantly larger group of patients on the horizon.

Michael S. Weiss: With successful phase three studies in chronic lymphocytic leukemia, referred to as CLL, and multiple sclerosis, MS, already completed and reported, we see the potential to positively impact a significantly larger group of patients on the horizon. Beyond that, our pipeline has the potential to deliver novel combinations, building off a foundation of eukonic and eukotoximab, our U2 combination, that can further enhance outcomes for patients Before I hand over the call to our chief commercialization officer, Adam Waldman, to discuss the iconic launch and preparations for the potential CLL and MS launches, I wanted to review some of our recent accomplishments, as well as the current status of our ongoing programs.

Beyond that our pipeline has the potential to deliver novel combination building off of a foundation of your panic and look for tuck snap our use of combination that can further enhance outcomes for patients with b cell diseases.

Before I hand over the call of to our Chief commercialization Officer, Adam Wallman discussing the iconic launch of preparations for the potential CLO and then that's the launches.

I wanted to review some of our recent accomplishments as well as the current status.

All of our ongoing programs first.

Michael S. Weiss: First and foremost, as I mentioned at the outset of these prepared remarks, in February, the FDA granted accelerated approval of Eukonic for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and for adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy. This approval was primarily based on the results from the Econic Monotherapy cohorts of the Unity NHL Phase 2B trial, and the approval came just shortly after the final results from this trial were presented at the American Society of Hematology Annual Conference. We refer to that as Ash in December 2020.

First and foremost as I mentioned at the outset of these prepared remarks in February the FDA granted accelerated approval of Uchronic for the treatment of adult patients with relapsed or refractory marginal zone lymphoma, who have received at least one prior anti CD 20, based regimen and for adult patients with relapsed or refractory.

Follicular lymphoma, who have received at least three prior lines of systemic therapy.

This approval was primarily based on the results from the economy monotherapy cohorts of the unity NHL phase two b trial in.

The approval came just shortly after the final results from this trial were presented at the American Society of Hematology Annual conference, we refer to that as Ash in December 2020.

Michael S. Weiss: Also of note, within a month of approval, these results were also published in the Journal of Clinical Oncology. The commercial team has been hard at work educating potential prescribers about Yukonic and building a strong foundation, which we believe will continue to translate into adoption of Yukonic and position us well for the planned CLL launch, potentially later this year or early next. On that note, as most of you know, we presented positive results from the Unity CLL phase-through trial at the Ash annual meeting in December.

Also of note within a month of approval. These results were also published in the journal of clinical oncology.

The commercial team has been hard at work educating potential prescribers about your chronic and building a strong foundation, which we believe will continue to translate into adoption of the economy and position us well for the plan for a lot of launch potentially later this year for early next.

On that note.

As most of you know we presented positive results from the Union. The C O L phase II trial at the Ash annual meeting in December and more recently at the end of March we announced the completion of our rolling submission of a biologics license application for <unk> was a BLA to the U S. F D. A.

Michael S. Weiss: And more recently, at the end of March, we announced the completion of a rolling submission of a biologics license application, referred to as a BLA, to the U.S. FDA, requesting approval of lupytocinap, an investigational, glyco-engineered, anti-CD-20 monocl antibody in combination with the U.C.A. The combination, as many of you know, we refer to as you too, as a treatment for patients with chronic lymphocytic leukemia.

Western approval of lots of talks about our investigational glycol engineer anti CD 20 of monoclonal antibody in combination with the economy.

The combination of as many of you know refrigerated you chip.

As a treatment for patients with chronic lymphocytic leukemia.

This BLA submission was based primarily on the results of the unique scale, all trial, which which was conducted under special protocol assessment.

Michael S. Weiss: This BLA submission was based primarily on the results of the UNY CLL trial, which was conducted under special protocol assessment, and as a reminder, the FDA previously granted fast-track designation to the U-2 combination for the treatment of adult patients with chronic lymphocytic leukemia and orphan drug designation to the U-2 combination for the treatment of CLL. The next step is we expect to hear from the FDA later this month on whether they have accepted the submission for filing.

And as a reminder, the FDA previously granted <unk> fast track designation to the East you combination for the treatment of adult patients with chronic lymphocytic leukemia, and the orphan drug designation for you for the Youtube combination for the treatment of CLO.

The next step is we expect to hear from the FDA later this month on whether they have accepted the submission for filing.

With approximately 185000 Americans living with the C. O L. On approximately 40000 patients seeking treatment annually cielo on remains an incurable disease and represents a large patient population, where we believe you too will provide the needed treatment option for these patients.

Michael S. Weiss: With approximately 185,000 Americans living with CLL and approximately 40,000 patients seeking treatment annually, CLL remains an incurable disease and represents a large patient population where we believe you, too, will provide a needed treatment option for these patients. Now, I'd like to turn to our MS program, where our BLA submission is slated for the third quarter of this year.

Now I'd like to turns of our MS program, where our BLA submission is slated for the third quarter of this year.

Michael S. Weiss: That BLA will be supported by the positive results from our ultimate one-and-two phase three trials, evaluating oobotoxymab in relapsing forms of MS, which were presented at the AAN conference last month. Both studies met their primary endpoint with Ubutoxinap treatment, demonstrating a statistically significant reduction in annualized relapse rate, which we call ARR annualized relapse rate, over a That's compared to teraphylutamide, and the eulbituximab treatment resulted in an ARR of 0.076 in Ultimate 1 and 0.091 in Ultimate 2.

I feel they will be supported by the positive results from our ultimate one into phase III trials evaluating with Rituximab in relapsing forms of M. S, which were presented during the AAN conference last month.

Both studies met their primary endpoint with the.

Net treatment demonstrating a statistically significant reduction in annualized relapse rate, which we would call a or our annualized relapse rate over 96 week period with the P value of less than 005 in both of the trials that's compared to tariff solidified.

And deal with Hudson of treatment are resulting in the air or a 0.076 and the ultimate one endpoint 091, and the ultimate to for those who were on the call with the experts, which I'll talk about momentarily.

Michael S. Weiss: For those who were on the call with the experts, which I'll talk about momentarily, they were very excited to see that those ARR numbers were below 0.1, which has never occurred before in a Phase 3 trial. So they were really excited about those results.

We're very excited to see that those those are our numbers were below 0.1, which is never occurred before the phase III trial. So really excited about those results. We also hit key secondary MRI endpoints.

Michael S. Weiss: We also hit key secondary MRI endpoints, including statistically significant reductions in both T1 GAD enhancing lesions as well as T2 lesions. Lubotoxinam also reduced disability progression and increased the rate of disability improvement as compared to terafluidamide, although the former was not statistically significant.

Including a statistically significant reductions in both the T. One enhancing lesions as well as T. Two lesions.

Ooh protection of them also reduce disability progression and increased the rate of disability improvement as compared to the tariff the demand. However, the former was not statistically significant.

Michael S. Weiss: In addition to the presentation A&, we hosted a call with leading neurologists to review this data. A replay of that call is available on our website, and I do encourage folks who are interested in TG to listen to that call. The doctors on the call were very enthusiastic about the profile of oopletoxymab and its potential in the treatment of MS. For our part, we are extremely pleased with the results from the ultimate one and two trials and believe these data showcase the potential of Lubotoximab to provide a highly efficacious treatment option with a generally well-tolerated safety profile.

In addition to the presentation of N. We hosted a call with leading neurologists to review this day that replay.

A replay of that call is available on our website and I do encourage folks who are interested in T. G. A travel listen to that call. The doctors on the call. We're very enthusiastic about the profile of of Botox map and its potential in the treatment of M. S.

For our part we are extremely pleased with the results from the ultimate one and two trials and believe these day to showcase the potential of Google talks of map to provide the highly efficacious treatment option for the generally well tolerated safety profile.

Michael S. Weiss: If approved,ubotoximab will be the only CD20 offered in a convenient one-hour fusion every six months, of course, following the first infusion, which treating physicians have shared is an important benefit for them and their patients. As a reminder, this trial was also conducted under special protocol assessment with the FDA, and as noted earlier, we are targeting a BLA submission for Oblatuximab to treat patients with relapsing forms of multiple sclerosis in the third quarter of this year.

If approved we will talk some of that will be the only see the 20th offered in the convenient one hour infusion every six months.

Of course, following the first infusion, which treating physicians have shared is an important benefit for them and their patients. As a reminder, this trial was also conducted under special protocol assessment with the FDA and as noted earlier, we are targeting of BLA submission for whom the tuck snap to treat patients with relapsing form.

Of multiple sclerosis in the third quarter of this year.

Michael S. Weiss: The last topic I want to cover before turning the call over to Adam is our U2 plus Vanatoplax program and our U2 plus 1701 program. As a reminder, 1701 is our internal BTK inhibitor. We view both of these programs to be an important part of the growth strategy for U2 and CLL.

The last topic I want to cover before turning the call over to Adam is our Youtube husband out of tax program and our Youtube plus 17 on one program as a reminder, 17 of them one is our internal the TK inhibitor.

We view both of these programs to be an important part of the growth strategy for Ya Chu in C O L.

For the Youtube for spin out of class program, we of the Phase One study led by Dr. Paul Barr Professor of Medicine, and director of the clinical trials of office for the women's Cancer Center in Rochester, New York.

Michael S. Weiss: For the U2 Plus Vanatoclox program, we have the Phase 1 study led by Dr. Paul Barr, Professor of Medicine and Director of the Clinical Trials Office for the Wilmot Cancer Center in Rochester, New York. Preliminary results from the first 27 patients in this study to complete 12 cycles of fixed duration therapy were presented at Ash this past December. In those patients, there was a 100% overall response rate, and greater than 75% of those patients achieved undetectable minimal residual disease in the bone marrow.

Preliminary results from the first 27 patients in this study to complete 12 cycles of fixed duration of therapy were presented at Ash. This past December.

And those patients there was 100 per cent overall response rate and greater than 75 per cent of those patients achieved undetectable minimal residual disease in the bone marrow.

Michael S. Weiss: To my knowledge, that is the best reported rate of undetectable minimal residual disease in the bone barrel to date in patients with relapsed refractory CLL. Later this year, we should have almost twice as many patients to report through 12 cycles of treatment. So hopefully, that will be something we were able to present at Ash this year.

To my knowledge that has the best reported rate of undetectable minimal residual disease in the bone marrow.

To date in patients with relapsed refractory CLO.

Later this year, we should have almost two times as many patients to report on through 12 cycles of treatment. So hopefully that will be something we were able to present at ash this year.

Now that phase one set the foundation for Ultra V phase two slash three trial, which is evaluating the combination.

Michael S. Weiss: Now, that phase one set the foundation for our Ultra V, a phase two slash three trial, which is evaluating the combination of U2 plus vanatoclass in patients with both treatment-naive CLL as well as relaps refractory CLL. The phase two portion of the Ultra V trial completed enrollment with approximately 165 patients being enrolled in just 16 months. The phase three portion is now open to enrollment and is a multi-center randomized trial comparing U2 plus Venaticlax to an active control arm of U2. This trial is being led by Dr. Richard Furman, who is the Director of CLL Research Center at Wild Cornell at Wal Cornell Medicine.

Of Youtube clustering of out of class.

In patients with both treatment naive C O L as well as relapse refractory CLO.

The phase II portion of the Ultra V trial completed enrollment there.

Proximately 165 patients being enrolled just 16 months the.

The phase III portion is now open to enrollment and is a multi center randomized trial, comparing Youtube plus vanadic lax to an active control arm of Youtube.

This trial is being led by Doctor Richard Berman Who's the director of C of O L Research Center at the Wild Cornell at Weill Cornell Medicine.

We are excited about this combination and believe it can potentially offer patients Inc.

Michael S. Weiss: We are excited about this combination and believe it can potentially offer patients a very active treatment that is of limited duration. Finally, I'll mention that our BTK inhibitor TG1701 continues to impress us. We reported preliminary data at Ash and will provide another update in the coming weeks at ASCO. Our goal is to explore the potential combination of Eukonic and U2 with 1701 to offer the benefits of the triple inhibition of BTK, PI3K, and KK1 Epsilon, which would be the first of its kind, putting them together but also dialing down the known toxicity of each of those classes. Again, this would be a very novel, first-in-class product.

Very active treatment that is of limited duration.

Finally, I'll mention that of be TK inhibitor TG 17 of one continues to impress US we reported preliminary data at Ash and we'll provide another update in the coming weeks at Astro.

Our goal is to explore the potential combination of.

Of your Konica and Youtube with 17 of one to offer the benefits of the triple inhibition of the Teekay P. I K and she came on Epsilon, which would be the first of its kind and putting them together, but also dialing down the known toxicity of each of those classes again this would be.

Novel first in class product.

As you can see significant progress has been made across all of our pivotal programs setting us up for an exciting remainder of 2020, one and hopefully even more impactful 2022 with the potential of expanding our commercialization efforts and just C O L and M S with that I'm excited to turn the.

Michael S. Weiss: As you can see, significant progress has been made across all of our pivotal programs, setting us up for an exciting remainder of 2021 and hopefully, an even more impactful 2022, with the potential to expand our commercialization efforts into CLL and MS. With that, I'm excited to turn the call over to our chief commercialization officer, Adam Walman, to share some highlights from our early commercialization efforts with Yukon. Great, thanks Mike, and I am very excited to provide a commercial update on the Eukonic launch as we report revenues for the first time. With this launch, we are not only bringing an important new option to patients, but we are setting the foundation for multiple potential future approvals, including the combination of eukonic and ubutoxinab, known as U2, and CLL as our next major milestone.

All of her to our chief commercialization officer at a moment to share some highlights from our early cause of the commercialization efforts of the economy.

Great. Thanks, Mike and I'm I'm I'm very excited to provide the commercial update on the U Connick launch as we report revenues for the first time with.

With this launch we're not only bringing in an important new option of patients, but we are setting the foundation for multiple potential future of few approvals.

Including the combination of your chronic and it talks about of known as you two and C. L. L. As our next major milestone.

Michael S. Weiss: While it is still early, we are pleased with our initial launch execution and feel we have made significant progress against our initial launch objectives. These were to build awareness of the Econics differentiated profile, drive adoption with our targeted customers, and ensure a positive first experience. And as I mentioned, set the foundation for Kigi and lymphoma as we plan for the anticipated launch of U2 in CLL. In our first partial quarter, we achieved 0.8 million in net sales of Yukon.

While it is still early we are pleased with our initial launch execution of deal. We have made significant progress against our initial launch objectives.

These were to build awareness of the connex differentiate the profile.

Drive adoption with our targeted customers ensure of positive first experience and as I mentioned set the foundation for TG on lymphoma, as we plan for an anticipated launch of Youtube and C O L.

And our first partial quarter, we achieved point 8 million of net sales of the economy you.

<unk> is the first and only inhibitor of P on Delta and CK. One Epsilon is the unique treatment option for patients with relapsed Follicular marginal zone lymphoma.

Adam Waldman: Eukonic, as the first and only inhibitor of PI3K Delta and K1 Epsilon, is a unique treatment option for patients with relapsed follicular or marginal zon lymphoma. Consistently, we have received specific and positive feedback about its clinical profile from our customers. Through market research, advisory boards, and our field team engagements, we have confirmed that Yukonic is seen as a differentiated product. We've consistently heard that the proven efficacy across marginal zone and follicular, its unique MOA, tolerable safety profile, low rates of discontinuation, and a lot of box warning are important differentiators with health care providers and payers. We believe that these factors help establish Econic in a class of its own.

Consistently we have received specific and positive feedback about its clinical profile for more customers.

Through market research advisory boards, and our field team engagements, we have confirmed the new konica the different is seen as a differentiated product.

We've consistently heard the the proven efficacy the cross modules on the Follicular its unique M away tolerable safety profile low rates of discontinue.

Just a continuation and a lot of of block box warning are important differentiators with health care providers and payers.

We believe that these factors help establish iconic in the class of its own.

We recognize the second line marginal zone and fourth line plus Follicular lymphoma, our labeled indications.

Representing a relatively small patient populations.

Therefore, our strategy out of the gate has been the target the higher volume prescribers of academic centers and large community practices.

Further reinforcing our strategy, we estimate that there was of roughly 85% overlap in the prescriber base between.

Adam Waldman: We recognize that second-line marginal zone and fourth-line plus molecular lymphoma are labeled indications, and represent a relatively small patient population. Therefore, our strategy out of the gate has been to target the higher volume prescribers at academic centers and large community practices. Further reinforcing our strategy, we estimate that there is a roughly 85% overlap in the prescriber base between Indolent-Mahatian lymphoma and CLL. So we also view the lymphoma approval as a valuable opportunity to introduce ourselves to the training community and build the credibility and trust that will be critical to the CLL law.

Indolent non hodgkin lymphoma.

And C O L. So we also view of the lymphoma approval as a valuable opportunity to introduce ourselves of the treating community.

And build the credibility and trust that will be critical to the CLO launch.

So far you conics initial uptake indicates that the strategy was well informed with the majority of our initial use coming from targeted customers.

It has been roughly 50 50 between the academic and community setting with many of our early adopters, having prior clinical trial experience with iconic.

While all of our customer facing teams have been resourceful and strategic in the approach to engage and educate our customers COVID-19 restrictions have posed some challenges.

Adam Waldman: So far, Eukonics' initial uptake indicates that this strategy was well informed, with the majority of its initial use coming from targeted customers. Uptake has been roughly 50-50 between the academic and community settings, with many of our early adopters having prior clinical trial experience with Yukon. While our customer-facing teams have been resourceful and strategic in their approach to engage and educate our customers, COVID restrictions have posed some challenges. Physicians report being fatigued after over a year of virtual engagement.

<unk> report being zoomed fatigued after a year after over a year of virtual engagement of wherever the good news is that we are seeing live engagements continue to increase and.

I believe COVID-19 restrictions will continue to dissipate over the next several quarters, which should accelerate customer engagement going forward.

Our latest market research shows that over 80% of our target customers are aware of bucolic approval.

And approximately 90 per cent of the physicians, we surveyed that of met with the TG represented the either live or virtually.

Adam Waldman: However, the good news is that we are seeing live engagements continue to increase and believe COVID restrictions will continue to dissipate over the next several quarters, which should accelerate customer engagement going forward. Our latest market research shows that over 80% of our target customers are aware of Eukonic approval. And approximately 90% of the physicians we surveyed who have met with a TG representative either live or virtually, view the efficacy and safety profile of Eukonic as favorable versus available options.

Do you have the efficacy and safety profile of your of your Connick is favorable versus available options.

We believe this to be very positive and demonstrates the effectiveness of our early launch efforts.

On the patient access fronts.

Excuse me on the patient access front, we worked hard to provide robust service offerings immediately upon approval through our T. G patient support program.

We've received very positive feedback from patients and health care providers to date.

We are committed to making sure that each and every health care provider of patient has a positive experience with TG and eugonic.

In addition, we have been successful securing coverage for Ya Connick, we're happy to share that we have been able to rapidly achieve coverage of mechanic, which with large health plans, such as Cigna, Aetna anthem and Kaiser.

Adam Waldman: We believe this to be very positive and demonstrates the effectiveness of our early launch effort. On the patient access front, excuse me, on the patient access front, we worked hard to provide robust service offerings immediately upon approval through our TG patient support program, which has received very positive feedback from patients and health care providers to date. We are committed to making sure that each and every health care provider and patient has a positive experience with TG and Eukon.

Connick is now covered for 85% to 90% of Medicare and commercial lives.

Additionally are you kind of has been added to the U S oncology clearer view pathways for Follicular lymphoma, consistent with our label.

Ducati has also been added to the M. D C on guidelines to two a option for patients with fourth line Follicular fourth line plus follicular.

The second line plus marginal zone lymphoma, together with the payer coverage. These inclusions further enable patient access of institutions and practices.

Adam Waldman: In addition, we've been successful securing coverage for Econic. We're happy to share that we've been able to rapidly achieve coverage for Econic with large health plans such as Stigna, Aetna, Anthem, and Kaiser. Eukonic is now covered for 85 to 90% of Medicare and Commercial Lives. Additionally, Eukonic has been added to the U.S. Oncology Clearview Pathways for follic lymphoma, consistent with our label. Eukotic has also been added to the NCCN guidelines as a 2A option for patients with fourth-line follicular, fourth line plus follicular, and second line plus marginal zon lymphoma.

Overall, we are pleased with the launch progress to date and we are positioning ourselves for success as we prepare to potentially launch Youtube and CLO we.

We have some of the most cash.

Talented commercial people on the industry and T. G I T G and despite launching during a global pandemic pandemic I believe we have made great progress with the conic wants to date.

With that I'll turn it over the Shanghai.

Okay.

Thank you Adam and thanks, again to everyone for joining us.

Earlier. This morning, we reported our detailed first quarter 2021 financial results, which can be viewed on our website at www Dot TG therapeutics Dot com.

For today's call I'll touch on a few highlights from the quarter, beginning with our cash position.

Adam Waldman: Together with payer coverage, these inclusions further enable patient access at institutions and practices. Overall, we are pleased with the launch progress to date, and we are positioned ourselves for success as we prepare to potentially launch U2 in CLL. We have some of the most talented commercial people in the industry at TG. And despite launching during a global pandemic, I believe we have made great progress with the Econic launch to date. With that, I'll turn it over to Sean Pahl. Thank you, Adam. And thanks again to everyone.

We ended the first quarter with approximately $525 million of cash, which we believe will be sufficient to take us into 2023.

As Adam noted earlier following the Fda's accelerated approval of the economy on February 5th.

We're pleased to report zero point $8 million of your chronic net revenue in the first quarter.

Yeah.

Our net loss for the first quarter of 2021, excluding noncash items was approximately $74 million compared to approximately $40 million in the first quarter of 2020.

The increase we've seen the net loss as compared to the first quarter of 2020 is primarily related to increased selling general and administrative expenses associated with the preparations for and now execution of the commercial the commercialization and launch of you cut your connick.

Sean A. Power: Earlier this morning, we reported our detailed first quarter 2021 financial results, which can be viewed on our website at www.tetherputics.com. For today's call, I'll touch on a few highlights from the quarter, beginning with our cash. We ended the first quarter with approximately $525 million in cash, which we believe will be sufficient to take us into 2020. As Adam noted earlier, following the FDA's accelerated approval of Econic on February 5th, we were pleased to report 0.8 million of Eukonic net revenue for the first quarter.

Which occurred in the first quarter of 2020 one.

Additionally, during the first quarter of 'twenty, one we saw an increase in R&D expenses over the 2020 period, which was primarily driven by one time licensing milestone payments of approximately $14 million consisting in large part of the 12 million miles $12 million milestone do you on approval of <unk>.

Got it.

Our GAAP net loss for the first quarter of 2021 inclusive of non cash items with 96 million or <unk> 69 per share compared to a net loss of $51 1 million for 48 per share during the comparable quarter in 2020.

Sean A. Power: Our net loss for the first quarter of, including non-cash items, was approximately 74 minutes, compared to approximately 40 million in the first quarter of 2020. The increase we've seen in net loss as compared to the first quarter of 2020 is primarily related to increased selling, general, and administrative expenses associated with the preparations for and now execution of the commercialization and launch of Eukon, which occurred in the first quarter of 2020. Additionally, during the first quarter of 21, we saw an increase in R&D expenses over the 2020 period, which was primarily driven by one-time licensing miles of approximately 14 minutes, consisting in large part of a $12 million you want to prove a gap. The net loss for the first quarter of 20, inclusive of non-cash, was 90.6 million or 69 cents per share compared to a net loss of 51.1 million or 48 cents per share With that, I'll now turn the call back over to the conference opportunity.

With that I'll now turn the call back over to the conference operator to begin the Q&A.

Thank you at this time, we will conduct a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.

A confirmation tone will indicate your line is the other question queue you.

You May press Star two if you would like to remove the question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.

One moment, while we poll for our first question.

The first question comes from Alicia Young with Cantor Fitzgerald. Please proceed.

Hey, guys. Thanks for taking my question.

With the watch.

A couple of one can you talk maybe a little bit about the breakout roughly the kind of of ethylene.

And Philip Taylor is that you're seeing I know what the small number of I just wanted to kind of get a feel for what's the way that the tide.

The cutting on that and then.

And of course.

I was curious just on obviously kind of early feedback around some of the the G I.

Hi.

They've been paying for the past what people on what initially potentially thinking of.

Based on within the team there and then my third question is just was there any inventory stocking.

Adam you want to if you I don't know if you have any information yet on the breakout between Follicular marginal zone.

Operator: Thank you. At this time, we will conduct a question-and-answer session. If you would like to ask a question, please press Star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we pull for our first question. Our first question comes from Aletia Young with Cantor Fitzgerald. Please proceed. Hey guys.

And stocking question.

Sure sure sure yeah. So.

So from what we've seen so far and it's early but what we've seen demand for both marginal zone Follicular, it's hard to do.

It's hard to estimate exactly the breakdown, but we've seen a usage of boats.

We were very happy to see that.

As far as the stocking question.

Given that the.

Many practices the only see a few part of the Follicular.

<unk> follicular and marginal zone patients per year.

We anticipate the pharmacy on ordering generally the be on as needed basis. So we have placed some inventory and with distributors to fulfill pharmacy orders consistent.

Unknown Speaker: Hey guys, thank you for taking my questions and congrats on the launch. A couple, one, can you talk maybe a little bit about the breakout, roughly, the kind of between MZL and the follicular, is that what you're seeing?

With the industry norms for a product like the economy.

And then I think the third question was Gi Tox.

That's one.

Yeah.

So far so good it's obviously still early.

Unknown Speaker: I know it's a small number, but I just wanted to kind of get a feel for which way the tide was cutting on that for a second question. I was curious, obviously, kind of early feedback around some of the GI talks that have been seen in the past and what people have, initially physicians have been seeing and patients have been seeing there. And then my third question is just, was there any inventory stockings think?

But the reactions of the profile has been a very good obviously, we've been educating our customers to stay on top of it and be ready for it in the know how they are treated if they see it but.

But so far so good.

Great. Thank you.

Our next question comes from Chris Howerton with Jefferies. Please proceed.

Hi, good morning, congratulations on all of the progress obviously commercial and in R&D and then thanks for taking the questions.

Unknown Speaker: Adam, you want to, if you, I don't know if you have any information yet on the break opportunity for it to our Marble Zone and stocking questions. Sure, sure, sure. Yeah, so, from what we've seen so far, and it's early, but we've seen demand for both marginal zones and collicular, it's hard to, it's hard to estimate exactly the breakdown, but we've seen usage in both. So we were very happy to see that.

Thanks.

Oh, yeah, absolutely and so let's see I guess first of all for the I just don't recall, what the status was of and maybe some information around the design for the confirmatory studies for Follicular.

Silicula, Ed Marshalls zone, just maybe some updates or some color on on that side of the story.

Adam Waldman: As far as the stocking question, given that there are many practices when we see a few follicular margin zone patients per year, we anticipate pharmacy ordering generally to be on an as-needed basis. So we have placed some inventory and worked with distributors to fulfill pharmacy orders consistent with industry norms for a product like Nick. And then I think the third question was GI Talks. Yeah, whatever. Yeah, so far, so good.

And then moving for towards the end of the year. So I, just maybe wanted to get a little bit of a level set in terms of what kind of information. We can get from the pipeline I know that you said 17 I wanted to ask go but just maybe what are kind of the the key highlights of data expectations for ash at the end of this year for me.

Thanks.

Sure so on the the confirmatory trial.

I don't.

I don't want to say too much yet we have noted in the Oh, it's part of the approval we had a.

Adam Waldman: It's obviously still early, but the reaction to the profile has been very good. Obviously, we've been educating customers to stay on top of it and be ready for it and know how to treat it if they see it, but so far, so good.

Basic design discussed with the F D a but we do need to finalize that.

So I think it's going to be in and around where the what other companies have announced previously from there the confirmatory trials.

And our hope is to get it up and running before year end.

Operator: Our next question comes from Chris Harrowton with Jeffries. Please proceed.

And we'll give a lot more detail at the time, but again the the.

The ZIP relatively standard trial design that that's out there the other companies that in a buyer for the kind of listen on Duvelisib.

Unknown Speaker: Hi, good morning.

Unknown Speaker: on all the progress, obviously, commercial and R&D, and thanks for taking the question. Thanks, yes. Yeah, absolutely. And so let's see. I guess first off for the, I just don't recall what the status was of and maybe some information around the designs for the confirmatory study.

I have announced I think it will be.

Sort of closer to the mindset to those kinds of studies.

In terms of pipeline updates on.

This year so.

As I noted we will have some more information on 17 on one of the NASCAR for them.

I was I've been relatively vocal that Ah I was pretty pleased with the results that we saw at ash I'd encourage folks to take the results and and line them up.

Unknown Speaker: For the follicular and marginal zones,

Unknown Speaker: Just maybe some updates or some color on that side of the story.

Unknown Speaker: and then moving forward towards the end of the year, so I just maybe wanted to

With other B Teekay is both cobalt and non covalent.

Unknown Speaker: So I just maybe wanted to get a little bit of a level set in terms of what kind of information we can get from the pipeline. I know that you said 17-1 at ASCO, but just maybe what are the kind of key highlights and data access for Ash. Sure.

And and see for themselves you know if they're seeing the same thing I'm, saying.

Like I said, we'll have some more of that information available of ask though.

And I imagine, we'll have even more available at ash later this year.

Michael S. Weiss: So on the confirmatory trial, I don't want to say too much yet. We have noted in the approval that, as part of the approval, we had a basic design discussed with the FDA, but we do need to finalize that. So I think it's going to be in and around what other companies have announced previously from their confirmatory trials, and our hope is to get it up and running before year end. And we'll give a lot more details about that later.

For ash as well.

As I noted in my prepared remarks, we do hope.

To have twice as many patients are approximately twice as many patients seven.

Nearly 50 ish patients.

The available for that 12 month end point for us for the Youtube plus for nine o'clock phase one trial.

The.

So that is what I'd say is the the goal for for huge wasn't out of cash would be that dataset for the phase one.

Michael S. Weiss: But again, there's a relatively standard trial design that's out there that other companies, including the buyer for Caponelisib and Juvalisib, have announced. And I think we'll be sort of closer in line to those kinds of studies. In terms of pipeline updates, this year. As I noted, we'll have some more information on 1701 at ASCO, and, you know, I've been relatively vocal that I was pretty pleased with the results that we started at Ash. I've encouraged folks to take those results and line them up with other BTKs, both covalent and non-covalent, and see for themselves if they're seeing the same thing I'm seeing.

Follow up on I assume that's the follow up on all patients at that point or close to all patients and then for the Ultra V phase two portion.

As we noted we finished the enrollment in early this.

This year on there this year. So we won't have all of the 165 patients enrolled through 12 months.

At that time, so the question is going to be whether.

Any of it gets presented in the partial format for it's held to.

Until a full presentation that'll be primarily.

Michael S. Weiss: Like I said, we'll have some more of that information at ASCO, and I imagine we'll have even more available at ASCO later this year. For ASH, as I noted in my pair of remarks, we do hope to have twice as many patients, or approximately twice as many patients, so nearly 50-ish patients available for that 12-month end point in the U2 plus Vanatoclax phase one trial. So that is what I'd say the goal for U2Natoclase would be that data set.

Primarily an investigator driven decision.

For me personally I guess it doesn't matter of the all that much we're going to have plenty of the data from the phase one a M. And then yeah on the phase two will come on the 10, if we can get some out from the ultra V. It at the at the Ash Conference, we'll do it if not that'll be a pretty.

Fulsome data set available for ask of E. Our approach in the June timeframe of next year. So that's that's the ultra V. And then each one no matter of fingers crossed we'd like to present some early data.

Michael S. Weiss: The phase one follow-up, I assume that's a follow-up on all patients at that point, or close to all patients. And then for the UltraV Phase 2 portion, you know, as we noted, we finished the enrollment early this year, earlier this year. So we won't have all 165 patients enrolled through 12 months at that time.

At at Ash this year.

So it's you know one is our a C. D 47, CD 19 bi specific antibody.

On the we've just opened up the of the trial here in the U S moving.

Michael S. Weiss: So the question is going to be whether any of it gets presented in a partial format, or it's held for a full presentation. That'll be primarily an investigator-driven decision. For me personally, I guess it doesn't matter all that much.

Because we started the study ex U S.

We weren't able to move as fast as we read of light.

I think things are going to start to accelerate.

But we're already in in May.

Michael S. Weiss: We're going to have plenty of data from phase one, and then phase two will come on in 10. If we can get from UltraVee at the Ash Conference, we'll do it. If not, that will be a pretty... fullsome data set available for the ASCO-EHA approach in the June timeframe of next year. So that's the Ultra V. And then in 1801, we've got our fingers crossed. We'd like to present some early data at Ash this year. So 1801 is our CD-47, CD-19 bi-specific antibody. We've just opened up the trial here in the U.S. Here in the U.S., because when we started to study X-rays, we weren't able to move as fast as we were light.

Having said that the goal is to get some information on on that compound them by yearend.

And I think that's probably what we have to offer for the moment there may be other.

The cuts of data that we look at it and we present, but I'd say those are probably the the major updates for our for later this year.

Okay, Alright, well, that's really a lot going on and then you know I mean.

Maybe just to remind us the the phase two portion of the ultra the study that does have the possibility to have a registrational implication is that right.

Yeah. It is possible you know, it's something that's probably going to be a.

Somewhat challenging as the single arm of multiple drugs, but.

You know once we have all the day to put together will definitely have a conversation with the FDA and see what their appetite is for.

Michael S. Weiss: I think things are going to start to accelerate, but we're already in May, and we said that the goal was to get some information out on that compound by year-end. And I think that's probably what we have to offer for the moment. There may be other cuts of data that we look at, and we present, and say those are probably the major updates for later this year.

For an accelerated approval are the you know we know that accelerated approvals in C. O L. A challenging these days for them but.

But we do feel like the data will be quite encouraging so well.

Well, we will take our shot.

No guarantees for sure no guarantees, but we will take our shot if not.

Again, we think it's a very robust dataset.

Unknown Speaker: Okay, all right. Well, I certainly have a lot going on. And then, you know, I mean, maybe just to remind us of the phase two portion of the ultra.

On that that should.

Provide potential updates of the NCC in the guidelines of our phase III, and we well into the enrollment season, and so that'll be ongoing.

Unknown Speaker: two portion of the Ultra V study, that does have the possibility to have a registrational Yeah, it is possible. You know, it's something that's probably going to be somewhat challenging as a single arm with multiple drugs. But, you know, once we have all the data put together, we'll definitely have a conversation with the FDA and see what their appetite is for an accelerated approval. We know that accelerated approvals in CLL are challenging these days for them, but we do feel like the data will be quite encouraging.

And you know both drugs are approved.

And obviously, we would not be a marketing at all of two two of Youtube Huntsman advertise.

The physicians are capable of making their own decisions and again, both drugs would be approved in.

In the indications.

That someone might be kind of use them. So again.

Well, we will at best have something that's useful for <unk>.

Compendium listing.

Oh, I mean not that [laughter].

[laughter] baskets nairobian, especially as noted the approval, but this the second option would be it'll be useful for of companion listing.

Unknown Speaker: So we'll take our shot. No guarantees, for sure, no guarantees, but we'll take our shot. If not, again, we think it's a very robust data set that should provide potential updates to the NCSCM guidelines. Our phase will be well into the involvement phase, and so that'll be ongoing. And, you know, both drugs are approved, and obviously, we would not be marketing it all to a U2 plus vanatoplast.

And that's pretty good too and then the like I said the registration trial is argon.

Yeah, Okay all.

Right.

Good well, thanks again, Mike I appreciate it.

Thanks, Chris.

Our next question comes from Josh Shimmer with Evercore. Please proceed.

The picture on taking the questions a few primarily housekeeping questions for for SG&A. The non cash comp cadence can you help us understand it looks like in the second half loaded at least over the last.

Unknown Speaker: But physicians are capable of making their own decisions. And, again, both drugs would be approved for the indications that someone might be going to use them. So, again, you know, we'll at best have something that's useful for compendial listing. I mean, not at best.

18 months of is that is that by design or is that coincidence and then for the R&D milestones that you had recorded in the the first quarter of are there any additional ones that you would expect to be booking in 2021, and then last question. If you can update us on your plans for ex U S commercialization for territories for which you have the range.

Unknown Speaker: Best case scenario would be approval. But the second option would be it'll be useful for a companion listing, and that's pretty good, too. And then, like I said, the registration trial is on.

Unknown Speaker: Okay, all right, very good. Well, thanks again, Mike. I appreciate it.

Operator: Our next question comes from Josh Shimmer with Evercore. Please proceed.

For.

A number of things.

Alright, Thanks, Josh.

Unknown Speaker: Thanks for taking the questions, a few primarily housekeeping questions. For SG&A, the non-cash comp cadence, can you help us understand? It looks like it's second half loaded, at least over the last 18 months. Is that by design or is that just coincidence?

Sean do you want to hit on the SG&A in the R&D milestones and I'll talk about the ex U S.

Sure I think the SG&A.

Non cash comp being back loaded the last year or so we're.

It was certainly not by design I think it was a function of.

The the commercial build.

Unknown Speaker: And then for the R&D milestones that you had recorded in the first quarter, are there any additional ones that you would expect to be booking in 2021? And then last question, maybe you can update us on your plans for ex-U.S. commercialization for territories for which you have the rights to Uble and Umbra. Great, thanks, Josh.

Certainly last year of prepping for the your chronic launch I think it'll probably be a bit more level in in 'twenty, one although as we do continue to ramp for a potential <unk> launch.

Might be a slight trend upward again in the in the second half.

In terms of R&D milestones are left for a potentially of 'twenty one.

Unknown Speaker: Great, thanks, Josh. Sean, do you want to talk about SGNA and the R&D milestones, and I'll talk about XUS? Sure.

There is a milestone due.

To L. A fee on the approval of the talks about so should that should we be fortunate enough for that to come in in 'twenty. One are that would be a 21 milestone.

Sean A. Power: I think the SG&A non-catch backloaded last year, so it was certainly not by design. I think it was a function of the commercial build, certainly last year, prepping for the Eukonical On. I think it'll probably be a bit more level, although as we do continue to ramp for a potential CLL launch, you might see a slight trend upward again in the second. In terms of R&D milestones left for, potentially 21,

Yeah.

Yes.

Okay.

What's the approximate amount of that milestone Sean.

Low.

Double digits.

Okay.

Excellent Okay, and then in terms of.

Ex U S a.

Josh we are we're still.

We'll work in working out the details there are Adam and his team have.

Been doing kind of a full court press the valuation of <unk>.

Sean A. Power: There is a milestone due, uh, to LFB on the approval of Ubiz Hux. So should we be fortunate enough for that to come in 21, that would, May it be done. Okay. We'll see the approximate amount of that milestone, Sean, uh, low double-disc. Okay, and then in terms of... XUS, Josh, we are still working out the details there. Adam and his team have been doing kind of a full court press evaluation of what's the best approach there.

What's the the best approach there.

You know, we've given ourselves a little bit of time to make those applications. After the approvals for U two ends for ULE and the M. S. So.

The symposium on the U S and we're working towards the approvals here and then we'll work towards the approvals abroad seem a little bit of time to make that call, but I would say and items can confirm that this team is leaning toward.

Keeping it internal.

Michael S. Weiss: You know, we've given ourselves a little bit of time to make those applications after the approvals for U2 and for Ubley and MS. So we're going to, after the troubles here in the U.S. We're working toward approvals here, and then we'll work toward approvals abroad. So we have a little bit of time to make that call, but I would say, and Adam can confirm, that this team is leaning toward keeping it internal and launching ourselves, at least in the major European markets.

And launching ourselves at least in the major European markets.

And then I think opportunistically, we'd look for partnerships.

In places like Japan, or China to see if for some some value to be extracted, but probably the major European markets The league.

<unk> today is toward doing it ourselves.

And one of the timelines for for registration in Europe.

So I think the filings will be made probably six to 12 months. After a one of the approvals here in the U S.

Thanks very much.

Michael S. Weiss: And then I think opportunistically, we'd look for partnerships in places like Japan or China to see if there's some value to be extracted. But probably the major European markets that lean today are toward doing it themselves.

Thanks, Josh.

Our next question comes from Eric Joseph with JP Morgan. Please proceed.

Hi, good morning, Thanks for taking the questions on the cocoa.

Michael S. Weiss: And what are the timelines for registration?

First on the product commercial do you have a sense of repeat prescribing pattern so far.

Michael S. Weiss: So I think the filings will be made probably six to 12 months after we get the approvals here in the U.S.

And what are your insurer what are you anticipating in terms of our growth in new patient adds.

Operator: Our next question comes from Eric Joseph with J.P. Morgan. Please proceed.

The duration on therapy over the course of for 'twenty, One and then just following up on the question about the registration of potential of both would be.

Unknown Speaker: Hi, good morning; thanks for taking the questions. A couple.

Unknown Speaker: First on the Econic Commercial, do you have a sense of repeat prescribing patterns so far? And what are you anticipating in terms of growth in new patient ads and duration on therapy over the course of 2021? And then just following up on the question about the registration potential of OQV, Yeah, how should it be?

On.

Yes.

Yeah, Yeah, how should we be thinking about the accrual of timelines for the phase III trial the.

For the phase two.

And of itself as the visit.

The strong enough for approval.

The phase III trial represented at all of the headwind to Youtube commercial of assuming we're able to expansion of the channel of the year. Thanks.

Yeah.

Sure Thanks, Erik for those questions.

Unknown Speaker: Yeah, how should we be thinking about a cruel timeline for a phase three trial if the phase two, in and of itself, isn't, um, strong enough for approval? And does the phase three trial represent at all a headwind for U2 commercial, assuming label expansion at the turn of the year? Thanks. Sure. Thanks, Eric, for those questions. Adam, you want to tackle the first two, the... Econmercial, reuse

Adam you want to tackle the first to the on.

Yeah on kind of commercial yeah, we're users.

Yeah, Yeah certainly.

It is still early but the good news is we have seen refills and we've also seen.

Physicians are prescribing for more than one patient. So we think this is a really positive.

Indicator.

But it is still early as far as the duration goes we'll see obviously, we're doing everything we can to educate the physicians and health care providers on on.

Adam Waldman: Yeah, go ahead. Yeah, yeah, certainly, you know, Eric, it is still early, but the good news is we have seen refills, and we've also seen physicians prescribing for more than one patient. So we think this is a really positive indicator, but it is still early as far as duration goes. We'll see. Obviously, we're doing everything we can to educate physicians and health care providers on managing patients and keeping them on therapy. We think that is key to our future success. Great, thanks Adam.

On managing patients and keeping them on therapy, we think that is key to our future.

<unk> future success.

Yes.

Alright, Thanks, Adam and in terms of the.

Accrual timelines for for Ultra V phase III.

And we think there's probably going to be 12 to 18 months of accrual period.

And that'll be followed by a similar probably 12 to 18 months of follow up now.

Michael S. Weiss: And in terms of the accrual timelines for UltraVee, Phase 3, you know, we think there's probably going to be a 12 to 18 month accrual period, and that will be followed by a similar 12 to 18 months of follow-up. Now, there are two groups here that we're conducting, so we have two separate. Basically, separate studies almost built into the one study. So we have a cohort for relapsing fractures, and we have a cohort for frontline. So they could enroll at different paces, and certainly, the follow-up on the voluropshire fracture side will be shorter. So it's altogether possible that, and they're separately powered.

There is.

Theres two groups here that weren't so we have two separate.

Basically separate studies almost built into the one studies so we have of cohort for <unk>.

Lapsed refractory of of cohort for frontline.

So they could enroll at different paces.

And certainly the follow up on the velocity of factor side will be shorter.

So it's altogether possible that.

And then separately powers. So the studies can be completed independently for the study can be completed in two parts.

So we think there's probably a greater chance that the relapsed refractory who would go to the F. D. A more quickly potentially in the sort of the.

Okay.

24 to 36 month timeframe.

On the front line, probably a little bit longer.

Michael S. Weiss: So the studies can be completed independently, so the study can be completed in two parts. So we think there's probably a greater chance that the relapsing fractory would go to the FDA more quickly, potentially in sort of the 24 to 36 month timeframe in the front line, probably a little bit longer. I don't think there's really too much in terms of headwinds.

I don't think there is there's really two months in terms of headwinds recall that you know the.

The net of taxes is still not.

On a.

A fully accepted regimen and that's using being generous fully accept the regiment in the community right. It's pretty it's used in the community is still very limited.

And like I said, we like we said previously not today, but previously you said you know we do think that in time it will get there.

Michael S. Weiss: Recall that, you know, Venatoclax is still not a fully accepted regimen, and that's using, being generous, a fully accepted regimen in the community, right? It's pretty, but its use in the community is still very limited. And like I said, we've said previously, not today, but previously, we said, you know, we do think that in time it will get there. And our focus has been, you know, we want to make sure we have a label within the next three to five years to meet the move of banana clocks into the community. Setting.

And I'll focus has been we want to make sure we have a label within the next three to five years to meet the to meet the the move of the nine o'clock into the community setting on the academic centers, we see definitely see nice uptake of.

Of the 90 fives in first line patients.

So that's a market that we'd like to be in and you know again I think the academic centers are very familiar with.

Vanadic clients and they will be familiar with you too and the <unk>.

Companion listing like I said, they will do as they wish.

And the community is not quite there yet anyway.

Michael S. Weiss: We definitely see nice uptake of Venataclax in first-line patients, so that's a market that we'd like to be in. And, you know, again, I think the academic centers are very familiar with Vanataclats, and they will be familiar with you too. And with companion listing, like I said, they will do as they wish. And the community is not quite there yet, anyway.

And we're still you know fingers crossed for so.

Gonna have the first initial launch of Youtube.

Later this year potentially early next year.

Yeah, we definitely want some time.

Two to build the U two as Youtube before we move on to the combination. So I think the timing I don't perceive it any headwinds I think the timing is working out exactly the way. We wanted to we think there's a lot of value to be derived for you too as you too.

Michael S. Weiss: and we're still, you know, fingers crossed, we're still going to have our first initial launch of U2 later this year, potentially early next year. And, you know, we definitely want some time to build the band as U2 before we move on to the combination. So I think the timing, I don't perceive it in any headwinds.

Particularly in the community, particularly in patients who were either.

Poor candidates for BT gait therapy or.

I have already seen be ticket therapy.

I don't think there's a lot of patients out there that will benefit for me too.

Michael S. Weiss: I think the timing is working out exactly the way we'd want it to. We think there's a lot of value to be derived from U2 as a band. particularly in the community, particularly in patients who are either poor candidates for BTK therapy or have already seen BTCA therapy. We think there are a lot of patients out there that will benefit from U2. And then as the data evolves, and we move into a world where Venataclaps is more broadly available, then U2 plus Venataclaps should be labeled at that point.

And then as the data evolves.

Moving to a world where the amount of classes more broadly.

Available than Youtube placement out of class shouldn't be labeled at that point.

And that.

We believe has a shot of becoming standard of care for for first line treatment on and certainly in patients who have already seen the PTK across both academic and community centers. So I think there's time for this market to evolve.

And we're gonna be Ah I think lined up perfectly in the timeframe for that so I don't think there's any headwinds in my opinion.

Okay got it thanks for taking the question maybe one quick follow up if I could in terms of the player.

The locations or geographies that the ultra V phase III has recruited some of the you.

Michael S. Weiss: And that, we believe, has a shot of becoming, you know, standard of care for first-line treatment and certainly in patients who have already seen a BTK across both academic and community centers. So I think there's time for this market to evolve. And we're going to be, I think, lined up perfectly in a time frame for that. So I don't think there are any headwrecks, in my opinion.

Is it primarily in the U S.

Recruiting patients ex U S as well.

So currently it's exclusively of the U S. A we are looking at.

Some very high.

Enrolling centers ex U S that would be.

Potentially may add to the trial.

But currently it's excess of the U S trial.

And the sites are primarily a major academic centers of which is which is very nice wave of good good very good group of that.

Unknown Speaker: Okay, got it. Thanks for taking the question. Maybe one quick call if I could.

Unknown Speaker: In terms of site locations or geography where the UltraVe phase three is recruiting someone, do you, is it primarily in the U.S.? Are you recruiting patients outside the U.S. as well? So currently, it's exclusively the U.S. We are looking at some very high-enrolling centers XUS that we potentially may add to the trial, but currently, it's exclusively a U.S. trial. And those sites are primarily major academic centers, which is very nice. We have a very good group of academic centers.

Of the gummy centers with expanded even beyond those that were involved in the phase two portion.

And for the Phase III, we've also.

Included large community centers that do use went out of the plants.

And so we're excited to have those folks as part of the trial as well.

Okay, great. Thanks for taking the questions.

Thanks, Eric.

Our next question comes from Ed White with H C. Wainwright. Please proceed.

Good morning, Thanks for taking my question.

And just the follow up on.

On your European strategy.

Unknown Speaker: We've expanded even beyond those that were involved in the phase two portion. And for phase three, we've also included large community centers that do use Winataclops. And so we're excited to have those folks as part of the trial as well. Okay, great. Thanks for taking the questions.

What you were saying about going alone in Europe on partner in Japan, and China. The instead apply for the Ms opportunity as well.

As of the moment, yes, it does.

Okay. Thanks again.

It's a lean Ed it's not we haven't seen we haven't confirms the yet it's a lean right now just to be clear leaning on that direction.

Operator: Our next question comes from Ed White with H.C. Wainwright. Please proceed.

Okay.

And then maybe a question for for Sean and just following up.

Unknown Speaker: Good morning. Thanks for taking my questions. Just a follow-up on your European strategy, what you were saying about going alone in Europe and partners in Japan and China, does that apply for the MS opportunity as well? As of this moment, yes, it does. Okay, thank you.

About the noncash compensation of U.

You had discussed.

That line item for SG&A.

Was curious about R&D as well as non cash compensation was up 30% about.

Michael S. Weiss: Again, it's a lean ed, it's not, we haven't confirmed yet, it's a lean right now, just to be clear, we're leaning in that direction, and then maybe a question, and just following up about the non-cash compensation you had discussed that line item for SD&A. I was curious about R&D as well, as non-cash compensation was up 30% quarter over quarter. I'm just wondering if there was something special in nature in there, or if that's sort of the new bait.

Quarter over quarter I'm, just wondering if there was something onetime in nature in there or if that's sort of the new base.

Yeah. Thanks, Ed I think the this is probably the new base for R&D I think the change there was likely a function of.

A change in the stock price and a slight add in head count, but its probably the new base.

Thanks, Sean and then my last question, Mike You gave updates on on a few of the products can you just give us an update on 15 of one.

Michael S. Weiss: Yeah, thanks, Ed. I think this is probably the new base for R&D. I think the change there was likely a function, change in stock price, and a slight add in headcount, but this is probably, Thanks, John.

Yeah.

Yeah. So you know 15 on one is is.

And of Phase one here in the U S right now in here obviously.

On the drug itself as the.

Sean A. Power: And then my last question. Mikey gave updates on a few of the products. Can you just give us an update on 1501? Yeah, so, um, you know, 1501 is, um, in phase one here in the U.S. right now, and obviously, the drug itself is getting close to a registration in the non-heam area being developed by another company. But for us, we are in phase one. We're collecting data, but it's still very early.

Getting close to a registration and now in the non heme area.

He developed on the company, but for us.

We are.

We are in the phase one we're collecting data it's still very early I will say that.

We've had some challenges with enrollment because PD one PD L. One is not viewed very attractively and in Inc.

The heme malignancies, such as unfortunate as Inc.

I think there is a role.

And it needs to be vetted out of just think some early work was it was not a.

It was not overly positive compared to other agents, but I do think of combinations. That's the mechanism that that actually could.

Michael S. Weiss: I will say that we've had some challenges with that enrollment because PD1, PDL1 is not viewed very attractively in hemaligncies, which is unfortunate. I think there is a role, and it needs to be vetted out. I just think some early work was not overly positive compared to other agents, but I do think in combinations, that's a mechanism that actually could be very interesting.

Could be very interesting. So we're continuing to pursue we've been adding some additional combinations to help enrollment.

And we'll keep you posted.

Yes.

Okay. Thanks, Mike that's all I have.

Okay.

Our next question comes from Matt Kaplan with Ladenburg Thalmann. Please proceed.

Hi, Good morning, guys and thanks for taking the questions just.

Just wanted to focus a little bit of on the initial use you're seeing of <unk>.

Michael S. Weiss: So we're continuing to pursue this. We've been adding some additional combinations to help enrollment, and we'll keep you posted. Okay, thanks, Mike. That's all I have.

Connick I guess in the community versus academic setting, you're saying that it was about 50 50.

Initial of do you I guess expect that to change over time, and and and when you add kind of Youtube to the to the commercial.

Operator: Our next question comes from Matt Captain with Ladenberg-Dalman. Please proceed. Hi, good morning, guys, and thanks for taking the question.

Unknown Speaker: Hi, good morning, guys, and thanks for taking the questions. I just wanted to focus a little bit on the initial use you're seeing of Eukonik, I guess, in the community versus the academic setting. You're saying that it was about 50-50 initially.

Profile.

How do you think that will rollout in terms of community versus academic.

Hi, Adam.

Uh huh.

Yeah sure. So yeah. We were we were very pleased the see the split between academic and community and the initial uptake, which we think is good.

Unknown Speaker: Do you, I guess, expect that to change over time and when you add a kind of U-2 to the commercial profile? How do you think that will roll out in terms of community versus action, Adam?

As you know on we said before the vast majority of these patients are treated in the community, but the dispersed amongst many many community physicians where in the academic centers. The it is concentrated so we certainly have focused on the academic centers, but also getting out in the community.

Adam Waldman: I don't know, hit that one. Yeah, sure. So, yeah, we were very pleased to see the split between academic and community and the initial uptake, which we think is good. As you know, and we said before, the vast majority of these patients are treated in the community, but it's dispersed amongst many, many community physicians, where in academic centers it is concentrated. So we certainly have focused on the academic centers but also on getting out in the community.

I will say that this the split seems about right to me I think we will continue to track it and see as far as your question about what we see how this will change going forward.

I think it could as as the the product becomes more widespread use across the community. It could could go up across the community centers if anything.

Adam Waldman: I will say that this split seems about right to me. I think we'll continue to track it and see as far as your question about how this will change going forward. You know, I think it could, as the product becomes more widespread use across the community, it could go up across community centers, if anything. Was there a second question beyond that? No, I think that was it.

Was there a second question beyond that.

No.

You kind of yeah.

And then I guess, maybe I don't know if for instance for you on them, but I guess you you mentioned in your prepared remarks that your you know getting good payer coverage now 80 590 per cent has there been any issue in terms of the patient access even though with that coverage in place how are you.

Unknown Speaker: You covered, yeah. And then I guess maybe, I don't know if this is for you, Adam, but I guess you mentioned your prepared marks that you're, you know, getting good payer coverage, 85, 90%. Has there been any issue in terms of patient access, even though with that coverage in place, are you? Are you seeing any access issues with patients, either getting coverage or reimbursement? Nothing that is not typical for a launch product.

Are you seeing any access issues with with patients either getting getting coverage on reimbursement and and that kind of ex.

Nothing that is not typical for a for for a launch product. So I think of everything that we've seen is as normal as we get on the on formularies and and so we've not seen any any issues.

Unknown Speaker: So I think everything that we've seen is as normal as we get on formularies, and so, no, we've not seen any issue. And then, I guess, last question in terms of the ultimate one and two, phase three trials. As you're thinking about commercialization preparation there, how should we think about that product as differentiating in the marketplace? So, Matt, thanks for that.

And then I guess last question in terms of.

The ultimate one and two phase III trials as you as you're thinking about commercialization preparation there.

How should we think about that product is differentiating and and and and and the market place.

So thanks, Matt for that yeah. So obviously, we were super pleased with the results from from Ultimate one and the ultimate too.

Michael S. Weiss: So obviously, we were super pleased with the results from Ultimate 1 and Ultimate 2. You know, the easiest differentiator in the marketplace will certainly be the one-hour fusion. We're also working on that.

Yeah on the easiest differentiator in the marketplace will be certainly the one hour infusion.

We're also.

Working a pair of group is actively studying and and and and meeting with payers to better understand.

Michael S. Weiss: Our payer group is actively studying and meeting with payers to better understand what it will take to create the best access possible for patients with Obitokinam. So, as we've noted multiple times, if we can identify a price that will enhance access for patients, we will do that. So we think that there is a price difference.

What it will take to create the best access possible for patients with.

Some of them. So as we've noted multiple times that.

If we can identify of price that will enhance access for patients we will do that.

So we think that Theres, a price differentiator and then on the on the clinical profile look you know we will leave it to the experts to to say, but you know in our opinion, we've got some of the best day than it's ever been seen in the treatment of M. S.

Michael S. Weiss: And then on the clinical profile, look, you know, we'll leave it to the experts to say, but, you know, in our opinion, we've got some of the best data that's ever been seen in the treatment of MS. We think that the annualized relapse rates are incredibly low in the Obituxmaab arm under 0, which is, as many of you have heard, or would listen to the calls, a pretty big with relapses, you know, the lower patients who see lots of relapses; it's usually connected with disability progression.

We think that the annualized relapsed rates are incredibly low.

In renewable talks of Mab arm of under 0.1 O, which is as many of the unheard of to listen to the calls of pretty big hurdle and.

In the M S landscape.

<unk> with relapses you know the lower you know patients who see lots of relapses, it's usually connected with disability progression of these are relapsing remitting disease, you have of relapse.

Michael S. Weiss: These are, you know, it's a relapsing, remitting disease. You have a relapse. Not every relapse results in disability progression, but very few patients will progress with their disability without in the absence of relapses. So keeping those relapses down is obviously super important, that's why it's prime nonplugs for these trials. So, yeah, we think that, across the board, every one of the endpoints on the efficacy side looks as good, if not better, than anything else that's out there today. So we feel that, you know, safety and efficacy look quite good. We've got really nice differentiation on convenience, and hopefully, we'll have a differentiator on price. Thanks, and congratulations on the progress.

Not every relapse results in disability.

Hum progression so.

But but very few patients will progress their disability without in the absence of relapsed. So keeping those relapses down is obviously super important and Thats why its primary end point for these trials.

So yeah, we think that the profile you know across the board every every one of the endpoints on.

On the efficacy side books looks as good if not better than anything else that's out there today.

So we feel that the safety and efficacy look look quite good we got really nice differentiation on on convenience.

And hopefully we'll have the differentiator on price.

Thanks, Michael that's that's very helpful and congrats on the progress.

Thanks, Matt.

Our next question comes from me ex Montanan with B Riley. Please proceed.

Operator: Our next question comes from Mayek, Montani, and B. Raleigh. Please proceed.

Unknown Speaker: Hi, good morning, this is Sahel Casby. I'm from my own. Thanks for taking our questions. Just a quick one for months, maybe.

Hi, Good morning is the thought of Academy on for Mike. Thanks for taking our questions. Just a quick one for Michael maybe as it relates to the phase three Ultra V study could you talk to the kind of thought process and rationale about half of you too as the active comparator arm and kind of any underlying assumptions on surrogates like all of our our PFS.

Unknown Speaker: As it relates to the Phase 3 Ultra V study, could you talk about the kind of thought process and rationale about having you, too, as the active comparator arm, and any underlying assumptions on surrogates, like ORPFS, and maybe any key learnings from the CLL-14 program with Vanita Klaxen, Gazeera? Uh, yeah, I mean, I think we... From the studies that are being run currently, I think the Van Anaclaxis was a Brutinib trial that is still using the Zyva colandercell as the control. So we think, you know, U2 is, based on our studies, a very active control arm. It's also a control arm that we're familiar with.

And maybe any key learnings from the CLO 14 program with the need of classroom because of that.

Yeah, I mean, I think we.

From from the studies that are being run on currently.

I think the.

And then out of class was ibrutinib trial or using the XI the clamour Sars as the control still so we think you choose.

<unk>.

Based on our studies are very active control arm.

It's also.

A the control arm that.

We're familiar with and we understand the property's profiles and and the run clinical trials with Ya Chu before quite extensively so for US it was kind of of natural go to.

Michael S. Weiss: We understand the profiles of properties, and we've run clinical trials with YouTube before quite extensively. So for us, it was kind of a natural go-to. The expectation, of course, is that YouTube, by the time this study reads out, will be an approved regimen in CLL, both in front-line and relapsed settings. So it seems kind of natural, and for us, it does help to separate. Obviously, it's U2 plus Vanatoclax versus U2 alone, so we get to see a very nice comparison to the control arm versus using a sort of a non-rigid control on that was testing.

The expectation of course is that you too.

By the time the study would read out will be at a an approved regimen in.

And C O L. Both in frontline on the lab settings. So it seems kind of of natural and for US. It does help to separate obviously its Youtube was moving out of class versus U two alone. So we get to see a fairly nice.

Comparison to the control arm versus using that sort of a non.

The regimented control on the that we're testing so I think for US it was kind of a natural to easier too and we think going forward. Other companies are likely to use you too is that as a control arm as well as jussi becomes.

Michael S. Weiss: So I think for us, it was kind of natural to ease you in. And we think going forward, other companies are likely to use you too as a control as GC becomes less usable going forward. Absolutely, definitely makes sense. I think that's it from us. Thanks very much for taking the questions, and congrats on the quarter.

The less feasible going forward.

Absolutely definitely makes sense I think that's it from us thanks, very much for taking the questions and congrats on the quarter.

Sure. Thank you.

Our next question comes from Craigs Vantage with Goldman Sachs. Please proceed.

Thank you very much good morning, everyone. Thanks for taking my questions I've got maybe two.

One just.

As we think about.

Operator: Our next question comes from Craig Souvanage with Goldman Sachs. Please proceed.

The current uptake.

Congrats on the other thing for sales are any any color I think he can provide some high level comments early in your prepared remarks, just how to think about.

Unknown Speaker: Thank you very much. Good morning, everyone, got maybe two one just as we think about the current uptake Correct, sales, any color, progression of the the balance of the year, vaccination world, and inflection, if there is going to be one, and then second for me would be, just thinking about your product portfolio, products in two different therapeutic areas, and just wondering if you could provide you most tangible synergy, those two if there are, back end versus, Sure, thanks, Craig.

The progression of.

The uptake throughout the balance of the year, particularly around kind of expectations on.

Post COVID-19 vaccination of world and kind of when you expect the kind of.

Election.

If there is going to the one and then second for me would be.

Just thinking about your product portfolio in terms of having.

Having products in two different therapeutic areas on.

The collagen.

En masse and just wondering if you could provide your perspective around kind of where you see the.

The most tangible synergies.

Between those two if there are any of it and maybe it's more back ended versus obviously.

Unknown Speaker: Adam, you want to talk about the... uptake of eutonics and maybe progression and potential COVID inflection points? Sure, yeah. I mean, you know, I think it's still early, obviously, but we're inspired by the positive reactions we're seeing to Eukonics profile. However, these are small patient populations, and we've had limited time so far to determine any definitive trends. But, you know, I think with more live engagements and, you know, restrictions sort of loosening, hopefully over the next few quarters, we hope that increased engagements will lead to meaningful discussions about the product and, hopefully, adoption.

The sales reps in the tactics or strategy.

Thanks.

Sure. Thanks, Craig.

Adam do you want to talk about the Oh.

I'll take the Buchanan can maybe progression and potential of both.

The inflection points.

Sure Yeah, I mean, I think it's still early obviously.

Where we're at.

Twos by the positive reactions were seeing two Yukon ex profile.

However, these are small patient populations and we've had a moment of time, so far to defend it in the.

The chairman any definitive trends.

But you know I think with increase.

The increase of live engagements.

And you know restrictions sort of loosening hopefully over the next few quarters.

We hope that increased engagements will lead to meaningful discussions about the product the and hopefully adoption.

Unknown Speaker: So I think it's, just to summarize, I think it's a little too early to say, and we'll see how it goes, but we're enthused that we can get in front of physicians and have these conversations moving forward. Thanks, Adam.

So I think it's the just to summarize I think it's a little too early to say and we'll see how it goes but we were enthused that we can get in front of the physicians and have.

All of these conversations moving forward.

And so on them.

And to your point on the the portfolio on the two therapeutic areas.

Michael S. Weiss: And to your point on the portfolio, the two therapeutic areas, I guess, first and foremost, it starts with the science, right? So these are all diseases that are characterized by aberrant B cells. Obviously, in cancer, you've got malignant B cells, and on the MS and autoimmune side, you've got these aberrant B cells that are part of the immune system and autoimmune cascade.

I guess first and foremost the.

With the science right. So these are all diseases that are characterized by aberrant b cells, obviously and can't you've got malignant b cells and on the M. S. N on immune side, you've got <unk> T cells that are part of the immune autoimmune cascade. So I think.

Michael S. Weiss: So I think scientifically there's a big overlap, and you know, it's sort of natural. The ability to manipulate our compounds in both therapeutic areas because of their underlying sciences is, I think, important to us and important for why we're doing this. In terms of other tangible synergies, you know, I think in terms of the commercial side, we're going to obviously need to build a sales and medical team that is focused on MS.

Scientifically.

There, there's a big overlap and sort of of natural the ability to maneuver our compounds in both therapeutic areas.

Cause of there the underlying science is I think important to us and an important for for why we're doing this.

In terms of other tangible synergies.

You know I think in terms of the commercial side.

We're gonna moving obviously need to build.

A b cells and medical team that are focused on.

On the M S.

Michael S. Weiss: But I do think that a lot of the commercial pieces that we've built in terms of operations and organization will support the focus in both therapeutic areas. So there's more to build, but the overlay into the current organization, I think, is a pretty nice synergy across both indications. Adam, I don't know if you have anything more to add on the commercial side. No, Mike, I think he covered it.

But I do think that a lot of the commercial.

<unk> pieces that we've built in terms of.

The operations and organization will support the focus in both therapeutic areas, so theres more to build but the.

The over overlay into the current organization I think is a pretty nice.

The synergy across the crush spoke of indications.

Adam I don't know if you have anything more to add on the commercial side.

No Michael I think you've covered it.

Okay.

Okay. Thanks, so much.

Yeah.

Thank you at this time I would like to turn the call back over to Mr. Michael Weiss for closing comments.

Operator: Thank you at this time. I would like to turn the call back over to Mr. Mike Weiss for closing comments.

Michael S. Weiss: Great. So just want to, again, thank everyone for joining us. A nice start to the year, and we're looking forward to some exciting additional things to come for the remainder of the year. So let me just summarize some of those.

Great.

So just want to again, thank everyone for joining us.

On a nice start to the year.

And and we're looking forward to to some exciting additional.

Things to come.

For the remainder of the year. So let me just summarize some of those.

Michael S. Weiss: First, we're going to continue to execute the commercialization of Eukonic, commercialization of Eukonic, in both relaps, refractory, margin zone, and extra-advanced lymphoma. The potentially big thing coming up is we're waiting to hear from the FDA on whether they've accepted our BLA for filing for U2, both previously untreated and the Lapture Fractor CLL. And then, assuming positive news and they accept that filing, we'll be looking for working closer with the agency to get that application approved as quickly as we can. We're going to complete the BLA submission for Ubitoxoneb and RMS. MESS.

First we're gonna of continuing to execute on the commercial.

All of the Yukon of commercialization Eugonic.

In both the relapse and refractory margins on on Follicular lymphoma.

Sort of the next.

The Big thing coming up is we're waiting to hear from the FDA, whether they have accepted our BLA for filing for <unk> for you too.

And both previously untreated in relapse refractory CLO.

And then I.

Assuming a positive news on the accept that filing will be looking for are working closely with the agency.

To get that application approved as quickly as we can we're going to complete the BLA submission for <unk> and out of an RMS again, that's targeted for the third quarter of this year.

Michael S. Weiss: Again, that's targeted for the third quarter this year. And as part of that, we're going to be preparing our commercial organization for a potential launch in CLL. And obviously, we're going to be working on the build-out for Obilbutoxonevin RMS, which we've got a little more time for. If the third quarter is the target for the filing, the target for approval would be about 12 months after that. So 4Q of 22 would be the target there, so then we get the application in.

And that's part of that and that's what we're gonna be preparing our commercial organization for for potential launch in C O L.

And obviously, we're gonna be working also on the build out for the protection of it on a message got a little more time for the third quarter is the target for the filing.

On the target for approval would be about 12 months after that.

So for two of 22 would be the target there so when we get the application in.

Michael S. Weiss: Through this year. So a little bit of time, but again, we're working on that as well. And then, beyond that, we're continuing to advance our pipeline. You know, we've got an Ultra V phase three trial. We're looking to potentially move TG 1701 into phase three this year as well. And then the earlier pipeline; we've got 1801 and 1501 that continue to progress, as well as, As to one of the questions later this year, we're looking forward to presenting data on the U2 plus Manitoclux combination, more data from 1701 or BT inhibitor, both at ASCO and later this year, and, as I noted, possibly phase one data from TG 1801 or CD47 and 19 bi-specific antibodies.

True to this year, so a little bit of time, but again, we're working on that as well and then beyond that we're continuing to advance our pipeline.

We've got ultra V phase.

Phase III trial, we're looking to potentially move T. G 17 on one into a phase III this year as well.

And then the earlier pipeline, we've got 18 of one in 15 of them on that continue to progress.

As of.

Asked and one of the questions. Later this year, we're looking forward of presenting data on.

On the Youtube for spin out of thoughts.

Combination.

More data from 17 on one of the P. P inhibitor of both the Nashville and later this year and as I noted, possibly.

Possibly phase one data from T. G. H N of one of our C. D 47, the CD 19, five specific antibody so.

Hi.

Michael S. Weiss: Very busy remainder of the year. We've got a lot to execute on. We've got a great team coming together on all fronts. So that is our update. So on behalf of everyone here at TG, I want to thank every one of you for your support and for joining us today. Have a great day.

Very busy remainder of the year, where we've got a lot to execute on we've got on a great team coming together on all fronts.

So that is our update so on behalf of everyone here at T. G. I again want to thank.

Our every one of you for the support and for joining US today have a great day.

Operator: Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. And thank you for your participation. Have a great day.

Thank you. This does conclude today's teleconference. You may disconnect. Your lines at this time and thank you for your participation and have a great day.

Okay.