Traws Pharma Inc (TRAW) 2023 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to Onconova Therapeutics third quarter 2023 financial results and business update conference call. (Operator instructions) As a reminder, this call is being recorded today, November 14, 2023.

At this time, I would like to turn the call over to Bruce Mackle of LifeSci Advisors.

Thank you, operator, and welcome, everyone, to Onconova's third quarter 2023 financial results and business update conference call. Earlier this afternoon, Onconova issued a press release reporting its financial results and business progress. If you have not yet seen this press release, it is available in the Investors and Media section of the company's website at www.onconova.com.

Following my introduction, we will hear from Onconova's President and CEO, Dr Steven Fruchtman; Chief Medical Officer, Dr Victor Moyo; and Chief Operating Officer and Chief Financial Officer, Mark Guerin; Onconova's VP of Global Medical Affairs and research and development, Meena Arora will also be available during the Q&A session following the prepared remarks.

Before we begin, I would like to remind everyone that statements made during this conference call will include forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially.

Forward-looking statements speak only as of the date they are made as the underlying facts and circumstances may change, except as required by law, Onconova disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. For more information on forward-looking statements, please review the disclaimer in today's press release and the risk factors in the company's SEC filings.

With that, I will now turn the call over to Onconova's President and CEO, Dr Steven Fruchtman

Thanks, Bruce, and thanks to everyone who is joining us today for this call. I'll open by saying that Onconova has made excellent progress in the third quarter of 2023. During the call today, our Chief Medical Officer, Dr Victor Moyo, and our Chief Operating Officer and Chief Financial Officer, Mark Guerin, and I will provide you with an update on our lead program [narazaciclib].

Review the data from our recent scientific presentations, we outlined upcoming milestones, provide a brief update on the rigosertib development program. Summarize our third quarter financial results and outlook on our cash runway and from this bullish, importantly, open the call for your questions.

As you know, our mission remains to develop novel proprietary products for patients with hard-to-treat cancer and with an unmet medical need. Starting with our lead program, our internal efforts are dedicated to preparations for narazaciclib. Our proprietary kinase inhibitor of CDK4/6 as with the complete (Technical difficulty) cell growth and DNA synthesis.

The CDK4/6 class of inhibitory drugs has changed the face of cancer care in several indications, particularly in hormone receptor positive and negative metastatic breast cancer. And narazaciclib was designed by Onconova scientist as a potent next generation entrant into this multibillion-dollar drug class.

In addition to his multi-kinase activity, we believe there as cycle may be differentiated from the other approved CDK4/6 inhibitors because of the potential for an improved tolerability profile. And based on our preclinical studies, improved efficacy as well. The ability to act on targets beyond CDK4/6, it may lower the risk of drug resistance, based by other CDK4/6 inhibitors.

Our expansive preclinical studies have helped to define narazaciclib's ability to impact on additional viral targets involved in cell signaling and cancer survival, including the proteins, [OCT5, also known as new RAC1 CSF1R and Bob Warren]. Whole important in how cancer establishes its presence and sites of metastatic disease as well as proliferation of the cancer cells.

We have selected low grade endometrial cancer to be our lead registration indication for narazaciclib in combination with hormone therapy [leprozol]. We believe this is the right choice in endometrioid endometrial cancer of to two main reasons. Number one, the proposed registrational trial has a high technical and regulatory probability of success.

Publications of positive studies with other CDK4/6 inhibitors and combinations and compendia data indicating off-label use support the potential for a higher probability of technical success. These data and a lack of an approved label underscore the unmet medical need and support the potential for high regulatory success.

Second reason is the initial data from a dose ranging studies suggest narazaciclib has the potential to be safer than the other CDK4/6 approved members with a wide dosing window that's a proactive exercise therapeutic index. During our call today, we may use the acronym algae to describe this indication in endometrioid endometrial cancer.

To be registrational trial ready we plan to one complete dose escalation of our Phase one two programs and define a recommended Phase two dose for RP2D. Secondly, engage with the FDA on the pivotal trial design under construction. Number three, work with key external clinical experts on the design and coding conduct of this trial, including the Gynaecologic Oncology Group or GOG and the European network for gynaecologic oncology trials for ENGOT.

Our plan is to conduct the registration trial as part of our ongoing collaboration with both of these very prestigious groups. We intend to provide more information on each of these steps over the next year quarters. As you know, there are three early-stage studies underway in the narazaciclib program, including monotherapy and combination trials.

Given the narazaciclib with multi kinase mechanism of action, we have conducted our dose escalation studies very carefully. While Victor will summarize the status of these studies based on the clinical and biological target engagement and the acceptable overall safety we are observing, we have decided to dose escalate during at least one more dosing cohort to fully evaluate the safety profile of narazaciclib and achieve the optimal recommended Phase two dose.

As a result of the Phase one two program for narazaciclib may continue into the first quarter of 2024. We believe this is very good news from the Florida program because it underscores the potential for narazaciclib to have a differentiated safety profile and a wide therapeutic index.

Changing gears, I would like to touch briefly on our second program that is rigosertib. As you know, in keeping with our focus on capital efficiency, we have been exploring the clinical utility of rigosertib through a series of signal-finding investigator-sponsored trials focused on solid tumor indications driven by legal shortage impact on one of two mechanisms.

First is the PLK-1 pathway involved in squamous cell carcinoma, complicating recessive dystrophic epidermolysis bullosa and the second mutated KRAS mutated non-small cell lung cancer in combination with checkpoint inhibitors. As outlined in our second quarter call, we are focused on mapping out a registrational study planned for the ultra-rare indication of IDM associated squamous cell carcinoma.

Note that we will define that as our debit associated SCC in this call, we selected this to be the lead registrational indication based on the very impressive clinical responses we have seen to date in previously refractory patients and with the significant unmet medical need for this desperate patient population.

As you know, we had a Type B meeting with the FDA in June based on this meeting and feedback from the agency. And as outlined in our second quarter call, we intend to develop a protocol for a registrational trial, out following interactions with the rare disease group at FDA in pursuit of an orphan designation for IBM associated squamous cell. We plan to provide an update on our next steps in the first half of 2024.

Looking ahead to the rest of this year and into 2024. We are focusing on key achieving the following milestones. narazaciclib we intend to one continue the dose escalation segment, the Phase one two program, which will bring us and which may bring us into the first quarter of 2024. So we can add at least one more dosing cohort to this study.

Number two provide a readout narazaciclib's safety and pharmacology in the first half of 2024. Once we have completed the dose escalation studies. Number three provide an update on our registrational trial readiness over the next couple of quarters, including the definition of the recommended Phase two dose are engaging with the FDA and the scheduled trial design and obtaining the rare disease indication, orphan disease indication. And our work with internal external clinical experts, including the GOG and endoc.

Achievement of these milestones will also enable us to establish a solid foundation to expand the program to include other indications such as breast cancer and ovarian cancer. For rigosertib as I just noted, in the first half of 2024, we continued to plan to provide an update on the next steps to obtain orphan drug designation and from the registrational program.

Before I hand the call, I would like to warmly congratulate Victor, formally taking on the role of Chief Medical Officer and warmly welcome Meena Arora as Vice President of Global Medical Affairs research and development. Victor and I previously worked together at J&J, and he was instrumental in getting approval for some of the most revolutionary and impactful drugs in both supportive care and haematology oncology.

Both of them are accomplished experts in their field and doing significant and wide depth of experience in drug development. I believe Victor's extensive track record as a clinical researcher and drug development in oncology and many unique medical affairs expertise in rare diseases and oncology will be instrumental the company's success as we prepare the clinical plan and regulatory strategy narazaciclib and rigosertib.

Now I would like to turn the call over to Victor to provide some more details on narazaciclib program. Victor?

Thank you, Steve, and good afternoon, everyone. Today I'd like to provide you with an update on the narazaciclib Phase one two program and touch briefly on our recent and upcoming medical meeting presentations.

Starting with narazaciclib. As you may recall, there are three studies in the Phase one two program in advance solid tumors in patients. There is a Phase one monotherapy dose escalation study underway with our partner, Hynix in China is the Phase one monotherapy dose escalation study underway at three centers in the US. A Phase one two combination dose escalation and dose expansion study, which is underway at six centers in the United States.

This study is evaluating the combination of increasing narazaciclib doses and a fix and the 2.5 milligram per day dose of the widely prescribed anti oestrogen agent letrozole. This study has been conducted in patients with [elite], and other gynecological tumors were undergoing second and third line after treatment.

As of November 18, 2023, we have dosed about 30 patients across the entire Phase one two program. In the US Phase one monotherapy study, we are dosing patients in the seventh cohort at 280 milligrams per today. In the Phase one two combination study, we are starting the second cohort at 200 milligrams per day of narazaciclib with 2.5 milligrams per day of Letrozole and have identified patients who could enroll on the next cohort.

Based on the data we have observed to date we have three important initial observations, number one, narazaciclib is safe and well tolerated to date. I'd like to make two points about the emerging safety characteristics of narazaciclib. Based on the initial safety data from our prokinetic studies, it may be possible to dose narazaciclib once daily without the need for time off during treatment.

This is important because it may address and or the need for a three week on and one week off dosing strategy that is required for bone marrow recovery, following treatment with the most commonly prescribed CDK4/6 inhibitors. We believe this is an important potential feature of narazaciclib because the requirement for three weeks on one week off dosing strategies may also permit tumor cell proliferation in between dosing.

Secondly, initial data from our dosing studies suggest that narazaciclib may be able to avoid the difficult adverse events diarrhea. We believe that these two distinctive characteristics may enable a wide dosing window that supports an excellent therapeutic index for narazaciclib.

Number two, we are seeing target engagement based on the observation of Grade one and two neutropenia in patients receiving a dose of at least 120 milligrams per day.

Number three, we are seeing biological target engagement based on the results of that thymidine kinase, at doses of 200 milligrams and above. As indicated by Steve, based on the good target engagement and overall safety that we are observing, we believe that it would be reasonable to dose escalate to at least one more dosing cohort. In order to fully explore the safety profile of narazaciclib and to enable us to achieve the optimal recommended Phase two dose. This will extend the Phase one two program for narazaciclib into the first quarter.

I would like to echo Steve's comment that our decision to add at least one more dose in cohort two. The dose escalation study is very good news for the program because it underscores the potential for narazaciclib to have a differentiated safety profile and why therapeutic index.

We expect to provide a readout on safety and pharmacology in the first half of 2024. Once we've completed the dose escalation study. This approach will help define the optimal recommended Phase two dose, and we believe it is also in keeping with the FDA guidance from Project Optimus, for dose optimization prior to approval.

Also in the third quarter, there were two medical meeting presentations related to our programs. This included a presentation number one of clinical data affirming the potential for rigosertib in our DEB associated squamous cell carcinoma, which was made by our colleagues from the University Hospital in Salzburg, Austria and Thomas Jefferson in Philadelphia.

This data were presented as a late-breaker at the European Academy of Dermatology and venereology or EADV. The second presentation of promising preclinical data in combination with the of narazaciclib in combination with ibrutinib in the treatment of sensitive and resistant mantle cell lymphoma cell line was up even at the European MCL or mantle cell met with lymphoma annual meeting. Each of these presentations underscore the biology and activity for narazaciclib and rigosertib.

Looking ahead to December, we plan to present two additional preclinical abstracts. The first one is at San Antonio Breast Cancer Symposium often called SABCS. One of our collaborators will present a poster titled narazaciclib differentiated targets and kinase inhibitory activity contribute to the enhanced inhibition of tumor growth in preclinical models.

We have a second presentation at the American Society for Haematology or ASH, where our collaborators will present a poster titled narazaciclib of a differentiated CDK4/6 antagonist, prolonged cell cycle arrest and metabolic reprogramming, enabling restoration of the ibrutinib in PTKI resistant mantle cell lymphoma.

We will share more of this abstract in the coming weeks. In closing, I am optimistic about our programs, our progress and the outlook for the rigosertib and narazaciclib in 2024. For rigosertib the promising activity that we have observed in our DAB associative squamous cell cancer is distinct and could address a critical medical need for this ultra rare condition.

These data plus its unique activity on PLK-1 and KRAS pathways make rigosertib a very interesting anticancer agent. Now that we have better defined the indications where we believe it will be more likely to be successful based on its mechanism of action and studying cancers where these targets can be engaged by rigosertib.

For narazaciclib CDK4/6 inhibitors have substantially changed the face of cancer for the better. Those consistent positive clinical data on the class in endometrial cancer. In addition to target engagement our program is showing acceptable initial safety, which could give narazaciclib a unique profile. Based on our expansive large preclinical studies, we have defined a multi-kinase profile that enables -- that could result in differentiated activity and the potential for broader clinical utility. These features are the cornerstone of my enthusiasm and optimism for narazaciclib.

With that, I'll conclude my portion of the call. I'll hand it off to Mark.

Thanks very much, Victor, and good afternoon. Everyone. Onconova closed the third quarter of 2023 with cash and cash equivalents of $25.2 million compared to $38.8 million as of December 31, 2022. Based on our current projections, we believe our current cash position will be sufficient to fund our ongoing clinical trials and business operations into the third quarter of 2024.

Research and development expenses for the third quarter of 2023 were $2.5 million compared to $3.6 million for the same period in 2022. General and administrative expenses for the third quarter of 2023 were $2.7 million, and this compares with $2.1 million for the same period in 2022.

Net loss for the third quarter of 2023 was $4.7 million or $0.23 per share on 21 million weighted average shares outstanding. This compares with a net loss for the third quarter of 2022 of $5.4 million or $0.26 per share on 20.9 million weighted average shares outstanding.

The change in net loss for the third quarter of 2023 compared with the same period in 2022 was primarily result of the timing of manufacturing batch production and clinical trial expenses, partially offset by higher general and administrative costs related to our AGM in the 2023 period.

From a corporate development perspective, we continue to actively engage in a range of discussions related to partnering opportunities to support the progression of our programs.

With my financial review complete, I'll now hand the call back to Steve for his concluding remarks.

Thank you, Mark. In closing, we are enthusiastic about the excellent progress that has been made for both narazaciclib and rigosertib in the third quarter. We look forward to building on that progress as we wrap up 2023 and begin the new year.

Looking ahead, we are focused on achieving the following milestones. Our differentiated multi-kinase inhibitor narazaciclib, we intend to what present two abstracts at the December important medical meetings. Two, continue dose escalation to segment and the Phase one two program, which may bring us into the first quarter of 2024.

Three, readout narazaciclib's safety and pharmacology for the first half of 2024. Four, provide an update on our Phase three readiness over the next couple of quarters, including definition of our recommended Phase two dose are engagement with the FDA on the pivotal Phase three trial design and plans to work to continue to work with external clinical experts, including the Gynecologic Oncology Group, GOG and the European network for gynecological oncology trials.

And that, our plan is to conduct a registration trial as part of our ongoing collaboration with both of these groups. These milestones provide a strong foundation for the next steps for narazaciclib and LG, we've added potential indications, including breast cancer, ovarian cancer and mantle cell lymphoma. We've got assertive, our program a year like an investigator-sponsored trial strategy for several solid tumor indications on the way.

Our main effort here is to remain focused on our debt associated squamous cell carcinoma. And we continue to plan to provide an update on our next steps to obtain orphan drug designation and a registrational program in the first half of 2024.

In closing, I want to recognize for diligent and dedicated work of our management team, employees, partners and investigators. And most important is to as well as the brave dedicated patients to participate in our clinical trials and the investment of the investment community for the support of our turnover and our very important work. And we look forward to updating you on our continued progress.

With that, we'll begin today's question and answer session. Operator?

(Operator instructions)

Charles Zhu, Guggenheim Partners.

Hi, everyone. This is Edward on for Charles Zhu at Guggenheim. Maybe I have to start off with just a question on how you are -- how the narazaciclib plus letrozole combination, how that trial is tracking and maybe when we could see potential initial efficacy data? I think you talked about in the past with that at for a data update at 4Q 2023. So I'm just wondering how you're thinking about that now.

Strong, Victor, you would like to take that?

Yes. Thank you for that question. Right now, we are still in the process of a dose escalation as both Steve and I mentioned, we are seeing a wide therapeutic index requiring us to go to higher doses before we go into expansion mode. So this study will extend into the 2024 as a result as well, along with the monotherapy study.

And just to add to what Victor said, I want to remind everybody that the approved CDK4/6 inhibitors are approved that are in response for a prolongation of progression-free survival and overall survival. The reason for that, our CDK4/6 inhibitor are not cytotoxic drugs and they don't cause response, they could prevent tumor proliferation, size improvement, hopefully in PFS and overall survival, which we anticipate seeing in our registration trail.

Great. And maybe just a follow-up question, if I can, On the monotherapy dose escalation, it sounds like you have both the neutropenia and the thymidine kinase assay. I guess what how much room based on at least on the PKPD characterization, do you think you have to keep escalating? Do you think you still have sufficient room to gain efficacy by escalating further? How are you thinking about that?

Yes. Ultimately to make decisions or aware that we reached an optimal dose for the Phase two, we would look at a combination of the safety and the PK characteristics as well as the pharmaco dynamic studies. You do raise a good point. You do point out that since we might not see the same degree of neutropenia and diarrhea as some of the other beautiful K inhibitors.

We will be focusing on the data coming from the PK as well, including the tolerability, of course, but as well as pharmacodynamics. We have had to expand the last couple of cohorts. And usually when you see that, it would suggest that we are close to reaching what might be really the optimal dose or maximum tolerated dose.

Ahu Demir, Ladenburg Thalmann.

Good afternoon, team. Thank you for taking my questions and providing a full update. I have three questions on the results likely beneath, if I have time, I'll ask one more on our debt program. My first question is, have two portions. First one is what how many patients are we expecting to see data from the Phase two portion of the study?

And the second part of the question is following up on the adverse question, when do we expect to see any efficacy data? And given your comments, Steve, on the PFS versus response rates, when would you envision the data would mature to show any clinical activity on the PFS?

Yes, Victor will take the second part of your question. First, if I may add -- So we're out of control on weakening of the PFS for Newsday Powerball matches letrozole in breast cancer it's 8.3 months. We're not going to wait 8.3 months a what the PFS and the PI on this Phase one study. The purpose of the Phase one is to just clearly establish the recommended Phase two dose B should be and what it does for our registration trial, I'll answer a little bit.

PFS is 12 months or eight months obtain much ever, it may be very hard to interpret that were out of control on me in this patient population. From the goal is really to just determine what dose of Mirage CyClean will be in combination with Gretchen zone for our registration trial which clearly will have a control arm and should be able to compare the combination of neurons aside from plush that dissolves PR events to watch the control arm that the FDA will tell us that they accept.

So we really may see some efficacy data if there is a response. Again, these are not cytotoxic drugs, but sometimes you will see tumor shrinkage or more likely register that more of a registration trial will be determined by both PFS and overall response overall survival, PFS and overall survival rather than response stage. And I know, remember the first part of your question, and I don't know if I answered it, would you like to repeat it?

This was helpful. The first part was the Phase B portion of the study, how many patients, what are we going to see, are we going to see any target engagement and others other analysis as well?

Okay. Victor, I think you've had enough of rest, could you take that, please?

Yes, the dose escalation portion will be is driven by, of course, the number of call box that we ultimately enroll. So that is a variable number and we keep an approximation of where we might end up. The Phase two portion is slated to enroll up to 30 patients in that Phase two portion.

Thank you, Victor. My next question is on the safety profile. So having no -- not much or not high impact diarrhea or neutropenia, is new and the information that you mentioned, taking the one the core portion in the clinical setting is often even formation. What are the steps you need to take to remove that from the portion of -- what are the discussions like with the agency? How are you going to move forward with that part?

Well, first off, we have still to have our discussions with the agency. Right now, what we observe in our setting is that we add dosing continuously. And as long as that safety is supportive for continuous dosing, our recommended Phase two dose will include continuous dosing, and that would be the provider basis of the discussions that we hold with the agency subsequently.

So right now, we are not holding at that at a dose -- we're not doing that three weeks on one week on that some of the CDK4/6 inhibitors have to do, we are dosing continuously.

I see that's very helpful. Thank you. I'll keep my other question. I'll jump into queue to be mindful of others. Thank you so much for answering my questions.

Joe Pantginis, HC. Wainwright.

Hi, this is Josh on for Joe. Thank you for the update. I had a question about the enrollment and how that's looking in a number of patients for the Phase two study for rigosertib in that TKI resistant KRAS non-small cell lung cancer?

Victor?

Yes, we since the last update, we enroll three more patients in that study. We are looking to have an update in terms of outcomes. Subsequently, once we obtain a report from the investigators.

Thank you. And for the scenario of cyclic trial on solid tumors, are you seeing any specific solid tumor indications, more of a certain kind of important been pretty uniform across solid tumors to up for the monotherapy trial.

We have enrolled a truly a diverse set of patients with solid tumors. And so there isn't a particular pad in the monotherapy that I can that describe is standing out. Our initial patients tended to be more on the GI, gastrointestinal type of tumors but there really isn't anything that stands out in terms of the patient population we've seen.

Alright, thank you. Thank you again for the update.

You're welcome.

Robert LeBoyer, Noble Capital Markets.

Since you're going to be doing an additional cohort in the neuro side with solid tumors. What is your projected start date for Phase two at this point?

I'm going to give direct interest on that so I will take it. That's a great question for Robert. If we see additional DLT's in 2023 at the joining 80 milligram cohort. We maybe Guy, if not, then we may go into the first quarter to establish the recommended Phase two dose. We can't meet with the agency until we know the dose of the registration trial because they want to see the safety from the dose.

So we have to go into the first quarter of '24 to establish the recommended Phase two dose and meet with the agency, a free estimate that the registration trial will begin in first half of 2024 and no grade endometrial cancer.

Okay. And if there were no DLTs in the cohort to be added, would you add another second cohort in 2024?

It's always hard to predict these things Robert. And compared to what we see regarding, as Victor explained, we have a pharmacodynamic marker of a tiny marker. We are already seeing engagement. And as we dose escalate more engagement. We know we're engaging a kind is involved with stem cell proliferation to see some mild neutropenia.

So it really depends also depends on the TK are maxing out, as we dose escalate with PKD going up or staying at a maximum level. So there's no need to dose escalate. So those all of those things and you get some limited to go into the decision, are we done it to 280 million into the SGLT at 280, which means and recommended Phase two dose in the eight 240. We're seeing enough of an answer to it is safe with target engagement with inaction TKT plane to HD to be the recommended Phase two tariff. So those just say it's easier to answer that question mandated that hypothetically. I entered into the best of my ability.

Okay, great. Thank you very much.

James Molloy, Alliance Global Partners.

Good afternoon and thank you for taking my question. My question is on the rigosertib on getting the orphan designation. I know that we've discussed before some of the challenges on that. Can you walk through sort of steps you have to take to sort of get the rigorous over sort of orphan designation and how the clinical trial plan might look, should you get that?

Sure, and Meena as our RDEB expert. Expert in rare diseases, would you like to take that question of how we introduced the concept of RDEB squamous cell to the often group and FDA.

Meena? Meena is calling in from UK, perhaps the connection is lost. I'll take that if I may, this is clearly an orphan disease, right? There are 60 to 100 patients per year. It could go up or down in the US once squamous cell develops the patients 50% of mutations by 2.5 years.

So clearly, this is an orphan disease. Our goal at the orphan grew is to explain to FDA why this is different. We were, of course, spontaneous way in this a branch in sun damage claimants is different because one RDEB squamous cell develops in late teenage years, early 20s, some damage squamous cell and develop drugs in the elderly, some damage squamous cell and a very good prognosis using removed surgically. And that's the endotherapy pie slide that squamous cell is a very aggressive disease, as I just mentioned.

And we should have known that differentiates spontaneous squamous cell from by RDEB squamous cell is the fact that squamous cell, complicating RDEB and mutation in the collagen seven gene, which spontaneous claims founders. So our goal I do often group is to explain why this disease, RDEB squamous cell is different, in screens, which in fact is not blinded definition in Los Angeles.

But clearly the idea of squamous cell is our goal is to interact with the agency to explain in great detail what I just said.

Apologies. My line dropped and thank you for answering that. I have got new set of things to add upon. We can also -- presented last month at the EADV meeting as a late-breaking abstract. And we'll be taking learnings from the initial patient experience and moving that into the clinical development registrational program as well and into discussions.

So in addition to the discussion we mentioned about the orphan drug designation, we'll be also doing. My apologies, my line got dropped there.

that written premium luxury brands, Bulmers, it manages to answer much informed than I did only based on outside my control.

Thank you very much. And I guess the one follow-up question will be is it is it more sort of a check various boxes or do you have to go make a presentation and sort of bitumen on the disease? Or is this just kind of form to fill out? How does that sort of mechanically work?

I will basically give you a view of the automation group launches too. And hopefully there'll be a chance remains an interaction with them. We think that's much more value per day will give the FDA profit growth momentum. We will request a face-to-face meeting. My understanding is that doing most of these merchant, right? And they may just respond to written crashing bump on why we believe we deserve off sales, it's uptake.

Thanks for taking the questions.

I'm showing no further questions in the queue.

Ladies and gentlemen, thank you for your participation and for today's conference call includes today's event. You may now disconnect.