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Edited Transcript of UMRX earnings conference call or presentation 12-Aug-19 8:30pm GMT

Q2 2019 Unum Therapeutics Inc Earnings Call

CAMBRIDGE Aug 20, 2019 (Thomson StreetEvents) -- Edited Transcript of Unum Therapeutics Inc earnings conference call or presentation Monday, August 12, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Charles Wilson

Unum Therapeutics Inc. - CEO, President & Director

* Jessica Sachs

Unum Therapeutics Inc. - Chief Medical Officer

* Matthew S. Osborne

Unum Therapeutics Inc. - CFO

* Seth Ettenberg

Unum Therapeutics Inc. - Chief Scientific Officer

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Conference Call Participants

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* Peter Richard Lawson

SunTrust Robinson Humphrey, Inc., Research Division - Director

* Vikram Purohit

Morgan Stanley, Research Division - Research Associate

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Presentation

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Operator [1]

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Good afternoon, and welcome to the Unum Therapeutics quarterly investor conference call. Today, we'll be showing updates on our company's progress and our financial results for the second quarter of 2019.

With me on our call today are Chuck Wilson, CEO; Jessica Sachs, CMO; Seth Ettenberg, CSO; and Matt Osborne, CFO. Following our prepared remarks, we'll open the line for questions. Before we begin our prepared remarks, I'll remind you that the estimates and forward-looking statements included in this call represent the company's view as of today, August 12, 2019. Unum Therapeutics disclaims any obligation to update these statements to reflect the future events or circumstances. Please refer to today's press release as well as Unum's filings with the SEC for information concerning risk factors that could cause actual results to differ materially from those expressed or implied by such statements. Please note that the call is simultaneously webcast online. With that, I'll turn the call over to Chuck Wilson, Unum's CEO. Chuck?

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [2]

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Thank you, and good afternoon. I'm pleased to report the progress we've made during the quarter across our preclinical and pipeline programs based on our ACTR and BOXR platforms. On this call, Jessica will discuss the updated results presented today from our ACTR707 trial in non-Hodgkin lymphoma, our activities with ACTR087 targeting BCMA in multiple myeloma, and our progress with ACTR707 in combination with trastuzumab targeting solid tumors. Seth will describe BOXR1030, the first product candidate to emerge from our BOXR platform; and Matt will review the financials.

Before turning it over to Jessica, I want to take a moment to highlight from a broader level the approach with both ACTR and BOXR, and the ability of these technologies to service platforms for Unum. With ACTR, we can use the same ACTR T cell product in potentially many different types of cancer. This is because the extracellular portion of ACTR derived from CD16, an immune cell receptor, targets the T cell [to] the tumor in a directed way, only in the presence of a monoclonal antibody. We can then combine this ACTR T cell with a range of different monoclonal antibodies to target tumor antigens. We don't need to reengineer the T cell each time we want to target a different tumor antigen. We're currently testing this approach with rituximab and anti-BCMA antibody in hematologic malignancies and with trastuzumab and HER2+ solid tumors to drive tumor cell killing. The second potential key benefit of ACTR is the ability to control or tune the level of its activity. This ability to control T cell activity doesn't exist with current generation T cell therapy. We're currently exploring the impact of antibody dose on ACTR T cell activity in multiple dose escalating Phase I trials.

BOXR was specifically developed by Unum to improve engineered T cell functionality by identifying and incorporating a bolt-on transgene to overcome resistance by the solid tumor microenvironment to T cell attack. Solid tumors are very good at making a hostile environment to T cells. They do this in part by creating competition for metabolic resources by suppressing immune cells and by exhausting T cells due to chronic stimulation. BOXR is designed to identify transgenes to potentially overcome these mechanisms and incorporate them into different types of T cells. As Seth will describe, we expect to advance BOXR1030 towards clinical trials to treat liver and lung cancers. We're excited by the ability of ACTR and BOXR to generate novel product candidates. We've been able to create 3 unique constructs and drive them forward in 4 separate clinical trials, while applying best-in-class manufacturing, clinical development and regulatory capabilities.

I also want to take a moment to highlight the new addition to Unum's leadership team, 2 of whom are joining us on today's call. Jessica Sachs was recently appointed to her new role as Chief Medical Officer, having joined Unum in 2017. Jessica has been a core member of the team in setting clinical development strategy and providing medical and translational oversight of the Unum portfolio. She brings deep experience in oncology and pediatrics and a decade in industry, including a decade in Millennium where she led multiple clinical programs in oncology and transplantation, and at Genzyme Corporation where she was responsible for postmarketing, safety surveillance and risk management activities for a variety of oncology products.

Matt Osborne joined us just over a month ago as Chief Financial Officer. Many of you may know Matt from his role [in] the biotechnology industry over the past 20 years, serving as Investor Relations, Corporate Affairs and Communications lead and as a former sell-side analyst where he helped biotechnology companies grow through various stages of development.

And we're also pleased to have Mert Aktar join us as Head of Business and Corporate Development. Mert brings significant multinational experience in pharmaceuticals and biotechnology, including leadership roles in business development and technical operations. And he joins Unum from Shire where he most recently served as a global Head of Hematology and Immunology Business Development. We also recently announced the appointments of 2 new independent board members, Arlene Morris and Matthew Ros. Together they bring significant commercial and corporate development experience within oncology to the board.

I'm thrilled with the additions of these members to the team and the Board. Their deep experience and their respective functions will be important to our work, building and advancing a pipeline of engineered T cell therapies. With that, I'll turn it over to Jessica to discuss updates from our clinical pipeline.

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Jessica Sachs, Unum Therapeutics Inc. - Chief Medical Officer [3]

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Thanks, Chuck. Today, we provide preliminary results from the 5 patients treated with ACTR707 and cohort 3 of the ATTCK-20-03 trial. 20-03 trial is a Phase I dose-escalating multicenter trial evaluating ACTR707 in combination with rituximab in patients with relapsed or refractory B cell non-Hodgkin lymphoma. Patients who have enrolled in this trial have had advanced lymphoma, which has proven refractory or resistant to prior treatment. The majority of patients treated today have required alternative therapy following 3 or more prior lines of treatment. We continue to be very encouraged by the preliminary data on the trial to date. Complete responses have been achieved in 5 of the 14 patients treated in the first 3 cohorts, and the overall response rate in the first 2 cohorts combined is more than 50%. This preliminary antitumor activity is particularly encouraging in the context of the observed safety data, specifically no adverse events of cytokine release syndrome or severe neurotoxicity that have been reported with other autologous T cell [product] have been reported in the first 3 cohorts of the trial as of the data cutoff in May of this year. As an update of preliminary data provided today, from the 5 patients treated in cohort 3 after 707 administered in combination with rituximab, following a lymphodepletion regimen, generated a complete response in 1 of 5 patients and an overall response in 4 of 5 patients.

There was also evidence of deepening responses after the first clinical assessment at day 42, where 2 patients with stable disease following the first response assessment subsequently improved to a partial response and a complete response, as of the last data cutoff, which was in May of this year. Overall, we're encouraged with the overall response rate, including complete responses with no adverse events of cytokine release syndrome or severe neurotoxicity in cohorts 1 through 3. We're looking forward to analyzing all of the results, including the results from cohort 4 later this year, to continue to build our understanding of the relationship of cell dose to antitumor activity and safety before determining the recommended dose for further study.

Turning to our ACTR087 Phase I trials in multiple myeloma and non-Hodgkin lymphoma. Dose escalations continued during the quarter in the ATTCK-17-01 Phase I trial, a trial that we're conducting in collaboration with Seattle Genetics, to develop a BCMA targeted therapy for multiple myeloma. Enrollment and dosing of patients in cohorts 4 and 5 of this study is complete, and we expect to report data from this trial in the second half of 2019. As we previously announced, our ATTCK-20-2 Phase I trial, which is a study of ACTR087 in combination with rituximab in patients with relapsed or refractory non-Hodgkin lymphoma, was placed on clinical hold by the FDA in July of 2019 due to serious adverse events, including severe neurotoxicity experienced by a patient on this trial. As an update to this case, this patient subsequently experienced septic shock that was ultimately fatal and reported by the investigator as related to ACTR087.

Since our announcement of the hold, the FDA provided written comments to us clarifying that the trial was on partial clinical hold. Patients who previously received ACTR087 and have ongoing clinical responses can continue to receive rituximab infusions with continued monitoring for adverse event per protocol. Recall that late last year, Unum did deprioritize the ACTR087 lymphoma program in favor of the ACTR707 lymphoma program. We plan to report data from the ATTCK-20-2 trial at the end of 2019.

Now turning to our effort with ACTR707 in solid tumors. We're excited to pursue ACTR707 in solid tumors based on the results from our preclinical efforts, which suggest that ACTR707 can potentially overcome some of the challenges with traditional T cell therapies in the solid tumor environment. After an extensive screening campaign searching for novel active receptors, we selected the ACTR707 construct for solid tumor cancers based on its improved activity and proliferation, cytokine secretion and persistent assays against solid tumor targets.

In preclinical studies, ACTR707+ T cells administered with trastuzumab were highly selective for HER2 overexpressing tumor cells and were able to discriminate [against] cells from normal tissues known to express low levels of HER2.

We initiated the Phase I trial, ATTCK-34-01, with ACTR707 in HER2+ advanced solid tumor cancers earlier, this year. Clinical trials site activation, patient identification, screening and enrollment are underway in this Phase I multicenter, open-label, single-arm dose escalation trial evaluating ACTR707 in combination with trastuzumab. The adaptive design of this study allows us to escalate both the trastuzumab and ACTR707 doses to define the dose combinations that's relevant for a Phase II trial. To date, we've activated 5 clinical trial sites with more [plans] , and we plan to report patient enrollment status and preliminary safety data at the end of 2019.

With that, I'll turn the call over to Seth Ettenberg, our Chief Scientific Officer, who'll discuss our BOXR platform and pipeline initiatives in solid tumors.

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Seth Ettenberg, Unum Therapeutics Inc. - Chief Scientific Officer [4]

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Thanks, Jessica. The BOXR technology was created at Unum and is designed to further engineer T cells to overcome the immunosuppressive mechanisms of solid tumors, including metabolic competition, immunosuppressive cells and exhaustion due to chronic stimulation. The BOXR platform does this by identifying bolt-on transgenes that offer the potential to add enhanced functionality to T cells. We've demonstrated that the bolt-on transgenes are interchangeable, and we can incorporate these transgenes into different types of therapeutic T cells, including ACTR T cells and CAR-T cells. Importantly, the new functionality added to T cells by the BOXR transgenes may not be readily achievable by traditional therapeutic approaches. For example, by inserting the gene for an enzyme into an engineered T cell, we are able to [change] it to metabolic pathways in very defined ways while avoiding direct effects on either cancer cells or normal cells, something that cannot easily be accomplished using small molecule or antibody-based drugs.

BOXR1030 is our first product candidate to emerge from the platform and consists of a T cell co-expressing a CAR targeted to glypican-3 or GPC3, and an undisclosed metabolism enhancing bolt-on transgene. GPC3 is a well-known oncofetal antigen, which is selectively expressed in a variety of tumor types, including certain liver and lung cancers. We've shown that the bolt-on transgene incorporated [the] BOXR1030 acts as a central regulator of T cell metabolism, and its expression impacts several important functions of T cell biology necessary for activity in solid tumors. In preclinical studies, expression of the metabolic bolt-on transgene achieved complete tumor regressions across a range of stringent xenograft models. In the absence of the bolt-on transgene, there was little to no antitumor activity of the CAR-T in these same stringent models. IND-enabling activities, including toxicology testing and process development to support GMP manufacturing are progressing nicely. We plan to expand the capabilities of the BOXR platform to identify and further pursue new transgenes. Additionally, we plan to provide further preclinical data on BOXR1030 later this year. With that, let me turn the call over to Matt.

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Matthew S. Osborne, Unum Therapeutics Inc. - CFO [5]

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Thank you, Seth. During the second quarter of 2019, we realized collaboration revenue of $3.1 million compared to $1.7 million for the same period of 2018. The increase reflects the recognition of a portion of the upfront payment received from Seattle Genetics under Unum's collaboration agreement as well as reimbursements of research and development costs attributed to the collaboration agreement.

R&D expenses of $10.6 million for the second quarter ended June 30, 2019, compared to $9.1 million for the same period of 2018. The increase primarily reflects higher clinical trial costs for the active Phase I trials as well as increased personnel-related costs to support these trials. G&A expenses of $3.1 million for the quarter ended June 30 compared to $2 million for the same period of 2018. The increase primarily related to higher personnel-related costs due to increased headcount and increased expenses related to operating as a public company. Unum's net loss of $10.5 million for the second quarter of 2019 compared to a net loss of $9 million for the same period of 2018. As of the end of Q2, Unum had cash and cash equivalents of $55.9 million, an amount that we believe will fund operating expenses and capital expenditure requirements into early 2021.

With that, I'll turn it over to Chuck.

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [6]

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Thank you, Matt. We're excited with the progress during the quarter with our ACTR and BOXR platforms, with the data emerging from ACTR707 and relapsed/refractory non-Hodgkin lymphoma and with the progress within this construct in solid tumors. With BOXR1030, our first program to emerge from the BOXR platform, we're excited to advance this towards the clinic to potentially improve T cell functionality and the tumor microenvironment. We look forward to reporting on the progress of these programs over the next 6 to 12 months. With that, I'll be ready to take questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question will come from the line of Matthew Harrison of Morgan Stanley.

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Vikram Purohit, Morgan Stanley, Research Division - Research Associate [2]

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This is Vikram on for Matthew. So 2 questions on the DLBCL data presented today for the cohort 3 data. So for the partial responses you saw, would you expect them to turn into complete responses over time? And overall, why do you think you're seeing lower CR rates as you go up in dose? And then separately, beyond the cohort 3 data, on the HER2 study, you mentioned you'll have data by year end '19. We just wanted to get a sense of how much data you think you'll be able to present them in terms of status? How many patients that you enrolled yet, if enrollment has started?

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [3]

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Vikram, thanks for calling in and thanks for the questions. Starting with the questions on the DLCBL program. So I think -- I don't think we want to necessarily predict the future course of the partial responses. We do note, as Jessica indicated, that we have seen in this cohort deepening responses over time, and obviously we'll continue to monitor patients and update their status as we continue the program.

In terms of changes in response rates across cohorts, I do think it is obviously worth making the point that these are relatively small cohorts. It's hard to infer any sort of statistical significance based on differences from one cohort to the next. I do think the important aspect from our perspective is that, as we continue to advance this trial starting initially with cohorts 1 and 2, data presented last year, now with cohort 3, a very consistent picture is emerging of potent anti-tumor activity, but with what looks like a very differentiated safety profile. And so simply expanding out that data set, I think, gives us a lot of encouragement. Maybe, I'll just pause here and ask Jessica if there's anything to add.

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Jessica Sachs, Unum Therapeutics Inc. - Chief Medical Officer [4]

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Thank you, Jeff. No, I don't have anything to add. That sounds all right.

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [5]

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Great. And then moving on to your question about ATTCK-34-01. So again, just as a quick reminder, this design is an adaptive Bayesian design, dose escalation, where we have the ability to escalate both ACTR T cells and the antibody dose. We're running this as a multisensor study. Today, we've activated 5 sites, and we're continuing to enroll and treat patients in the first cohort. So our expectation at this point is, by the end of the year to be in a position to report updates both in terms of enrollment status and initial safety data, our expectation is for meaningful efficacy data to report it sometime in 2020 and provide more specifics in terms of the timing around that later in the year.

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Operator [6]

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And our next question will come from the line of Peter Lawson with SunTrust Robinson.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [7]

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Just -- as we think about, I guess, durability. Is there anything you can comment around the cohort 1, 2 or 3 around the durability you have been seeing?

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [8]

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It's a great question. I think, obviously, from our perspective, response rates are important, as is durability. We presented really just high-level data at this update. We'll be repeating -- reporting more complete data on aspects of the data of the trial, including durability as well as more details in terms of efficacy and safety aspects at the appropriate venue later this year.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [9]

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Do you get any sense that as you go up in dose, the durability would increase?

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [10]

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I think it's -- that's speculation -- again, obviously we're continuing dose escalation. We're expecting to report data later this year from cohort 4. And obviously, we'll be continuing to look at how does the efficacy profile, both in terms of response rate and durability change as we continue dose escalation as well as looking at what happens with the safety profile.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [11]

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And you mentioned deepening responses in answer to one of the questions. How -- have you seen PRs go to CRs or is it kind of -- has it not been that extreme?

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [12]

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We have and just for clarity, I think we've also seen this, as we reported earlier, I think in the ATTCK-20-2 study. And again, we're seeing a handful of deepening responses in the most recent cohort in ATTCK-20-03 study, including going from stable disease to partial response to complete response.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [13]

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Got you. And then you may have mentioned in the prepared comments, I apologize if I missed it. The IND for BOXR1030. When could we see that?

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [14]

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Yes. So again we're on track for completing the work, that will allow us to file the IND, but we haven't committed to a specific time before IND filing.

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Operator [15]

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And our next question will come from the line of Yaron Werber with Cowen.

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Unidentified Analyst, [16]

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This is [Leo] on for Yaron. Congrats on the good quarter. I just have couple questions regarding the program ATTCK-17-01. Do you guys see any signal in terms of [FT] in the expanded cohorts? And also, you mentioned that this trial design -- this adaptive design. I guess, the other trial, the ATTCK-34-01, is also adaptive design. So I'm just wondering if this adaptive design is helping you guys in terms of the dose [winding] and avoiding the [FTs]. Please give us a little bit of color on that?

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [17]

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Sure. Just a couple of quick points. So it's obviously -- this program, the 17-01 program, where we're using SEA-BCMA -- in combination with ACTR707s to target relapsed/refractory multiple myeloma this is a partnered program with Seattle Genetics. And so I think we can provide high-level operational details on the study, but anything beyond that requires essentially a joint communication. So just also to clarify, in terms of the study design it is like really all of our trials at this point, an adaptive design, which gives us the flexibility in terms of adjusting cohort size as well as some flexibility as we sort of think about the process for dose escalation. With both the BCMA study and the 34-01 study with trastuzumab, in particular what it allows us to do is to make decisions in terms of escalating either antibody dose or ACTR T cell dose separately and separate cohorts in a way to allow us to really efficiently sort of map out parameter space around the dosing of those 2 components to really drive efficacy and safety. So in terms of the 17-01 study, just again from an operational update perspective, we've completed enrollment and treatment in cohorts 4 and 5. Cohorts 1 through 3, we presented at the end of last year, we're expecting to present data from the cohorts 4 and 5 later this year.

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Operator [18]

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And I'm showing no further questions in the queue. So now it's my pleasure to hand the conference back over to Dr. Chuck Wilson, President and Chief Executive Officer, for closing comments or remarks.

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Charles Wilson, Unum Therapeutics Inc. - CEO, President & Director [19]

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Great. Well, thank you very much everyone for joining us today, and we look forward to providing you with the updates on all of our programs throughout the rest of the year. Thank you, and goodbye.

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Operator [20]

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Ladies and gentlemen, thank you for your participation on today's conference. This does conclude our program, and you may all disconnect. Everybody, have a wonderful day.