Greetings, and welcome to the Cue Biopharma Investor Update Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to Dan Passeri, Cue Biopharma’s Chief Executive Officer. Thank you. You may begin.

Hi. Thank you very much, and good afternoon, everyone. As a reminder, this presentation and discussions being recorded and will be available on our website for the next 30 days. Also please be aware that the slide accompanying today’s update maybe advance directly by those listening in on the call, and we'll notifying you as we proceed through the presentation. Joining me on today's call is Dr. Anish Suri, our President and Chief Scientific Officer; Dr. Matteo Levisetti, our Chief Medical Officer; and Kerri Millar, our Chief Financial Officer. As shown on slide number 2, this presentation and overview may contain some forward-looking statements, and any forward-looking statements made during this call represents the company's views as of today, August 09, 2023. On the next slide, which is slide number 3, it just outlines the agenda for today's call, and I'll begin with a brief summary followed by Anish. Anish will provide you with some background context pertaining to our approach and result in developments regarding the Immuno-STAT platform with a brief synopsis of associated competitive advantages pertaining to the observations from our ongoing clinical trials. Following the background provided by Anish, Matteo will then provide an update on observations from our ongoing clinical development regarding mechanistic insights, having corporate development implications for our ongoing corporate strategic positioning. Both Anish and Matteo, during the presentation, we'll be providing updates with some of the data and slides having been previously presented and discussed on prior calls. The repeat of that data is meant to provide context and continuity in our foundational premise, but also serves to reinforce the consistent and steady progress forward, demonstrating the realization of our foundational vision to enable precision immunotherapy helping to transform the treatment of cancer. Following Matteo, Anish will return with a brief overview of our preclinical pipeline developments and then they will be followed by Kerri, who will provide an overview of our financials for Q2 and going forward guidance. I'll then return for concluding remarks, and we'll open the call up for questions. I'm now going to turn the call over to Anish. Anish?

Thanks, Dan. As noted on slide 4, the foundational premise and vision for our therapeutic platform has centered on harnessing the natural signals on HSQs that the immune system utilizes to guide its effective functions, including recognition and destruction of malignant tumor cells. We believe this approach provides us with a significant advantage by exploiting what evolution has already refined, which is the herculean task of creating molecules and signaling pathways that lead to balanced immune responses. Most importantly, these signals on HSQs have been fine-tuned and optimized to provide protective immunity while preserving the safety of the host. Using these underlying principles of selectivity, we have engineered and now clinically validated a new class of bispecific T cell engagers termed Immuno-STATs for the selective modulation of disease-relevant T cells while sparing the broad nonspecific immune activation or carpet bombing of the entire immune system. For oncology applications, we've been able to deliver natural immune activation signals such as the cytokine IL-2 selectively to the tumor-specific T cells. This property enables us to create a meaningful therapeutic index to exploit the promise and potential of targeted immune activation in the patient. The same principle can be applied to any other cytokine or immune modulation signals. To the last point, we have published several key papers in top-tier journals demonstrating the modularity and breadth of our platform. As Matteo will discuss in detail shortly, we now have exciting insights from recent clinical data that we believe provide very strong support and validation for our biologics platform. Further, we believe that these data position us to exploit the breadth of our platform modularity, to address patient needs in many cancers, and I will comment more on this as we discuss our pipeline and potential for expansion into indications with significant market potential.…

Thanks Anish. The clinical data from the ongoing CUE-101 trial continues to demonstrate highly encouraging and robust metrics of clinical benefit for heavily pretreated recurrent metastatic HPV-positive head and neck cancer patients treated with monotherapy and for newly diagnosed patients with recurrent metastatic HPV-positive head and neck cancer treated in combination with pembrolizumab. As shown on slide eight, data from the ongoing clinical trials with CUE-101 is monotherapy and in combination with pembrolizumab have provided clinical proof-of-concept and derisking of our Immuno-STAT platform. The latest data generated to-date in 2023 continues to support prior observations and further enhances our confidence in CUE-101 as a potential therapeutic for patients battling HPV-positive head and neck cancer. As previously and consistently stated, we believe CUE-101's mechanism of action, as evidenced by the ongoing data generated to date provides effective and tolerated dose levels, enabling selective expansion of targeted tumor-specific T cells directly in the patient's body. Recurrent metastatic HPV positive head and neck cancer is a tough incurable disease. The data we have observed throughout the monotherapy trial bolsters our position and enhances our confidence that CUE-101 is in fact, stimulating the targeted cancer-specific T cells within these patients, resulting in demonstrable antitumor effect. Furthermore, nd importantly, we continue to observe an evolving pattern of disease control and enhanced survival in the monotherapy trial. We believe this enhanced survival is due to the persistent expansion of tumor-specific T cells given CUE-101's mechanism of action, especially in the tumor microenvironment. As shown on previous webcast, I'd like to review the data on slide nine, as it is very important to understand the mechanistic differentiating features of CUE-101, including its effects on NK cells and tumor-specific T cells in the blood and the tumor microenvironment. In clinical trials to date, CUE-101 demonstrates well behaved and…

Thanks, Matteo. As discussed by Matteo, the clinical validation data with CUE-101 and 102 provides us enormous confidence to exploit the breadth of our platform to cover many cancers. As shown on Slide 21, the core IL-2 framework for each distinct immuno state remains constant. The primary difference between each molecule is that T cell targeting moiety, which is unique to the cancer specificity. In other words, these different Immuno-STATs are essentially analogs of each other. To that end, we believe that the clinical experience with our first clinical candidate, CUE-101, provides platform validation and platform derisking.We believe this unique positioning has a read through for the entire class of therapeutic molecules that can be developed using our technology platform, which provides a significant competitive advantage. The core advantage around platform modularity to enhance precision immunotherapy is also exemplified on this slide. As shown, we can easily swap tumor-specific T cell targeting modules to cover many different cancers. CUE-101 serves as a beachhead that provides not only a registrational path for HPV-driven cancers, but also provides proof of concept for developing additional immuno stats for different cancers by targeting shared tumor antigens, personalized tumor antigens and/or neoantigens. This extensibility is highlighted by CUE-102 that targets Wilms Tumor 1 for multiple indications and by preclinical validation of additional immuno-STAT that incorporate important tumor targets such as mutated KRAS, MAGE, et cetera. The other aspect of platform modularity allows us to incorporate multiple HLA alleles to expand patient -- global patient coverage. We've already demonstrated this versatility by generating immunostatus with HLA-A02, AO3, A11 and A24, as examples. The next slide, Slide 22 gives a snapshot of our current pipeline in oncology and autoimmunity. We remain focused on our clinical stage assets, that is CUE-101 and 102 which continue to generate data…

Thanks, Anish. I'd like to provide a brief update on our financial results for the three and six months ended June 30, 2023. As shown on slide 23, during the second quarter of 2023, the company continued to use its resources in a disciplined and efficient manner while maintaining a consistent level of overall spend when compared to the same period in 2022. Importantly, we reported collaboration revenue of approximately $1.4 million for the three months ended June 30, 2023, as compared to $26,000 for the three months ended June 2022. Revenue in the second quarter of 2023 was due to work related to the recent collaboration and option agreement with Ono Pharmaceuticals that Anish just mentioned. As of June 30, 2023, the company had approximately $57.9 million in cash, cash equivalents and marketable securities compared with $66.1 million as of June 30, 2022. Our current cash position includes proceeds from the sale of shares of our common stock in July under the October 2021 ATM agreement with Jefferies. We expect our current cash position, cash equivalents and marketable securities to fund operations through the third quarter of 2024. I'll now turn the call back over to Dan for closing the remarks. Dan?

Yeah. Thanks, Kerri. So in summary, we view the updated data from our ongoing trials with CUE-101 and CUE-102 to be foundational, representing breakthrough potential by enabling what we consider to be precision activation of the patient's own immune system to destroy cancer. Furthermore, in combination with existing standard of care therapies, such as checkpoint inhibitors, and Immuno-STAT may significantly expand patient reach and clinical efficacy. These developments could be transformational for the future of cancer immunotherapy. And our CUE-102 trial, we're very pleased to already observe metrics of anti-tumor activity in several patients in the dose escalation portion. Furthermore, an increased demand for patient access to our trial we believe, underscores the therapeutic platform's potential and addressing the significant unmet medical need for these patients, especially since many of these cancers have largely been unresponsive to checkpoint inhibitor therapy. Our platform versatility and modularity also offers market expansion opportunities into additional indications and broad HLA coverage to treat global patient populations. We also believe the application of our platform in autoimmune disease, as Anish just touched upon. More specifically, CUE-401 holds blockbuster market potential as a possible treatment for a myriad of autoimmune diseases. We continue to make impressive progress forward with our partner, Ono Pharmaceutical, and we look forward to providing further details on this program later in the year. I want to thank everyone listening in, particularly our shareholders for their support and appreciate the ongoing interest and our important progress for developing promising therapeutics for patients in need. Speaking of, I want to thank the patients participating in our trials as well as their families for support. I also want to thank our dedicated employees for their commitment and constant professionalism for bringing these promising therapeutic candidates forward. With that, I'll now turn the call over to the operator and open up for any questions. Operator?

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Your first question comes from Ted Tenthoff from Piper Sandler. Please go ahead.

Great. Thank you very much. And thank you for the update and congrats on the strong data to date. You guys are presented with sort of a win-win scenario here where you're seeing an enhanced activity on top of KEYTRUDA in frontline now with 101 as well as monotherapy in later stage patients, what goes into the process throughout the rest of the year as you generate more data, and we're looking forward to that at SITC. What really is going to go into that process. And even beyond the data, what other factors, whether they be strategic or financial, how does all that kind of come together to sort of chart our path forward. Thank you. A – Dan Passeri: Yes. Thanks, Ted. This is Dan. I appreciate the question. Yes. It is a dilemma because we have positive data on both fronts, but more importantly, we're a platform company, not a head and neck cancer company and we have limited resources. So we're thinking on a very strategic level. This obviously has to do with our corporate development initiatives, partnering initiatives, what's the best strategy for developing both this particular asset and various scenarios, monotherapy combination. We do plan to have a meeting with the FDA in the coming months, and that will define possible registration path. And I think that would also be an asset for strategic partnering discussions as well. But we also have this data emerging from CUE-102 as a monotherapy in cancers that by and large, have not been responsive to checkpoint inhibition. And if we can demonstrate that we're turning these cold tumors into hot tumors and expanding patient reach, that's going to put us in an enviable position in terms of enabling the application of checkpoints and cancers that have previously not been available. So we're looking at all of this, obviously, in a pragmatic strategic manner, we're looking at various strategic scenarios, and we're in ongoing dialogue with our Board, which ultimately is part of this decision process. So I appreciate the question. It's an important one for us to continue to define and refine. And I think in essence, we're going to have a decision tree based on pros and cons, based on capital access requirements, cost of capital and our various alternatives on strategic partnering. And all of these are -- they are good problems to have. We just have to address them head on and in a timely manner going forward.

Great. Thank you. I'll hop back in the queue.

Thank you.

Thank you. Your next question comes from Ren Benjamin from JMP Securities. Please go ahead.

Hey guys, thanks for taking the questions, and congratulations on all the progress. I have a couple of questions, maybe just starting off with the monotherapy study and the update on overall survival. Can you talk a little bit about what additional information is really needed from the study, so that you can book the appointment with the regulatory body, have your discussion? And what would you consider to be a trial design agreement win, if you will in terms of -- once you've had that meeting? And then I have a couple of follow-ups.

Sure. I'm going to ask Matteo to handle that question.

Certainly. So thanks for the question. As this data has matured in the cohort of 20 patients treated at 4 mgs per kg, it's really strengthened now with an approximate median OS of 14 months, which really compares very favorably to that, which was observed even in the second-line setting at eight months. So component of the planned FDA interaction is to put forth a proposal for a registrational trial. We've developed a synopsis and design for that trial and it's basically a randomized trial, most likely, 2:1 randomization of CUE-101 monotherapy to investigator's choice of three potential chemotherapeutic regimens. So we have all of the details and statistical parameters defined. And so in our interaction with FDA with regards to win, it's really -- we anticipate having, if you will, endorsements “for a single registrational trial” to support an approval in late-line patients.

Got it. And then just switching gears, because I know we've talked in the past about the neoadjuvant study, the importance of the neoadjuvant study. I might have missed it in the prepared remarks, but can you talk a little bit about where we are, when we might expect to see any data? And how that program might ultimately move forward?

Yeah. Matteoo, I think that's also you.

Yes, certainly. So the neoadjuvant trial at Washington University is going very, very well, okay? And the trial is currently enrolling patients in the second schedule, which is patients are getting two doses of CUE-101 before treatment with curative intent, either surgery or chemo-RT. So important to note that this is an investigator-sponsored trial and so the timing of sharing and presenting this data will occur as a collaboration with the group there that hold the IND for the IST. We have seen some early data that looks very encouraging. And so we really feel that this will further our understanding of CUE-101's effect in the tumor microenvironment, since the analysis and characterization of tissue-based TME blood-based immune markers and even T cell receptor presence in the tumor pre and post-treatment really is going to be really an exciting data set to look at when it is presented with our collaborators.

Got it. And then I guess, just finally, as we think about CUE-101 -- sorry, CUE-201, I think, going after CUE-101. Can you -- you mentioned on the call, clinical activity that you've seen -- can you maybe provide some additional color on those responses in the tumors where you saw an impact? And maybe related to that, as you think about that program moving forward, how should we be thinking about the ideal combinations and the potential to sequence with subsequent checkpoints?

Certainly. So thanks for the question. So to begin, the next steps are really to determine the recommended Phase 2 dose, okay? So that is the primary objective of the dose escalation component. With regards to the activity that we're observing, okay, we have four cancer types here. And as we've stated, we've seen now a reduction that's been sustained for over 18 weeks in a patient with advanced metastatic gastric cancer. We have several patients now that have stable disease confirmed up to 18 weeks, so across different indications. So we look forward to presenting the formal analysis of what we've seen with regards to effects on tumors at the CT meeting. With regards to where we'll be going, I think once we establish the monotherapy activity okay, these various indications that will certainly assess rational combinations to consider taking forward. And really importantly, I think understanding that unique biologies of different tumor types, okay, may really direct based on the data where it would make sense to combine Q1 02. So we look forward to seeing that just as an example, in colorectal cancer, it's -- I think, believe they're pretty much accepted that part of the resistance to checkpoint inhibitors in immunotherapy is born out of a dominant immunosuppressive environment. And so in that tumor type, it would make sense to consider combining with something that that interferes with that immunosuppressive pathway, it could be a TKI, it could be another agent. So that's where we'll be heading. And for example, in gastric cancer, I think there's been some activity with checkpoint inhibitors. There's an approval in the HER2-positive subset of gastric cancer for pembro plus HER2 targeting agent that may be a cancer indication where it would make sense to combine with an anti-PD-1 or other checkpoint inhibitor, and that's what I think we'll be considering.

Perfect. Thanks very much for taking the questions. Good luck.

Thanks, Ren.

Thank you. Your next question comes from Stephen Willey with Stifel. Please go ahead.

Hi, guys. This is Toni [ph] on for Steve. Can you guys hear me okay?

We can hear you just fine. Thank you.

Okay. Great. Thank you. Thank you for taking my questions. So I have two questions on my end. Starting with the CUE-101 plus pembrolizumab, the combination cohort, do you think you guys will pursue specific target population moving forward? Like because you have mentioned a lot about how this combination improves low CPS low-figure score population even better compared to, let's say, high, for example, do you think there will be any potential signal indication that you guys would be targeting specific population. So that's related to CUE-101. And regarding CUE-102, can you please provide a little more color on enrollment dynamics and maybe possibly additional comment on like how many pieces have been enrolled so far? And if possible, maybe additional color on like data disclosure data update at six week? So that's all on my end. Thank you very much.

I think the first question had to do with stratifying with CPS score.

Yes. I can -- I'm happy to take it.

Yes, go ahead.

Thank you for the super great questions. And so with regards to CUE-101 and pembrolizumab and the data that we're observing, right, where we have a really meaningful tripling of response rate in the CPS low population. Also, we have about 1.6 times increase in the CPS high population. So the way I think we're thinking about this, this is actually really a win-win for any patients that are being treated in the first-line setting with a checkpoint inhibitor such as pembrolizumab. So if you actually look at the data on the low population, it's less than one in five patients that benefit or have a response. And so if we can push that up to 50% that's fantastic for the patients. And then even in the CPS high population, we have a clear benefit of improving the activity there. So I think where things stand now. Pembrolizumab is approved in the first line for treating any patients that are CPS greater than or equal to 1%. And it's not clear that stratification really would be needed or specific targeting since really all of these patients appear to benefit more from the combination. With regards to CUE-102 the enrollment is -- in my experience, been close to the fastest for a dose escalation Phase 1 advanced cancer study. And as I mentioned before, this is really borne out of the remarkable enthusiasm of the investigators. And I think also it underscores the large unmet need of patients with advanced disease in these four indications. Regarding the numbers of patients, I think we anticipate presenting the initial data on approximately 20 patients or more at SITC in November. And the data that we'll be presenting at that time is the initial observations on the safety and tolerability of CUE-102 monotherapy. We have already and we will fill out more some preliminary pharmacokinetic data from the dose escalation patients characterized the clinical course that's been observed and also share any correlative data sets that we have available at that time. As I'm sure you know well, we're working very actively with several different vendors that are going to help us do the correlative analysis, and we hope to have some of that data to share at SITC as well.

Thank you very much.

Thank you. [Operator Instructions] Your next question comes from Peter Lard [ph] with Oppenheimer. Please go ahead.

Hey guys. It's Trevor. Thanks for taking the question. Excited to see the SITC updates. So, looking ahead to 2024, can you guys discuss some of the additional data that we might see throughout the year there?

Yes. On 2024, obviously, we'll have resolution from our FDA discussions, what the strategy is on 101 and also clarity on our strategic decision on what indication, what line, front line, third line, both by -- in 2024, we should have also the decision of whether we're partnering 101 and with whom, what structure? 102, as Matteo just articulated, we have a very enviable position. We have multiple cancers. We're seeing early activity and dose escalation. Just to reiterate what Matteo conveyed during the call, we've seen activity at the 1 mg and 2 mg dose level. So, we also have the scans for 4 and 8 will be providing at SITC. So, going into 2024, it's going to be a pretty exciting year just from a standpoint of prioritizing. Obviously, in this current financial climate, we have resource requirements that we're going to have to address. So most likely through strategic. We also have data from 401 that is emerging, we'll have clarity by end of year going into 2024. We consider that to be a really important transitional year for us. So, I think it's going to be a year of multiple milestones that will be clearly defining by the end of the year as well as expansion decisions.

Thank you.

Okay. Yes, appreciate it.

Thank you. At this time, there are no further questions. Please proceed with your closing remarks.

Yes. I want to thank everyone for your time and interest in our continued progress. We're clearly making very good steady progress as we move forward, and we're looking forward to SITC and providing you with further updates as we continue developing for the remainder of the year. I wish everyone a pleasant remainder of the week. And again, thank you for your interest and take care.

This concludes your conference call for today. You may now disconnect your lines. Thank you.