Good day, and welcome to the Cue Biopharma Business Update call. All participants are in a listen-only mode. I would now like to turn over to Eric Ribner from LifeSci Advisors. Please go ahead, Mr. Ribner.
Thank you, and good afternoon, everyone. Thank you for joining the Cue Biopharma Business Update call. Today's call will focus on the press release issued yesterday announcing our strategic collaboration and licensing agreement with Boehringer Ingelheim. Joining me on today's call is Cue Biopharma's Chief Executive Officer, Dan Passeri, and Chief Business Officer, Lucinda Warren. Please note that this presentation and discussion is being recorded and will be available in the investor and media section of the company's website at cuebiopharma.com for the next 30 days. Also, please be aware that the slides accompanying today's update may be advanced directly by those listening in on the call. You will be notified of the slides shown throughout the presentation. Additionally, some of the statements we make on this call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Actual results could differ materially from those stated or implied by these forward-looking statements due to the risks and uncertainties associated with the company's business, including those set forth in the risk factor section of Cue Biopharma's annual report on Form 10-K for the year ended December 31st 2024, filed on March 31st 2025, and any other filings that we make with the SEC. In addition, any forward-looking statements represent our views as of today, April 15th 2025. Cue undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now, I would like to hand it over to Cue's CEO, Dan Passeri. Dan, go ahead.
Thank you, Eric. Good afternoon, everyone. Welcome to Cue Biopharma's Business Update call. On today's call, we're going to provide an overview of the Boehringer Ingelheim, our BI collaboration pertaining to the targeting and depletion of B cells, starting with the license of Cue- 501, which we announced yesterday. We'll also briefly describe our novel approach for treating autoimmune disease resulting from autoreactive B cells. We're pleased to have announced the pricing also of an equity financing, which we expect to close tomorrow, Wednesday, April 16, and refer you to our press release issued yesterday regarding the financing for further details. First, let me begin with a brief reminder, as captured here on slide number three, that Cue's mission is to develop therapies to mobilize the patient's immune system to address serious conditions such as autoimmune and inflammatory diseases and cancer.
As conveyed in the next slide, we aim to achieve this by developing unique, differentiated biologics capable of precisely activating or inactivating, as well as expanding disease-relevant T cells with reduced risk of adverse events, particularly from cytokine release syndrome and neurotoxicity, often associated with global nonspecific pan-T cell activators. Our biologic platform series are based on what we consider to be a foundational understanding of the structure and function of the immune synapse, and we've talked about that historically in our oncology programs, and that is the membrane interface between T cells and the antigen-presenting cells that engage and specifically regulate T cells with specific signals or cues. That is the signals that nature uses to activate or inactivate and expand specific T cell populations.
Based on our latest important strategic development combined with our core pipeline progress, we believe we're well-positioned to continue making excellent progress towards delivering on our mission. We were pleased to make two important announcements yesterday. First, as shown here on slide five, that Cue Biopharma and Boehringer Ingelheim have entered into a strategic collaboration and license agreement, and separately, that the company priced a financing expected to close tomorrow to provide us with funding to further augment and enable continued execution towards our corporate objectives. We believe the combination of these two transactions positions us well to further advance our mission and provide patients with more effective standards of care in the treatment of serious diseases with the prospects of significant long-term value to our shareholders.
The first transaction that we're going to discuss now is the strategic collaboration with Boehringer Ingelheim, representing a validating and important development for Cue Biopharma and the Cue- 500 series. We believe this collaboration with BI will enhance and accelerate the development of Cue- 501 and optimize the prospective value of what we believe to be a disruptive first-in-class bispecific for treating B cell-mediated autoimmune and inflammatory disease. In addition, it provides non-dilutive funding to advance the development of our proprietary pipeline. We believe that BI is an ideal partner for the Cue- 501 program, as well as the 500 series for targeting B cells, with a closely aligned and shared vision to leverage Cue's proprietary T cell engager program to work towards the goal of providing this first-in-class and disruptive program to patients suffering from B cell-mediated autoimmune disease.
While today's discussion is focused on the importance and strategic significance of our collaboration and license agreements with BI pertaining to the development of our Cue- 501 program, as shown here on slide six, we're also planning to host an R&D day in mid-May where Cue management, as well as prominent immunology key opinion leaders, plan to discuss and review updated Cue- 401 data and discuss the promise of our various other programs. During the R&D day call, we plan to provide a detailed overview of our technology platform and pipeline programs with a particular emphasis on Cue- 401 from the Cue- 400 series, as well as providing an update on the maturing data that we've been seeing from our oncology programs.
We hope you can join us on this call, which will be subsequently announced in further detail, and this call will be recorded and available on our website if you're unable to make the call. Now, proceeding to slide seven, I'd like to take you through some of the background data for Cue- 501 representing our approach for targeting and depleting B cells. As shown here on slide eight, immune balance is essential in maintaining health. It allows the immune system to, in essence, fight pathogens, foreign cells that don't belong in our body, while preventing the immune system from engaging and attacking cells comprised of self. This immune balance is managed through a highly regulated and targeted activation and inactivation of specific T cell populations.
When the proper balance and maintenance of the immune system breaks down, the activation or inactivation of too many specific T cell types can result in autoimmune disease or cancer, respectively. We believe we've developed an effective solution designed to address this problem. Through protein engineering, we have designed and developed various biologic candidates that aim to selectively regulate the immune system to restore the proper balance and function. As previously stated, we'll be providing an update on our progress with our programs during an R&D day call in mid-May, with the emphasis of today's call being principally on our strategic collaboration with BI for targeted B cell depletion. As conveyed in the next few slides, beginning here with slide nine, I'll provide a high-level introduction to the Cue- 500 series and describe why we believe our approach to be disruptive and potentially superior to other approaches.
First, it's generally recognized that selective depletion of pathogenic cells could represent a direct and elegant treatment for autoimmune inflammatory disorders, also with potential application to cancer. Despite progress in the field, the use of non-selective pan-bispecific T cell activators, such as bispecifics utilizing what's known as CD3, this is a sort of general T cell activator, there still remains ongoing challenges with this approach with the problem of cytokine release syndrome and associated neurotoxicity with these pan-activation approaches. We believe we've addressed this challenge by addressing and developing a highly selective bispecific that targets a defined pathogenic cell type, for example, B cells that may be autoreactive and causing autoimmune disease, and depletes the target pathogenic cell by redirecting the patient-specific antiviral killer T cell population to recognize that target cell as virally infected.
In other words, we're not just activating every T cell that comes by with a CD3, but we're specifically exploiting already present specific antiviral T cells. We believe that this approach enables for the potent and specific eradication of target pathogenic cells with the reduced risk of adverse events, for example, of cytokine release syndrome associated with this indiscriminate nonspecific T cell activation that occurs, for example, with utilizing CD3. As seen here on slide 10, we've designed a bispecific biologic to precisely redirect antiviral killer T cells to target and eradicate selected pathogenic cell types. The technology builds on the Cue- 100 series protein scaffold and, as such, takes advantage of observations from the clinical trials we conducted with Cue- 101 and Cue- 102 pertaining to selective T cell activation, and we believe by implication will provide a very favorable tolerability profile.
This first-in-class bispecific biologic is designed so that on one end the biologic binds to the target cell, for example, CD19 or BCMA present on B cell lymphocytes, so therefore will attach to and target B cell lymphocytes, with the other end of the molecule having been engineered with an HLA peptide or epitope that's specific to a common virus such as cytomegalovirus or CMV, a member of the herpes virus family, and it's a common infection often during childhood. Importantly, most healthy individuals throughout adulthood remain asymptomatic after initial infection due to a continuous surveillance by long-lived antiviral memory killer T cells. Through this design, we're basically able to, in essence, paint the target T cell with the virus-specific peptide on the HLA scaffold, thereby prompting the immune system to redirect antiviral killer T cells circulating in the patient's bloodstream to identify, attack, and destroy the target cell.
This is essentially the core mechanism of our approach, and this is what makes it potentially so powerful as a therapeutic. That is, it takes advantage of the killing capacity of the existing antiviral killer T cells we all harbor to be redirected to attack and destroy pathogenic disease-causing cells, potentially without the adverse effects of global indiscriminate T cell activation approaches. We also believe there's a strong base of tolerability data supporting the program since the technology uses a similar scaffold to the Cue- 100 series, having already been administered in phase I clinical trials to approximately 120 patients. Just to remind you, we'll provide an update on those trials during the R&D day call.
Cue has developed a supportive body of preclinical data with Cue- 501 targeting B cell lymphocytes, and we're very pleased to collaborate with Boehringer Ingelheim to further develop this exciting first-in-class biologic with the intention of bringing it to patients suffering with B cell-mediated autoimmune disease. Excuse me. On slide 11, this shows the results of an important experiment where we used a CMV, again, that's cytomegalovirus, based bispecific from the Cue- 500 series. We studied white blood cells from human donors. These cells are also known as PBMCs to, in essence, compare the ability of Cue- 501 against the benchmark pan-specific, pan-bi-specific, which is a non-selective and indiscriminate T cell activator. To remind you, 501 has, for instance, in this case, CD19 for binding to B cells and CMV on the other end, and the pan-bi-specific has CD19 and a CD3.
In this comparison study, Cue- 501 depleted CD19 specific B cells with comparable efficacy or activity as the CD19 CD3 bispecific. Importantly, however, as you can see on the two bottom charts here, Cue- 501 treatment resulted in a dramatic reduction in the production of two pro-inflammatory cytokines, interferon gamma and TNF alpha, both associated with cytokine release syndrome, as compared to the CD19 CD3 bispecific, where you can see a very profound and significant increase of both of those pro-inflammatory cytokines. This experiment, in essence, supports our premise that Cue- 501, representing the Cue- 500 series specifically, ineffectively depletes targeted B cells without triggering the pro-inflammatory cytokines associated with cytokine release syndrome by exploiting the selective and specific killing potential of antiviral killer T cells circulating in the blood. I want to remind you that this study was conducted on human blood.
On slide 12, we've summarized what we believe to be the key differentiators for the design of the Cue- 500 series: selective activation of virus-specific killer T cells, including long-lived memory T cells, avoiding systemic immune reactivity, including reduced risk of cytokine release syndrome and neurotoxicity, off-the-shelf administration without the manufacturing logistics that have complicated, for instance, CAR T therapies, thereby also avoiding patient preconditioning regimens required for cell therapy approaches, and the ability to leverage an existing manufacturing supply chain built on our learnings from the Cue- 100 series. Okay. Here on slide 13, you can see that these attributes readily differentiate Cue- 500 from non-selective pan-T cell bispecific engagement molecules and CAR T cell therapies.
We believe the combination of effective cell depletion and significantly reduced risk of cytokine release syndrome positions Cue- 501 as a potentially breakthrough new standard of care for autoimmune and inflammatory disease with expansion potential into oncology. Importantly, as shown here on slide 14, the Cue- 500 series is modular. That is, it basically gives us the opportunity to target a broad range of cell types, including B cells, potentially fibroblasts involved in fibrotic diseases, eosinophils, mast cells, and cancer cells. Through our novel approach, we believe that 501 and other biologics from the Cue- 500 series have the potential to change the standard of care for autoimmune patients and potentially also of cancer patients. We're very pleased to have entered into this important strategic collaboration and license agreement with BI, and believe they represent the ideal development partner for this important, innovative, and potentially disruptive approach.
I'm now going to turn the call over to Cindy Warren, our Chief Business Officer, who will provide some key details of our collaboration with Boehringer Ingelheim, and then I'll return for closing remarks. Cindy?
Thanks, Dan. As we turn to slide 16, I'd like to start by echoing Dan's comments. We cannot be more pleased to be collaborating with the BI team to accelerate the development of Cue- 501. They bring a focused concentration and expertise in both immunology and inflammatory diseases with a real-world perspective and expertise from their active clinical programs. We've thoroughly enjoyed establishing a working relationship with our new colleagues, and I can say that the BI collaboration is off to a great start. I'd like to highlight some of the key financial details of yesterday's announcement. Under the terms of the agreement, Cue will receive an upfront payment of $12 million and research support payments. Cue is eligible to receive up to $345 million in success-based milestone payments, beginning with two preclinical development milestones, as well as royalties on net sales.
The collaboration will initially focus on autoimmune and inflammatory diseases targeting B cell depletion, with the potential to offer improved benefit and safety versus other therapeutic approaches targeting B cells. As seen on slide 17, from a strategic perspective, we believe the BI transaction provides two key elements to Cue and our investors: acceleration and validation. First, acceleration. Partnering with BI provides dedicated support that will help to accelerate and advance the development of Cue- 501 for B cell-mediated autoimmune diseases. The R&D teams are in place. There's a solid development plan, and work on 501 is already moving forward. The non-dilutive financing from BI's upfront payment will also enable us to continue our focus advancing our autoimmune programs, specifically Cue- 401 for T cell-mediated autoimmune diseases, as well as the Cue- 500 series for targeting specific pathogenic cells.
We'll be sure to update you on that at the R&D day in mid-May. Second, validation. BI has established immunology and immune-mediated diseases as a key area of concentration. The collaboration represents a strategic expansion of BI's autoimmune and inflammatory disease pipeline portfolio and provides important validation for Cue's approach to autoimmune and inflammatory diseases through the Cue- 500 platform. With that, I'd like to turn it back to Dan for closing remarks. Dan?
Thanks, Cindy. I’d like to summarize the key messages from today’s call. As stated on this call, we’re very pleased to have partnered with Boehringer Ingelheim for the research, development, and commercialization of what we believe to be a disruptive and highly differentiated B cell depletion approach with our Cue- 500 series, including a license to Cue- 501. We believe this collaboration represents a shared vision for the potential establishment of a new standard of care for patients suffering with B cell-mediated autoimmune disease. This partnership, combined with the expected closing of the financing we announced yesterday, will provide us with an extended runway, which we expect will enable us to focus upon the achievement of the next important milestones of our ongoing corporate evolution. As a reminder, we’re planning to host a virtual R&D day in mid-May.
We're going to make a subsequent announcement with further details on that call. During that call, we'll provide a detailed overview of our technology platform and pipeline programs, including a detailed overview of supporting data from our Cue- 401 program, as well as an update on the oncology programs and some of our other autoimmune developments. The event will also feature prominent key opinion leaders to basically provide their perspective on the data we've generated with Cue 401. We look forward to the upcoming R&D call and hope you can join us. With that, we'd like to thank you for joining us today. Operator?
That concludes our call for today. Thank you, everyone. You may now disconnect.