Cue Biopharma, Inc.

Greetings and welcome to the QBioPharma update call. At this time, all participants are in a listen-only mode. A question and answer session will follow the presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn this conference over to Mr. Dan Passeri, QBioPharma's Chief Executive Officer. Thank you, sir. You may begin.

Okay, thank you and good afternoon everyone. Just to remind you as we proceed through the presentation, we'll convey which slide we're on and you can advance the slides directly. We appreciate your time and interest in our update call regarding our ongoing trials of Q101 as well as Q102, our initial representative drug candidates of the IL-2 based Q100 series. Joining me on today's call is Dr. Anish Suri, our President and Chief Scientific Officer, Dr. Ken Pienta, our Acting Chief Medical Officer, and Dr. Matteo Levassetti, our Senior Vice President of Clinical Development, and Kerry Millar, our Chief Financial Officer. This conference is being recorded and will be available on our website for the next 30 days. As a reminder, and as shown here on slide number two, this presentation An overview may contain some forward-looking statements, and any forward-looking statements made during the call represents the company's views only as today, August 23rd, 2022. So, our agenda for today's call is shown on the next slide. As an introduction, Anish will provide a synopsis of our progress to date, as well as describing our strategic and competitive positioning prior to turning the call over to Ken and Matteo, who will I each provide a summary and status update of the data associated with observations from our ongoing phase one trials of Q101, as well as the recently initiated Q102 trial. Following Ken and Matteo, I'll provide an overview of our corporate strategy and additional pipeline expansions within the Q100 series. Kerry will then provide a brief update of our financials, after which I'll return for closing remarks and then open up the call for a Q&A session. With that, I'll now pass the call over to Anish.

Thanks, Dan. I'd like to start today's presentation by reminding folks of the genesis of our company's quest and the mission we seek to accomplish. Our mission is to address a very fundamental and consequential question for immunotherapy, which is can we selectively and specifically activate anti-tumor T cells while avoiding the carpet bombing of the immune system to maximize efficacy and minimize toxicities? This is a very basic yet fundamental distinction from how others may be approaching the challenge of turning the immune system against cancers. To accomplish our objective as shown in slide four, we envisioned exploiting the one unique marker of an anti-tumor T cell which is the tumor-specific T-cell receptor, or TCR. We've engineered an innovative biologics platform termed Immunostat that generates TCR selective engages to deliver immune activating signals to tumor-specific T-cells. The figure on the left in slide four depicts the core structure of an immunostat, which is essentially an antibody FC-based biologic containing stabilized tumor peptide HLA molecules to selectively target tumor-specific T cells along with desirable activation signals that are consumed by those T cells. This framework provides a molecular basis for improved specificity for anti-tumor T cell activation while minimizing off-target toxicities due to systemic immune activation, which, by the way, continues to be a key impediment for many other broadly targeted immunotherapeutic approaches. On the right slide of this slide, You can see a figure depicting the Q100 series, which is designed to selectively deliver IL-2 to tumor-specific T cells over irrelevant T cells, hence generating a therapeutic index for IL-2, which as of yet has been a challenge. We believe this is a superior approach for harnessing the fullest potential of IL-2, especially since the tumor-specific T cells are present in a very low frequency. Our current clinical candidates, namely Q101, and Q102 are derived from the Q100 series and share the core IL-2 framework as depicted here. The next slide, slide five, summarizes the key and impactful takeaways that highlight the progress and clinical validation of our approach. Ken and Matteo will provide detailed insights into the clinical data and patient benefit that support the conclusions noted here. To summarize, We've engineered a novel biologics platform immunostat for selective targeting of anti-tumor T cell activation. As an initial drug construct, we chose to deploy IL-2 as the targeted activation signal. IL-2 is a well-characterized and validated therapeutic target, but has suffered from significant safety liabilities due to lack of a therapeutic index. We have successfully generated a therapeutic index for IL-2 as evidenced by the fact that we have observed clinical activity between one mcg per kg and four mcg per kg and have dosed up to eight mcg per kg with no MTD. Most other IL-2 variants that are in the clinic have been dosed in the low microgram per kilogram range due to unwanted adverse side effects. Our first clinical candidate, Q101, targets IL-2 to HPV-specific T cells to attack HPV-driven cancers such as head and neck cancer. Our clinical experience with Q101 highlights several important findings for our technology platform. Our molecules are well tolerated with no evidence of systemic IL-2 toxicities, such as vascular leak syndrome or cytokine storms. They exhibit drug-like properties, including favorable PK, on-target PD signals, and monoclonal antibody-like manufacturability to support desirable cost of goods. We have demonstrated clinical efficacy as monotherapy in late-stage cancer patients that have failed numerous prior therapies, including checkpoint inhibitors. Ken and Matteo will describe these signals in detail, including an emerging benefit in overall survival. The observed clinical benefit is supported by mechanistic signals demonstrating T-cell infiltration, which catalyzed our ongoing neoadjuvant trial in head and neck cancer. we have evidence for long benefit and anti-tumor activity in patients remaining on therapy for long periods, which underscores the extended kinetics for evolution of a beneficial immunotherapy response, as also noted previously by others. And lastly, early data from our first clinical experience in combo with the checkpoint inhibitor supports the potential for significant expansion of patient benefit All these metrics will be described in greater detail in the ensuing clinical discussion. Importantly, since the core IL-2 framework is conserved across the Q100 series, we believe the clinical de-risking attained by Q101 has essentially de-risked our entire platform. The recent IND acceptance for our next clinical candidate, Q102, targeting Wilms Tumor 1, or WT1, underscores the strategic advantages of platform de-risking accomplished by Q101. The FDA accepted the Q102 IND with no requirement for preclinical talks and has authorized us to initiate the trial at one milligram per kilogram, a dose that has demonstrated clinical activity in the Q101 trial and is a significantly higher starting dose than the 0.06 mg per kg starting dose for Q101. These metrics highlight the resource, time, and operational efficiencies gained by the platform de-risking by Q101. To end, we believe the modularity of our platform, coupled with the clinical validation, positions us to generate a rich repository of therapeutic molecules targeting many cancers. As one evaluates the potential of IL-2 for cancer immunotherapy, we believe our platform has cracked the code for selective targeting of the cytokine to the tumor-specific T-cell repertoire. Dan will address this in context of our corporate growth strategy toward the end of today's presentation. With that backdrop, I'll now pass the call to Ken for the clinical update. Ken?