Cue Biopharma, Inc.

Ladies and gentlemen, this is the operator. Today's conference is scheduled to begin momentarily. Until that time, your lines will remain on music hold. Thank you for your patience. Thank you. Greetings and welcome to the QBioPharma investor update call. At this time, all participants are in listen-only mode. A question and answer session will follow the presentation. If anyone should require immediate 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 the conference over to Jan Passeri, QBioPharma's Chief Executive Officer, You may begin now.

All right, thank you, and good afternoon, everyone. As a reminder, this presentation and discussion is being recorded and will be available on our website 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, and we'll notify you on what slide we're on throughout this presentation. Joining me on today's call are Dr. Anish Suri, our President and Chief Scientific Officer, Dr. Matteo Levesetti, our Chief Medical Officer, and Kerri-Ann Millar, our Chief Financial Officer. As shown on slide two, this presentation and overview may contain some forward-looking statements, and any forward-looking statement made during this call represents the company's views only as of today, April 8th, 2024. Okay, as shown on slide three, I'm going to begin with a summary overview of the broad reach of our therapeutic platform and review our competitive positioning and key corporate objectives going forward. Anish will then provide an overarching summary of our platform approach in support of developments, reinforcing our positioning as a leading solution provider, and the development of selective immunotherapeutic biologics to address pressing unmet medical needs in both oncology and autoimmune disease. Matteo is then going to review and update of our promising and evolving oncology clinical data sets, as well as provide a summary synopsis of our recent and productive Type B meeting with the FDA to align on registration paths forward for Q101. Anish will then return to provide an overview of highly promising data from our preclinical autoimmune programs, with the potential of having a profound impact on the treatment of autoimmune disease. Carrie will then join the call and provide a brief update on our financials, and I'll return for closing remarks prior to opening the call to questions. Okay, so to summarize, the data generated to date from our ongoing clinical trials with Q101 and Q102, as well as our preclinical programs, continue to move us closer to achieving our core mission and vision of becoming a leading solution provider for realizing the tremendous therapeutic potential of selective modulation of the patient's immune system in the treatment of cancer and autoimmune disease. As shown here on slide number four, we aim to achieve this by engineering biologics that translate nature's cues, that is signals from nature that are built into our biology, and to breakthrough immunotherapies. We have continued to progress forward with positive and evident results in our ongoing clinical trials, demonstrating and further bolstering the therapeutic potential of our Immunostat platform for treating cancer. To date, the strengthening data from our ongoing clinical Phase 1A and B trial with Q101 for HPV-positive head and neck cancer And Q102, for treating the numerous types of WT1 or Wilms tumor 1 overexpressing cancers, strengthens our belief that we've developed a therapeutically effective and well-tolerated approach for the selective modulation of cancer-relevant T cells. Importantly, we recently received guidance in alignment with the FDA through an end-of-phase 1 type B meeting for the continued development of Q101 towards registrational trials. Mateo will provide further details on this prospect momentarily. We've also made significant prospect with our preclinical autoimmune programs, principally Q401 in collaboration with our partner, Ono Pharmaceutical, and the Q500 series, with both programs demonstrating clear evidence of the desired mechanistic effect of these novel approaches. Anish is going to cover these in more detail momentarily. Through these ongoing developments, both in oncology as well as autoimmune disease, we're well positioned for strategic alignment with third parties for further increasing and enhancing our capacity to develop our highly promising and potentially transformative therapeutics. We've made significant progress towards our goal of consummating a transformational transaction that would enable greater capacity and enhanced productivity. I'm going to come back at the end of this call and further elaborate on this topic. in the closing remarks. I'll now turn the call over to Anish, who will describe our core competitive positioning and the strategic implications of our approach for treating both oncology as well as autoimmune disease. Anish?

Thanks, Dan. Good afternoon to all listening in on today's call. I'll provide a brief summary of our platform and the significant potential of our therapeutics for treating cancers and autoimmune diseases. As shown in slide five, immune balance is a key central pillar human health, and deviation from this state underscores diseases such as cancer and autoimmunity. Hence, an effective therapeutic strategy for resetting immune balance should focus on selective modulation of disease-relevant immune cells while avoiding broad perturbations of the immune system. Most importantly, this approach allows us to maximize efficacy while preserving patient safety. Slide 6 provides an introduction to our Immunostat platform for resetting immune balance via selective modulation of disease-relevant immune cells. The core framework of an Immunostat builds upon nature's selectivity for T-cell engagement and activation. Disease-specific T-cells express singular T-cell receptors, or TCRs, that engage the stabilized peptide HLA molecules, or PHLAs, in an Immunostat. Only those engaged T cells can then receive a disease-modifying secondary signal. This approach enables selective targeting and modification of disease-specific T cells while sparing broad effects on other T cells that are not relevant to the disease of interest. Importantly, the Immunostat framework was engineered to be highly flexible and modular, enabling us to deploy the same or similar core functional elements for diverse therapeutic approaches. For example, in the case of oncology, immunostats can selectively engage and activate tumor-specific T cells while avoiding systemic immune activation. In contrast for autoimmune diseases, immunostats can selectively down-modulate autoreactive T cells while avoiding broad immunosuppression. The next slide, slide seven, highlights the pipeline of assets that we have developed for restoration of immune balance. In oncology, we have clinically validated the Q100 series that selectively delivers the potent cytokine IL-2 along with a TCR activating signal to preferentially activate tumor-specific T cells while sparing all other irrelevant T cells. This selective stimulation allows for the generation of a therapeutic index for IL-2, which has eluded many others trying to develop IL-2-based cancer therapies. In over 100 patients dosed, we have demonstrated a substantial increase in efficacy with favorable tolerability. For our lead clinical candidate, Q101, in recurrent metastatic head and neck cancer, we have recently concluded a meeting with the FDA aligning on a registration path, which will be further elaborated upon momentarily by Matteo. With our next clinical candidate, Q102, that targets Wilms Tumor 1, or WT1, we have completed the phase one monotherapy dose escalation in patients with gastric, ovarian, colorectal, and pancreatic cancers, and have noted evidence of antitumor activity and disease control in multiple patients. Mattia will describe this efficacy data in detail along with the plans for our registrational path forward with Q101. On the autoimmune front, as shown here, we have developed two novel and highly promising approaches for restoring immune balance. Q401 is a novel bispecific composed of an attenuated IL-2 and TGF-beta that together can stimulate the generation and expansion of regulatory T cells. Regulatory T-cells, or Tregs, possess the ability to dampen and control autoreactive lymphocytes, which are responsible for inducing tissue damage in autoimmune disease. Hence, in this regard, Tregs are the master regulators of maintaining immune homeostasis and health. Q401 is currently partnered with Ono Pharmaceuticals, and this collaboration is moving forward at a strong pace with much productivity. In addition to Q401, we've also developed the Q500 series, to enable T-cell mediated depletion of B-cells. We believe this biologic holds the promise for achieving CAR T-like efficacy in autoimmune patients and is significantly differentiated from other competing approaches such as ADCC, PAN T-cell engagers, or CAR T-cell therapies. We will expand on both autoimmune programs in the later part of this presentation. With that background, I'll now turn the call over to Matteo to provide a detailed clinical update on the data and future plans. Mateo?