Release Date: April 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Cue Biopharma Inc (CUE, Financial) has demonstrated positive and evident results in ongoing clinical trials, particularly with Q101 for HPV-positive head and neck cancer and Q102 for WT1 overexpressing cancers.
- The company has received guidance and alignment with the FDA for the continued development of Q101 towards a registrational trial, indicating regulatory progress.
- Significant progress with preclinical autoimmune programs, notably Q401 in collaboration with Ono Pharmaceutical, demonstrating the desired mechanistic effect.
- Cue Biopharma Inc (CUE) is well-positioned for strategic alignment with third parties, potentially enhancing capacity to develop promising therapeutics.
- The company's financials indicate that current cash and cash equivalents are expected to fund operations into the first quarter of 2025, providing a solid runway.
Negative Points
- The company's research and development expenses remain high, with $10.9 million reported for the three months ended December 31, 2023.
- General and administrative expenses have increased, indicating higher operational costs.
- The company is still in the clinical trial phase for its leading candidates, which means there is a significant time before potential product commercialization.
- Cue Biopharma Inc (CUE) is dependent on the success of ongoing discussions with multiple prospective strategic partners for future development and funding.
- The company faces the challenge of navigating a dynamic and potentially unfavorable capital market environment, particularly in the oncology sector.
Q & A Highlights
Q: Can you talk about how many patients you anticipate you'll need in each arm of the randomized Phase two combo study for Q101? And if you're successful on that first interim on overall response rate, would that allow you to advance into a registrational Phase three?
A: Matteo Levisetti, Chief Medical Officer of Cue Biopharma, responded that the patient sample size for the entire trial is planned to be less than 100 patients, with approximately 25 patients per arm. The first interim analysis will be determined when about 70% to 80% of patients have reached their cycle five scan. The final analysis at 24 months will serve as the substrate to proceed into a registrational trial, although trial startup could begin once the interim analysis provides a positive recommendation to move forward.
Q: Can you clarify what stage you would look to potentially partner for Q101 and Q102? Would it be as you're running the Phase two or before the Phase three? And what could potential partnership look like from a development and economic standpoint?
A: Daniel Passeri, CEO of Cue Biopharma, explained that the decision to partner will be based on various factors, including the type of support and the economics downstream. Discussions are ongoing with multiple parties, and the objective is to retain as much upside for shareholders as possible. The company is considering different economic structures and will make a decision based on the options available, with the ultimate decision being made by the Board.
Q: For the Q501 program, can you talk more about where you're at with preclinical development, and would this be one asset or part of the Q500 Series platform?
A: Anish Suri, President and Chief Scientific Officer, mentioned that they have clear evidence that the scaffold is biologically active and are testing it across different memory T cell specificities. The Q500 series builds upon the clinical derisking accomplished with the CUE-100 series. There has been significant inbound interest from companies interested in achieving CAR-T like efficacy in autoimmunity. They are aiming to present more data at either an autoimmune meeting or a translational autoimmunity meeting later in the year or early next year.
Q: Can you speak to the second Q101 dose that you're contemplating, including in the randomized Phase two? And can you also speak as to what triggers the interim analysis?
A: Matteo Levisetti clarified that they are considering two doses for Q101, likely four milligrams per kilogram and two milligrams per kilogram. The interim analysis will be triggered when about 70% to 80% of patients have gotten through their cycle five scan. This analysis will help increase confidence in being successful in the subsequent Phase three trial.
Q: Can you talk a little bit about the pushes and pulls that were under consideration as you thought about carving out an independent randomized Phase two versus trying to do something more Phase two/three adaptive seamless?
A: Matteo Levisetti mentioned that a Phase two/three seamless design is a larger endeavor and investment. The Phase two trial offers the opportunity to generate data that confirms the dose for Phase three, making the Phase three trial simpler in design. This approach is seen as valuable because it provides a confirmatory analysis that increases confidence in being successful in the Phase three trial.
Q: Can you maybe just talk a little bit about kind of the pushes and pulls that were under consideration as have you thought about carving out kind of an independent randomized Phase two versus trying to do something more Phase two, three, adaptive seamless and maybe in answering that you can speak to, I guess, to what extent if any, was this path forward kind of informed by some of these ongoing strategic discussions.
A: Matteo Levisetti explained that the option to further develop the combination is to go with a Phase two/three sort of seamless design, the first component of that. And this has become, I think, quite common since a Project Optimus has sort of gone into effect as a directive or her mandate on is to have a lead in with the two doses to select your dose and then to go into the Phase three randomized portion.
Q: Can you maybe just talk a little bit about kind of the pushes and pulls that were under consideration as have you thought about carving out kind of an independent randomized Phase two versus trying to do something more Phase two, three, adaptive seamless and maybe in answering that you can speak to, I guess, to what extent if any, was this path forward kind of informed by some of these ongoing strategic discussions.
A: Matteo Levisetti explained that the option to further develop the combination is to go with a Phase two/three sort of seamless design, the first component of that. And this has become, I think, quite common since a Project Optimus has sort of gone into effect as a directive or her mandate on is to have a lead in with the two doses to select your dose and then to go into the Phase three randomized portion.
Q: Can you maybe just talk a little bit about kind of the pushes and pulls that were under consideration as have you thought about carving out kind of an independent randomized Phase two versus trying to do something more Phase two, three, adaptive seamless and maybe in answering that you can speak to, I guess, to what extent if any, was this path forward kind of informed by some of these ongoing strategic discussions.
A: Matteo Levisetti explained that the option to further develop the combination is to go with a Phase two/three sort of seamless design, the first component of that. And this has become, I think, quite common since a Project Optimus has sort of gone into effect as a directive or her mandate on is to have a lead in with the two doses to select your dose and then to go into the Phase three randomized portion.
Q: Can you maybe just talk a little bit about kind of the pushes and pulls that were under consideration as have you thought about carving out kind of an independent randomized Phase two versus trying to do something more Phase two, three, adaptive seamless and maybe in answering that you can speak to, I guess, to what extent if any, was this path forward kind of informed by some of these ongoing strategic discussions.
A: Matteo Levisetti explained that the option to further develop the combination is to go with a Phase two/three sort of seamless design, the first component of that. And this has become, I think, quite common since a Project Optimus has sort of gone into effect as a directive or her mandate on is to have a lead in with the two doses to select your dose and then to go into the Phase three randomized portion.
Q: Can you maybe just talk a
