Cue Biopharma, Inc. (CUE) Q4 2023 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call summary presents a mixed picture. Financial performance is stable, but there's no significant growth. The Q&A reveals potential partnerships and development updates, which are positive, but management's lack of clarity on partnerships and preclinical timelines raises concerns. The sentiment is neutral due to balanced positive and negative aspects.

Key Financial Performance

Collaboration Revenue (Q4 2023) $1.8 million (up from $150,000 in Q4 2022); increase due to collaboration and option agreement with Ono Pharmaceuticals for CUE-401.

Research and Development Expenses (Q4 2023) $10.9 million (down from $11.3 million in Q4 2022); decrease primarily due to completion of drug substance manufacturing projects for CUE-101 and CUE-102 in 2022.

General Administrative Expenses (Q4 2023) $4.6 million (up from $3.7 million in Q4 2022); increase primarily due to higher professional and consulting fees.

Collaboration Revenue (Full Year 2023) $5.5 million (up from $1.2 million in 2022); increase due to revenue from strategic collaboration agreement with Ono Pharmaceuticals.

Research and Development Expenses (Full Year 2023) $40.8 million (up from $38.6 million in 2022); increase due to clinical development costs and research and laboratory expenses, partially offset by decreases in employee costs and rent.

General Administrative Expenses (Full Year 2023) $16.7 million (relatively flat compared to $16.2 million in 2022); slight increase.

Cash and Cash Equivalents (as of December 31, 2023) $48.5 million; expected to fund operations into the first quarter of 2025.

Working Capital (as of December 31, 2023) $34.4 million.

Common Shares Outstanding (as of December 31, 2023) 47.2 million.

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Operating Highlights

CUE-101: CUE-101 is in ongoing clinical trials for HPV-positive head and neck cancer, showing promising results and recently received FDA guidance for a registrational trial.

CUE-102: CUE-102 targets Wilms Tumor 1 and has completed Phase 1 dose escalation, showing anti-tumor activity in various cancers.

CUE-401: CUE-401 is a bispecific molecule in collaboration with Ono Pharmaceuticals, aimed at generating regulatory T cells for autoimmune diseases.

CUE-500 series: The CUE-500 series aims for T-cell mediated B-cell depletion, offering a novel approach to treat autoimmune diseases.

Market Expansion for CUE-101: CUE-101 is moving into a randomized Phase 2 study, targeting a larger market opportunity in first-line treatment for recurrent metastatic HPV-positive head and neck cancer.

Market Expansion for CUE-102: CUE-102 is expanding into multiple indications, including gastric, ovarian, pancreatic, and colon cancers.

Collaboration Revenue: Collaboration revenue increased to approximately $1.8 million in Q4 2023, primarily from the Ono Pharmaceuticals agreement.

Cash Position: As of December 31, 2023, Cue Biopharma had approximately $48.5 million in cash and cash equivalents, expected to fund operations into Q1 2025.

Strategic Partnerships: Cue Biopharma is engaging in strategic discussions with multiple partners to enhance capacity and access capital for ongoing developments.

Transformational Transaction: The company aims to consummate a transformational transaction to enhance productivity and capacity.

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Risk or Challenges

Competitive Pressures: The company faces significant competitive pressures in the oncology and autoimmune disease markets, particularly with the development of immunotherapies that may not achieve the desired efficacy or safety profiles.

Regulatory Issues: The company is navigating regulatory challenges, particularly in aligning with the FDA on registration paths for their therapies, which can impact timelines and development strategies.

Supply Chain Challenges: There are potential supply chain challenges related to drug substance manufacturing for CUE-101 and CUE-102, which could affect the availability of these therapies for clinical trials.

Economic Factors: Economic factors, including funding and investment climate, may impact the company's ability to secure necessary capital for ongoing and future projects.

Clinical Development Risks: The company faces risks associated with clinical development, including the potential for adverse events in trials, which could affect patient safety and regulatory approval.

Market Access Risks: There are risks related to market access for their therapies, particularly in demonstrating superior efficacy compared to existing treatments, which is crucial for gaining market share.

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Guidance & Outlook

Strategic Initiatives: Cue Biopharma aims to become a leading solution provider for selective modulation of the immune system in treating cancer and autoimmune diseases through its Immuno-STAT platform.

Strategic Initiatives: The company is pursuing a transformational transaction to enhance capacity and productivity.

Strategic Initiatives: CUE-101 is moving into a randomized Phase 2 study to confirm enhanced efficacy in combination with pembrolizumab for treating recurrent metastatic HPV-positive head and neck cancer.

Strategic Initiatives: CUE-401 and CUE-500 series are being developed for autoimmune diseases, with CUE-401 partnered with Ono Pharmaceuticals.

Revenue Expectations: Collaboration revenue for Q4 2023 was approximately $1.8 million, up from $150,000 in Q4 2022, primarily due to the collaboration with Ono Pharmaceuticals.

Financial Projections: The company expects its cash and cash equivalents to fund operations into the first quarter of 2025.

Future Milestones: CUE-101's Phase 2 trial is expected to provide interim analysis at 14 months and overall response rate and median progression-free survival analysis between 22 and 24 months.

Market Opportunities: CUE-102 aims to expand into large indication segments where checkpoint inhibitors have historically failed.

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Shareholder Return Plan

Collaboration Revenue Q4 2023: Approximately $1.8 million, up from $150,000 in Q4 2022, primarily due to collaboration with Ono Pharmaceuticals.

Collaboration Revenue Full Year 2023: Approximately $5.5 million, compared to $1.2 million in 2022, driven by the strategic collaboration with Ono Pharmaceuticals.

Cash and Cash Equivalents: Approximately $48.5 million as of December 31, 2023.

Working Capital: Approximately $34.4 million as of December 31, 2023.

Common Shares Outstanding: Approximately 47.2 million as of December 31, 2023.

Funding Outlook: Current cash and cash equivalents expected to fund operations into the first quarter of 2025.

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Key Q&A

Q:Can you talk about how many patients you anticipate you'll need in each arm?

A:The patient sample size for the entire trial is planned to be less than 100 patients, so approximately 25 patients per arm.

Q:If you're successful on that first interim, on overall response rate, would that allow you to advance into a registrational phase 3?

A:The final analysis at 24 months would serve as the substrate to proceed into a registrational trial, although a fair bit of trial startup could be done once the interim analysis provides a positive recommendation.

Q:Can you clarify what stage you would look to potentially partner? Would it be as you're running the Phase 2 or before the Phase 3?

A:We're presently in discussions with multiple parties across various asset classes and will consider a number of factors, including the type of support and economics.

Q:For the 501 program, just wondering if you'd talk more about where you're at with preclinical development for that program?

A:We have clear evidence that we've been able to make the scaffold and it's biologically active, and we've tested this across a number of different memory T cell specificities.

Q:Can you just maybe speak to the second key one-on-one dose that you're contemplating including into the randomized Phase 2?

A:The doses anticipated are 4 mg per kg and likely a 2 mg per kg dose where we've seen strong activity.

Q:Can you maybe just talk a little bit about kind of the pushes and pulls that were under consideration as you thought about carving out kind of an independent randomized Phase 2 versus trying to do something more Phase 2, 3, adaptive, seamless?

A:The Phase 2 offers the opportunity to generate data that confirms the dose to go into Phase 3, which is simpler in design.

Q:Can you just give us a sense as to the 101 studies, it's largely just longer term follow-up?

A:We will have a comprehensive analysis of all the data with longer follow-up for CUE101-01.

Q:How are you thinking about potentially just wrapping up 101 and 102 kind of in a nice typo and presenting that as a potential acquisition?

A:We are looking at the dynamic of capital requirements and aligning with a company that has the capacity to get through a registrational path.

Q:How T-cells that are targeting CMV can completely deplete all the B-cells?

A:The T-cell mediated depletion is essentially Pan-B-cell depletion simply because of the CD-19 anchoring that's on every B-cell.

Q:Review of Unclear Management Responses

A:Management's response regarding the Pembro survival number from the LEAP-10 trial lacked clarity, as they mentioned it was a mystery and did not provide a clear explanation.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

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