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Cue Biopharma, Inc. (CUE): Business Model Canvas [Dec-2025 Updated] |
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Cue Biopharma, Inc. (CUE) Bundle
You're looking past the noise to see the real business engine driving Cue Biopharma, Inc. (CUE) right now, and frankly, it's a classic high-risk, high-reward biotech play. Their core value rests on the Immuno-STAT™ platform, which delivered a compelling 50% overall response rate in their lead oncology asset, CUE-101. To fund this R&D-which ran at \$4.8 million in Q3 2025-they rely heavily on strategic cash, like the \$2.1 million in collaboration revenue that same quarter, plus upfront cash from deals like the \$10 million expected from ImmunoScape in Q4 2025. I've broken down the nine essential blocks that show you exactly where the money goes and where the next big payout might come from, so dive in below to see the full picture.
Cue Biopharma, Inc. (CUE) - Canvas Business Model: Key Partnerships
The Key Partnerships block for Cue Biopharma, Inc. (CUE) in late 2025 centers on leveraging external expertise and capital to advance its Immuno-STAT platform, particularly in the autoimmune space while maintaining clinical oncology data maturation.
Boehringer Ingelheim for CUE-501 development and commercialization
The strategic research collaboration and license agreement with Boehringer Ingelheim (BI) for CUE-501, a differentiated B cell depletion therapy, is a cornerstone partnership. This deal, announced April 14, 2025, provides immediate, non-dilutive funding and validation for the Immuno-STAT platform in autoimmune diseases. The collaboration includes an exclusive license for BI to develop, manufacture, and commercialize the licensed products worldwide. The multi-year collaboration also allows for expanding research into various B cell-targeting bispecifics.
The financial structure of this partnership is concrete:
| Financial Component | Amount/Terms |
| Upfront Payment to Cue Biopharma, Inc. | $12 million |
| Potential Success-Based Milestones (Total) | Approximately $345 million |
| Royalty Eligibility | On future net sales |
| Research Term | Multi-year (Four-year research term specified) |
This deal was critical, especially as Cue Biopharma, Inc. reported a significant negative free cash flow yield of -77% prior to this influx, and the upfront fee was received shortly after the Q1 2025 period where cash and cash equivalents stood at $13.1 million as of March 31, 2025.
ImmunoScape for a novel Seed-and-Boost cell therapy approach
Cue Biopharma, Inc. entered a collaboration and license agreement with ImmunoScape, Pte. Ltd. to advance a novel in vivo approach to cell therapy for solid tumors, announced in November 2025. This involves developing a Seed-and-Boost immunotherapy combining Cue Biopharma, Inc.'s CUE-100 series Immuno-STAT engagers with ImmunoScape's proprietary T-cell receptors (TCRs). The goal is to overcome core limitations of existing cell therapies, aiming for superior antitumor activity and durable T-cell persistence.
The terms of this agreement include significant equity and near-term cash components:
- Upfront total payment: $15 million, structured as $10 million in Q4 2025 and $5 million in November of 2026.
- Equity Stake in ImmunoScape: 40%.
- Royalty Payments: High-single-digit on net sales.
The preclinical work supporting this approach targets antigens like WT1, expressed across multiple solid tumors. The parties have IND-enabling studies on track for a 2027 submission.
Clinical research organizations (CROs) for managing ongoing Phase 1 trials
While specific CRO contract values are not public, CROs are essential for managing the ongoing clinical evaluation of the CUE-100 series biologics. Cue Biopharma, Inc. retains the capability to mature clinical survival data from these ongoing trials, which supports future strategic partnerships for the oncology assets.
Key clinical data points generated from these Phase 1 evaluations include:
- CUE-101 and pembrolizumab combination trial in HPV+ recurrent/metastatic HNSCC showed a 50% overall response rate (ORR) as of Q3 2025.
- Observed survival metrics from this trial included a 12-month overall survival of 88% and a median overall survival (mOS) of 32.7 months in Q3 2025.
- An Investigator Sponsored Trial (IST) for CUE-102 in recurrent Glioblastoma Multiforme (rGBM) initiated in August 2025 at the DFCI.
- A prior Phase 1 trial for CUE-102 (NCT05360680) demonstrated a favorable tolerability profile with no dose limited toxicities observed.
Academic Key Opinion Leaders (KOLs) for scientific validation and events
Scientific validation is reinforced through engagement with leading academic experts. Cue Biopharma, Inc. hosted a virtual event on May 15, 2025, featuring prominent KOLs to discuss Immunology and updates on drug programs. This type of engagement helps frame the scientific narrative around the Immuno-STAT platform's potential to improve therapeutic indices.
KOLs featured in the May 2025 event included:
- Richard DiPaolo, PhD from Saint Louis University.
- Andrew Cope, MD, PhD from the Centre for Rheumatic Diseases, King's College.
The company also regained worldwide rights to CUE-401, its lead autoimmune asset, positioning it to advance this tolerogenic bifunctional molecule toward the clinic.
Cue Biopharma, Inc. (CUE) - Canvas Business Model: Key Activities
You're looking at the core engine room of Cue Biopharma, Inc. as of late 2025. These are the actions the company absolutely has to nail to move its pipeline forward, especially given the recent leadership transition and focus on optionality.
Research and development (R&D) of the Immuno-STAT™ platform.
The fundamental work centers on the proprietary Immuno-STAT™ platform. This R&D effort is a significant cash drain, but it's the source of all future value. For the three months ended September 30, 2025, Research and development expenses were reported at $4.8 million. That's a noticeable step down from the $9.4 million spent in the same three months of 2024. Honestly, this reduction was largely driven by lower clinical trial costs for the CUE-100 series and changes in employee compensation. The platform's application is being detailed scientifically; for instance, a poster presentation at the November 2025 Cytokines (ICIS) Annual Meeting covered CUE-401 as a novel TGF-beta/IL-2 fusion protein.
Advancing lead autoimmune asset CUE-401 toward clinical trials.
CUE-401 is the lead autoimmune candidate, and getting it into the clinic is a major near-term objective. The company received encouraging FDA feedback on its Pre-IND Briefing Document, which supports the plan to submit an Investigational New Drug (IND) application. This asset is engineered to use transforming growth factor beta (TGF-β) and interleukin 2 (IL-2) to re-establish immune tolerance. You need to watch the IND filing date closely; that's the gate to the next stage of value creation for this program.
Managing ongoing Phase 1 clinical trials for CUE-100 series oncology programs.
The CUE-100 series, particularly CUE-101, is generating the most tangible clinical data right now. In the ongoing Phase 1 trial combining CUE-101 with pembrolizumab (KEYTRUDA®) for recurrent/metastatic HPV+ head and neck cancer, the company confirmed a 50% overall response rate (ORR). Furthermore, the data showed a 12-month overall survival of 88% and a median overall survival (mOS) of 32.7 months. These are the hard numbers supporting the platform's clinical tolerability. The costs associated with these trials directly impacted the R&D spend reduction seen in Q3 2025.
Securing new strategic collaborations for pipeline assets.
Partnerships are critical for funding development and expanding platform reach. Cue Biopharma, Inc. secured a major deal with ImmunoScape to advance T cell therapy for solid tumors. This collaboration is structured to deliver an upfront payment totaling $15 million, with $10 million expected in Q4 2025 and the remaining $5 million in November of 2026. Plus, Cue Biopharma, Inc. took a 40% equity stake in ImmunoScape. This follows the earlier strategic collaboration with Boehringer Ingelheim (BI) for CUE-501, which brought an upfront fee of $12 million in April 2025 and carries potential milestone payments up to $345 million. Collaboration revenue for the three months ending September 30, 2025, was $2.1 million.
Here's a quick look at the recent partnership financial structure:
- Upfront payment from ImmunoScape: $15 million total
- ImmunoScape payment scheduled for Q4 2025: $10 million
- Equity stake in ImmunoScape: 40%
- Upfront payment from Boehringer Ingelheim (received April 2025): $12 million
- Potential milestones from Boehringer Ingelheim deal: Up to $345 million
The timing of revenue recognition matters, as Q3 2025 collaboration revenue of $2.1 million was down from $3.3 million in Q3 2024, reflecting the shift in milestone timing between the BI and the terminated Ono agreements.
You can see the financial impact of these deals in the quarterly revenue figures:
| Period Ended | Collaboration Revenue (Three Months) |
|---|---|
| September 30, 2025 | $2.1 million |
| September 30, 2024 | $3.3 million |
| March 31, 2025 | $0.4 million |
Cue Biopharma, Inc. (CUE) - Canvas Business Model: Key Resources
The Key Resources for Cue Biopharma, Inc. as of late 2025 center on its proprietary technology, its intellectual property estate, and its current financial position following recent capital events.
The core technological asset is the Proprietary Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform. This technology is designed to translate nature's signals into protein therapeutics by generating a new class of T cell engagers for selective modulation of disease-specific T cells, such as stimulation for cancer cell killing or specific down-regulation for autoimmune disease.
Protection for these novel injectable biologic candidates is secured through a growing intellectual property portfolio that the company actively seeks to maintain, expand, and protect.
Key clinical data supporting the platform's value proposition, particularly for the oncology program, includes specific metrics from the CUE-101 study:
- Objective Response Rate (ORR) for CUE-101 + pembrolizumab in the Phase 1 HNSCC study: 50%.
- Median Overall Survival (mOS) reported for the CUE-101 study: 32.7 months.
- Twelve-month Overall Survival (OS) reported: 88%.
The financial resources are a critical component, reflecting recent financing activities aimed at supporting the advancement of assets like CUE-401 toward the clinic.
| Financial Metric | Amount/Date | Context |
| Cash and Cash Equivalents (as of June 30, 2025) | \$27.5 million | Latest reported balance. |
| Net Proceeds from April 2025 Public Offering | Approximately \$18 million | Received subsequent to March 31, 2025 balance. |
| Cash and Cash Equivalents (as of March 31, 2025) | \$13.1 million | Balance before April 2025 capital raise. |
| Upfront Fee from Boehringer Ingelheim Agreement (April 2025) | \$12 million | Pursuant to the CUE-501 collaboration. |
| Upfront Payment from ImmunoScape Collaboration (Q3 2025) | Totaling \$15 million (with \$10 million expected in Q4 2025) | For solid tumor cell therapy approach. |
The company's ability to generate revenue from partnerships also contributes to the resource base. For example, Q3 2025 collaboration revenue was reported at \$2.149 million.
Cue Biopharma, Inc. (CUE) - Canvas Business Model: Value Propositions
The core value proposition of Cue Biopharma, Inc. centers on its proprietary Immuno-STAT® platform, which is designed to selectively engage and modulate disease-specific T cells directly in the body, aiming to avoid the adverse effects of broad systemic immune modulation.
Selective T cell modulation to reduce systemic toxicity in cancer and autoimmune disease.
The platform's design seeks to harness the body's intrinsic immune system with precision. This approach is engineered to provide a therapeutic index for cytokines like IL-2 by selectively targeting anti-tumor T cells, which presents a broad opportunity for addressing many cancers. The platform's strategy for creating this therapeutic index can be deployed for any other cytokine or immune activation signal.
CUE-401 designed to re-establish immune tolerance for autoimmune diseases.
CUE-401, the Company's lead autoimmune asset, is engineered as a tolerogenic bifunctional molecule. It harnesses the power of transforming growth factor beta (TGF-$\beta$) and interleukin 2 (IL-2) to re-establish immune tolerance and balance. Preclinical models suggest CUE-401 effectively converts inflammatory cells into regulatory ones, addressing the underlying dysfunction driving autoimmune diseases by creating a "tolerance positive feedback loop." The Company received positive Pre-Investigational New Drug (Pre-IND) feedback from the FDA regarding the planned first-in-human trial for CUE-401.
CUE-101 showing a confirmed 50% overall response rate in Phase 1b HPV+ cancer.
Clinical validation of the Immuno-STAT platform is demonstrated through CUE-101. In the expansion portion of the Phase 1 trial evaluating CUE-101 at the recommended Phase 2 dose of 4 mg/kg in combination with pembrolizumab in first-line patients (data cutoff of July 14, 2025), the results were compelling compared to historical data. You can see the key metrics here:
| Metric | CUE-101 Combination (Data Cutoff July 14, 2025) | Historical KEYNOTE-048 (Pembrolizumab Alone) |
| Confirmed Overall Response Rate (ORR) for CPS $\ge 1$ | 50% (2 Complete Responses, 10 Partial Responses) | 19% |
| 12-Month Overall Survival (OS) Rate | 88% | 57% |
| Median Overall Survival (mOS) | 32 months | 12.3 months |
The ORR of 50% was also confirmed in patients with low PD-L1 expression CPS (1-19). This favorable survival data represents a reduction in the risk of death (HR 0.23) compared to historical data.
Modular platform design enabling rapid pipeline expansion.
The platform's modularity allows for the development of additional pipeline assets, de-risking the overall program. This is evidenced by recent strategic business development activities and the existing pipeline:
- Announced a strategic collaboration and license agreement with ImmunoScape, for which Cue Biopharma is entitled to receive upfront payments totaling $15M, with $10M expected in Q4 2025 and $5M in November 2026.
- Cue Biopharma also secured a 40% equity stake in ImmunoScape as part of this deal.
- The CUE-100 series supports platform expansion into broad indications, with CUE-102 currently in trials for WT-1+ recurrent cancers (ovarian, CRC, gastric, pancreatic).
- Additional pipeline assets are planned to target mutated KRAS, MAGE-A4, PRAME, and others.
Financially, the collaboration revenue for the three months ended September 30, 2025, was $2.1 million, reflecting the ongoing value derived from these partnerships, even as the nine-month net loss narrowed to $28.19 million compared to $31.18 million a year ago.
Cue Biopharma, Inc. (CUE) - Canvas Business Model: Customer Relationships
You're looking at how Cue Biopharma, Inc. manages its critical relationships, which are almost entirely centered on strategic alliances and the scientific community, given its clinical-stage status. It's about validation and shared risk.
Strategic, long-term collaboration management with large pharmaceutical partners
The core of Cue Biopharma, Inc.'s external relationship strategy is securing and managing high-value, non-dilutive funding through partnerships. These deals validate the Immuno-STAT® platform and provide the necessary capital to advance the pipeline, especially the autoimmune assets.
The relationship with Boehringer Ingelheim (BI) for CUE-501, announced in Q1 2025, is a prime example. This strategic collaboration and license agreement brought in an upfront payment of $12 million, with potential milestone payments reaching ~$345 million. This deal is crucial for developing the B cell depletion therapy for autoimmune and inflammatory diseases.
More recently, in Q4 2025, a new strategic collaboration and license agreement was struck with ImmunoScape to develop a cell therapy approach for solid tumors. This deal is structured to provide upfront payments totaling $15 million, with $10 million expected in Q4 2025 and an additional $5 million scheduled for November 2026. This partnership also included Cue Biopharma, Inc. receiving a 40% equity stake in ImmunoScape.
Relationship management also involves strategic divestiture and regaining control. For instance, the agreement with Ono Pharmaceutical Co., Ltd. for CUE-401 was terminated in March 2025, allowing Cue Biopharma, Inc. to retain all rights to its lead autoimmune asset. Similarly, the Ninth Amendment to the LG Chem Collaboration Agreement in March 2025 saw Cue Biopharma, Inc. regain its rights to the CUE-101 program in the LG Chem Territory.
Here's a look at the recent partnership activity:
| Partner | Asset/Focus | Upfront Payment (USD) | Potential Milestones (USD) | Key Date/Status |
|---|---|---|---|---|
| Boehringer Ingelheim | CUE-501 (B cell depletion) | $12,000,000 | ~$345,000,000 | Announced Q1 2025 |
| ImmunoScape | Cell Therapy ('Seed-and-Boost') | $15,000,000 (Total) | Not specified | Announced Q3/Q4 2025 |
| Ono Pharmaceutical | CUE-401 (Autoimmune) | Undisclosed (Upfront received) | N/A | Terminated March 2025 |
High-touch engagement with the scientific and medical community (KOLs)
Engagement with Key Opinion Leaders (KOLs) is used to build credibility and communicate the potential of the Immuno-STAT® platform, especially as CUE-401 moves toward the clinic. This is a direct, focused relationship style, not broad marketing.
Cue Biopharma, Inc. hosted a Novel Biologics Portfolio Virtual Event on May 15, 2025, which featured two prominent KOLs to highlight preclinical data for CUE-401 and updates on CUE-100 series oncology programs.
- Richard DiPaolo, PhD (Saint Louis University) participated in the May 2025 event.
- Andrew Cope, MD, PhD (Centre for Rheumatic Diseases, King's College London) participated in the May 2025 event.
The clinical data shared with this community is a key relationship driver. For example, the CUE-101 + pembrolizumab Phase 1 HNSCC study reported a 50% ORR in patients with low CPS scores and a 12-month OS of 88%.
Investor relations focused on clinical milestones and cash runway extension
Investor relations communication is tightly linked to achieving financing milestones and demonstrating operational discipline to extend the cash runway. The focus is on non-dilutive capital events and expense management.
The company actively manages investor perception around its financial stability. Following a 25% workforce reduction and strategic realignment announced in 2024, the projected annualized cash burn was reduced to approximately $30 million for fiscal year 2025. This discipline, combined with partnership proceeds, extended the cash runway to an estimated 3-4 quarters as of June 30, 2025.
Financially, Cue Biopharma, Inc. bolstered its position by raising gross proceeds of approximately $20 million in a follow-on public offering in April 2025. As of March 31, 2025, cash and cash equivalents stood at $13.1 million, growing to $27.49 million by June 30, 2025.
The narrative for investors in late 2025 centers on the ImmunoScape deal providing non-dilutive capital and the expected $10 million cash inflow in Q4 2025 from that upfront payment. Despite Q3 2025 collaboration revenue slipping to $2.149 million, the net loss narrowed to $7.45 million, beating consensus EPS estimates. Analyst sentiment remains positive, with each of the three firms covering the stock issuing a 'buy' or 'strong buy' rating, and their average target price sitting nearly 83% above the recent close.
Key financial and investor metrics as of late 2025:
- Cash and Cash Equivalents (March 31, 2025): $13.1 million.
- Cash Reserves (June 30, 2025): $27.49 million.
- Projected Annualized Cash Burn (FY 2025): $30 million.
- Expected Cash Inflow (Q4 2025 from ImmunoScape): $10,000,000.
- Q3 2025 Collaboration Revenue: $2.149 million.
- Analyst Coverage: 3 firms with 'buy' or 'strong buy' ratings.
Finance: draft 13-week cash view by Friday.
Cue Biopharma, Inc. (CUE) - Canvas Business Model: Channels
You're looking at how Cue Biopharma, Inc. gets its value propositions-novel biologics that selectively engage T cells-out to the world, which for a clinical-stage biotech means partners, clinical sites, and the financial markets. It's all about external validation and funding to keep the pipeline moving.
Direct licensing and collaboration agreements with global pharma companies
Cue Biopharma, Inc. uses strategic partnerships as a primary channel to advance and fund its drug candidates. These deals provide non-dilutive capital and external expertise for development and commercialization. The company announced a significant strategic collaboration and license agreement with Boehringer Ingelheim International GmbH (BI) for CUE-501 in April 2025. This channel also includes a new agreement with ImmunoScape announced in late 2025.
Here's a look at the financial impact and structure of these key external channels as of late 2025:
| Partner/Agreement | Asset/Focus | Upfront Payment (USD) | Potential Milestones (USD) | Key Timing/Equity |
| Boehringer Ingelheim | CUE-501 | $12 million | ~$345 million | Announced April 2025 |
| ImmunoScape | Cell Therapy (Seed-and-Boost) | $15 million total | Not specified | $10 million expected in Q4 2025; 40% equity stake in ImmunoScape |
| Ono Pharmaceutical | Autoimmune Program (CUE-401) | N/A | N/A | Agreement terminated in March 2025 |
The flow of cash from these channels directly impacts operations; for instance, Cue Biopharma, Inc. received the $12 million upfront fee from BI in April 2025, supplementing capital raised from the public markets. Collaboration revenue for the three months ended September 30, 2025, was $2.1 million, a decrease from $3.3 million in the same period in 2024, reflecting the timing of revenue recognition from past deals like the Ono agreement.
Clinical trial sites for drug candidate testing and data generation
Clinical trial sites are the essential physical channel for generating the data needed to prove the value proposition of the Immuno-STAT® platform. The company's most advanced asset, CUE-101 (from the CUE-100 series), is being tested in Phase 1 trials for HPV+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The FDA feedback received on the Pre-IND Briefing Document for the lead autoimmune asset, CUE-401, signals the next major step for that program through clinical sites.
Data generated from these sites is crucial for attracting future partners and investors. Highlights from the CUE-101 trial as of the July 14, 2025, data cutoff include:
- Objective Response Rate (ORR) of 50% in patients with Combined Positive Score (CPS) $\ge$1.
- 12-month overall survival (OS) of 88%, compared to 57% in historical data.
- Median overall survival (mOS) of 32 months, compared to 12.3 months historically.
These clinical activities are a major component of spending. Research and development expenses for Q3 2025 were $4.8 million, which was primarily due to decreases in clinical trial costs for the CUE-100 series compared to Q3 2024's $9.4 million. You see the cost of this channel reflected in the R&D line item.
Scientific publications and conferences to disseminate clinical data
Dissemination through peer-reviewed channels and scientific forums validates the science and informs the medical community, which is a necessary precursor to broad adoption or licensing. Cue Biopharma, Inc. actively uses these channels to communicate its platform's potential.
Recent and upcoming dissemination activities in 2025 include:
- Poster Presentation at the ASGCT Annual Meeting in May, 2025.
- Publication in the Journal of Virology in August, 2025.
- Poster Presentation at the Cytokines (ICIS) Annual Meeting in November, 2025, focusing on CUE-401.
This communication channel supports the narrative for the autoimmune asset, CUE-401, which is uniquely engineered to harness TGF-$\beta$ and IL-2 signals to re-establish immune tolerance.
Investor presentations and financial reporting (Nasdaq: CUE)
The public market channel is vital for securing the necessary capital to fund the R&D and clinical trial channels. Cue Biopharma, Inc. reports its financial status regularly on the Nasdaq exchange under the ticker CUE. The company executed a capital raise to bolster its position.
Key financial metrics reported through this channel as of late 2025:
- Cash and cash equivalents as of March 31, 2025: $13.1 million.
- Net proceeds raised from an underwritten public offering in April 2025: approximately $18 million.
- Q3 2025 net loss: $7.4 million on operating expenses of $9.7 million.
- Market Capitalization as of December 5, 2025: $43,211,270.
- Stock price on December 1, 2025: $0.595.
The short sale ratio as of November 28, 2025, stood at 29.82%, indicating a level of bearish sentiment in the market. Finance: draft 13-week cash view by Friday.
Cue Biopharma, Inc. (CUE) - Canvas Business Model: Customer Segments
You're looking at the specific groups Cue Biopharma, Inc. (CUE) targets with its novel T-cell engaging biologics, which is crucial for understanding their path to revenue.
Global pharmaceutical and biotechnology companies seeking novel immunotherapies represent a primary segment, particularly those looking to bolster pipelines against the backdrop of a looming patent cliff, which put an estimated US$300 billion in revenue at risk for major players between 2023 through 2028. These potential partners are active, with venture financing deal value in the biotech industry reaching $3.1bn in Q3 2025. Cue Biopharma, Inc. (CUE) has already executed deals, securing an upfront payment of $12 million from Boehringer Ingelheim for CUE-501 and an agreement with ImmunoScape for upfront payments totaling $15M. The broader cancer immunotherapy market is valued at an estimated $136.39 billion in 2025, expected to reach $338.40 billion by 2034. Another estimate places the global market size at $253.48 billion in 2025.
Oncologists and specialists treating recurrent/metastatic HPV+ cancers are the immediate clinical focus, driven by the data from CUE-101. The target patient population is significant; across 7MM markets, there were an estimated 170K incident cases of head and neck cancer in 2024, with nearly 150K being HNSCC. Specifically, in the US in 2024, approximately 20K cases of HPV+ Oropharyngeal Squamous Cell Carcinoma (OPSCC) were reported, over 70% of which were regional stages (III-IVB). Clinical results for CUE-101 in combination with pembrolizumab showed a 50% overall response rate (ORR) in treatment-naïve patients with HPV-positive recurrent/metastatic HNSCC. This efficacy is highlighted by a 12-month overall survival rate of 88% and an estimated median overall survival (mOS) of 32 months, which represents a significant reduction in the risk of death (HR 0.23) compared to historical data of 19% ORR with pembrolizumab alone.
Autoimmune disease specialists for future CUE-401 and CUE-501 therapies represent a future, high-potential segment. Cue Biopharma, Inc. (CUE) is advancing CUE-401, its lead autoimmune asset, toward the clinic. The company received FDA feedback reinforcing its intention to advance the Investigational New Drug (IND) submission for CUE-401. CUE-501, for autoimmune and inflammatory diseases, is being developed in collaboration with Boehringer Ingelheim.
Equity investors in the high-risk, high-reward clinical-stage biotech sector monitor the company's financial health and clinical milestones closely. As of the third quarter ended September 30, 2025, Cue Biopharma, Inc. (CUE) reported collaboration revenue of $2.1 million and a net loss of $7.4 million for the quarter. The company bolstered its position by raising approximately $18.0 million in net proceeds through a public offering in April 2025. Cash and cash equivalents stood at $13.1 million as of March 31, 2025. The Zacks Industry Rank for Medical - Biomedical and Genetics is currently in the top 34% of over 250 Zacks industries.
Here's a quick view of the customer segments and relevant metrics:
| Customer Segment | Key Metric/Data Point | Associated Cue Biopharma, Inc. (CUE) Asset/Event |
| Global Pharma/Biotech | Global Cancer Immunotherapy Market Size: $136.39 billion (2025 Est.) | CUE-501/CUE-401 Partnering Potential |
| Oncologists/Specialists (HPV+ HNSCC) | CUE-101 ORR: 50% in treatment-naïve patients | CUE-101 (CUE-100 Series) |
| Oncologists/Specialists (HPV+ HNSCC) | Historical ORR for pembrolizumab alone: 19% | CUE-101 Clinical Data Comparison |
| Autoimmune Specialists | Upfront Payment from BI Collaboration: $12 million | CUE-501 (with Boehringer Ingelheim) |
| Equity Investors | Q3 2025 Net Loss: $7.4 million | Recent Financial Performance |
| Equity Investors | Capital Raised (April 2025): $18.0 million | Balance Sheet Strength |
The immediate clinical target group for CUE-101 is defined by the need for better outcomes in recurrent/metastatic HPV+ HNSCC, where the 32 months estimated median overall survival is a key differentiator. For the broader autoimmune segment, the company is advancing CUE-401, which is designed as a tolerogenic bifunctional molecule harnessing TGF-β and IL-2.
You'll want to track the cash burn rate, as R&D expenses were $4.8 million for the three months ended September 30, 2025. Finance: draft 13-week cash view by Friday.
Cue Biopharma, Inc. (CUE) - Canvas Business Model: Cost Structure
You're looking at the cost side of the business as of late 2025, which is heavily weighted toward research and development, as is typical for a clinical-stage biopharma. The company has been actively managing these costs following a major restructuring in 2024.
The most immediate figures come from the third quarter of 2025, showing where the operating cash was being spent:
| Expense Category | Q3 2025 Amount (USD) | Q3 2024 Amount (USD) |
| Research and Development (R&D) Expenses | \$4.8 million | \$9.4 million |
| General and Administrative (G&A) Expenses | \$4.9 million | \$2.9 million |
| Total Operating Expenses (Q3 2025) | \$9.60 million | N/A |
| Net Loss (Q3 2025) | \$7.45 million | N/A |
The R&D spend reduction from the prior year's quarter is notable, but the G&A increase in Q3 2025 needs a closer look. Honestly, that jump suggests one-time costs hit that quarter.
Here's a breakdown of the key cost drivers and related financial context:
- High Research and Development expenses, totaling \$4.8 million in Q3 2025.
- General and Administrative expenses, totaling \$4.9 million in Q3 2025, an increase driven primarily by a one-time employee severance accrual in September 2025, plus higher professional fees.
- Clinical trial costs for the CUE-100 series decreased in Q3 2025 compared to Q3 2024.
- IND-enabling studies for CUE-401 were anticipated to initiate in the first half of 2025.
Personnel costs are a central element of the cost structure, especially given the recent restructuring efforts. The company made a significant move to control this burn rate.
Here's the quick math on the workforce impact:
- A workforce realignment in July 2024 involved an approximately 25% reduction of staff across research, development, and G&A.
- This reduction, combined with other operational efficiencies, was projected to reduce fiscal year 2025 operating expenses by approximately 25%.
- The goal of this cost control was to achieve a projected annual cash burn of approximately \$30 million for 2025.
- Decreases in employee compensation, including stock-based compensation, were cited as a reason for lower R&D expenses in Q3 2025 compared to Q3 2024.
What this estimate hides is the impact of the one-time severance accrual in Q3 2025, which temporarily inflated G&A despite the underlying personnel cost savings from the 2024 reduction. Finance: draft 13-week cash view by Friday.
Cue Biopharma, Inc. (CUE) - Canvas Business Model: Revenue Streams
You're looking at the core ways Cue Biopharma, Inc. brings in cash right now, late in 2025. It's heavily weighted on these strategic deals, which is typical for a clinical-stage biotech. Honestly, the numbers show a clear shift in focus and revenue recognition based on recent agreements.
The collaboration revenue is the most immediate, recurring piece of the puzzle, though it can fluctuate based on when milestones are hit or when specific development activities are billed under the agreements. For the third quarter ended September 30, 2025, Cue Biopharma reported collaboration revenue of \$2.1 million. That was down from \$3.3 million in the third quarter of 2024. This dip was directly tied to the timing of revenue recognition from the Boehringer Ingelheim International GmbH (BI) agreement in 2025 versus the Ono Collaboration revenue recognized in 2024.
The big news driving near-term cash flow is the new license agreement with ImmunoScape, announced in November 2025. This deal is structured to provide immediate capital infusion.
Here's the quick math on the upfront payments secured from these key partnerships:
| Revenue Source | Type of Payment | Amount (USD) | Timing/Notes |
| ImmunoScape Collaboration | Upfront Payment (Total) | \$15 million | \$10 million expected in Q4 2025 |
| ImmunoScape Collaboration | Upfront Payment (Future) | \$5 million | Due in November 2026 |
| Boehringer Ingelheim (BI) Collaboration | Upfront Payment | \$12 million | Received following the April 14, 2025 announcement |
Beyond the upfront cash, the long-term value is baked into the potential for future payments. This is where the real upside lives, contingent on clinical and commercial success. You need to track these potential streams closely.
The structure of potential future revenue streams includes:
- Potential milestone payments from the Boehringer Ingelheim agreement totaling approximately \$345 million.
- Eligibility for high-single-digit royalty payments on net sales from the ImmunoScape collaboration.
- Additional milestone payments tied to the ImmunoScape deal, though the exact structure beyond the upfront is not detailed as clearly as the BI milestones.
The ImmunoScape deal also nets Cue Biopharma a 40% equity stake in ImmunoScape, which isn't a direct revenue stream but represents a significant asset value tied to that partnership's success. What this estimate hides is that milestone achievement is never guaranteed; it's a probability-weighted asset, not cash in the bank.
Finance: draft 13-week cash view by Friday.
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