Cue Biopharma, Inc.
CUE evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for CUE—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · CUE
Cue Biopharma, Inc. is a clinical-stage biotechnology company focused on developing its Immuno-STAT platform to design biologic drug candidates for oncology and autoimmune diseases, with lead assets CUE-221 and CUE-401.
Key risk: Going concern uncertainty
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 4 pipeline candidates · 4 clinical trials for Cue Biopharma, Inc..
Cue Biopharma, Inc. is a clinical-stage biotechnology company focused on developing its Immuno-STAT platform to design biologic drug candidates for oncology and autoimmune diseases, with lead assets CUE-221 and CUE-401.
- Cue Biopharma is a clinical-stage company focused on its Immuno-STAT platform for developing drug candidates in oncology and autoimmune diseases [sec_mda · as of 2026-08-14].
- Lead assets are CUE-221 and CUE-401, with CUE-501 licensed to Boehringer Ingelheim (BI) under a strategic collaboration [sec_mda · as of 2026-08-14].
- Cash and equivalents were $17.4M as of 2026-06-30, with total revenue of $7.9M and a net loss of -$153.1M for the latest reported period [sec].
- The company has incurred significant losses since inception and has never generated revenue or profit from product sales [sec_mda · as of 2026-08-14].
- Cue Biopharma plans to file an IND for CUE-401 in the third quarter of 2026 [sec_mda · as of 2025-05-12].
What works
- The Immuno-STAT platform has shown clinical tolerability across a wide range of cancers in Phase 1 trials of CUE-101 and CUE-102, de-risking the science for potential autoimmune applications [sec_mda · as of 2025-05-12].
- A strategic collaboration and license agreement with Boehringer Ingelheim for CUE-501 provides external validation and potential funding support [sec_mda · as of 2026-08-14].
- The company is focusing resources on two lead assets (CUE-221 and CUE-401) and leveraging collaborations to advance the pipeline, which may improve capital efficiency [sec_mda · as of 2026-08-14].
What to weigh
- Cue Biopharma has incurred significant losses since inception and has never generated revenue or profit from product sales, raising substantial doubt about its ability to continue as a going concern [sec_mda · as of 2026-08-14].
- The company faces uncertainty in estimating working capital requirements due to risks in clinical trial progress, regulatory approvals, and the need for additional financing [sec_mda · as of 2026-08-14].
- CUE-101 and CUE-102 have been deprioritized and licensed to IMSCP, indicating a shift in pipeline focus that may limit near-term value from those assets [sec_mda · as of 2026-08-14].
- The company's cash position of $17.4M as of 2026-06-30 may be insufficient to fund all planned development activities without additional capital raises [sec].
From the filings
Quoted directly from source documents.
The company has incurred significant losses and never generated product revenue.
“We have incurred significant losses since our inception and have never generated revenue or profit from product sales”
SEC MD&A · August 14, 2026
Lead assets are CUE-221 and CUE-401.
“We intend that the majority of our business activities will be devoted to furthering the development of our two lead assets: CUE-221 and CUE-401.”
SEC MD&A · August 14, 2026
The company plans to file an IND for CUE-401 in Q3 2026.
“focusing on the development of CUE-401, for which we are preparing to file an IND application in the third quarter of 2026”
SEC MD&A · May 12, 2025
Clinical tolerability of the platform has been shown in Phase 1 trials.
“We also believe that our science is de-risked with clinical tolerability across a wide range of cancers from our Phase 1 trials of CUE-101 and CUE-102”
SEC MD&A · May 12, 2025
Risks & what to watch (4)›
Key risks
- Going concern uncertainty — Substantial doubt about ability to continue as a going concern due to cumulative losses and no product revenue [sec_mda · as of 2026-08-14].
- Need for additional financing — Unable to estimate exact working capital needs; future capital requirements may accelerate due to clinical trial costs and regulatory timelines [sec_mda · as of 2026-08-14].
- Clinical and regulatory risks — Progress, timing, and costs of clinical trials and regulatory approvals are uncertain and could impact operations [sec_mda · as of 2026-08-14].
- Dependence on collaborations — Reliance on third-party partnerships (e.g., BI, IMSCP) for pipeline development introduces execution risk [sec_mda · as of 2026-08-14].
What to watch
- IND filing for CUE-401, expected in Q3 2026 [sec_mda · as of 2025-05-12].
- Progress of clinical trials for CUE-221 and any updates on CUE-401 development [sec_mda · as of 2026-08-14].
- Updates on the strategic collaboration with Boehringer Ingelheim for CUE-501 [sec_mda · as of 2026-08-14].
- Cash runway and any additional financing activities, given the $17.4M cash position as of 2026-06-30 [sec].
Sources: SEC filings · SEC MD&A · Generated August 28, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
2.1 months
D/E 12.29 · 0% dilution
Lead: Phase 1
4 candidates
No upcoming catalysts tracked
2 buys · 11 sells (180d)
Runway
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
2
Total value held
$391
| Holder | Shares | Value |
|---|---|---|
| tidemark, llc | 1,500 | $345 |
| advisory services network, llc | 200 | $46 |
Short Interest
as of May 20, 2026- % of float
- 8.9%
- Days to cover
- 0.3
- Shares short
- 288,887
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
CUE short interestGovernance
Frequently asked questions
What is the AI investment thesis for Cue Biopharma, Inc.?
Cue Biopharma, Inc. is a clinical-stage biotechnology company focused on developing its Immuno-STAT platform to design biologic drug candidates for oncology and autoimmune diseases, with lead assets CUE-221 and CUE-401.
What is Cue Biopharma, Inc.'s lead drug candidate?
Cue Biopharma, Inc.'s most advanced tracked candidate is CUE-101 (Phase 1) for Head and Neck Cancer.
Who is the CEO of Cue Biopharma, Inc.?
Dr. Shao-Lee Lin M.D., Ph.D. is the chief executive officer of Cue Biopharma, Inc. (CUE).
Where is Cue Biopharma, Inc. headquartered?
Cue Biopharma, Inc. (CUE) is headquartered in Boston, MA, United States.
What therapeutic areas does Cue Biopharma, Inc. focus on?
Cue Biopharma, Inc. develops therapies across Oncology, Immunology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.