Cue Biopharma Inc.
11/12/2025 | Press release | Distributed by Public on 11/12/2025 15:01
Cue Biopharma Reports Third Quarter 2025 Financial Results and Recent Business Highlights (Form 8-K)
Cue Biopharma Reports Third Quarter 2025 Financial Results and Recent Business Highlights
•
Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors - Company is entitled to receive upfront payments totaling $15M
•
Announced strategic transition in leadership to further enable next stage of growth with disruptive autoimmune therapeutic candidates most notably, CUE-401, the Company's lead autoimmune asset
BOSTON, Mass., November 12, 2025-- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, today provided a business and financial update for the third quarter 2025.
"During the third quarter of 2025 and early in the fourth quarter, the Company made tremendous progress from having successfully implemented a plan of optionality and laying the necessary groundwork for future growth," said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. "I am deeply proud of the Cue team and believe we are strategically positioned to further advance our differentiating Immuno-STAT® platform and lead autoimmune asset, CUE-401, toward the clinic to address a major unmet need in autoimmune disease treatment."
Business Highlights
•
Announced strategic transition in leadership to further enable next stage of growth with disruptive autoimmune therapeutic candidates most notably, CUE-401, the Company's lead autoimmune asset
-
Usman Azam, M.D., appointed President and Chief Executive Officer, effective as of September 29
-
CUE-401 is uniquely engineered and designed as a tolerogenic bifunctional molecule harnessing the power of TGF-beta and IL-2 to re-establish immune tolerance and balance
•
Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors
-
Upfront total payment of $15 million, $10 million in Q4 2025 and $5 million in November of 2026, as well as a 40% equity stake in ImmunoScape
-
Exclusive collaboration and license agreement focuses on advancing novel, T cell therapy "Seed-and-Boost" approach exploiting the mechanism of the CUE-100 series of Immuno-STATs®
•
Reported new complete response and confirmed 50% overall response rate (ORR) in ongoing Phase 1 trial of CUE-101 and pembrolizumab (KEYTRUDA®) in recurrent/metastatic HPV+ head and neck cancer. New data observed included 12-month overall survival of 88% and median overall survival (mOS) of 32.7 months
Third Quarter 2025 Financial Results
The Company reported collaboration revenue of $2.1 million and $3.3 million for the three months ended September 30, 2025 and 2024, respectively. The decrease was due to the timing of revenue earned from the Company's collaboration and license agreement with Boehringer Ingelheim International GmbH (BI) in 2025 compared to the timing of revenue earned from the Company's Ono Collaboration and Option Agreement in 2024.
Research and development expenses were $4.8 million and $9.4 million for the three months ended September 30, 2025 and 2024, respectively. The decrease was primarily due to decreases in clinical trial costs for the Company's CUE-100 series, as well as decreases in employee compensation.
General and administrative expenses were $4.9 million and $2.9 million for the three months ended September 30, 2025 and 2024, respectively. The increase was primarily due to a one-time employee severance accrual in September of 2025, as well as an increase in professional fees.
|
Cue Biopharma, Inc. |
|
Condensed Consolidated Statement of Operations and Comprehensive Loss (Unaudited) |
|
(In thousands, except share and per share amounts) |
|
Three Months Ended |
Nine Months Ended |
|||||||||||||||
|
2025 |
2024 |
2025 |
2024 |
|||||||||||||
|
Collaboration revenue |
$ |
2,149 |
$ |
3,336 |
$ |
5,524 |
$ |
7,711 |
||||||||
|
Operating expenses: |
||||||||||||||||
|
General and administrative |
4,939 |
2,867 |
12,792 |
10,564 |
||||||||||||
|
Research and development |
4,754 |
9,381 |
21,211 |
29,111 |
||||||||||||
|
Loss (gain) on fixed asset disposal |
51 |
(97 |
) |
51 |
(97 |
) |
||||||||||
|
Total operating expenses |
9,744 |
12,151 |
34,054 |
39,578 |
||||||||||||
|
Loss from operations |
(7,595 |
) |
(8,815 |
) |
(28,530 |
) |
(31,867 |
) |
||||||||
|
Other income (expense): |
||||||||||||||||
|
Interest income |
222 |
343 |
649 |
1,332 |
||||||||||||
|
Interest expense |
(75 |
) |
(188 |
) |
(306 |
) |
(643 |
) |
||||||||
|
Total other income, net |
147 |
155 |
343 |
689 |
||||||||||||
|
Net loss |
$ |
(7,448 |
) |
$ |
(8,660 |
) |
$ |
(28,187 |
) |
$ |
(31,178 |
) |
||||
|
Unrealized gain from available-for-sale securities |
1 |
- |
1 |
- |
||||||||||||
|
Comprehensive loss |
$ |
(7,447 |
) |
$ |
(8,660 |
) |
$ |
(28,186 |
) |
$ |
(31,178 |
) |
||||
|
Net loss per common share - basic and diluted |
$ |
(0.07 |
) |
$ |
(0.17 |
) |
$ |
(0.31 |
) |
$ |
(0.62 |
) |
||||
|
Weighted average common shares outstanding - basic and diluted |
100,869,349 |
51,229,701 |
90,271,072 |
50,292,983 |
||||||||||||
Cue Biopharma, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, In thousands)
|
September 30, |
December 31, |
|||||||
|
Assets |
||||||||
|
Cash and cash equivalents |
$ |
11,701 |
$ |
22,459 |
||||
|
Other assets |
19,943 |
9,732 |
||||||
|
Total assets |
$ |
31,644 |
$ |
32,191 |
||||
|
Liabilities and stockholders' equity |
||||||||
|
Liabilities |
$ |
18,398 |
$ |
14,692 |
||||
|
Stockholders' equity |
13,246 |
17,499 |
||||||
|
Total liabilities and stockholders' equity |
$ |
31,644 |
$ |
32,191 |
||||
About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient's body. The company's proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body's intrinsic immune system without the adverse effects of broad systemic immune modulation. CUE-401, the company's lead autoimmune asset, is designed to act mechanistically as a master switch for regulatory T cell (Treg) differentiation and tolerance induction. It is a highly innovative bifunctional molecule combining a TGF-beta breathing-mask moiety with Cue Biopharma's clinically validated interleukin (IL-2) mutein in a single injectable biologic.
Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.
For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn.
Cue Biopharma Inc. published this content on November 12, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 12, 2025 at 21:01 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]