Cue Biopharma听Reports Second Quarter 2025 Financial Results and Recent Business Highlights
Cue Biopharma (NASDAQ: CUE) reported Q2 2025 financial results and significant business developments. The company secured a strategic collaboration with Boehringer Ingelheim for CUE-501 development, receiving a $12 million upfront payment with potential milestone payments of ~$345 million.
Key highlights include positive FDA feedback on CUE-401's Pre-IND submission for autoimmune disease treatment, and impressive clinical results from the Phase 1 trial of CUE-101 in HPV+ head and neck cancer, showing a 50% overall response rate and 32-month median overall survival. The company strengthened its financial position by raising $20 million through a public offering.
Q2 2025 financial results showed collaboration revenue of $3.0 million, with reduced R&D expenses of $7.9 million compared to $9.5 million in Q2 2024. The company reported a net loss of $8.5 million, an improvement from the $10.2 million loss in Q2 2024.
Cue Biopharma (NASDAQ: CUE) ha pubblicato i risultati finanziari del Q2 2025 e importanti sviluppi aziendali. L'azienda ha stretto una collaborazione strategica con Boehringer Ingelheim per lo sviluppo di CUE-501, ricevendo un pagamento iniziale di $12 million e con potenziali pagamenti legati a milestone per circa $345 million.
Tra i punti salienti c'猫 il riscontro positivo della FDA sulla submission Pre-IND di CUE-401 per il trattamento delle malattie autoimmuni e i risultati clinici incoraggianti della fase 1 di CUE-101 nel cancro testa-collo HPV+, con un tasso di risposta globale del 50% e una mediana di sopravvivenza globale di 32 mesi. L'azienda ha inoltre rafforzato la propria posizione finanziaria raccogliendo $20 million tramite un'offerta pubblica.
I risultati finanziari del Q2 2025 mostrano ricavi da collaborazione di $3.0 million, spese di R&S ridotte a $7.9 million rispetto a $9.5 million nel Q2 2024, e una perdita netta di $8.5 million, migliorata rispetto alla perdita di $10.2 million del Q2 2024.
Cue Biopharma (NASDAQ: CUE) inform贸 resultados financieros del 2T 2025 y avances comerciales significativos. La compa帽铆a asegur贸 una colaboraci贸n estrat茅gica con Boehringer Ingelheim para el desarrollo de CUE-501, recibiendo un pago inicial de $12 million y potenciales pagos por hitos por aproximadamente $345 million.
Entre los puntos destacados figura la retroalimentaci贸n positiva de la FDA sobre la presentaci贸n Pre-IND de CUE-401 para el tratamiento de enfermedades autoinmunes, y resultados cl铆nicos notables del ensayo de fase 1 de CUE-101 en c谩ncer de cabeza y cuello HPV+, con una tasa de respuesta global del 50% y una supervivencia global mediana de 32 meses. Adem谩s, la compa帽铆a fortaleci贸 su posici贸n financiera al recaudar $20 million mediante una oferta p煤blica.
Los resultados del 2T 2025 mostraron ingresos por colaboraci贸n de $3.0 million, gastos de I+D reducidos a $7.9 million frente a $9.5 million en el 2T 2024, y una p茅rdida neta de $8.5 million, mejorando respecto a la p茅rdida de $10.2 million en el 2T 2024.
Cue Biopharma (NASDAQ: CUE)電� 2025 須岅硠鞐半弰 2攵勱赴 鞁れ爜瓿� 欤检殧 靷梾 霃欗枼鞚� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� Boehringer Ingelheim瓿� CUE-501 臧滊皽鞚� 鞙勴暅 鞝勲灥鞝� 鞝滍湸毳� 觳搓舶頃橁碃 $12 million鞚� 靹犼笁旮�鞚� 靾橂牴頄堨溂氅�, 鞎� $345 million 攴滊鞚� 毵堨澕鞀ろ啢 歆�旮� 臧�電レ劚鞚� 鞛堨姷雼堧嫟.
欤检殧 雮挫毄鞙茧電� 鞛愱皜氅挫棴 歆堩櫂 旃橂毳� 鞙勴暅 CUE-401鞚� Pre-IND 鞝滌稖鞐� 雽�頃� FDA鞚� 旮嶌爼鞝� 頂茧摐氚�鞚� 氚涭潃 鞝愱臣, HPV 鞏戩劚 霊愱步攵�鞎� 頇橃瀽毳� 雽�靸侅溂搿� 頃� CUE-101 1靸� 鞛勳儊鞐愳劀 鞝勲皹鞝� 氚橃潙毳� 50% 氚� 欷戩暀 鞝勳泊 靸濎〈旮瓣皠 32臧滌洈鞚措澕電� 鞚胳儊鞝侅澑 瓴瓣臣臧� 韽暔霅╇媹雼�. 霕愴暅 須岇偓電� 瓿惦毳� 韱淀暣 $20 million鞚� 臁半嫭頃� 鞛 旮半皹鞚� 臧曧檾頄堨姷雼堧嫟.
2025雲� 2攵勱赴 鞛 瓴瓣臣電� 順戨牓 靾橃澋 $3.0 million, 鞐瓣惮臧滊皽牍勲姅 $7.9 million鞙茧 2024雲� 2攵勱赴鞚� $9.5 million鞐愳劀 臧愳唽頄堨溂氅�, 靾滌啇鞁れ潃 $8.5 million鞙茧 2024雲� 2攵勱赴鞚� $10.2 million 靻愳嫟鞐愳劀 臧滌劆霅橃棃鞀惦媹雼�.
Cue Biopharma (NASDAQ: CUE) a publi茅 ses r茅sultats financiers du T2 2025 et des d茅veloppements commerciaux majeurs. La soci茅t茅 a conclu une collaboration strat茅gique avec Boehringer Ingelheim pour le d茅veloppement de CUE-501, recevant un paiement initial de $12 million et des paiements d'茅tape potentiels d'environ $345 million.
Les points cl茅s incluent un retour positif de la FDA sur la soumission Pre-IND de CUE-401 pour le traitement des maladies auto-immunes, ainsi que des r茅sultats cliniques probants de l'essai de phase 1 de CUE-101 dans les cancers t锚te-et-cou HPV+, avec un taux de r茅ponse globale de 50% et une survie globale m茅diane de 32 mois. La soci茅t茅 a par ailleurs renforc茅 sa situation financi猫re en levant $20 million via une offre publique.
Les r茅sultats du T2 2025 indiquent des revenus de collaboration de $3.0 million, des d茅penses R&D r茅duites 脿 $7.9 million contre $9.5 million au T2 2024, et une perte nette de $8.5 million, en am茅lioration par rapport 脿 la perte de $10.2 million au T2 2024.
Cue Biopharma (NASDAQ: CUE) ver枚ffentlichte die Finanzergebnisse f眉r Q2 2025 und wichtige gesch盲ftliche Entwicklungen. Das Unternehmen ging eine strategische Zusammenarbeit mit Boehringer Ingelheim zur Entwicklung von CUE-501 ein und erhielt eine Vorauszahlung von $12 million sowie potenzielle Meilensteinzahlungen von rund $345 million.
Zu den Highlights z盲hlen positives Feedback der FDA zur Pre-IND-Einreichung von CUE-401 zur Behandlung Autoimmunerkrankungen sowie beeindruckende klinische Ergebnisse der Phase-1-Studie von CUE-101 bei HPV-positivem Kopf-Hals-Krebs mit einer Gesamtansprechrate von 50% und einem medianen Gesamt眉berleben von 32 Monaten. Das Unternehmen st盲rkte seine Finanzlage zudem durch eine 枚ffentliche Platzierung, mit der $20 million aufgenommen wurden.
Die Q2-2025-Zahlen zeigten Kooperationsums盲tze in H枚he von $3.0 million, verringerte F&E-Aufwendungen von $7.9 million gegen眉ber $9.5 million im Q2 2024 und einen Nettoverlust von $8.5 million, eine Verbesserung gegen眉ber dem Verlust von $10.2 million im Q2 2024.
- Strategic collaboration with Boehringer Ingelheim securing $12M upfront and potential $345M in milestone payments
- Positive FDA feedback on CUE-401 Pre-IND submission for autoimmune disease treatment
- Strong clinical results with 50% ORR and 32-month mOS in CUE-101 Phase 1 trial
- Successfully raised $20M through public offering
- Reduced quarterly net loss to $8.5M from $10.2M year-over-year
- Decreased R&D expenses by 17% year-over-year
- Operating loss of $8.6M in Q2 2025
- Reduced interest income to $198K from $427K year-over-year
- Increased G&A expenses to $3.7M from $3.5M year-over-year
Insights
Cue Biopharma shows promising pipeline progress with positive FDA feedback, secured $12M upfront from Boehringer Ingelheim partnership, and raised $20M through public offering.
Cue Biopharma's Q2 2025 results highlight several positive catalysts that strengthen the company's strategic position. The FDA feedback on their Pre-IND briefing document for CUE-401 represents a significant de-risking step for their autoimmune disease program, validating their development approach and increasing the probability of a successful IND submission.
The
The
The clinical data for CUE-101 in HPV+ head and neck cancer is particularly encouraging, with a
Financially, while quarterly revenue increased slightly to
- Received FDA feedback on Pre-IND Briefing Document reinforcing Company鈥檚 intention to advance investigational new drug (IND) submission for CUE-401 to address unmet need in the treatment of autoimmune disease.
- Announced strategic research collaboration and license agreement with Boehringer Ingelheim to develop and commercialize CUE-501, a differentiated B cell depletion therapy for autoimmune and inflammatory diseases.
- Upfront payment of听
$12 million 听and听~$345 million 听in potential milestone payments
- Upfront payment of听
- Raised approximately
$20 million through a public offering.
BOSTON, Aug. 12, 2025 (GLOBE NEWSWIRE) -- 听(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 second quarter 2025.
鈥�We made significant progress during the second quarter with highly encouraging clinical data from our ongoing Phase 1b clinical trial, supporting our belief that CUE-101, representative of the CUE-100 series, has the potential to establish a new standard of care for HPV+ HNSCC patients,鈥� said Daniel Passeri, chief executive officer of Cue Biopharma. 鈥淭hese maturing data, together with the continued advancements of our lead autoimmune programs, reinforces our commitment to provide patients with more effective and well tolerated therapies to treat serious disease.鈥�
Business Highlights
- Received FDA feedback on Pre-IND Briefing Document reinforcing Company鈥檚 intention to advance IND submission for CUE-401 to address unmet need in the treatment of autoimmune disease.
- Announced strategic research collaboration and license agreement with Boehringer Ingelheim to develop and commercialize CUE-501, a differentiated B cell depletion therapy for autoimmune and inflammatory diseases.
- Upfront payment of听
$12 million 听and听~$345 million 听in potential milestone payments
- Upfront payment of听
- Raised approximately
$20 million through a public offering.
- Hosted virtual investor event, Mobilizing the Immune System: Cue Biopharma鈥檚 Novel Biologics Portfolio, featuring key opinion leaders, Richard DiPaolo, PhD, and Andrew Cope, MD PhD.
- Poster presentation delivered by Dana-Farber Cancer Institute at the American Society of Gene & Cell Therapy Annual Meeting presented proof-of-concept data on CUE-101 and its potential to control CAR-T cell expansion and persistence in vivo.
- Reported new complete response and confirmed
50% overall response rate (ORR) in ongoing Phase 1 trial of CUE-101 and pembrolizumab (KEYTRUDA庐) in recurrent/metastatic HPV+ head and neck cancer. Data observed included 12-month overall survival of88% and median overall survival (mOS) of 32 months.
Second Quarter 2025 Financial Results
The Company reported collaboration revenue of听
Research and development expenses were听
General and administrative expenses were听
| Cue Biopharma, Inc. Condensed Consolidated Statement of Operations and Comprehensive Loss (Unaudited) (In thousands, except share and per share amounts) | ||||||||||||||||
| 听 | ||||||||||||||||
| 听 | Three Months Ended June听30, | 听 | 听Six Months Ended June 30, | 听 | ||||||||||||
| 听 | 2025 | 听 | 2024 | 听 | 听2025 | 听 | 听2024 | 听 | ||||||||
| Collaboration revenue | $ | 2,954 | 听 | 听 | $ | 2,658 | 听 | 听 | $ | 3,374 | 听 | 听 | $ | 4,375 | 听 | 听 |
| Operating expenses: | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 |
| 听 General and administrative | 听 | 3,679 | 听 | 听 | 听 | 3,511 | 听 | 听 | 听 | 7,852 | 听 | 听 | 听 | 7,697 | 听 | 听 |
| 听 Research and development | 听 | 7,910 | 听 | 听 | 听 | 9,530 | 听 | 听 | 听 | 16,457 | 听 | 听 | 听 | 19,729 | 听 | 听 |
| 听 听 听 听 听 听Total operating expenses | 听 | 11,589 | 听 | 听 | 听 | 13,041 | 听 | 听 | 听 | 24,309 | 听 | 听 | 听 | 27,426 | 听 | 听 |
| Loss from operations | 听 | (8,635 | ) | 听 | 听 | (10,383 | ) | 听 | 听 | (20,935 | ) | 听 | 听 | (23,051 | ) | 听 |
| Other income (expense): | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 |
| 听 Interest income | 听 | 198 | 听 | 听 | 听 | 427 | 听 | 听 | 听 | 368 | 听 | 听 | 听 | 989 | 听 | 听 |
| 听 Interest expense | 听 | (45 | ) | 听 | 听 | (215 | ) | 听 | 听 | (172 | ) | 听 | 听 | (456 | ) | 听 |
| Total other income, net | 听 | 153 | 听 | 听 | 听 | 212 | 听 | 听 | 听 | 196 | 听 | 听 | 听 | 533 | 听 | 听 |
| Net loss | $ | (8,482 | ) | 听 | $ | (10,171 | ) | 听 | $ | (20,739 | ) | 听 | $ | (22,518 | ) | 听 |
| Comprehensive loss | $ | (8,482 | ) | 听 | $ | (10,171 | ) | 听 | $ | (20,739 | ) | 听 | $ | (22,518 | ) | 听 |
| Net loss per common share 鈥� basic and diluted | $ | (0.09 | ) | 听 | $ | (0.20 | ) | 听 | $ | (0.24 | ) | 听 | $ | (0.45 | ) | 听 |
| Weighted average common shares outstanding 鈥� basic and diluted | 听 | 95,459,401 | 听 | 听 | 听 | 50,174,756 | 听 | 听 | 听 | 84,857,051 | 听 | 听 | 听 | 49,822,689 | 听 | 听 |
| 听 | ||||||||||||||||
| Cue Biopharma, Inc. Condensed Consolidated Balance Sheets (Unaudited, In thousands) | ||||||
| 听 | ||||||
| 听 | June 30, 2025 | 听 | December 31, 2024 | 听 | ||
| Assets | 听 | 听 | 听 | 听 | 听 | 听 |
| 听 Cash and cash equivalents | $ | 27,492 | 听 | $ | 22,459 | 听 |
| 听 Other assets | 听 | 13,215 | 听 | 听 | 9,732 | 听 |
| 听 听 听 听 听 听Total assets | $ | 40,707 | 听 | $ | 32,191 | 听 |
| Liabilities and stockholders鈥� equity | 听 | 听 | 听 | 听 | 听 | 听 |
| 听 Liabilities | $ | 22,548 | 听 | $ | 14,692 | 听 |
| 听 Stockholders' equity | 听 | 18,159 | 听 | 听 | 17,499 | 听 |
| 听 听 听 听 听 听Total liabilities and stockholders鈥� equity | $ | 40,707 | 听 | $ | 32,191 | 听 |
| 听 | ||||||
About听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鈥檚 body. The company鈥檚 proprietary platform, Immuno-STAT庐 (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body鈥檚 intrinsic immune system without the adverse effects of broad systemic immune modulation.
Headquartered in听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听听and follow us on听听and听.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company鈥檚 belief regarding the potential benefits and applications of its drug candidates and programs, including CUE-101鈥檚 potential to control CAR-T cell expansion and persistence in vivo and that CUE-101 has the potential to establish a new standard of care for HPV+ HNSCC patients; the company鈥檚 plans to submit an IND for CUE-401; the company鈥檚 business strategies, plans and prospects; and the company鈥檚 potential receipt of future milestone-based payments. Forward-looking statements, which are based on certain assumptions and describe the company鈥檚 future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渃ould,鈥� 鈥渟eek,鈥� 鈥渋ntend,鈥� 鈥減lan,鈥� 鈥済oal,鈥� 鈥減roject,鈥� 鈥渆stimate,鈥� 鈥渁nticipate,鈥� 鈥渟trategy,鈥� 鈥渇uture,鈥� 鈥渓ikely,鈥� 鈥減romise鈥� or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company鈥檚 strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company鈥檚 actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company鈥檚 limited operating history, limited cash and a history of losses; the company鈥檚 ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current 鈥済oing concern鈥� determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company鈥檚 ability to achieve profitability; potential setbacks in the company鈥檚 research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company鈥檚 ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required听U.S. Food and Drug Administration听(鈥淔DA鈥�) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company鈥檚 operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company鈥檚 reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company鈥檚 ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company鈥檚 ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company鈥檚 most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Contact
Marie Campinell听
Senior Director, Corporate Communications
Cue Biopharma, Inc.
Media Contact
Jonathan Pappas
LifeSci Communications
FAQ
What are the key financial results for Cue Biopharma (CUE) in Q2 2025?
What is the significance of Cue Biopharma's partnership with Boehringer Ingelheim?
What clinical results did CUE report for its CUE-101 trial in HPV+ head and neck cancer?
How much capital did Cue Biopharma raise in their public offering?
What progress has Cue Biopharma made with CUE-401 development?
