Cue Biopharma Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Cue Biopharma reported Q3 2024 financial results and clinical progress. The company's Phase 1 trial of CUE-101 with KEYTRUDA showed 46% objective response rate and 91.3% 12-month survival in HPV+ head and neck cancer patients. CUE-102 demonstrated 67% disease control rate in pancreatic cancer. Financially, collaboration revenue increased to $3.3M from $2.1M year-over-year, while R&D expenses decreased to $9.4M from $9.9M. The company ended Q3 with $32.4M in cash, expected to fund operations into Q4 2025.
Cue Biopharma ha riportato i risultati finanziari e i progressi clinici del terzo trimestre del 2024. La sperimentazione di fase 1 di CUE-101 con KEYTRUDA ha mostrato un tasso di risposta obiettivo del 46% e una sopravvivenza del 91,3% a 12 mesi nei pazienti affetti da cancro della testa e del collo HPV+. CUE-102 ha dimostrato un tasso di controllo della malattia del 67% nel cancro pancreatico. Dal punto di vista finanziario, i ricavi da collaborazione sono aumentati a $3,3 milioni rispetto ai $2,1 milioni dell'anno precedente, mentre le spese per R&S sono diminuite a $9,4 milioni rispetto ai $9,9 milioni. L'azienda ha concluso il terzo trimestre con $32,4 milioni in contante, previsti per finanziare le operazioni fino al quarto trimestre del 2025.
Cue Biopharma informó sobre los resultados financieros y avances clínicos del tercer trimestre de 2024. El ensayo de fase 1 de CUE-101 con KEYTRUDA mostró una tasa de respuesta objetiva del 46% y una supervivencia del 91,3% a 12 meses en pacientes con cáncer de cabeza y cuello positivo para VPH. CUE-102 demostró una tasa de control de la enfermedad del 67% en cáncer de páncreas. Desde el punto de vista financiero, los ingresos por colaboración aumentaron a $3,3 millones desde $2,1 millones año tras año, mientras que los gastos en I+D disminuyeron a $9,4 millones desde $9,9 millones. La empresa terminó el tercer trimestre con $32,4 millones en efectivo, que se espera financien las operaciones hasta el cuarto trimestre de 2025.
Cue Biopharma는 2024년 3분기 재무 결과와 임상 진행 상황을 보고했습니다. CUE-101의 KEYTRUDA와의 1상 시험에서 HPV+ 두경부암 환자에서 46%의 객관적 반응률과 12개월 생존율 91.3%를 나타냈습니다. CUE-102는 췌장암에서 67%의 질병 조절률을 보여주었습니다. 재무적으로는 협업 수익이 지난해 $2.1M에서 $3.3M으로 증가했으며, R&D 비용은 $9.9M에서 $9.4M으로 감소했습니다. 이 회사는 3분기를 현금 $32.4M으로 마감했으며, 이는 2025년 4분기까지 운영 자금을 지원할 것으로 예상됩니다.
Cue Biopharma a annoncé les résultats financiers et les avancées cliniques du troisième trimestre 2024. L'essai de phase 1 de CUE-101 avec KEYTRUDA a montré un taux de réponse objective de 46 % et un taux de survie à 12 mois de 91,3 % chez les patients atteints d'un cancer de la tête et du cou positif au VPH. CUE-102 a démontré un taux de contrôle de la maladie de 67 % dans le cancer du pancréas. Sur le plan financier, les revenus de collaboration ont augmenté à 3,3 millions de dollars contre 2,1 millions de dollars l'année précédente, tandis que les dépenses de R&D ont diminué à 9,4 millions de dollars par rapport à 9,9 millions de dollars. L'entreprise a terminé le troisième trimestre avec 32,4 millions de dollars en liquide, prévus pour financer les opérations jusqu'au quatrième trimestre 2025.
Cue Biopharma hat die finanziellen Ergebnisse und klinischen Fortschritte für das dritte Quartal 2024 gemeldet. Die Phase-1-Studie von CUE-101 mit KEYTRUDA zeigte eine objektive Ansprechrate von 46% und eine 12-Monats-Überlebensrate von 91,3% bei HPV+ Patienten mit Kopf- und Halskrebs. CUE-102 zeigte eine Krankheitskontrollrate von 67% bei Bauchspeicheldrüsenkrebs. Finanzielle gesehen stiegen die Einnahmen aus der Zusammenarbeit auf 3,3 Millionen Dollar im Vergleich zu 2,1 Millionen Dollar im Vorjahr, während die F&E-Ausgaben auf 9,4 Millionen Dollar von 9,9 Millionen Dollar sanken. Das Unternehmen schloss das dritte Quartal mit 32,4 Millionen Dollar Bargeld ab, was voraussichtlich die Betriebe bis zum vierten Quartal 2025 finanzieren wird.
- Phase 1 CUE-101 trial showed 46% ORR and 91.3% 12-month survival rate
- CUE-102 achieved 67% disease control rate in pancreatic cancer patients
- Collaboration revenue increased by $1.2M to $3.3M YoY
- R&D expenses decreased by $0.5M to $9.4M
- G&A expenses reduced by $0.7M to $2.9M
- Net loss of $8.66M in Q3 2024
- Cash position decreased to $32.4M from $48.5M at year-end 2023
- $12.0M public offering announced, indicating potential dilution
- Operating expenses remain high at $12.15M for Q3
Insights
The Q3 2024 results reveal a mixed financial picture for Cue Biopharma. While collaboration revenue increased by
Cash position stands at
The clinical data shows promising developments in the company's pipeline. CUE-101's combination therapy with KEYTRUDA® demonstrated significant efficacy with an
The favorable tolerability profile and selective T cell expansion in CUE-102 trials, coupled with positive responses in low PD-L1 expression patients for CUE-101, suggests potential competitive advantages in the immuno-oncology space. The advancement of autoimmune programs CUE-401 and CUE-501 further diversifies the pipeline.
BOSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- 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 cancer and autoimmune disease, today provided a business and financial update for the third quarter of 2024.
Recent Business Highlights
- Presented positive updated data from the Phase 1 trials of CUE-101 and CUE-102 at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024) November 6-10
- Updated data from Phase 1 trial of CUE-101 in combination with KEYTRUDA® (pembrolizumab) continued to demonstrate enhanced benefit versus historical studies with pembrolizumab alone. Key findings included an objective response rate (ORR) of
46% , 12-month overall survival (OS) of91.3% and a median overall survival (mOS) of 21.8 months in first line (1L) HPV+ R/M HNSCC patients, as well as an ORR of50% in the subset of 1L patients with low PD-L1 expression (combined positive score (CPS) 1-19) - Updated data from Phase 1 monotherapy trial of CUE-102 included evidence of selective expansion of WT1-specific T cells and anti-tumor activity, as well as a favorable tolerability profile with no dose limiting toxicities (DLTs) in patients with Wilms’ Tumor 1 (WT1)-expressing colorectal, gastric, ovarian and pancreatic cancers
- Updated data from Phase 1 trial of CUE-101 in combination with KEYTRUDA® (pembrolizumab) continued to demonstrate enhanced benefit versus historical studies with pembrolizumab alone. Key findings included an objective response rate (ORR) of
- Demonstrated disease control rate (DCR) of
67% in late-stage pancreatic cancer patients treated with CUE-102 monotherapy, including an unconfirmed partial response (PR) with a40% decrease in tumor burden - Announced pricing of
$12.0 million public offering - Appointed industry veteran Lucinda Warren as Chief Business Officer
- Continued advancement of preclinical programs, CUE-401 for induction and expansion of regulatory T cells, in collaboration with Ono Pharmaceutical, and CUE-501 for B cell depletion, positioning both programs towards drug candidate selection
“We are very pleased with the validating updated clinical data from our Phase 1 trials for both CUE-101 and CUE-102,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Importantly, we believe the maturing data further supports and strengthens our competitive differentiation and positioning for selective modulation of disease-specific T cells. This data further bolsters our confidence that the CUE-100 series, exemplified by CUE-101 and CUE-102, represents the potential of establishing a new standard of care for cancer patients. We are also very pleased with the continued progress of our preclinical autoimmune programs, both of which have moved closer towards drug candidate selection.”
Third Quarter 2024 Financial Results
Collaboration revenue increased by
Research and development expenses decreased by
General and administrative expenses decreased by
Collaboration revenue increased by
Research and development expenses decreased by
General and administrative expenses decreased by
As of September 30, 2024, the Company had approximately
| Cue Biopharma, Inc. | |||||||||||||||||||||||
| Condensed Consolidated Statements of Operations and Other Comprehensive Loss | |||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||
| (In thousands, except share and per share amounts) | |||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
| Collaboration revenue | $ | 3,336 | $ | 2,100 | $ | 7,711 | $ | 3,669 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| General and administrative | 2,867 | 3,645 | 10,564 | 12,071 | |||||||||||||||||||
| Research and development | 9,381 | 9,874 | 29,111 | 29,915 | |||||||||||||||||||
| Gain on fixed asset disposal | (97) | - | (97) | - | |||||||||||||||||||
| Total operating expenses | 12,151 | 13,519 | 39,578 | 41,986 | |||||||||||||||||||
| Loss from operations | (8,815) | (11,419) | (31,867) | (38,317) | |||||||||||||||||||
| Other income (expense): | |||||||||||||||||||||||
| Interest income | 343 | 700 | 1,332 | 1,756 | |||||||||||||||||||
| Interest expense | (188) | (286) | (643) | (738) | |||||||||||||||||||
| Total other income, net | 155 | 414 | 689 | 1,018 | |||||||||||||||||||
| Net loss | $ | (8,660) | $ | (11,005) | $ | (31,178) | $ | (37,299) | |||||||||||||||
| Unrealized gain from available-for-sale securities | - | 5 | - | 96 | |||||||||||||||||||
| Comprehensive loss | $ | (8,660) | $ | (11,000) | $ | (31,178) | $ | (37,203) | |||||||||||||||
| Net loss per common share – basic and diluted | $ | (0.17) | $ | (0.24) | $ | (0.62) | $ | (0.82) | |||||||||||||||
| Weighted average common shares outstanding – basic and diluted | 51,229,701 | 46,358,555 | 50,292,983 | 45,274,124 | |||||||||||||||||||
| Cue Biopharma, Inc. | ||||||
| Condensed Consolidated Balance Sheets | ||||||
| (Unaudited, In thousands) | ||||||
| September 30, 2024 | December 31, 2023 | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 32,420 | $ | 48,514 | ||
| Other assets | 12,390 | 13,016 | ||||
| Total assets | $ | 44,810 | $ | 61,530 | ||
| Liabilities and stockholders’ equity | ||||||
| Liabilities | $ | 19,444 | $ | 24,445 | ||
| Stockholders' equity | 25,366 | 37,085 | ||||
| Total Liabilities and stockholders’ equity | $ | 44,810 | $ | 61,530 | ||
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 through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation.
Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors 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.
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’s belief that the CUE-100 series represents the potential of establishing a new standard of care for cancer patients; the company’s belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective modulation of disease-relevant T cell and the applicability of the company’s platform across many cancers and autoimmune diseases; the company’s business strategies, plans and prospects, including the advancement of the company’s preclinical autoimmune programs toward drug candidate selection ; and the cash runway of the company and the sufficiency of the company’s cash and cash equivalents to fund its operations. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” 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’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to shift its focus to its autoimmune assets and achieve the cost savings that it is projecting; the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s 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 U.S. Food and Drug Administration (“FDA”) 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’s trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future; the company’s 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 in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s 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
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com
Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com
FAQ
What was Cue Biopharma's (CUE) objective response rate for CUE-101 in Phase 1 trials?
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What was the disease control rate for CUE-102 in pancreatic cancer patients?
