Cue Biopharma Reports Second Quarter 2024 Financial Results and Recent Business Highlights
Cue Biopharma (Nasdaq: CUE) reported Q2 2024 financial results and recent business highlights. Key points include:
1. CUE-101 showed promising results in HPV+ R/M HNSCC, with 46% ORR in 1L therapy and 20.8 months mOS in 2L+ monotherapy.
2. CUE-102 demonstrated dose-dependent T cell activation and anti-tumor activity in refractory metastatic cancers.
3. Q2 2024 collaboration revenue increased to $2.7 million from $1.4 million in Q2 2023.
4. R&D expenses decreased to $9.5 million in Q2 2024 from $10.7 million in Q2 2023.
5. Cash and cash equivalents were $30.0 million as of June 30, 2024, expected to fund operations through Q2 2025.
Cue Biopharma (Nasdaq: CUE) ha riportato i risultati finanziari del secondo trimestre 2024 e gli ultimi aggiornamenti aziendali. I punti chiave includono:
1. CUE-101 ha mostrato risultati promettenti nel trattamento di HNSCC R/M HPV+, con un tasso di risposta obiettiva (ORR) del 46% nella terapia di prima linea e una sopravvivenza mediana (mOS) di 20,8 mesi nella monoterapia di seconda linea e oltre.
2. CUE-102 ha dimostrato un'attivazione dei linfociti T dipendente dalla dose e un'attività anti-tumorale nei tumori metastatici refrattari.
3. Le entrate da collaborazioni nel secondo trimestre 2024 sono aumentate a 2,7 milioni di dollari rispetto a 1,4 milioni di dollari nel secondo trimestre 2023.
4. Le spese di ricerca e sviluppo sono diminuite a 9,5 milioni di dollari nel secondo trimestre 2024, rispetto a 10,7 milioni di dollari nel secondo trimestre 2023.
5. Le disponibilità liquide e i mezzi equivalenti ammontavano a 30,0 milioni di dollari al 30 giugno 2024, previsti per finanziare le operazioni fino al secondo trimestre 2025.
Cue Biopharma (Nasdaq: CUE) reportó los resultados financieros del segundo trimestre de 2024 y aspectos destacados recientes del negocio. Los puntos clave incluyen:
1. CUE-101 mostró resultados prometedores en HNSCC R/M positivo por HPV, con una tasa de respuesta objetiva (ORR) del 46% en la terapia de primera línea y 20,8 meses de supervivencia media (mOS) en la monoterapia de segunda línea y más.
2. CUE-102 demostró activación de células T dependiente de la dosis y actividad antitumoral en cánceres metastásicos refractarios.
3. Los ingresos por colaboraciones en el segundo trimestre de 2024 aumentaron a $2.7 millones desde $1.4 millones en el segundo trimestre de 2023.
4. Los gastos de I+D disminuyeron a $9.5 millones en el segundo trimestre de 2024 desde $10.7 millones en el segundo trimestre de 2023.
5. El efectivo y equivalentes de efectivo eran de $30.0 millones al 30 de junio de 2024, se espera que financien las operaciones hasta el segundo trimestre de 2025.
큐 바이오파마 (Nasdaq: CUE)가 2024년 2분기 재무 결과 및 최근 사업 성과를 보고했습니다. 주요 내용은 다음과 같습니다:
1. CUE-101은 HPV+ R/M HNSCC 치료에서 1차 요법으로 46%의 객관적 반응률(ORR)과 2차 이상 단독 요법에서 20.8개월의 중앙 생존 기간(mOS)을 기록하며 유망한 결과를 보였습니다.
2. CUE-102는 내성 전이암에서 용량 의존적인 T 세포 활성화 및 항종양 활성을 입증했습니다.
3. 2024년 2분기 협업 수익은 2023년 2분기 140만 달러에서 270만 달러로 증가했습니다.
4. 연구 개발 비용은 2024년 2분기 1070만 달러에서 950만 달러로 감소했습니다.
5. 2024년 6월 30일 기준 현금 및 현금성 자산은 3000만 달러로, 2025년 2분기까지 운영에 필요한 자금을 조달할 것으로 예상됩니다.
Cue Biopharma (Nasdaq: CUE) a annoncé les résultats financiers du deuxième trimestre 2024 et les récents points forts de l'entreprise. Les points clés incluent :
1. CUE-101 a montré des résultats prometteurs dans le traitement du HNSCC R/M positif pour HPV, avec un taux de réponse objective (ORR) de 46 % en thérapie de première ligne et une survie médiane (mOS) de 20,8 mois en monothérapie de deuxième ligne et plus.
2. CUE-102 a démontré une activation des cellules T dépendante de la dose et une activité antitumorale dans les cancers métastatiques réfractaires.
3. Les revenus de collaboration du deuxième trimestre 2024 ont augmenté à 2,7 millions de dollars contre 1,4 million de dollars au deuxième trimestre 2023.
4. Les dépenses de recherche et développement ont diminué à 9,5 millions de dollars au deuxième trimestre 2024 contre 10,7 millions de dollars au deuxième trimestre 2023.
5. Les liquidités et équivalents de liquidités s'élevaient à 30,0 millions de dollars au 30 juin 2024, prévus pour financer les opérations jusqu'au deuxième trimestre 2025.
Cue Biopharma (Nasdaq: CUE) hat die finanziellen Ergebnisse des zweiten Quartals 2024 und aktuelle Geschäftshighlights vorgestellt. Die wichtigsten Punkte sind:
1. CUE-101 zeigte vielversprechende Ergebnisse bei HPV+ R/M HNSCC mit einer objektiven Ansprechrate (ORR) von 46% in der Erstanwendungstherapie und einer medianen Überlebenszeit (mOS) von 20,8 Monaten bei der Monotherapie der zweiten Linie und darüber hinaus.
2. CUE-102 zeigte eine dosisabhängige Aktivierung von T-Zellen und antitumorale Aktivitäten bei refraktären metastasierenden Krebserkrankungen.
3. Die Einnahmen aus der Zusammenarbeit im zweiten Quartal 2024 stiegen auf 2,7 Millionen Dollar, verglichen mit 1,4 Millionen Dollar im zweiten Quartal 2023.
4. Die Forschung und Entwicklungskosten sanken im zweiten Quartal 2024 auf 9,5 Millionen Dollar, nach 10,7 Millionen Dollar im zweiten Quartal 2023.
5. Die liquiden Mittel und Zahlungsmitteläquivalente betrugen zum 30. Juni 2024 30,0 Millionen Dollar und sollen die Betriebe bis zum zweiten Quartal 2025 finanzieren.
- CUE-101 showed 46% ORR in 1L R/M HNSCC therapy and 20.8 months mOS in 2L+ monotherapy
- CUE-102 demonstrated dose-dependent T cell activation and anti-tumor activity in refractory metastatic cancers
- Collaboration revenue increased to $2.7 million in Q2 2024 from $1.4 million in Q2 2023
- R&D expenses decreased to $9.5 million in Q2 2024 from $10.7 million in Q2 2023
- G&A expenses decreased to $3.5 million in Q2 2024 from $4.2 million in Q2 2023
- Net loss of $10.2 million in Q2 2024
- Cash and cash equivalents decreased to $30.0 million as of June 30, 2024, from $48.5 million as of June 30, 2023
Insights
Cue Biopharma's Q2 2024 results show mixed signals. Collaboration revenue increased to
The company's cash position has deteriorated, with
While R&D and G&A expenses have decreased, indicating cost control efforts, the company's path to profitability is still unclear. Investors should closely monitor the progress of CUE-101 and CUE-102, as their success could significantly impact the company's financial future.
The clinical data for CUE-101 in combination with pembrolizumab for first-line R/M HNSCC is promising. An objective response rate of 46% in CPS ≥1 patients and 50% in CPS <20 patients is impressive. The median overall survival of 21.8 months is particularly noteworthy, as it suggests a potential improvement over current standards of care.
For CUE-101 monotherapy in 2L+ HPV+ R/M HNSCC, the median overall survival of 20.8 months is substantially higher than the 7.5 and 8.4 months observed with nivolumab and pembrolizumab, respectively. This could indicate a significant advancement in treatment options for these patients.
The early data from CUE-102 in late-stage refractory metastatic cancers, showing dose-dependent T cell activation and anti-tumor activity in gastric and ovarian patients, is encouraging but requires further validation. Overall, these results suggest that Cue Biopharma's Immuno-STAT platform has potential to improve outcomes in difficult-to-treat cancers.
Cue Biopharma's strategic focus on both oncology and autoimmune diseases positions it well in the competitive biotech landscape. The positive clinical data from CUE-101 and CUE-102 in oncology could potentially lead to lucrative partnerships or licensing deals if the trend continues in larger trials.
The company's collaboration with Ono Pharmaceutical for CUE-401 in autoimmune diseases is a significant asset, providing both validation and potential milestone payments. The decision to prioritize autoimmune programs for near-term value creation while maintaining oncology assets is a balanced approach that could appeal to different investor profiles.
However, the declining cash position and ongoing losses present a near-term challenge. The company may need to secure additional funding before Q2 2025, which could lead to dilution for existing shareholders. The success of upcoming clinical milestones will be important in determining the company's ability to attract favorable financing terms or potential acquirers.
BOSTON, Aug. 19, 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, provided a business and financial update for the second quarter 2024.
Recent Business Highlights
- Delivered oral presentation on updated data from ongoing Phase 1(b) trial of CUE-101 as a first line (1L) therapy in human papillomavirus positive (HPV+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), with standard of care (SOC) checkpoint inhibitor (CPI) KEYTRUDA® (pembrolizumab) and as a monotherapy in second line and beyond (2L+) HPV+ R/M HNSCC, as well as a poster presentation on CUE-102 in Wilms’ Tumor 1 (WT1) positive cancers at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held in June.
- Further advanced autoimmune program CUE-401, partnered with Ono Pharmaceutical, Ltd., and CUE-501, our lead CUE-500 series asset.
- Programs are designed to address significant unmet medical need in large patient populations across numerous autoimmune and inflammatory diseases
- Preclinical data has progressed well with consistent positive activity in multiple disease models
- Initiated strategic prioritization of autoimmune programs to focus upon near-term and intermediate value creation potential, to enable optimization and reduction of capital requirements, while retaining oncology programs, CUE-101 and CUE-102, as promising clinical data further matures.
- Positive observations as updated data continues to mature from ongoing oncology clinical trials, CUE-101 and CUE-102.
- CUE-101 in combination with pembrolizumab in 1L R/M HNSCC, as of August 4, 2024, demonstrated an objective response rate (ORR) of
46% in all patients with combined positive score (CPS) ≥1 and50% ORR with CPS <20, median progression free survival (mPFS) of 5.8 months and median overall survival (mOS) of 21.8 months - CUE-101 monotherapy in 2L+ HPV+ R/M HNSCC demonstrated mOS of 20.8 months vs. mOS of 7.5 and 8.4 months observed in trials in 2L patients with two different CPIs: OPDIVO® (nivolumab) and pembrolizumab, respectively
- CUE-102 monotherapy in late-stage refractory metastatic cancers has been well tolerated and to date, has demonstrated dose-dependent increases in exposure and activation and expansion of WT1-specific T cells with observed anti-tumor activity in two gastric and ovarian patients, as well as disease control in several tumor types in multiple patients in the dose escalation Phase 1 trial
- CUE-101 in combination with pembrolizumab in 1L R/M HNSCC, as of August 4, 2024, demonstrated an objective response rate (ORR) of
“We had a highly productive second quarter with promising clinical data continuing to mature from our ongoing oncology trials further supporting our belief that CUE-101, as our lead representative CUE-100 program, has the potential to establish a new standard of care for HPV+ HNSCC patients,” said Daniel Passeri, chief executive officer of Cue Biopharma. “These observations, combined with the ongoing advancements of our prioritized autoimmune programs and the recent implementation of a highly focused, strategic business model underscoring our objectives to proactively manage and mitigate capital access risk, support the transformational potential of our Immuno-STAT™ platform to accomplish our mission of developing breakthrough immunotherapies to establish a new standard of care in the treatment of cancer and autoimmune disease.”
Second Quarter 2024 Financial Results
The Company reported collaboration revenue of
Research and development expenses were
General and administrative expenses were
The Company reported collaboration revenue of
Research and development expenses were
General and administrative expenses were
As of June 30, 2024, the Company had
| Cue Biopharma, Inc. | |||||||||||||
| Condensed Consolidated Statement of Operations and Comprehensive Loss (Unaudited) | |||||||||||||
| (In thousands, except share and per share amounts) | |||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| Collaboration revenue | $ | 2,658 | $ | 1,382 | $ | 4,375 | $ | 1,570 | |||||
| Operating expenses: | |||||||||||||
| General and administrative | 3,511 | 4,249 | 7,697 | 8,425 | |||||||||
| Research and development | 9,530 | 10,650 | 19,729 | 20,041 | |||||||||
| Total operating expenses | 13,041 | 14,899 | 27,426 | 28,466 | |||||||||
| Loss from operations | (10,383) | (13,517) | (23,051) | (26,896) | |||||||||
| Other income (expense): | |||||||||||||
| Interest income | 427 | 564 | 989 | 1,056 | |||||||||
| Interest expense | (215) | (232) | (456) | (454) | |||||||||
| Total other income, net | 212 | 332 | 533 | 602 | |||||||||
| Net loss | $ | (10,171) | $ | (13,185) | $ | (22,518) | $ | (26,294) | |||||
| Unrealized gain from available-for-sale securities | — | 34 | — | 91 | |||||||||
| Comprehensive loss | $ | (10,171) | $ | (13,151) | $ | (22,518) | $ | (26,203) | |||||
| Net loss per common share – basic and diluted | $ | (0.20) | $ | (0.29) | $ | (0.45) | $ | (0.59) | |||||
| Weighted average common shares outstanding – basic and diluted | 50,174,756 | 44,798,760 | 49,822,689 | 44,725,875 | |||||||||
| Cue Biopharma, Inc. | ||||||
| Condensed Consolidated Balance Sheets | ||||||
| (Unaudited, In thousands) | ||||||
| June 30, 2024 | December 31, 2023 | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 30,029 | $ | 48,514 | ||
| Other assets | 12,300 | 13,016 | ||||
| Total assets | $ | 42,329 | $ | 61,530 | ||
| Liabilities and stockholders’ equity | ||||||
| Liabilities | $ | 20,707 | $ | 24,445 | ||
| Stockholders' equity | 21,622 | 37,085 | ||||
| Total Liabilities and stockholders’ equity | $ | 42,329 | $ | 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 regarding the potential benefits and applications of its drug candidates and programs, including the transformational potential of the company’s Immuno-STAT™ platform to accomplish its mission of developing breakthrough immunotherapies to establish a new standard of care in the treatment of cancer and autoimmune disease; the near-term and intermediate value creation potential of its autoimmune programs; the company’s intention to preserve the value of its oncology programs; the company’s business strategies, plans and prospects, including those related to the prioritization of CUE-401 and CUE-501, and the potential benefits of the company’s program prioritization and realignment on its burn rate; 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,” “promise” 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 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’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 and ability to continue as a going concern; 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 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 were Cue Biopharma's (CUE) Q2 2024 financial results?
What were the clinical results for CUE-101 in HPV+ R/M HNSCC?
How long is Cue Biopharma's (CUE) current cash expected to fund operations?
What progress has been made with CUE-102 in Q2 2024?
