Compass Therapeutics Reports 2024 Third Quarter Financial Results and Provides Corporate Update
Compass Therapeutics (NASDAQ: CMPX) reported Q3 2024 financial results and corporate updates. The company fully enrolled its Phase 2/3 trial of CTX-009 in biliary tract cancers, with top-line data expected by Q1 2025. Net loss was $10.5 million ($0.08 per share) for Q3 2024. The company maintains a strong financial position with $135 million in cash and marketable securities, providing runway into Q1 2027. R&D expenses were $8.6 million, while G&A expenses increased to $3.6 million. Key pipeline developments include progress in CTX-471 trials with NCAM identified as a potential response biomarker, and advancement in CTX-8371's Phase 1 dose-escalation study.
Compass Therapeutics (NASDAQ: CMPX) ha riportato i risultati finanziari del terzo trimestre 2024 e gli aggiornamenti aziendali. L'azienda ha completato l'arruolamento per la sua sperimentazione clinica di fase 2/3 di CTX-009 nei tumori delle vie biliari, con i dati preliminari attesi per il primo trimestre del 2025. La perdita netta è stata di 10,5 milioni di dollari (0,08 dollari per azione) per il terzo trimestre 2024. L'azienda mantiene una solida posizione finanziaria con 135 milioni di dollari in contante e titoli negoziabili, garantendo liquidità fino al primo trimestre del 2027. Le spese per ricerca e sviluppo sono state di 8,6 milioni di dollari, mentre le spese generali e amministrative sono aumentate a 3,6 milioni di dollari. Tra gli sviluppi chiave nella pipeline ci sono progressi negli studi di CTX-471 con NCAM identificato come un potenziale biomarcatore di risposta, e l'avanzamento dello studio di escalation della dose di fase 1 di CTX-8371.
Compass Therapeutics (NASDAQ: CMPX) informó los resultados financieros del tercer trimestre de 2024 y las actualizaciones corporativas. La compañía completó la inscripción en su ensayo clínico de fase 2/3 de CTX-009 en cánceres de las vías biliares, con datos preliminares esperados para el primer trimestre de 2025. La pérdida neta fue de 10.5 millones de dólares (0.08 dólares por acción) para el tercer trimestre de 2024. La compañía mantiene una sólida posición financiera con 135 millones de dólares en efectivo y valores negociables, lo que proporciona liquidez hasta el primer trimestre de 2027. Los gastos en I+D fueron de 8.6 millones de dólares, mientras que los gastos generales y administrativos aumentaron a 3.6 millones de dólares. Los desarrollos clave en la cartera incluyen avances en los ensayos de CTX-471, con NCAM identificado como un posible biomarcador de respuesta, y el avance en el estudio de escalado de dosis de fase 1 de CTX-8371.
Compass Therapeutics (NASDAQ: CMPX)는 2024년 3분기 재무 결과와 기업 업데이트를 보고했습니다. 본 회사는 담관암에 대한 CTX-009의 2/3상 임상시험에 대한 모집을 완료했으며, 주요 데이터는 2025년 1분기에 예상됩니다. 2024년 3분기 순손실은 1,050만 달러(주당 0.08달러)였습니다. 본 회사는 현금 및 유가증권으로 1억 3,500만 달러를 보유하여 2027년 1분기까지 운영할 수 있는 재원을 확보하고 있습니다. 연구개발비는 860만 달러였으며, 일반 관리비는 360만 달러로 증가했습니다. 주요 파이프라인 개발 사항으로는 CTX-471 임상시험에서 NCAM이 잠재적인 반응 바이오마커로 확인되었고, CTX-8371의 1상 용량 증량 연구에서의 진전을 포함합니다.
Compass Therapeutics (NASDAQ: CMPX) a publié des résultats financiers pour le troisième trimestre 2024 ainsi que des mises à jour d'entreprise. La société a complètement recruté pour son essai clinique de phase 2/3 de CTX-009 dans les cancers des voies biliaires, avec des données préliminaires attendues au premier trimestre 2025. La perte nette était de 10,5 millions de dollars (0,08 dollar par action) pour le troisième trimestre 2024. L'entreprise maintient une solide position financière avec 135 millions de dollars en espèces et titres négociables, ce qui lui assure une liquidité jusqu'au premier trimestre 2027. Les dépenses de R&D s'élevaient à 8,6 millions de dollars, tandis que les dépenses générales et administratives ont augmenté à 3,6 millions de dollars. Les développements clés dans le pipeline comprennent des progrès dans les essais de CTX-471 avec NCAM identifié comme un biomarqueur de réponse potentiel, et des avancées dans l'étude d'escalade de dose de phase 1 de CTX-8371.
Compass Therapeutics (NASDAQ: CMPX) hat die Finanzergebnisse für das dritte Quartal 2024 und Unternehmensaktualisierungen veröffentlicht. Das Unternehmen hat seine Phase 2/3-Studie zu CTX-009 bei biliären Tumoren vollständig rekrutiert, wobei die Ergebnisse im ersten Quartal 2025 erwartet werden. Der Nettoverlust betrug 10,5 Millionen Dollar (0,08 Dollar pro Aktie) für das dritte Quartal 2024. Das Unternehmen hält eine starke finanzielle Position mit 135 Millionen Dollar in Bargeld und handelbaren Wertpapieren, was Liquidität bis ins erste Quartal 2027 gewährleistet. Die Forschungs- und Entwicklungskosten betrugen 8,6 Millionen Dollar, während die allgemeinen Verwaltungsaufwendungen auf 3,6 Millionen Dollar anstiegen. Zu den wichtigsten Entwicklungen in der Pipeline gehören Fortschritte bei den CTX-471-Studien, bei denen NCAM als potenzieller Reaktionsbiomarker identifiziert wurde, und der Fortschritt in der Phase-1-Dosierungserhöhungsstudie von CTX-8371.
- Strong cash position of $135 million providing runway into Q1 2027
- Successful enrollment completion in Phase 2/3 trial of CTX-009
- Identification of NCAM as potential biomarker for CTX-471 response
- No dose limiting toxicities observed in CTX-8371 Phase 1 trial
- Net loss increased to $34.3 million for nine months vs $29.1 million in 2023
- R&D expenses increased by $3.6 million for nine months vs 2023
- G&A expenses increased by $2.3 million for nine months vs 2023
- Cash position decreased by $17 million during first nine months of 2024
Insights
The Q3 2024 results reveal significant financial metrics and clinical progress. The
The fully enrolled Phase 2/3 trial for CTX-009 in biliary tract cancers represents a important value inflection point, with data expected in Q1 2025. The pipeline diversification across multiple candidates (CTX-009, CTX-471, CTX-8371) provides multiple shots on goal, reducing clinical development risk.
The clinical development strategy shows promising evolution. The identification of NCAM (CD56) as a biomarker for CTX-471 response represents a significant advancement in patient selection strategy. This biomarker-driven approach could enhance trial success rates and potentially lead to more targeted therapeutic applications.
The CTX-009 program's pivot in colorectal cancer to focus on DLL4-positive patients in second-line treatment demonstrates adaptive trial design based on clinical insights. The expansion into first-line BTC treatment through the MD Anderson collaboration, combining with standard care (gemcitabine, cisplatin and durvalumab), suggests potential for broader therapeutic applications.
- Fully enrolled the Phase 2/3 trial of lead asset CTX-009 (DLL4 and VEGF-A bispecific antibody) in patients with biliary tract cancers (BTC); top-line data readout is on track for the end of the first quarter of 2025.
- Designing a Phase 2 trial of CTX-009 in combination with chemotherapy in patients with DLL4-positive colorectal cancer (CRC) treated in the second-line setting; trial initiation expected in mid-2025.
- Identified neural cell adhesion molecule (NCAM or CD56) as a potential biomarker of response to CTX-471 based on data from the Phase 1 trial; planning a Phase 2 trial in patients with tumors expressing NCAM for mid-2025.
- Fully enrolled the second dosing cohort of the Phase 1 dose-escalation study of CTX-8371 (PD-1 x PD-L1 bispecific antibody); enrollment into the third dosing cohort is expected to begin in the coming month.
- Cash balance of
$135 million in cash and marketable securities as of September 30, 2024, which is expected to provide cash runway into the first quarter of 2027.
BOSTON, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported third quarter 2024 financial results and provided a business update.
“We continue to be extremely encouraged with the progress across our clinical-stage programs, with three drugs already in the clinic and our deepening understanding of the potential clinical and regulatory pathways for each,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “In particular, we recently presented data showing a correlation between NCAM (CD56) expression and disease control with CTX-471 monotherapy. Given the high prevalence of NCAM expression across multiple tumor types, we are planning a Phase 2 monotherapy trial evaluating CTX-471 in patients whose tumors express this biomarker. With respect to our lead asset, CTX-009, we are on track for a top-line data readout in the U.S. at the end of the first quarter of 2025 for COMPANION-002, our Phase 2/3 combination study in patients with advanced BTC. Regarding CTX-009 in CRC, we are designing a Phase 2 study in the second-line setting in patients with metastatic CRC utilizing the DLL4 biomarker based on our observations from COMPANION-003.”
DEVELOPMENT PIPELINE UPDATES:
CTX-009 (DLL4 and VEGF-A bispecific antibody)
- Top-line data readout in the U.S. on track for the end of Q1 2025 for COMPANION-002, the Company’s Phase 2/3 randomized trial of CTX-009 in combination with paclitaxel in patients with advanced BTC (see press release).
- Stage 1 of COMPANION-003, a Phase 2 trial in the U.S. of CTX-009 as a monotherapy in patients with advanced metastatic CRC was completed and, although it is not advancing to Stage 2, showed encouraging preliminary efficacy and safety results. The data from this study has informed the design of a Phase 2 study in the second-line setting in combination with chemotherapy in patients with DLL4-positive CRC.
- An investigator sponsored study of CTX-009 in patients with BTC in the first-line setting at The University of Texas MD Anderson Cancer Center is being initiated. CTX-009 will be added to the standard first-line regimen of gemcitabine, cisplatin, and durvalumab.
CTX-471 (CD137 agonist antibody)
- CTX-471, a novel anti-CD137 agonist antibody, demonstrated durable clinical responses in Phase 1, which were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting earlier this year.
- An analysis of biopsy specimens from patients treated with CTX-471 monotherapy in the Phase 1b study identified pharmacodynamic and response biomarkers. These data were presented at the 39th Society for Immunotherapy of Cancer 2024 Annual Meeting. Specifically, data showed a correlation between the levels of NCAM (CD56) expression and disease control in patients treated with CTX-471 monotherapy.
CTX-8371 (PD-1 x PD-L1 bispecific antibody)
- CTX-8371 is a next generation bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1 and exhibits a unique mechanism-of-action that involves cleavage of cell surface PD-1.
- The second dosing cohort in the Phase 1 dose-escalation study of CTX-8371 is fully enrolled; no dose limiting toxicities (DLTs) have been observed to date. Enrollment into the third dosing cohort is expected to begin in the coming month.
Pre-clinical Research
- Continuing exploration of the synergies observed in pre-clinical and discovery work between VEGF blockade, CD137 agonism, checkpoint inhibition, and other cell engagement to identify novel bispecific antibody drug candidates with complementary anti-tumor activity.
FINANCIAL RESULTS:
Net loss for the quarter ended September 30, 2024, was
Research and Development (R&D) Expenses
R&D expenses were
General and Administrative (G&A) Expenses
G&A expenses were
CASH POSITION:
As of September 30, 2024, cash and marketable securities were
During the first nine months of 2024, Compass decreased its cash position by
About CTX-009
CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and early clinical data of CTX-009 suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated patients with cancer who were resistant to approved anti-VEGF therapies. COMPANION-002, a Phase 2/3 trial of CTX-009 (DLL4 and VEGF-A bispecific antibody) plus paclitaxel versus paclitaxel monotherapy in patients with previously treated, unresectable advanced metastatic or recurrent biliary tract cancers (BTC) is ongoing. Clinical Trial information: NCT05506943.
About CTX-471
CTX-471 is a fully human monoclonal antibody that binds and activates a novel epitope of the co-stimulatory receptor CD137, also known as 4-1BB, a member of the tumor necrosis factor receptor superfamily. The antibody is currently being evaluated in a Phase 1b clinical trial in patients with solid tumors that have progressed after at least three months on an approved PD-1 or PD-L1 inhibitor. Initial results reported from a monotherapy cohort of the study included five clinical responses, all in patients who previously received checkpoint inhibitors, including a durable partial response (PR) in a patient with small-cell lung cancer that converted to a complete response (as confirmed by PET scan) and four additional PRs (one unconfirmed) in patients with melanoma and mesothelioma. CTX-471 has been generally well tolerated. In preclinical studies, CTX-471 has demonstrated potent monotherapy activity against multiple syngeneic tumor models, including the generation of long-term functional immunological memory. Clinical Trial information: NCT03881488.
About CTX-8371
CTX-8371 is a next generation bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1 and exhibits a unique mechanism-of-action that involves cleavage of cell surface PD-1. CTX-8371 received FDA clearance of the IND in October 2023. The Phase 1 CTX-8371 study design includes five ascending doses (0.1, 0.3, 1.0, 3.0, and 10 mg/kg) and the study is enrolling patients with melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), Hodgkin Lymphoma, and triple negative breast cancer (TNBC) who have progressed on at least one prior regimen containing checkpoint blocker. No DLTs observed in the first dosing cohort and the second dosing cohort has been initiated. Clinical Trial information: NCT06150664.
About Compass Therapeutics
Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.
Investor Contact
ir@compasstherapeutics.com
Media Contact
Anna Gifford, Senior Manager of Communications
media@compasstherapeutics.com
617-500-8099
| Compass Therapeutics, Inc. and Subsidiaries | ||||||||||||||||
| Consolidated Statement of Operations (unaudited) | ||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| License revenue | $ | — | $ | — | $ | 850 | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 8,612 | 8,831 | 29,304 | 25,694 | ||||||||||||
| General and administrative | 3,627 | 3,095 | 11,597 | 9,276 | ||||||||||||
| Loss from operations | (12,239 | ) | (11,926 | ) | (40,051 | ) | (34,970 | ) | ||||||||
| Other income | 1,758 | 1,962 | 5,709 | 5,891 | ||||||||||||
| Net loss | $ | (10,481 | ) | $ | (9,964 | ) | $ | (34,342 | ) | $ | (29,079 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.08 | ) | $ | (0.08 | ) | $ | (0.25 | ) | $ | (0.23 | ) | ||||
| Compass Therapeutics, Inc. and Subsidiaries | ||||||
| Condensed Consolidated Balance Sheets | ||||||
| (In thousands, except par value) | ||||||
| September 30, 2024 | December 31, 2023 | |||||
| (unaudited) | ||||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 36,801 | $ | 24,228 | ||
| Marketable securities | 98,601 | 128,233 | ||||
| Prepaid expenses and other current assets | 5,738 | 1,420 | ||||
| Total current assets | 141,140 | 153,881 | ||||
| Property and equipment, net | 493 | 898 | ||||
| Operating lease, right-of-use ("ROU") asset | 6,950 | 1,776 | ||||
| Other assets | 568 | 320 | ||||
| Total assets | $ | 149,151 | $ | 156,875 | ||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 960 | $ | 4,090 | ||
| Accrued expenses | 2,916 | 2,514 | ||||
| Operating lease obligations, current portion | 557 | 1,197 | ||||
| Total current liabilities | 4,433 | 7,801 | ||||
| Operating lease obligations, long-term portion | 6,320 | 536 | ||||
| Total liabilities | 10,753 | 8,337 | ||||
| Total stockholders' equity | 138,398 | 148,538 | ||||
| Total liabilities and stockholders' equity | $ | 149,151 | $ | 156,875 | ||
FAQ
What was Compass Therapeutics (CMPX) Q3 2024 net loss?
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