Context Therapeutics Reports Third Quarter 2024 Operating and Financial Results
Context Therapeutics (CNTX) reported Q3 2024 financial results and business updates. The company expanded its pipeline through acquisitions of CT-95 and CT-202, two T cell engaging bispecific antibodies. Cash position stood at $84.8 million as of September 30, 2024. Q3 net loss increased to $17.5 million from $5.9 million year-over-year, primarily due to R&D expenses of $16.8 million. The company expects current cash to fund operations into 2027, including Phase 1 trials for CTIM-76 and CT-95, and IND filing for CT-202.
Context Therapeutics (CNTX) ha riportato i risultati finanziari per il terzo trimestre del 2024 e aggiornamenti aziendali. L'azienda ha ampliato il suo portafoglio attraverso l'acquisizione di CT-95 e CT-202, due anticorpi bispecifici ingaggianti le cellule T. La posizione di cassa era di 84,8 milioni di dollari al 30 settembre 2024. La perdita netta nel terzo trimestre è aumentata a 17,5 milioni di dollari rispetto ai 5,9 milioni dell'anno precedente, principalmente a causa delle spese per R&D di 16,8 milioni di dollari. L'azienda prevede che l'attuale liquidità sosterrà le operazioni fino al 2027, comprendendo le fasi cliniche 1 per CTIM-76 e CT-95, e la richiesta di IND per CT-202.
Context Therapeutics (CNTX) informó sobre los resultados financieros del tercer trimestre de 2024 y las actualizaciones comerciales. La empresa amplió su cartera mediante la adquisición de CT-95 y CT-202, dos anticuerpos biespecíficos que interactúan con células T. La posición de efectivo se situó en 84,8 millones de dólares al 30 de septiembre de 2024. La pérdida neta en el tercer trimestre aumentó a 17,5 millones de dólares desde 5,9 millones en comparación con el año anterior, debido principalmente a gastos de I+D de 16,8 millones de dólares. La empresa espera que el efectivo disponible financie sus operaciones hasta 2027, incluyendo ensayos de fase 1 para CTIM-76 y CT-95, y la presentación de IND para CT-202.
Context Therapeutics (CNTX)는 2024년 3분기 재무 결과 및 비즈니스 업데이트를 발표했습니다. 회사는 CT-95와 CT-202 두 개의 T세포 관련 이중 특이성 항체를 인수하여 파이프라인을 확장했습니다. 2024년 9월 30일 현재 현금 보유액은 8,480만 달러였습니다. 3분기 순손실은 전년 대비 5.9백만 달러에서 1,750만 달러로 증가했으며, 이는 주로 1,680만 달러의 연구개발 비용 때문입니다. 회사는 현재 현금으로 2027년까지 운영을 지속할 것으로 예상하며, CTIM-76 및 CT-95의 1상 시험, 그리고 CT-202의 IND 제출을 포함합니다.
Context Therapeutics (CNTX) a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour sur l'entreprise. La société a élargi son portefeuille grâce à l'acquisition de CT-95 et CT-202, deux anticorps bispécifiques engageant des cellules T. La position de trésorerie s'élevait à 84,8 millions de dollars au 30 septembre 2024. La perte nette du troisième trimestre a augmenté à 17,5 millions de dollars contre 5,9 millions l'année précédente, principalement en raison des dépenses de R&D de 16,8 millions de dollars. L'entreprise s'attend à ce que la trésorerie actuelle finance ses opérations jusqu'en 2027, y compris les essais de phase 1 pour CTIM-76 et CT-95, ainsi que le dépôt d'IND pour CT-202.
Context Therapeutics (CNTX) hat die Finanzergebnisse für das dritte Quartal 2024 und Unternehmensupdates veröffentlicht. Das Unternehmen hat seine Pipeline durch den Erwerb von CT-95 und CT-202, zwei T-Zell-bindenden bispezifischen Antikörpern, erweitert. Die Liquiditätsposition betrug zum 30. September 2024 84,8 Millionen US-Dollar. Der Nettoverlust im dritten Quartal stieg auf 17,5 Millionen US-Dollar, verglichen mit 5,9 Millionen im Vorjahr, insbesondere bedingt durch F&E-Ausgaben von 16,8 Millionen US-Dollar. Das Unternehmen erwartet, dass die aktuellen Mittel die Betriebsabläufe bis 2027 finanzieren werden, einschließlich Phase-1-Studien für CTIM-76 und CT-95 sowie der IND-Einreichung für CT-202.
- Strong cash position of $84.8 million, up from $14.4 million at end of 2023
- Cash runway extended into 2027
- Pipeline expansion through strategic acquisitions of CT-95 and CT-202
- Higher other income of $1.2 million, up from $0.3 million YoY
- Net loss widened to $17.5 million from $5.9 million YoY
- R&D expenses increased significantly to $16.8 million from $4.5 million YoY
- G&A expenses increased to $1.9 million from $1.7 million YoY
Insights
The Q3 results reveal significant strategic investments in Context's pipeline expansion, with
The company's strong cash position, up from
The pipeline expansion into T cell engaging bispecific antibodies represents a strategic move into a promising therapeutic area. The portfolio now includes three complementary targets: Claudin 6 (CTIM-76), Mesothelin (CT-95) and Nectin-4 (CT-202). These targets are well-validated in solid tumors, with existing approved therapies demonstrating their clinical relevance.
The imminent clinical trial initiations for CTIM-76 (end of 2024) and CT-95 (Q1 2025) mark important development milestones. The staggered development timeline allows for efficient resource allocation while maintaining multiple shots on goal. The addition of experienced leadership in clinical development strengthens execution capabilities for these complex trials.
Expands pipeline of T cell engaging bispecific antibodies through acquisitions of CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody
Strengthens board with appointments of Dr. Karen Smith and Dr. Luke Walker
Cash and cash equivalents of
PHILADELPHIA, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced its financial results for the third quarter ended September 30, 2024, and reported on recent and upcoming business highlights.
“Context executed on its strategy to build a pipeline of T cell engaging bispecific antibodies through its acquisitions of CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody,” said Martin Lehr, CEO of Context. “We continue to activate additional sites for our Phase 1 trial for CTIM-76, a Claudin 6 x CD3 bispecific antibody, and expect to dose our first patient by the end of this year. We also expect to advance CT-95 into the clinic soon and expect to enroll our first patient in our CT-95 Phase 1 study in the first quarter of 2025.”
Mr. Lehr continued, “Additionally, the expansion of our Board of Directors is exemplary of the transformation Context has made this year. Dr. Karen Smith and Dr. Luke Walker each bring a diversified skillset and we are excited to leverage their wealth of operational experience as we navigate the next stages of growth.”
Third Quarter 2024 and Recent Corporate Highlights
Pipeline Updates
- In September 2024, announced an exclusive worldwide license agreement with BioAtla, Inc. to develop and commercialize CT-202, a Nectin-4 x CD3 bispecific antibody. Context expects to file an Investigational New Drug (“IND”) application for CT-202 in mid-2026.
- In July 2024, completed the acquisition of CT-95, a potentially first-in-class Mesothelin x CD3 bispecific antibody that has received IND clearance from the U.S. Food and Drug Administration. The Company believes that CT-95 is on track for dosing the first patient in the Phase 1 trial in the first quarter of 2025.
Corporate Updates
- In November 2024, the Company will participate in the Guggenheim Global Healthcare Conference, the UBS Global Healthcare Conference, and the Stifel 2024 Healthcare Conference. A live webcast of each presentation will be available on the News and Events section of the Company’s website at https://ir.contexttherapeutics.com/.
- In November 2024, Context will present a poster titled “Determination of First In Human Dose of the T Cell-redirecting Bispecific Antibody CTIM-76 Targeting Claudin 6” at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting.
- In September 2024, announced the appointments of Dr. Karen Smith and Dr. Luke Walker to Context’s Board of Directors.
- In August 2024, announced the appointments of Dr. Claudio Dansky Ullmann as Chief Medical Officer and Ms. Karen Andreas as VP, Clinical Operations.
Third Quarter 2024 Financial Results
- Cash and cash equivalents were
$84.8 million at September 30, 2024, compared to$14.4 million at December 31, 2023. - Research and development (“R&D”) expenses were
$16.8 million for the third quarter of 2024, as compared to$4.5 million for the same period in 2023. The increase in R&D expenses was primarily driven by higher in-process research and development charges of$14.75 million related to the acquisitions of CT-95 and CT-202 in the third quarter 2024. This increase was partially offset by lower CTIM-76 expense of$2.8 million , which was mainly the result of lower contract manufacturing costs and preclinical costs. - General and administrative expenses were
$1.9 million for the third quarter 2024, as compared to$1.7 million for the same period in 2023. The increase was primarily driven by an increase in professional fees for legal services incurred. - Other income, net was
$1.2 million for the third quarter 2024, as compared to$0.3 million for the same period in 2023, primarily due to higher interest income earned on cash and cash equivalent balances. - Context reported a net loss of
$17.5 million for the third quarter of 2024, as compared to$5.9 million for the same period in 2023.
2024 Cash Guidance
The Company expects that its cash and cash equivalents will be sufficient to fund the estimated duration of the dose escalation portions of its CTIM-76 and CT-95 Phase 1 trials, the estimated expenses through IND filing for CT-202, as well as its operations into 2027.
About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn.
Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) our expectation to dose the first patient in the Phase 1 clinical trial for CTIM-76 by the end of 2024, (ii) our expectation to dose the first patient in the Phase 1 clinical trial for CT-95 in the first quarter of 2025, (iii) our expectation to file an IND for CT-202 in mid-2026, (iv) having sufficient cash and cash equivalents to fund the estimated duration of the dose escalation portions of our CTIM-76 and CT-95 Phase 1 trials, the estimated expenses through IND filing for CT-202, as well as our operations into 2027, (v) the ability of the Company and its employees to participate in and present at conferences, (vi) the potential benefits, characteristics, safety and side effect profile of our product candidates, (vii) the likelihood data will support future development of our product candidates, and (viii) the ability of the Company to build its portfolio. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.
| Context Therapeutics Inc. | ||||||||||||||||
| Condensed Statements of Operations | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | $ | 16,825,198 | $ | 4,485,223 | $ | 20,182,960 | $ | 12,480,836 | ||||||||
| General and administrative | 1,876,230 | 1,695,272 | 5,430,518 | 5,658,575 | ||||||||||||
| Loss from operations | (18,701,428 | ) | (6,180,495 | ) | (25,613,478 | ) | (18,139,411 | ) | ||||||||
| Other (expense) income, net | 1,241,535 | 305,809 | 2,231,282 | 945,086 | ||||||||||||
| Net loss | $ | (17,459,893 | ) | $ | (5,874,686 | ) | $ | (23,382,196 | ) | $ | (17,194,325 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.22 | ) | $ | (0.37 | ) | $ | (0.46 | ) | $ | (1.08 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 80,481,053 | 15,966,053 | 50,578,115 | 15,966,053 | ||||||||||||
| Context Therapeutics Inc. | ||||||||||||||||
| Condensed Balance Sheets Data | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| September 30, | December 31, | |||||||||||||||
| 2024 | 2023 | |||||||||||||||
| Cash and cash equivalents | $ | 84,801,556 | $ | 14,449,827 | ||||||||||||
| Other assets | 1,528,293 | 1,612,908 | ||||||||||||||
| Total assets | $ | 86,329,849 | $ | 16,062,735 | ||||||||||||
| Total liabilities | $ | 2,472,232 | $ | 4,191,715 | ||||||||||||
| Total stockholders' equity | 83,857,617 | 11,871,020 | ||||||||||||||
| Total liabilities and stockholders' equity | $ | 86,329,849 | $ | 16,062,735 | ||||||||||||
Investor Relations Contact:
Jennifer Minai-Azary
Context Therapeutics
IR@contexttherapeutics.com
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