CNS Pharmaceuticals Reports Third Quarter 2024 Financial Results
CNS Pharmaceuticals (NASDAQ:CNSP) reported Q3 2024 financial results, highlighting progress in its clinical development programs. The company completed enrollment of 252 patients in its pivotal Berubicin GBM study, with primary analysis data expected in H1 2025. Net loss increased to $5.6 million from $4.5 million year-over-year. R&D expenses rose to $4.2 million from $3.4 million. The company strengthened its cash position to $7.0 million, supplemented by post-quarter fundraising of $4.6 million, extending operations through Q2 2025. Additionally, CNS expanded its pipeline by in-licensing TPI 287, a late-stage brain malignancy treatment.
CNS Pharmaceuticals (NASDAQ:CNSP) ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando i progressi nei suoi programmi di sviluppo clinico. L'azienda ha completato l'arruolamento di 252 pazienti nello studio cruciale su Berubicin GBM, con i dati dell'analisi primaria attesi per la prima metà del 2025. La perdita netta è aumentata a 5,6 milioni di dollari rispetto a 4,5 milioni di dollari anno su anno. Le spese per ricerca e sviluppo sono aumentate a 4,2 milioni di dollari rispetto a 3,4 milioni di dollari. L'azienda ha rafforzato la sua posizione di liquidità a 7,0 milioni di dollari, integrata da un fundraising post-trimestrale di 4,6 milioni di dollari, estendendo le operazioni fino al secondo trimestre del 2025. Inoltre, CNS ha ampliato il suo portafoglio di prodotti ottenendo in licenza TPI 287, un trattamento per le neoplasie maligne cerebrali in fase avanzata.
CNS Pharmaceuticals (NASDAQ:CNSP) reportó los resultados financieros del tercer trimestre de 2024, destacando el progreso en sus programas de desarrollo clínico. La empresa completó la inscripción de 252 pacientes en su estudio pivotal de Berubicin GBM, con los datos del análisis primario esperados para la primera mitad de 2025. La pérdida neta aumentó a 5.6 millones de dólares desde 4.5 millones de dólares respecto al año anterior. Los gastos de I+D aumentaron a 4.2 millones de dólares desde 3.4 millones de dólares. La compañía fortaleció su posición de efectivo a 7.0 millones de dólares, complementada por una recaudación de fondos posterior al trimestre de 4.6 millones de dólares, extendiendo las operaciones hasta el segundo trimestre de 2025. Además, CNS amplió su cartera al obtener la licencia de TPI 287, un tratamiento para malignidades cerebrales en etapa avanzada.
CNS Pharmaceuticals (NASDAQ:CNSP)는 2024년 3분기 재무 결과를 발표하며 임상 개발 프로그램의 진전을 강조했습니다. 회사는 중추 신경계의 악성 종양에 대한 Berubicin 연구에 252명의 환자를 등록 완료하였으며, 주요 분석 데이터는 2025년 상반기에 예상되고 있습니다. 순손실은 작년 4.5백만 달러에서 5.6백만 달러로 증가하였습니다. 연구 및 개발 비용은 4.2백만 달러로 증가하였고, 이는 지난해 3.4백만 달러에서 상승한 수치입니다. 회사는 현금 보유량을 7.0백만 달러로 강화하였으며, 분기 후 4.6백만 달러의 자금 조달을 통해 운영을 2025년 2분기까지 연장하였습니다. 또한 CNS는 후기 단계의 뇌 악성 종양 치료제인 TPI 287에 대한 라이센스를 확보하여 파이프라인을 확장했습니다.
CNS Pharmaceuticals (NASDAQ:CNSP) a annoncé les résultats financiers du troisième trimestre 2024, soulignant les progrès de ses programmes de développement clinique. La société a terminé l'enrôlement de 252 patients dans son étude pivot sur le Berubicin pour le GBM, avec les données de l'analyse primaire attendues au premier semestre 2025. La perte nette a augmenté à 5,6 millions de dollars contre 4,5 millions de dollars l'année précédente. Les dépenses de R&D ont grimpé à 4,2 millions de dollars contre 3,4 millions de dollars. L'entreprise a renforcé sa position de trésorerie à 7,0 millions de dollars, complétée par une levée de fonds post-trimestrielle de 4,6 millions de dollars, prolongeant ses opérations jusqu'au deuxième trimestre 2025. De plus, CNS a élargi son portefeuille en acquérant une licence pour le TPI 287, un traitement pour les tumeurs cérébrales à un stade avancé.
CNS Pharmaceuticals (NASDAQ:CNSP) hat die Finanzzahlen für das dritte Quartal 2024 veröffentlicht und dabei Fortschritte in seinen klinischen Entwicklungsprogrammen hervorgehoben. Das Unternehmen hat die Rekrutierung von 252 Patienten in seiner entscheidenden Berubicin GBM-Studie abgeschlossen, wobei die Daten der primären Analyse im ersten Halbjahr 2025 erwartet werden. Der Nettoverlust stieg von 4,5 Millionen Dollar auf 5,6 Millionen Dollar im Jahresvergleich. Die F&E-Ausgaben erhöhten sich von 3,4 Millionen Dollar auf 4,2 Millionen Dollar. Das Unternehmen hat seine Liquiditätsposition auf 7,0 Millionen Dollar gestärkt und durch eine Nach-Quartalsfinanzierung von 4,6 Millionen Dollar, die den Betrieb bis zum zweiten Quartal 2025 ausdehnt, ergänzt. Darüber hinaus hat CNS sein Portfolio durch die Lizenzierung von TPI 287, einer Behandlung für fortgeschrittene Gehirntumoren, erweitert.
- Completed enrollment of 252 patients in pivotal Berubicin GBM study
- Secured $4.6 million in additional funding post-quarter
- Expanded pipeline through TPI 287 in-licensing
- Received FDA Fast Track Designation and Orphan Drug Designation for Berubicin
- Net loss increased 24% YoY to $5.6 million
- R&D expenses increased 23.5% to $4.2 million
- G&A expenses rose 27% to $1.4 million
- Current cash runway only extends through Q2 2025
Insights
The Q3 2024 results reveal a concerning financial position with a net loss of
The advancement of Berubicin's potentially pivotal trial with 252 enrolled patients and successful interim analysis represents significant progress. The dual regulatory advantages of Fast Track Designation and Orphan Drug Designation enhance market potential. The strategic acquisition of TPI 287, with its existing safety data from 350 patients and prior Orphan Drug Designation, diversifies the pipeline and reduces single-asset risk. However, both programs target the challenging GBM space, where historical success rates are notably low. The upcoming H1 2025 data readout for Berubicin will be a critical inflection point.
Primary analysis data in potentially pivotal GBM study with lead program, Berubicin, on track for the first half of 2025
Company strengthens cash position to extend runway to fund operations beyond data readout of Berubicin potentially pivotal GBM study
Quarter marked by pipeline expansion with in-license of TPI 287, a late stage novel potential blood brain barrier permeable abeotaxane for treatment of brain malignancies
HOUSTON, TX / ACCESSWIRE / November 15, 2024 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today reported its financial results for the third quarter 2024 ended September 30, 2024.
"Our team has made nothing short of transformational advancements throughout 2024. Fundamentally, the Company has never been stronger, and we believe we are poised to unlock value for all stakeholders in the near term," commented John Climaco, Chief Executive Officer of CNS Pharmaceuticals. "We have a strong cash position, expanded our pipeline in complete alignment with our mission and importantly, believe we are closer than ever to potentially bringing Berubicin, our targeted chemotherapy drug candidate, to market as a meaningful treatment option to GBM patients and practitioners."
Clinical Development Progress
Berubicin: Innovative, first-in-class anthracycline that appears to cross the blood brain barrier and kill tumor cells currently being evaluated in a potentially pivotal trial is a multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy.
As previously announced in April 2024, the Company completed enrollment with 252 patients in its global potentially pivotal study evaluating Berubicin for the treatment of GBM. In December 2023, the Company announced the successful completion of its pre-planned interim futility analysis of efficacy and safety and received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the study without modification.
CNS Pharmaceuticals expects to report primary analysis data from its potentially pivotal study of Berubicin in the first half of 2025.
The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the agency for guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA, which may provide seven years of marketing exclusivity upon approval of an NDA. For more information about the Berubicin clinical trial, visit clinicaltrials.gov and reference identifier NCT04762069.
TPI 287: Late stage, novel potentially blood brain barrier permeable abeotaxane for treatment of brain malignancies.
In July 2024, the Company entered into an exclusive license agreement with Cortice Biosciences, Inc. for drug candidate, TPI 287, which was previously awarded Orphan Drug Designation and studied in over 350 patients to date, including clinical trials as monotherapy and in combination with bevacizumab showing encouraging clinical efficacy and safety profile at target therapeutic doses.
CNS Pharmaceuticals plans to engage the FDA and obtain feedback on the design of a study focused on the registration of TPI 287 in recurrent GBM.
Summary of Financial Results for the Third Quarter 2024
The net loss for the three months ended September 30, 2024 was approximately
The Company reported research and development expenses of
General and administrative expense was approximately
As of September 30, 2024, the Company had cash of approximately
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system.
The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.
The Company's second drug candidate, TPI 287, is an abeotaxane which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. Similar to Berubicin, TPI 287 has shown the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 has been well tolerated in over 350 patients to date, including in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of recurrent neuroblastoma and medulloblastoma, as well as refractory prostate cancer and melanoma, and in tauopathy disease, which can result in dementia.
For more information, please visit www.CNSPharma.com, and connect with the Company on X, Facebook, and LinkedIn.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements include, without limitation, the timing of the release of the primary analysis data for the potentially pivotal study of Berubicin, the timing of the commencement of the registration study for TPI 287, and the Company's cash runway. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions and those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law.
CONTACTS:
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
908.824.0775
CNSP@jtcir.com
SOURCE: CNS Pharmaceuticals, Inc.
View the original press release on accesswire.com
FAQ
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