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CNS Pharmaceuticals Reports Second Quarter 2024 Financial Results

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CNS Pharmaceuticals (NASDAQ:CNSP) reported its Q2 2024 financial results and provided updates on its clinical programs. Key highlights include:

1. Completion of enrollment in the potentially pivotal GBM study for Berubicin, with topline data expected in H1 2025.

2. Strategic in-licensing of TPI 287, synergistic with Berubicin, for recurrent GBM treatment.

3. Net loss of $2.5 million for Q2 2024, down from $4.0 million in Q2 2023.

4. R&D expenses decreased to $1.1 million from $2.8 million year-over-year.

5. Cash position of $1.5 million as of June 30, 2024, with additional $12.4 million raised by August 14, 2024.

The company is focused on developing novel treatments for brain and central nervous system cancers, particularly glioblastoma multiforme (GBM).

CNS Pharmaceuticals (NASDAQ:CNSP) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito aggiornamenti sui suoi programmi clinici. Punti salienti includono:

1. Completamento dell'arruolamento nello studio potenzialmente cruciale per il GBM relativo a Berubicina, con dati preliminari attesi nel primo semestre del 2025.

2. Acquisizione strategica in licenza di TPI 287, sinergico con Berubicina, per il trattamento del GBM ricorrente.

3. Perdita netta di 2,5 milioni di dollari per il secondo trimestre 2024, in calo rispetto ai 4,0 milioni di dollari del secondo trimestre 2023.

4. Le spese per R&S sono diminuite a 1,1 milioni di dollari rispetto ai 2,8 milioni dell'anno precedente.

5. Posizione di cassa di 1,5 milioni di dollari al 30 giugno 2024, con ulteriori 12,4 milioni di dollari raccolti entro il 14 agosto 2024.

La società è focalizzata sullo sviluppo di nuovi trattamenti per i tumori cerebrali e del sistema nervoso centrale, in particolare per il glioblastoma multiforme (GBM).

CNS Pharmaceuticals (NASDAQ:CNSP) informó sobre sus resultados financieros del segundo trimestre de 2024 y proporcionó actualizaciones sobre sus programas clínicos. Los aspectos destacados incluyen:

1. Finalización de la inscripción en el estudio potencialmente decisivo para el GBM de Berubicina, con datos preliminares esperados en el primer semestre de 2025.

2. Licenciamiento estratégico de TPI 287, sinérgico con Berubicina, para el tratamiento del GBM recurrente.

3. Pérdida neta de $2.5 millones para el segundo trimestre de 2024, disminuyendo desde $4.0 millones en el segundo trimestre de 2023.

4. Los gastos de I+D disminuyeron a $1.1 millones desde $2.8 millones en el año anterior.

5. Posición de efectivo de $1.5 millones al 30 de junio de 2024, con $12.4 millones adicionales recaudados para el 14 de agosto de 2024.

La compañía se centra en desarrollar tratamientos novedosos para los cánceres cerebrales y del sistema nervioso central, en particular el glioblastoma multiforme (GBM).

CNS Pharmaceuticals (NASDAQ:CNSP)는 2024년 2분기 재무 결과를 보고하고 임상 프로그램에 대한 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:

1. 베루비신 관련 잠재적 핵심 GBM 연구의 참가자 모집 완료, 2025년 상반기에 결과 데이터 발표 예정.

2. 베루비신과 시너지를 이루는 TPI 287의 전략적 라이센스 취득, 재발성 GBM 치료를 위해.

3. 2024년 2분기에 250만 달러의 순손실, 2023년 2분기의 400만 달러에서 감소.

4. 연구개발 비용이 전년 대비 280만 달러에서 110만 달러로 감소.

5. 2024년 6월 30일 기준 현금 보유액이 150만 달러이며, 2024년 8월 14일까지 추가로 1240만 달러를 모금함.

회사는 뇌와 중추 신경계 암 치료를 위한 새로운 치료법 개발에 집중하고 있으며, 특히 다형성 교모세포종(GBM)에 초점을 맞추고 있습니다.

CNS Pharmaceuticals (NASDAQ:CNSP) a publié ses résultats financiers du deuxième trimestre 2024 et a fourni des mises à jour sur ses programmes cliniques. Les points clés incluent:

1. Achèvement du recrutement dans l'étude potentiellement décisive sur le GBM concernant la Berubicine, avec des données préliminaires attendues au premier semestre 2025.

2. Licenciement stratégique de TPI 287, synergique avec la Berubicine, pour le traitement du GBM récurrent.

3. Perte nette de 2,5 millions de dollars pour le deuxième trimestre 2024, en baisse par rapport à 4,0 millions de dollars au deuxième trimestre 2023.

4. Les dépenses de R&D ont diminué à 1,1 million de dollars contre 2,8 millions l'année précédente.

5. Position de trésorerie de 1,5 million de dollars au 30 juin 2024, avec un montant supplémentaire de 12,4 millions de dollars recueilli d'ici le 14 août 2024.

L'entreprise se concentre sur le développement de nouveaux traitements pour les cancers du cerveau et du système nerveux central, en particulier le glioblastome multiforme (GBM).

CNS Pharmaceuticals (NASDAQ:CNSP) hat seine Finanzzahlen für das zweite Quartal 2024 veröffentlicht und Updates zu seinen klinischen Programmen gegeben. Wichtige Punkte sind:

1. Abschluss der Rekrutierung in der potenziell entscheidenden GBM-Studie für Berubicin, mit Veröffentlichung der vorläufigen Daten im ersten Halbjahr 2025.

2. Strategische Lizenzierung von TPI 287, synergistisch mit Berubicin, zur Behandlung von wiederkehrendem GBM.

3. Nettoverlust von 2,5 Millionen Dollar für das zweite Quartal 2024, ein Rückgang von 4,0 Millionen Dollar im zweiten Quartal 2023.

4. R&D-Ausgaben sanken auf 1,1 Millionen Dollar von 2,8 Millionen im Vorjahr.

5. Geldposition von 1,5 Millionen Dollar zum 30. Juni 2024, mit zusätzlichen 12,4 Millionen Dollar, die bis zum 14. August 2024 gesammelt wurden.

Das Unternehmen konzentriert sich auf die Entwicklung neuartiger Behandlungen für Gehirn- und ZNS-Krebs, insbesondere für das glioblastoma multiforme (GBM).

Positive
  • Completed enrollment of 252 patients in potentially pivotal Berubicin study for GBM
  • Secured exclusive license for TPI 287, expanding pipeline for GBM treatment
  • Reduced net loss by 37.5% year-over-year in Q2 2024
  • Decreased R&D expenses by 60.7% compared to Q2 2023
  • Raised $12.4 million in financing between June 30 and August 14, 2024
  • FDA granted Fast Track Designation and Orphan Drug Designation for Berubicin
Negative
  • Cash position of $1.5 million as of June 30, 2024, only sufficient to fund operations through Q1 2025
  • Increased general and administrative expenses by 16.7% year-over-year in Q2 2024
  • Delay in topline results for Berubicin study, expected in first half of 2025

Insights

CNS Pharmaceuticals' Q2 2024 results show a narrowing net loss of $2.5 million, down from $4.0 million in Q2 2023. This improvement is primarily due to reduced research and development expenses, which decreased to $1.1 million from $2.8 million year-over-year. The company's cash position of $1.5 million as of June 30, 2024, supplemented by $12.4 million in gross proceeds raised post-quarter, extends their runway through Q1 2025. This financial positioning aligns with their timeline for releasing topline data from the Berubicin trial in H1 2025, a potential catalyst for the stock. However, investors should note the ongoing cash burn and potential need for additional financing to support long-term development efforts.

CNS Pharmaceuticals' focus on glioblastoma multiforme (GBM), an aggressive brain cancer with poor prognosis, represents a significant unmet medical need. The completion of enrollment in the potentially pivotal Berubicin trial with 252 patients is a important milestone. The expected topline results in H1 2025 could be a game-changer if positive. Additionally, the in-licensing of TPI 287, a BBB-permeable taxane, diversifies their pipeline and demonstrates a commitment to tackling GBM from multiple angles. The planned engagement with the FDA for TPI 287's potential registration study shows forward-thinking strategy. These developments position CNS Pharmaceuticals as a noteworthy player in the challenging field of brain cancer therapeutics.

The GBM market, while relatively small, is highly lucrative due to the lack of effective treatments. CNS Pharmaceuticals' dual approach with Berubicin and TPI 287 could potentially capture a significant market share if successful. The Fast Track and Orphan Drug designations for Berubicin provide regulatory advantages and potential market exclusivity, enhancing its commercial prospects. However, investors should be cautious as the brain cancer drug development landscape is notoriously challenging, with many candidates failing in late-stage trials. The company's ability to execute on its clinical programs and maintain sufficient funding will be important for long-term success and stock performance.

Potentially pivotal GBM study evaluating lead program, Berubicin, enrollment completed; Topline data expected in the first half of 2025

Recent strategic in-license of TPI 287 is highly synergistic with the ongoing potentially pivotal Berubicin program and demonstrates further commitment to changing the treatment paradigm in GBM

Company plans to engage the U.S. FDA to seek guidance on advancing TPI 287 into a potential registration study for recurrent GBM

Company committed to addressing the most aggressive type of brain cancer with an average survival of only 14 to 16 months after diagnosis and no cure

HOUSTON, TX / ACCESSWIRE / August 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 second quarter 2024 ended June 30, 2024.

"It has been an important year for CNS Pharmaceuticals with completion of enrollment in our Berubicin trial, and more recently, our in-licensing of a highly synergistic asset for development, TPI 287. As we look to the remainder of the year, we are executing on the path towards our planned topline results for our Berubicin trial, which we expect in the first half of next year and engaging the U.S. FDA to seek guidance on advancing TPI 287 into a potential registration study for recurrent GBM. We are poised for a catalytic 2025 with some value-driving milestones expected across our pipeline. Our mission and vision remain firm; bring a meaningful treatment option to GBM patients and practitioners, as well as value to all stakeholders," commented John Climaco, Chief Executive Officer of CNS Pharmaceuticals.

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 and received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the study without modification. CNS Pharmaceuticals expects to report topline results 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 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 has been awarded Orphan designation and studied in over 350 patients to date, including clinical trials as monotherapy and in combination with bevacizumab demonstrating encouraging clinical efficacy and safety profile at target therapeutic doses.

In clinical trials, TPI 287 has been administered as monotherapy as well as in combination with bevacizumab for the treatment of recurrent glioblastoma, neuroblastoma, medulloblastoma, refractory prostate cancer and in tauopathy disease (dementia caused by aggregation of abnormal tau proteins in the brain). Like other taxanes, TPI 287 inhibits cancer cell growth by disrupting microtubule dynamics which are required for cell division. However, unlike all other known taxanes, TPI 287 is not a substrate for a wide spectrum of efflux pumps that constitute the blood-brain barrier (BBB), including PgP, which may allow TPI 287 to reach the brain in high concentrations.

CNS Pharmaceuticals plans to engage the U.S. FDA and obtain feedback on the design of a study focused on the registration of TPI 287 in recurrent GBM, with the goal of initiating the study in 2025.

Summary of Financial Results for the Second Quarter 2024
The net loss for the three months ended June 30, 2024 was approximately $2.5 million compared to approximately $4.0 million for the comparable period in 2023. The change in net loss is attributable to a decrease in research organization ("CRO") expenses related to continued progress with the Company's clinical trial of Berubicin, as well as decreases in legal and professional fees and other expenses.

The Company reported research and development expenses of $1.1 million for the three months ended June 30, 2024 compared to approximately $2.8 million for the comparable period in 2023. The decrease in research and development expenses during the period was mainly attributed to the timing of CRO expenses related to continued progress with the Company's clinical trial.

General and administrative expense was approximately $1.4 million for the three months ended June 30, 2024 compared to approximately $1.2 million for the comparable period in 2023. The increase in general and administrative expense was mainly attributable to increases of approximately $333,000 in legal and professional expenses, which were offset by decreases of approximately $65,000 in marketing and advertising expenses and $35,000 in insurance expense.

As of June 30, 2024, the Company had cash of approximately $1.5 million. Between June 30, 2024 and August 14, 2024, the Company has raised total gross proceeds of approximately $12.4 million of financing, and has sufficient cash to fund its operations through the first quarter of 2025. The Company expects to be able to release final topline data from its potentially pivotal trial of Berubicin in the first half of 2025.

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.

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 topline results from the Company's potentially pivotal study of Berubicin in the first half of 2025. 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
833-475-8247
CNSP@jtcir.com

SOURCE: CNS Pharmaceuticals, Inc.







View the original press release on accesswire.com

FAQ

When does CNS Pharmaceuticals (CNSP) expect to report topline results for its Berubicin study?

CNS Pharmaceuticals expects to report topline results from its potentially pivotal study of Berubicin in the first half of 2025.

What was CNS Pharmaceuticals' (CNSP) net loss for Q2 2024?

CNS Pharmaceuticals reported a net loss of approximately $2.5 million for the second quarter of 2024.

How much cash did CNS Pharmaceuticals (CNSP) have as of June 30, 2024?

As of June 30, 2024, CNS Pharmaceuticals had cash of approximately $1.5 million.

What new drug candidate did CNS Pharmaceuticals (CNSP) in-license in July 2024?

In July 2024, CNS Pharmaceuticals entered into an exclusive license agreement for TPI 287, a novel blood-brain barrier permeable abeotaxane for the treatment of brain malignancies.

CNS Pharmaceuticals, Inc.

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