CERo Therapeutics, Inc. Announces Financing and Provides Update on Investigational New Drug Application for CER-1236
CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has announced a $1.25 million financing from existing investors to address the clinical hold on CER-1236. The company has requested a Type A Meeting with the FDA to discuss its plans and data collected to date. CERo is implementing significant management changes, with Chris Ehrlich becoming Chairman and Interim CEO, while Brian Atwood steps down to a consulting role. The CFO and CTO have also stepped down.
The company is focusing on resolving the remaining IND issues for CER-1236, which relate to two pharmacology and toxicology questions. CERo has initiated pre-clinical in vitro studies and experiments, with interim data submitted in the Type A Meeting Request. The company is implementing cost reductions to minimize capital needs and is working on identifying replacements for key positions.
CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) ha annunciato un finanziamento di 1,25 milioni di dollari da investitori esistenti per affrontare il blocco clinico su CER-1236. L'azienda ha richiesto un incontro di Tipo A con la FDA per discutere i propri piani e i dati raccolti fino ad oggi. CERo sta implementando cambiamenti significativi nella gestione, con Chris Ehrlich che diventa Presidente e CEO ad interim, mentre Brian Atwood assume un ruolo di consulenza. Anche il CFO e il CTO si sono dimessi.
L'azienda si sta concentrando sulla risoluzione delle restanti questioni IND per CER-1236, che riguardano due domande di farmacologia e tossicologia. CERo ha avviato studi pre-clinici in vitro ed esperimenti, con dati intermedi presentati nella richiesta di incontro di Tipo A. L'azienda sta implementando riduzioni dei costi per minimizzare le necessità di capitale e sta lavorando per identificare sostituti per posizioni chiave.
CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) ha anunciado un financiamiento de 1.25 millones de dólares de inversores existentes para abordar la pausa clínica en CER-1236. La compañía ha solicitado una reunión de Tipo A con la FDA para discutir sus planes y los datos recopilados hasta la fecha. CERo está implementando cambios significativos en la gestión, con Chris Ehrlich convirtiéndose en Presidente y CEO interino, mientras que Brian Atwood pasa a un rol de consultoría. El CFO y el CTO también han renunciado.
La compañía se está enfocando en resolver los problemas restantes del IND para CER-1236, que se relacionan con dos preguntas de farmacología y toxicología. CERo ha iniciado estudios preclínicos in vitro y experimentos, con datos intermedios presentados en la solicitud de reunión de Tipo A. La compañía está implementando reducciones de costos para minimizar las necesidades de capital y trabaja en identificar reemplazos para posiciones clave.
CERo Therapeutics Holdings, Inc. (Nasdaq: CERO)는 CER-1236에 대한 임상 보류 문제를 해결하기 위해 기존 투자자로부터 125만 달러의 자금 조달을 발표했습니다. 이 회사는 현재까지 수집된 데이터와 계획을 논의하기 위해 FDA와의 A형 회의를 요청했습니다. CERo는 Chris Ehrlich이 의장이자 임시 CEO가 되는 중대한 경영 변화를 시행하고 있으며, Brian Atwood는 자문 역할로 물러납니다. CFO와 CTO도 사임했습니다.
회사는 CER-1236에 대한 남은 IND 문제를 해결하는 데 집중하고 있으며, 이는 두 가지 약리학과 독성학 질문과 관련이 있습니다. CERo는 전임상 체외 연구와 실험을 시작했으며, A형 회의 요청서에 중간 데이터를 제출했습니다. 이 회사는 자본 필요를 최소화하기 위해 비용 절감을 시행하고 있으며 핵심 직위의 대체자를 찾고 있습니다.
CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) a annoncé un financement de 1,25 million de dollars de la part d'investisseurs existants pour faire face à la suspension clinique sur CER-1236. La société a demandé une réunion de type A avec la FDA pour discuter de ses plans et des données recueillies jusqu'à présent. CERo met en œuvre des changements significatifs dans la direction, Chris Ehrlich devenant Président et PDG par intérim, tandis que Brian Atwood passe à un rôle de consultant. Le CFO et le CTO ont également démissionné.
La société se concentre sur la résolution des problèmes restants d'IND pour CER-1236, qui concernent deux questions de pharmacologie et de toxicologie. CERo a lancé des études précliniques in vitro et des expériences, avec des données intermédiaires soumises dans la demande de réunion de type A. L'entreprise met en œuvre des réductions de coûts pour minimiser les besoins en capital et travaille à identifier des remplaçants pour les postes clés.
CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) hat eine Finanzierung in Höhe von 1,25 Millionen Dollar von bestehenden Investoren angekündigt, um die klinische Pause bei CER-1236 zu beheben. Das Unternehmen hat ein Typ-A-Meeting mit der FDA beantragt, um seine Pläne und die bis heute gesammelten Daten zu erörtern. CERo führt signifikante Änderungen im Management durch, wobei Chris Ehrlich zum Vorsitzenden und Interim-CEO wird, während Brian Atwood in eine Beratungsrolle wechselt. Auch der CFO und der CTO haben ihre Positionen aufgegeben.
Das Unternehmen konzentriert sich darauf, die verbleibenden IND-Probleme für CER-1236 zu lösen, die sich auf zwei Fragen zur Pharmakologie und Toxikologie beziehen. CERo hat präklinische In-vitro-Studien und Experimente initiiert, wobei vorläufige Daten im Antrag für das Typ-A-Meeting eingereicht wurden. Das Unternehmen führt Kostensenkungen durch, um den Kapitalbedarf zu minimieren und arbeitet daran, Ersatz für Schlüsselpositionen zu finden.
- Secured $1.25 million in financing from existing investors
- Requested Type A Meeting with FDA to address clinical hold on CER-1236
- Implementing cost reduction measures to minimize capital needs
- Initiated pre-clinical in vitro studies to address FDA concerns
- CER-1236 remains on clinical hold
- Significant management changes including CEO, CFO, and CTO stepping down
- Only two remaining pharmacology and toxicology questions delaying IND approval
Insights
The
The management shake-up, including the CEO transition and departures of key executives, signals a period of uncertainty. While Chris Ehrlich's appointment as Interim CEO may bring fresh perspective, the loss of experienced leadership during a critical phase is concerning.
The request for a Type A Meeting with the FDA is a positive step, but investors should be cautious. Resolving clinical holds can be time-consuming and costly, potentially requiring additional studies or data. The company's belief that they can address the two remaining pharmacology and toxicology questions is optimistic, but not guaranteed.
Cost-reduction measures are prudent given the financial constraints, but may limit the company's ability to progress other research programs. The focus on resolving the clinical hold for CER-1236 puts significant pressure on this single asset's success.
The clinical hold on CER-1236 is the central issue for CERo Therapeutics. The company's request for a Type A Meeting with the FDA is a standard procedure in this situation, aimed at gaining clarity and potentially expediting the resolution of the hold.
The fact that only two pharmacology and toxicology questions remain is somewhat encouraging, as it suggests the issues may be manageable. However, the nature and complexity of these questions are unknown and addressing them to the FDA's satisfaction could still be challenging.
The initiation of pre-clinical in vitro studies is a positive step, but investors should note that additional animal studies or human data might be required, depending on the FDA's concerns. The timeline for resolving the clinical hold remains uncertain and could extend well beyond October.
CERo's ability to navigate this regulatory hurdle will be important for its near-term prospects. The company's approach of continuing experiments while awaiting the FDA's response demonstrates proactivity, but also highlights the urgency of their situation.
Company requests Type A Meeting with U.S. Food and Drug Administration regarding clinical hold for CER-1236; announces key management changes
SOUTH SAN FRANCISCO, Calif., Sept. 25, 2024 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo”), an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, today announced that existing investors have committed a financing of
Vice Chairman Chris Ehrlich will become Chairman and Interim Chief Executive Officer. Brian Atwood has elected to step down as President and CEO to become a consultant to CERo and to Mr. Ehrlich during this transition; he will remain on the board of directors. Both Charles Carter, CERo’s Chief Financial Officer, and Daniel Corey, M.D., Chief Technology Officer have also elected to step down from their positions and board seat in the case of Dr. Corey. The Company has already identified consultants to continue to progress its ongoing work.
“This is a unique opportunity for us to reset and ensure that CERo is able to deliver on the promise of its science,” stated Mr. Ehrlich. “We will continue to benefit from Brian’s experience in the market, while we work diligently to progress CER-1236 into the clinic. In the meantime, we are implementing cost reductions to minimize our capital needs and have already made considerable headway in identifying replacements for the CFO and CTO positions, both activities which we believe will be instrumental in helping us to drive forward and complete the task at hand."
CERo continues to progress in its work to address the Clinical Hold placed on its Investigational New Drug Application for CER-1236. The company has requested a Type A Meeting with the U.S. Food and Drug Administration (FDA) regarding its open Investigational New Drug Application, which is currently on Clinical Hold. The Company intends to discuss its plans and data collected to date.
As announced previously, the clinical hold is related to only two pharmacology and toxicology questions which the Company believes can be addressed. CERo has initiated pre-clinical in vitro studies and experiments, interim data from which constituted the Company’s Type A Meeting Request regarding the clinical hold. These experiments will continue into October, as CERo awaits FDA’s response to the submitted Type A Meeting Request.
About CERo Therapeutics, Inc.
CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor (“CAR-T”) cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo anticipates initiating clinical trials for its lead product candidate, CER-1236, in 2024 for hematological malignancies.
Forward-Looking Statements
This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management.
Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, filed on April 2, 2024, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Brian Atwood
Chief Executive Officer
batwood@cero.bio
Investors:
CORE IR
investors@cero.bio
FAQ
What is the current status of CERo Therapeutics' (CERO) CER-1236 drug candidate?
How much financing did CERo Therapeutics (CERO) secure in September 2024?
What major management changes occurred at CERo Therapeutics (CERO) in September 2024?
What steps is CERo Therapeutics (CERO) taking to address the clinical hold on CER-1236?
