Scorpius Holdings Announces Collaboration with KaloCyte to Advance Manufacturing for ErythroMer™
Scorpius Holdings (NYSE American: SCPX) has announced a collaboration with KaloCyte to enhance manufacturing processes for ErythroMer™, a dried artificial red blood cell designed for life-threatening blood loss situations. The partnership involves utilizing Scorpius' scientific and technical expertise to improve manufacturing efficiencies, with potential for a commercial-scale manufacturing agreement.
KaloCyte's ErythroMer™ targets a $7B U.S. market and has received $17M in DARPA and NIH grants, plus $5M in investor funding. The company is currently seeking Series A financing for IND-enabling studies and Phase 1 clinical trials. The product is designed as a universal option for all blood types, particularly useful when stored blood is unavailable or unsuitable.
Scorpius, operating from its facilities in San Antonio, TX, provides comprehensive CDMO services including analytical testing, process development, and cGMP clinical manufacturing.
Scorpius Holdings (NYSE American: SCPX) ha annunciato una collaborazione con KaloCyte per migliorare i processi produttivi di ErythroMer™, una cellula rossa artificiale essiccata progettata per situazioni di grave perdita di sangue. La partnership prevede l'utilizzo dell'expertise scientifica e tecnica di Scorpius per migliorare l'efficienza produttiva, con la possibilità di un accordo per la produzione su scala commerciale.
ErythroMer™ di KaloCyte si rivolge a un mercato statunitense da 7 miliardi di dollari e ha ricevuto 17 milioni di dollari in sovvenzioni DARPA e NIH, oltre a 5 milioni di dollari di finanziamenti da investitori. Attualmente l'azienda sta cercando finanziamenti di Serie A per studi abilitanti IND e trial clinici di Fase 1. Il prodotto è progettato come un'opzione universale per tutti i gruppi sanguigni, particolarmente utile quando il sangue conservato non è disponibile o non è idoneo.
Scorpius, che opera dalle sue strutture a San Antonio, TX, fornisce servizi CDMO completi che includono test analitici, sviluppo di processi e produzione clinica cGMP.
Scorpius Holdings (NYSE American: SCPX) ha anunciado una colaboración con KaloCyte para mejorar los procesos de fabricación de ErythroMer™, una célula roja artificial deshidratada diseñada para situaciones de pérdida de sangre que amenazan la vida. La asociación implica utilizar la experiencia científica y técnica de Scorpius para mejorar la eficiencia de fabricación, con el potencial de un acuerdo de fabricación a escala comercial.
ErythroMer™ de KaloCyte apunta a un mercado estadounidense de 7 mil millones de dólares y ha recibido 17 millones de dólares en subvenciones de DARPA y NIH, además de 5 millones de dólares en financiamiento de inversores. Actualmente, la empresa busca financiamiento en la Serie A para estudios habilitadores IND y ensayos clínicos de Fase 1. El producto está diseñado como una opción universal para todos los tipos de sangre, especialmente útil cuando la sangre almacenada no está disponible o no es adecuada.
Scorpius, que opera desde sus instalaciones en San Antonio, TX, ofrece servicios CDMO integrales que incluyen pruebas analíticas, desarrollo de procesos y fabricación clínica cGMP.
Scorpius Holdings (NYSE American: SCPX)는 생명을 위협하는 혈액 손실 상황을 위해 설계된 가공된 인공 적혈구 ErythroMer™의 제조 과정을 개선하기 위해 KaloCyte와 협력하기로 발표했습니다. 이 파트너십은 Scorpius의 과학적 및 기술적 전문성을 활용하여 제조 효율성을 향상시키는 것을 포함하며, 상업용 제조 계약의 가능성도 있습니다.
KaloCyte의 ErythroMer™는 70억 달러 규모의 미국 시장을 목표로 하고 있으며, DARPA와 NIH로부터 1,700만 달러의 보조금을 받았고 투자자 자금으로 500만 달러를 확보했습니다. 현재 이 회사는 IND 승인 연구와 1상 임상 시험을 위한 시리즈 A 자금을 모색하고 있습니다. 이 제품은 모든 혈액형에 대한 보편적인 옵션으로 설계되었으며, 저장된 혈액이 없거나 부적절할 때 특히 유용합니다.
Scorpius는 텍사스주 샌안토니오에 위치한 시설에서 운영되며, 분석 테스트, 프로세스 개발 및 cGMP 임상 제조를 포함한 종합 CDMO 서비스를 제공합니다.
Scorpius Holdings (NYSE American: SCPX) a annoncé une collaboration avec KaloCyte pour améliorer les processus de fabrication d'ErythroMer™, une cellule sanguine rouge artificielle séchée conçue pour des situations de perte de sang mettant la vie en danger. Ce partenariat implique l'utilisation de l'expertise scientifique et technique de Scorpius pour améliorer l'efficacité de fabrication, avec un potentiel d'accord de fabrication à échelle commerciale.
ErythroMer™ de KaloCyte cible un marché américain de 7 milliards de dollars et a reçu 17 millions de dollars en subventions de la DARPA et des NIH, ainsi que 5 millions de dollars de financement d’investisseurs. L'entreprise recherche actuellement un financement de série A pour des études permettant l'IND et des essais cliniques de phase 1. Le produit est conçu comme une option universelle pour tous les groupes sanguins, particulièrement utile lorsque le sang conservé n'est pas disponible ou n'est pas approprié.
Scorpius, opérant depuis ses installations à San Antonio, TX, propose des services CDMO complets, y compris des tests analytiques, le développement de processus et la fabrication clinique cGMP.
Scorpius Holdings (NYSE American: SCPX) hat eine Zusammenarbeit mit KaloCyte angekündigt, um die Herstellungsprozesse für ErythroMer™, eine getrocknete künstliche rote Blutzelle, die für lebensbedrohliche Blutverluste konzipiert ist, zu verbessern. Die Partnerschaft beinhaltet die Nutzung von Scorpius' wissenschaftlicher und technischer Expertise zur Verbesserung der Fertigungseffizienz, mit dem Potenzial für eine Vereinbarung zur Fertigung im kommerziellen Maßstab.
Das ErythroMer™ von KaloCyte zielt auf einen US-Markt von 7 Milliarden Dollar ab und hat 17 Millionen Dollar an DARPA- und NIH-Zuschüssen erhalten sowie 5 Millionen Dollar an Investorenfinanzierung. Das Unternehmen sucht derzeit nach Serie-A-Finanzierungen für IND-erlaubte Studien und Phase-1-Studien. Das Produkt ist als universelle Option für alle Blutgruppen konzipiert und besonders nützlich, wenn gespeichertes Blut nicht verfügbar oder ungeeignet ist.
Scorpius bietet von seinen Einrichtungen in San Antonio, TX, umfassende CDMO-Dienstleistungen an, darunter analytische Tests, Prozessentwicklung und cGMP-Klinikproduktion.
- Partnership with potential for commercial-scale manufacturing agreement
- Target market size of $7B in the US
- KaloCyte has secured $22M in combined grants and investor funding
- Product still in pre-clinical phase, requiring additional funding for IND studies
- No guaranteed commercial manufacturing agreement yet
- Additional Series A financing needed for clinical trials
Insights
This strategic manufacturing collaboration between Scorpius Holdings and KaloCyte represents a significant opportunity in the emerging artificial blood substitute market. The partnership focuses on ErythroMer™, a freeze-dried artificial red blood cell product that could revolutionize trauma care and address critical blood shortage situations.
The deal structure is particularly noteworthy, starting with initial manufacturing optimization but potentially expanding to commercial-scale production. This tiered approach allows Scorpius to demonstrate capabilities while minimizing initial risk. For context, manufacturing partnerships in novel biologics typically begin with process development contracts valued in the
KaloCyte's strong financial backing, including
From a manufacturing perspective, producing artificial blood cells presents unique challenges that align with Scorpius' expertise in complex biologics. The freeze-drying capability of ErythroMer™ is particularly significant as it addresses critical logistics and storage challenges in blood product distribution. This could potentially transform emergency medicine and military applications, where traditional blood products face significant limitations.
For Scorpius, this partnership could provide multiple revenue streams: immediate process development fees, potential milestone payments and future commercial manufacturing revenues. It also positions them strategically in the biodefense sector, where government contracts often provide stable, long-term revenue opportunities.
Partnership highlights Scorpius’ expertise in supporting innovative therapeutic programs
DURHAM, N.C., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today announced its collaboration with KaloCyte, a pioneering pre-clinical company in the field of therapeutic innovation. Under this initial project, Scorpius will utilize its scientific and technical expertise to enhance manufacturing efficiencies for KaloCyte’s lead candidate, ErythroMer™, a dried, bio-inspired artificial red blood cell designed to address life-threatening blood loss in situations where stored red blood cells are unavailable, unsuitable, or in short supply. The two companies are also evaluating opportunities to establish a commercial-scale manufacturing agreement.
“This collaboration reinforces Scorpius’ reputation as a trusted and innovative biomanufacturing partner,” said Jeff Wolf, CEO of Scorpius. “ErythroMer™ is a groundbreaking advancement that addresses critical healthcare challenges, and we are thrilled to contribute our scientific and technical expertise to this transformative initiative. By refining manufacturing processes for KaloCyte’s lead candidate, we are poised to accelerate its journey toward clinical success and expand its reach to patients who need it most. The prospect of commercial-scale manufacturing further emphasizes our shared commitment to making this life-saving therapy widely available.”
Elaine Haynes, President and CEO of KaloCyte, commented, “Scorpius BioManufacturing’s specialized focus, alignment with federal funding within the biodefense space and plans to grow their commercial production capabilities are a unique match for KaloCyte’s mission to develop a lifeline for when blood is not available as we prepare to advance to the clinic.”
This collaboration underscores Scorpius’ reputation as a trusted partner for biomanufacturing at all stages of development. With state-of-the-art facilities in San Antonio, TX, and a team of experienced professionals, Scorpius provides a comprehensive suite of services, including analytical testing, process development, and cGMP clinical manufacturing. The Company’s flexible and responsive approach enables it to support small businesses and innovative biotech companies in advancing their programs to the clinic and beyond.
KaloCyte, Inc.
KaloCyte is a pre-clinical biotech therapeutic startup company developing ErythroMer™, a bioengineered artificial red blood cell (RBC) substitute that can be freeze-dried for long-term storage and is envisioned for pre-hospital treatment of traumatic hemorrhage when stored blood is unavailable or undesirable. ErythroMer™ is a universal option for all blood types and has potential for accelerated regulatory pathways to address a critical unmet need serving a
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit www.scorpiusbiologics.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements such Scorpius utilizing its scientific and technical expertise to enhance manufacturing efficiencies for KaloCyte’s lead candidate, ErythroMer™; being poised to accelerate the lead candidate’s journey toward clinical success and expand its reach to patients who need it most; Scorpius’ plans to grow its commercial production capabilities; KaloCyte’s mission to develop a lifeline for when blood is not available as it prepares to advance to the clinic; and the Company’s flexible and responsive approach enabling it to support small businesses and innovative biotech companies in advancing their programs to the clinic and beyond. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to enhance manufacturing efficiencies for KaloCyte’s lead candidate, ErythroMer™ ; the flexible and responsive approach enabling the Company to support small businesses and innovative biotech companies in advancing their programs to the clinic and beyond l; the Company’s ability to attract new customers, profit from its pipeline and continue to grow revenue; the ability to capture a meaningful market share; the ability to generate meaningful cash flow and become cash flow positive; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
ir@scorpiusbiologics.com
FAQ
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