Scorpius Holdings Announces Collaboration with KaloCyte to Advance Manufacturing for ErythroMer™

DURHAM, N.C., Jan. 22, 2025 (GLOBE NEWSWIRE) -- (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 $7B U.S. market. To date, KaloCyte has demonstrated proof of concept, safety, and efficacy in animal models. Funded by $17M in grants from DARPA and NIH, and over $5M investor funding, the company is seeking Series A financing to fund IND-enabling studies and Phase 1 clinical trials.

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 .

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.

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David Waldman