Scorpius Holdings Achieves Major Milestone with cGMP Facility Validation for Microbial Manufacturing

Rhea-AI Summary

Scorpius Holdings (NYSE American: SCPX) has achieved a significant milestone with the successful validation of its microbial manufacturing facilities for cGMP (current Good Manufacturing Practice) production. This approval enhances the company's ability to produce high-quality microbial biologic drugs, meeting stringent regulatory and client standards. The validation has led to a backlog of client bookings, reflecting trust in Scorpius' capabilities. Additionally, the company is transitioning its environmental monitoring responsibilities to internal teams, aiming to improve operational efficiency. CEO Jeff Wolf emphasized the importance of this milestone in reinforcing Scorpius' commitment to quality and supporting the development of breakthrough therapies.

Positive

• Successful cGMP facility validation enhances Scorpius' manufacturing capabilities.
• Backlog of client bookings indicates strong demand and trust in Scorpius' services.
• Transition to internal environmental monitoring expected to boost operational efficiency.
• Potential to further solidify position as a leader in clinical scale microbial manufacturing.

Negative

• No specific revenue figures or financial projections provided in the PR.
• Transitioning responsibilities internally could incur initial costs and challenges.

Gaining operating efficiency through transition to an internal environmental monitoring team

DURHAM, N.C., May 15, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the successful validation of its microbial facilities, marking a significant milestone in the Company's operations. This validation signifies that Scorpius’ microbial cleanrooms are now officially approved to manufacture current Good Manufacturing Practice (cGMP) microbial biologic drugs, underscoring the Company's commitment to quality and regulatory compliance.

Scorpius facilities have already garnered considerable interest, with a backlog of bookings from client programs. This achievement not only demonstrates Scorpius' capability to meet the regulatory and client driven high standards required for contract manufacturing of microbial biologics but also highlights the trust and confidence its clients place in its services.

In conjunction with the facility qualifications, Scorpius is also streamlining its operations by transitioning environmental monitoring responsibilities to internal teams, while it migrates from the previous reliance on third-party services. This shift is expected to allow for greater efficiency, further enhancing the Company's robust ability to deliver high-quality biomanufacturing services.

“Scorpius has experienced strong interest in our microbial capabilities, and we continue to add additional opportunities to our pipeline for 2024 and 2025,” stated Jeff Wolf, CEO of Scorpius Holdings. “This validation confirms our commitment to high-quality, state-of-the-art microbial production. We are dedicated to leveraging our advanced capabilities to support our clients' needs and contributing to the advancement of breakthrough therapies.”

“This validation is a testament to Scorpius’ rigorous quality standards and our dedication to supporting the development and manufacturing of microbial products. With this achievement, Scorpius is poised to further solidify its position as a leader in clinical scale microbial manufacturing, offering our clients unparalleled quality and service,” concluded Wolf.

Scorpius Holdings, Inc.

Scorpius Holdings Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy 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 as the transition of environmental monitoring responsibilities from third-parties to internal teams  being expected to allow for greater efficiency, further enhancing the Company's robust ability to deliver high-quality biomanufacturing services; continuing to add additional opportunities to the Company’s pipeline for 2024 and 2025; Scorpius being poised to further solidify its position as a leader in clinical scale microbial manufacturing, offering our clients unparalleled quality and service.  Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to continue to validate its microbial facilities; expand its large molecule biomanufacturing CDMO services and continue to grow revenue; 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 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

What milestone did Scorpius Holdings achieve in May 2024?

Scorpius Holdings achieved successful validation of its microbial manufacturing facilities for cGMP production.

What does the cGMP facility validation mean for Scorpius Holdings?

The cGMP facility validation allows Scorpius Holdings to manufacture microbial biologic drugs meeting high regulatory and client standards.

How has Scorpius Holdings' facility validation impacted client interest?

The facility validation has resulted in a backlog of client bookings, indicating strong interest and trust in Scorpius’ capabilities.

What operational change is Scorpius Holdings implementing for efficiency?

Scorpius Holdings is transitioning its environmental monitoring responsibilities to internal teams to enhance operational efficiency.

What is Scorpius Holdings' stock symbol?

Scorpius Holdings' stock symbol is SCPX.