Scorpius Holdings Successfully Executes First cGMP Microbial Batches at San Antonio Facility
Scorpius Holdings (NYSE American: SCPX) has successfully executed its first current Good Manufacturing Practice (cGMP) microbial batches at its San Antonio facility. This milestone marks the beginning of Scorpius' support for manufacturing programs through clinical manufacturing, with potential for future commercial activities. The company has attracted significant interest, resulting in a substantial backlog of client program bookings.
CEO Jeff Wolf emphasized that this achievement demonstrates Scorpius' robust systems and commitment to U.S.-based cGMP activities. The company is poised to execute additional cGMP activities throughout the remainder of the year, reinforcing its position as a leader in clinical scale microbial manufacturing.
- Successfully executed first cGMP microbial batches at San Antonio facility
- Substantial backlog of client program bookings
- Poised to execute additional cGMP activities throughout the year
- Demonstrates ability to meet stringent regulatory and client-driven standards
- None.
Insights
Scorpius Holdings achieved a significant milestone by successfully executing its first cGMP microbial batches. This is a positive indicator from a financial perspective, especially for a company within the contract development and manufacturing organization (CDMO) sector. The ability to meet cGMP standards is important as it signifies compliance with stringent regulatory requirements, which are essential for client trust and future commercial opportunities.
The backlog of client program bookings already indicates strong demand and potential revenue growth. For retail investors, this translates to expected stability in revenue streams, indicating a likely increase in share value over the short and long term, provided that Scorpius can maintain its operational standards and continue to meet client expectations. However, the company must ensure that it can scale its operations efficiently to manage this backlog; otherwise, it risks project delays or quality issues.
From a market perspective, the execution of cGMP microbial batches places Scorpius Holdings in a strong competitive position within the CDMO space. The cGMP certification is a respected benchmark that can enhance the company's marketability and attract more clientele from pharmaceutical and biotech firms who need reliable manufacturing partners for biologics and cell therapies.
This development is particularly relevant as the industry continues to experience growth, driven by the increasing demand for biologics and advanced cell therapies. The commitment to advancing U.S.-based GMP manufacturing capabilities may also appeal to domestic clients who prefer to minimize supply chain risks associated with overseas production.
For investors, this milestone can be seen as a strong signal of Scorpius's potential for market expansion and long-term growth, although they should remain vigilant about the company's ability to maintain quality and manage operational scalability.
Company poised to execute additional cGMP activities throughout the remainder of the year
DURHAM, N.C., July 18, 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 execution of its first current Good Manufacturing Practice (cGMP) microbial batches at its San Antonio manufacturing facility. This significant milestone marks the beginning of Scorpius’ support for manufacturing programs through clinical manufacturing, with aspirations for future commercial activities.
Scorpius' facilities have already attracted significant interest, resulting in a substantial backlog of client program bookings. This achievement underscores Scorpius' ability to meet the stringent regulatory and client-driven standards essential for the contract manufacturing of microbial biologics. It also highlights the trust and confidence that clients place in its services. Scorpius is poised to execute additional cGMP activities throughout the remainder of the year, reinforcing its commitment to advancing U.S.-based GMP manufacturing capabilities.
Jeff Wolf, CEO of Scorpius Holdings, remarked, "We are thrilled to have successfully completed our first cGMP microbial batches at the San Antonio facility. This milestone is a result of the dedication and collaboration among Scorpius’ manufacturing, process development, quality, and operations teams. The successful execution is a testament to the robust systems we have built and marks another step forward in our commitment to U.S. based cGMP activities for both current and future Scorpius clients."
"The Company remains dedicated to leveraging our advanced capabilities to support our clients' needs and contribute to the advancement of breakthrough therapies. With completion of this milestone, we believe that Scorpius is ready 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 Scorpius being poised to execute additional cGMP activities throughout the remainder of the year; aspirations for future commercial activities; Scorpius being ready to further solidify its position as a leader in clinical scale microbial manufacturing, offering its 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
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