Scorpius Holdings Commends the U.S. House of Representatives’ Passage of the BIOSECURE Act

Rhea-AI Summary

Scorpius Holdings (NYSE American: SCPX) commends the U.S. House of Representatives for passing the BIOSECURE Act with strong bipartisan support (306-81 vote). This legislation aims to secure America's pharmaceutical supply chain, strengthen national biosecurity, and improve preparedness for public health emergencies. The Act restricts U.S. Government-funded drug developers from contracting with select China-based biomanufacturing companies, potentially increasing demand for domestic production capabilities.

Scorpius CEO Jeff Wolf anticipates significant opportunities to expand the company's project pipeline as a result of this legislation. As a U.S.-based integrated contract development and manufacturing organization (CDMO), Scorpius is positioned to support biopharmaceutical companies navigating these changes with its cutting-edge expertise and modern facilities.

Positive

• Potential increase in demand for Scorpius' domestic biomanufacturing services due to the BIOSECURE Act
• Strong bipartisan support for the Act (306-81 vote) increases likelihood of Senate passage
• Scorpius' U.S.-based facilities and expertise position it favorably to benefit from the legislation

Negative

• The BIOSECURE Act still needs to pass the U.S. Senate to become law
• Increased competition from other domestic CDMOs as demand shifts to U.S.-based manufacturers

Insights

Policy Analyst

The passage of the BIOSECURE Act marks a significant shift in U.S. pharmaceutical policy. This legislation aims to reduce dependence on foreign biomanufacturing, particularly from China, for government-funded drug development. The Act's implications are far-reaching:

• Enhanced national security through domestic drug production
• Potential boost for U.S.-based CDMOs like Scorpius
• Increased costs for pharmaceutical companies transitioning to domestic suppliers

While the Act promises improved biosecurity, it may lead to short-term supply chain disruptions and higher drug prices. Long-term, it could stimulate domestic biomanufacturing innovation and create jobs. Investors should monitor how quickly the industry adapts and whether the Senate passes the bill.

Biotech Industry Analyst

The BIOSECURE Act represents a paradigm shift for the biotech industry. For companies like Scorpius, this legislation opens up substantial growth opportunities in the domestic CDMO market. Key points to consider:

• Increased demand for U.S.-based biomanufacturing capabilities
• Potential for expanded government contracts and partnerships
• Accelerated investment in domestic biotech infrastructure

However, the transition won't be without challenges. Smaller biotech firms may face increased costs and potential delays in drug development. Investors should look for companies with established U.S. manufacturing presence and strong government relationships to capitalize on this shift.

Financial Analyst

The BIOSECURE Act could be a game-changer for Scorpius Holdings and similar U.S.-based CDMOs. While specific financial projections aren't provided, several factors suggest positive implications:

• Potential for increased revenue streams from government-backed projects
• Likely expansion of client base as pharma companies seek domestic partners
• Possible need for capital investment to scale operations rapidly

Investors should watch for upcoming quarterly reports to gauge the Act's impact on Scorpius's project pipeline and revenue growth. The company's ability to quickly scale operations and secure new contracts will be important in capitalizing on this opportunity. Keep an eye on profit margins as competition in the domestic CDMO space may intensify.

Scorpius Poised to Support Expanded U.S. Government-Backed Project Pipeline as U.S. Drugmakers Seek to Shift to Domestic Suppliers Amid Industry-Changing Legislation

DURHAM, N.C., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today commended the U.S. House of Representatives on the passage of the BIOSECURE Act (the “Act”), a pivotal piece of legislation passed with strong bipartisan support following a 306-81 vote earlier this week.

The Act is designed to ensure the security of America’s pharmaceutical supply chain, strengthen national biosecurity, and improve overall preparedness for future public health emergencies. The Act now moves to the U.S. Senate, representing a critical step in bolstering the country's biotechnology and biomanufacturing infrastructure to ensure long-term public health resilience in the face of challenges from America’s adversaries.

The BIOSECURE Act aims to secure the U.S. pharmaceutical supply chain by restricting U.S. Government-funded drug developers from contracting with select China-based biomanufacturing companies of concern for production of their drugs. The Act is designed to reduce U.S. dependence on foreign owned and operated biomanufacturing supply chains which will enhance national security and generate more on-shoring jobs focused on improving robustness in us health care systems.

Jeff Wolf, CEO of Scorpius, stated, “We owe a debt of gratitude to Reps. Wenstrup, Krishnamoorthi, and Moolenaar for their leadership in advancing the BIOSECURE Act, that enhances America’s health security and protects our supply chain from foreign threats. The BIOSECURE Act enables Scorpius to leverage our expertise and resources to support America’s biopharmaceutical companies that collaborate with the U.S. Government in the production of their drugs. We believe that our cutting-edge biomanufacturing expertise, purpose-built capabilities, combined with our modern US-based production facilities gives us a distinct advantage in addressing the changing demands of biopharmaceutical companies and government agencies tasked with managing biological threats. We are fully dedicated to fast-tracking the development of medical countermeasures and delivering scalable, forward-thinking solutions that protect public health and reinforce national security.

"The BIOSECURE Act enhances our ability to deliver impactful, timely responses in critical moments of need. With the passage of the BIOSECURE Act, we foresee significant opportunities to further expand our already robust pipeline of projects. As a result of this legislation, we expect a growing demand for domestic production capabilities and biomanufacturing services, positioning Scorpius as a key partner for pharmaceutical companies navigating these changes,” concluded Mr. 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 BIOSECURE Act representing a pivotal opportunity for Scorpius to leverage its expertise and resources to support America’s biopharmaceutical companies who are responding to indications of interest to the U.S. Government in the production of their drugs; the Company’s cutting-edge biomanufacturing expertise, purpose-built capabilities, combined with its modern US-based production facilities, giving it a distinct advantage in addressing the changing demands of biopharmaceutical companies and government agencies tasked with managing biological threats; the legislation enhancing the Company’s ability to deliver impactful, timely responses in critical moments of need; the passage of the BIOSECURE Act resulting in significant opportunities to further expand the Company’s already robust pipeline of projects; positioning Scorpius as a key partner for pharmaceutical companies navigating the changes from the expected growing demand for domestic production capabilities and biomanufacturing services; and the Company’s advanced facilities and expertise making it well-equipped to meet the increasing need for reliable, secure supply chains in the U.S., further strengthening the Company’s position in the market. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to derive the anticipated benefits form the BIOSECURE Act; the Company’s ability to expand its large molecule biomanufacturing CDMO services, 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

What is the BIOSECURE Act and how does it affect Scorpius Holdings (SCPX)?

The BIOSECURE Act is legislation designed to secure America's pharmaceutical supply chain and strengthen national biosecurity. It potentially benefits Scorpius Holdings (SCPX) by increasing demand for domestic biomanufacturing services, as it restricts U.S. Government-funded drug developers from contracting with certain China-based biomanufacturing companies.

How did the U.S. House of Representatives vote on the BIOSECURE Act?

The U.S. House of Representatives passed the BIOSECURE Act with strong bipartisan support, resulting in a 306-81 vote in favor of the legislation.

What opportunities does Scorpius Holdings (SCPX) anticipate from the BIOSECURE Act?

Scorpius Holdings (SCPX) anticipates significant opportunities to expand its project pipeline due to expected growing demand for domestic production capabilities and biomanufacturing services as a result of the BIOSECURE Act.

What services does Scorpius Holdings (SCPX) offer as a CDMO?

Scorpius Holdings (SCPX) 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.