Paulness
1 주 전
NEWS -- Scorpius Holdings Announces Collaboration with KaloCyte to Advance Manufacturing for ErythroMer™
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 $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 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
mailto://ir@scorpiusbiologics.com
Paulness
2 주 전
NEWS -- Scorpius Holdings Announces Reverse Stock Split
DURHAM, N.C., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today announced that the Company’s Board of Directors approved a 1-for-20 reverse stock split (the “Reverse Stock Split”) of the Company’s common stock (the “Common Stock”), to increase the selling price of the Company’s Common Stock in order to maintain compliance with the requirements and policies of the NYSE American.
The Reverse Stock Split will take legal effect at 12:01 A.M. Eastern Time on January 21, 2025, and the Company's Common Stock will open for trading on the NYSE American on January 21, 2025, on a post-split basis, under the existing ticker symbol "SCPX" but with a new CUSIP number 42237K607.
At Scorpius’ Special Meeting of Stockholders (the “Special Meeting”) held on January 16, 2025, the Company’s stockholders approved a proposal to amend the Company’s certificate of incorporation to effect a reverse stock split of its Common Stock at a ratio of between 1-for-5 to 1-for-35, with the ratio within such range to be determined at the discretion of the Company’s Board. Following the Special Meeting, the Board approved a final split ratio of 1-for-20. Following the Reverse Stock Split, the ownership percentage of each stockholder will remain unchanged, other than with respect to fractional shares. No fractional shares will be issued in connection with the Reverse Stock Split. In lieu of fractional shares, any person who would otherwise be entitled to a fractional share of Common Stock as a result of the Reverse Stock Split will receive a cash payment equal to the number of fractional shares that would otherwise have been issued multiplied by the average closing sales price of the Common Stock as reported on the NYSE American LLC for the ten days prior to the effective date of the Reverse Stock Split.
Additional details regarding the Company’s Reverse Stock Split can be found in the Current Report on Form 8-K that the Company will file with the Securities and Exchange Commission (the “SEC”).
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 regarding continuing to be in compliance with the requirements and policies of the NYSE American. Important factors that could cause actual results to differ materially from current expectations include, among others, the Reverse Stock Split resulting in an increase the selling price of the Company’s Common Stock; the ability of the Company to continue to meet the listing requirements of the NYSE American and have its Common Stock remain listed on the NYSE American; the effectiveness of the Reverse Stock Split on the anticipated date and time; 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, current reports on Form 8-Ks 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
mailto://ir@scorpiusbiologics.com
Paulness
2 월 전
NEWS -- Scorpius Holdings Launches Scorpius Ventures to Support U.S. Biotech Innovation through Flexible Equity-Based Onshoring Model
Scorpius Holdings, Inc.
New business unit offers services for promising biotech companies through combined fee-for-service and equity-based model, fostering partnerships that align with BIOSECURE Act goals to onshore and strengthen U.S.-based biosecurity and production capacity
DURHAM, N.C., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today announced the launch of Scorpius Ventures, a new business unit designed to support emerging biotech companies with a flexible American onshoring model. By combining service fees with an equity stake, Scorpius Ventures lowers financial barriers for its partners to onshore production of their biologics, creating a mutually beneficial pathway to accelerate biotech advancements.
Scorpius Ventures’ hybrid model offers capital-efficient access to its cGMP manufacturing services through in-kind equity investment, sharing in the growth potential of its clients.
“At Scorpius, we’re committed to enabling biotech innovation by aiming to reduce financial obstacles and creating true partnerships,” said Jeff Wolf, CEO of Scorpius Holdings. “Through Scorpius Ventures, we’re providing biotech companies the resources they need to advance critical therapies through a hybrid fee and equity model, thereby, fostering shared success while advancing our mission to strengthen U.S. biosecurity and manufacturing independence.”
This new venture model aligns with the BIOSECURE Act, supporting onshore production of essential biological substances to bolster national security and economic resilience. Scorpius Ventures prioritizes U.S.-based manufacturing, in an effort to enhance supply chain stability and promote domestic job growth.
Biotech partners benefit from Scorpius’ industry-leading CMC (Chemistry, Manufacturing, and Controls) and manufacturing expertise, ensuring streamlined development, reduced risks, and clear communication regarding milestones and timelines. By combining Scorpius’ operational support with a fee-and-equity model, clients can leverage the Company’s manufacturing strengths to aid in their own fundraising efforts.
Scorpius Ventures represents a bold step in onshoring development of American-made biologics, advancing BIOSECURE Act goals while reshaping how emerging biotech companies access capital and manufacturing.
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 https://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 Ventures enabling biotech innovation by reducing financial obstacles and creating true partnerships; Scorpius fostering shared success while advancing its mission to strengthen U.S. biosecurity and manufacturing independence; Scorpius Ventures enhancing supply chain stability and promoting domestic job growth; clients leveraging the Company’s manufacturing strengths to aid in their own fundraising effort 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 from the flexible equity based manufacturing model; 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
mailto://ir@scorpiusbiologics.com
Paulness
3 월 전
NEWS -- Scorpius Holdings Reports Third Quarter 2024 Results, Highlighting Strategic Partnerships, Cost Savings, and Progress Toward Profitability
Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today provided a strategic, financial, and operational update for the third quarter ended September 30, 2024.
Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, “Scorpius continued to make strides in Q3, driven by key partnerships, disciplined financial management, and growth across our manufacturing and development services. We are proud to report a 142% year-over-year increase in revenue for the nine months ended September 30, 2024, reaching $5.2 million, which illustrates the demand for our services and the successful expansion of our client base. Alongside this revenue growth, we achieved a 23.5% reduction in operating expenses for the nine months, a reflection of our commitment to financial discipline and cost optimization. Our ongoing cost savings initiatives, expected to exceed $2 million annually, have strengthened our foundation and keep us on track to achieve positive cash flow. These actions, coupled with our recent client wins and government engagements, position us well to capture new high-margin opportunities in both the government and biopharmaceutical sectors.”
Wolf added, “The new clients we onboarded this quarter demonstrate Scorpius' reputation as a trusted biomanufacturing partner for early-stage and clinical development. These agreements further highlight our ability to support companies with secure, U.S.-based solutions for development and manufacturing needs. These partnerships are indicative of our growing influence in the industry and our role as a resource for companies seeking flexible, responsive CDMO services.”
“Additionally, our selection to join the Medical CBRN Defense Consortium (MCDC) underscores Scorpius' commitment to advancing U.S. biosecurity. As a member of the MCDC, Scorpius is now eligible to collaborate on a range of medical countermeasures addressing chemical, biological, radiological, and nuclear (CBRN) threats. Furthermore, the passage of the BIOSECURE Act in the House of Representatives on September 9, 2024, highlights the importance of strengthening the U.S. biomanufacturing sector, a mission that aligns closely with our own commitment to supporting public health and national defense through high-quality, domestic biomanufacturing capabilities.”
Concluding, Wolf stated, “Our future looks promising with a weighted average pipeline of business development opportunities now exceeding $100 million across diverse sectors. As we look ahead, we are focused on expanding our service offerings, utilizing our state-of-the-art GMP facility to its full potential, and driving long-term value for our shareholders. The momentum we have built this year has positioned the Company to become a leading CDMO, and we are excited to capitalize on the growth and opportunities that lie ahead.”
Third Quarter 2024 Financial Results
For the three months ended September 30, 2024, the Company recognized $0.9 million of revenue, primarily from process development services, compared to $0.7 million of CDMO revenue recognized in the 2023 comparable quarter. The increase in CDMO revenue is attributable to the completion of process development services over a larger number of customer contracts.
Cost of revenues were $0.9 million and $0.5 million for the three months ended September 30, 2024, and 2023, respectively, and primarily consisted of the direct cost of labor, overhead and material costs at Scorpius. The increase in cost of revenues is due to the expanded service offerings and completed milestone work on multiple CDMO contracts.
Research and development expenses were $4.3 million for the three months ended September 30, 2024, compared to $5.2 million for the three months ended September 30, 2023.
Selling, general and administrative expenses were $5.6 million and $6.1 million for the three months ended September 30, 2024, and 2023, respectively. The decrease of $0.5 million was primarily due to decreases in consultant services of $0.8 million, sales and marketing of $0.3 million, stock-based compensation of $0.3 million, partially offset by increases in rent of $0.3 million, professional services of $0.3 million, personnel of $0.1 million, and public company expenses of $0.1 million.
For the three months ended September 30, 2024, the change in fair value of contingent earn-out receivable, related party increased by $0.2 million, prior to its reclassification to related party receivable.
Total non-operating expense was $0.9 million for the three months ended September 30, 2024, which primarily consisted of $0.7 million from the loss on partial debt extinguishment, $0.2 million of interest expense on finance leases, $0.1 million from the change in fair value of the convertible and non-convertible promissory notes to a related party, partially offset by an increase of $0.1 million in change in fair value of related party receivable. Total non-operating expense was $0.1 million for the three months ended September 30, 2023, which primarily consisted of $0.2 million of interest expense partially offset by $0.1 million of interest income.
Net loss attributable to Scorpius was approximately $10.1 million, or ($1.43) per basic and diluted share, for the three months ended September 30, 2024, compared to approximately $13.1 million, or ($100.82) per basic and diluted share, for the three months ended September 30, 2023.
As of September 30, 2024, the Company had approximately $4.8 million in cash and cash equivalents and short-term investments. As of November 14, 2024, the Company’s cash and cash equivalents and short-term investments were approximately $0.8 million.
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 https://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 continuing to make strides in Q3, driven by key partnerships, disciplined financial management, and growth across the Company’s manufacturing and development services; ongoing cost savings initiatives, expected to exceed $2 million annually; being on track to achieve positive cash flow; being positioned to capture new high-margin opportunities in both the government and biopharmaceutical sectors; the Company’s growing influence in the industry and its role as a resource for companies seeking flexible, responsive CDMO services; the future looking promising with a sales pipeline now exceeding $100 million in weighted opportunities across diverse sectors; in the future expanding the Company’s service offerings, utilizing its state-of-the-art GMP facility to its full potential, and driving long-term value for its shareholders; and the Company being positioned to become a leading CDMO, and to capitalize on the growth and opportunities that lie ahead. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to capitalize on the Company’s sales pipeline; 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
mailto://ir@scorpiusbiologics.com
Paulness
3 월 전
NEWS -- Scorpius Holdings Announces Collaboration with Celltheon Corporation, a U.S.-Based Cell Line Development Company; First Client Signed Under New Partnership Agreement
Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today announced a partnership with Celltheon Corporation to provide cell line development services to clients using Celltheon’s proprietary GOLDILOCKS™ transposase-based platform.
This collaboration enables clients to integrate with Scorpius’ program management team and quality system while preparing to transfer a research cell bank (RCB) to the Company’s facilities in San Antonio, TX, for further biomanufacturing work. In addition to full-scale cell line development services, Celltheon offers Scorpius clients services in antibody discovery, variant screening and development, and comparability studies. The first client signed under this partnership aims to scale up to GMP manufacturing with Scorpius.
Jeff Wolf, CEO of Scorpius, commented, “We are excited to collaborate with Celltheon, a partner that shares Scorpius’ mission to deliver responsive, high-quality, flexible services to early-stage biotechs and academic researchers. This partnership allows our clients to secure their supply chain and intellectual property by working with Celltheon, a California-based company, and then transferring their high-expressing, stable cell line to our state-of-the-art GMP facility in Texas to continue manufacturing.”
“We look forward to helping Scorpius clients overcome their early development challenges so they can seamlessly move to GMP activity. Together, Celltheon and Scorpius are committed to ensuring that the next generation of biotherapeutics get to patients faster and more affordably,” added Divya Goel, VP of Business Development and Board Member at Celltheon.
Celltheon
Celltheon develops leading edge technologies and innovative solutions for the next generation of biotherapeutics. Celltheon offers platformed and custom end-to-end solutions for drug developability, cell line development, and process development to its clients, to bridge the gap between early drug development and manufacturing. For more information, please visit https://www.celltheon.com.
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 https://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 collaboration enabling clients to integrate with Scorpius’ program management team and quality system while preparing to transfer a research cell bank (RCB) to the Scorpius facilities in San Antonio, TX, for further biomanufacturing work; the partnership allowing Scorpius clients to secure their supply chain and intellectual property by working with Celltheon and then transferring their high-expressing, stable cell line to the Scorpius state-of-the-art GMP facility in Texas to continue manufacturing; delivering responsive, high-quality, flexible services to early-stage biotechs and academic researchers; helping Scorpius clients overcome their early development challenges so they can seamlessly move to GMP activity and ensuring that the next generation of biotherapeutics get to patients faster and more affordably 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 from the partnership including expanding the services to be provided; 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
mailto://ir@scorpiusbiologics.com
Paulness
3 월 전
NEWS -- Scorpius Holdings Announces Implementation of New Cost Savings Measures Expected to Save Over $2 Million Annually
Efficiency Initiatives Designed to Accelerate Path to Profitability
DURHAM, N.C., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or the “Company”), an integrated biomanufacturing company, today announced the implementation of strategic cost-saving measures expected to save over $2 million annually.
The recently implemented measures include the divestiture of certain non-core assets and the initiation of programs designed to optimize operational efficiency across the organization. The Company expects these measures to significantly enhance its financial position and enable a sharper focus on high-margin growth areas within its sales pipeline.
“We’re committed to accelerating our path to profitability and achieving positive cash flow through disciplined cost management and operational efficiency,” said Jeff Wolf, CEO of Scorpius. “With these cost-saving initiatives, we’re strengthening our financial foundation and positioning Scorpius to expand our robust service offerings. I am particularly encouraged by our growing sales pipeline and look forward to updating stakeholders on our continued progress in the weeks ahead.”
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 https://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 measures significantly enhancing the Company’s financial position and enabling a sharper focus on high-margin growth areas within its sales pipeline; accelerating the Company’s path to profitability and achieving positive cash flow through disciplined cost management and operational efficiency ; positioning Scorpius to expand its robust service offerings; being encouraged by the growing sales pipeline. 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 from the implemented measures; the Company’s ability to continue to grow its pipeline and expand its service offerings, 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
mailto://ir@scorpiusbiologics.com
Paulness
3 월 전
NEWS -- Scorpius Holdings Announces Partnership with U.S. Biotech Company
Agreement reinforces Scorpius' position as a respected U.S. biomanufacturing partner for early-stage and clinical development
DURHAM, N.C., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or the “Company”), an integrated biomanufacturing company, today announced a strategic partnership with a U.S.-based biotech company. Under this agreement, the biotech company will work with Scorpius' program management team, with plans to transfer a research cell bank (RCB) to Scorpius’ state-of-the-art facilities in San Antonio, TX for future biomanufacturing activities.
“This partnership underscores Scorpius' ability to support biotech companies at every stage of their journey, from innovative research to clinical trials,” said Jeff Wolf, CEO of Scorpius. “We are seeing a growing number of biotech companies seeking U.S.-based biomanufacturing partners, and Scorpius is equipped to provide early-stage development, preclinical manufacturing, and cGMP clinical manufacturing for both mammalian and microbial programs.”
Wolf added, “Our clients highlight our flexibility and responsiveness—qualities often lacking in larger multinational CDMOs. With this partnership, we continue to fulfill the critical need for secure, U.S.-based development and manufacturing support for groundbreaking biologics research.”
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 https://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 biotech company working with Scorpius' program management team, with plans to transfer a research cell bank (RCB) to Scorpius’ state-of-the-art facilities in San Antonio, TX for future biomanufacturing activities; and continuing to fulfill the critical need for secure, U.S.-based development and manufacturing support for groundbreaking biologics research with this partnership. 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 from the partnership including expanding the services to be provided 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
mailto://ir@scorpiusbiologics.com
Paulness
4 월 전
NEWS -- Scorpius Holdings Selected to Join Medical CBRN Defense Consortium to Advance Medical Countermeasures Against Chemical, Biological, Radiological, and Nuclear Threats
DURHAM, N.C., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today announced that it has been selected to join the Medical CBRN Defense Consortium (MCDC), a key organization advancing the development of medical countermeasures and related technologies to protect U.S. military personnel and civilians from chemical, biological, radiological, and nuclear (CBRN) threats.
The MCDC, established in 2015 under the U.S. Department of Defense (DoD), serves as a collaborative framework for government, industry, and academia to partner on cutting-edge medical solutions. Its mission is to rapidly advance research, development, and manufacturing of technologies that safeguard national security. As a member, Scorpius will contribute its proprietary scientific expertise and resources to accelerate innovations aimed at addressing CBRN threats.
“We are honored to be selected to join the Medical CBRN Defense Consortium, which plays a vital role in safeguarding public health against complex CBRN challenges,” said Jeff Wolf, CEO of Scorpius. “Our selection as a member reinforces our commitment to developing therapies that can protect both military personnel and civilians in the face of evolving threats.”
Membership in the consortium allows Scorpius to engage with government stakeholders, collaborate with other innovative companies and academic institutions, and pursue funding opportunities for projects aligned with the DoD’s medical CBRN defense priorities.
The Medical CBRN Defense Consortium includes organizations committed to the research and development of technologies and treatments for CBRN hazards. As Scorpius continues to advance its strategic initiatives, this selection represents a significant milestone in the company’s ongoing efforts to contribute to U.S. biosecurity and national defense.
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 https://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 contributing its proprietary scientific expertise and resources to accelerate innovations aimed at addressing CBRN threats and the selection to join the MCDC representing a significant milestone in the company’s ongoing efforts to contribute to U.S. biosecurity and national defense. 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 from joining the MCDC; 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
mailto://ir@scorpiusbiologics.com
Paulness
4 월 전
NEWS -- Scorpius Holdings Announces Contract with Premier Clinical-Stage Biotech Company; Opens Door to Future GMP Manufacturing Opportunities
DURHAM, N.C., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today announced it has signed a contract to provide bioanalytical services for a publicly traded clinical-stage immuno-oncology company.
This collaboration opens the door for further opportunities, as Scorpius expects to expand its services to include additional analytical work and future GMP manufacturing upon completion of this initial phase. This contract underscores Scorpius’ expertise in delivering critical bioanalytical and process development services, further establishing its role as a trusted partner in the biologics manufacturing space.
Jeff Wolf, CEO of Scorpius, commented, "This important contract is a clear validation of Scorpius’ comprehensive capabilities which include advanced bioanalytical services. Our state-of-the-art bioanalytical and process development facilities enable us to offer an integrated solution that meets the diverse needs of biologics manufacturers. We are excited by the potential to develop this partnership further and to offer ongoing bioanalytical support and future GMP manufacturing services to help advance this client’s clinical programs.”
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 https://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 expanding its services to include additional analytical work and future GMP manufacturing upon completion of the initial phase of the contract;. and the potential to develop the partnership further and to offer ongoing bioanalytical support and future GMP manufacturing services to help advance this client’s clinical programs contributing its proprietary scientific expertise and resources to accelerate innovations aimed at 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 from the partnership including expanding the services to be provided 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
mailto://ir@scorpiusbiologics.com
Paulness
5 월 전
NEWS -- Scorpius Holdings Commends the U.S. House of Representatives’ Passage of the BIOSECURE Act
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 https://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
mailto://ir@scorpiusbiologics.com
Paulness
5 월 전
NEWS -- Scorpius Selected for Rapid Response Partnership Vehicle (RRPV) to Accelerate Medical Countermeasure Development in Support of BARDA
September 09 2024 - 8:30AM
GlobeNewswire
Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today announced that it has been selected as a member of the Biomedical Advanced Research and Development Authority’s (BARDA) Rapid Response Partnership Vehicle (RRPV). The RRPV supports BARDA in its mission to accelerate the development of medical countermeasures (MCMs) to address emerging biological threats such as pandemic influenza, infectious diseases, and other public health emergencies.
As an active member of the RRPV, Scorpius will collaborate with BARDA and other federal partners to support MCM product and technology development in critical areas such as vaccines and therapeutics. Scorpius’ extensive capabilities in biomanufacturing and its state-of-the-art production facilities should uniquely position it to meet the evolving needs of government agencies tasked with responding to biological threats.
“We are honored to have been selected for the Rapid Response Partnership Vehicle,” said Jeff Wolf, CEO of Scorpius Holdings. “This opportunity allows us to leverage our manufacturing capabilities to support BARDA, the US government, and groups that service the US government in rapidly addressing public health emergencies. Our team is committed to accelerating the development of medical countermeasures and delivering scalable solutions to protect public health and national security.”
Scorpius’ facilities are equipped to handle the production of biological products, offering both standard and custom solutions for the development of biopharmaceuticals. The company's manufacturing platform is designed for flexibility, enabling swift responses to emerging health threats. By becoming part of the RRPV, Scorpius expects to play an important role in ensuring preparedness for future public health emergencies such as pandemics and other biological risks.
BARDA, a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR), works to support the development of medical countermeasures such as vaccines, drugs, and diagnostic tools to counteract health security threats. The inclusion of Scorpius in the RRPV highlights the company’s ability to innovate in the rapidly evolving landscape of biomanufacturing.
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 https://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 collaboration expediting the development of critical solutions for public health threats, including pandemic preparedness and emerging infectious diseases; Scorpius collaborating with BARDA and other federal partners to support MCM product and technology development in critical areas such as vaccines and therapeutics; Scorpius’ extensive capabilities in biomanufacturing and its state-of-the-art production facilities uniquely positioning it to meet the evolving needs of government agencies tasked with responding to biological threats; the opportunity allowing the Company to leverage our manufacturing capabilities to support BARDA, the US government, and groups that service the US government in rapidly addressing public health emergencies; Scorpius playing an important role in ensuring preparedness for future public health emergencies such as pandemics and other biological risks by becoming part of the RRPV Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to, due to the collaboration, expedite the development of critical solutions for public health threats, including pandemic preparedness and emerging infectious diseases; 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
mailto://ir@scorpiusbiologics.com
Paulness
5 월 전
NEWS -- Scorpius Holdings CEO Provides Corporate Update; Highlights Expanding Sales Pipeline, Enhanced Manufacturing Capabilities, and Path Toward Positive Cash Flow
Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today released a letter to shareholders from its CEO Jeff Wolf:
"We are excited to share an update on Scorpius as we continue to position the company to take a lead role in catering to the rapidly growing biologic and cell therapy markets. Over the past several years, we have made significant investments designed to establish Scorpius as a leading biologic manufacturing CDMO. Notably, we have expanded our mammalian and microbial production capability to enable us to offer a broad range of biologic manufacturing services to our customers. Our robust investments and ongoing efforts have already resulted in a threefold increase in revenue for the first half of 2024. Our current sales pipeline now includes more than $100 million in weighted opportunities across the biopharmaceutical and government sectors.
Given the extensive opportunities before us, we recently completed a financing, raising approximately $14.4 million in gross proceeds. These funds will enable us to better service our existing clients as well as attract larger prospective customers as we diversify our customer base with a strong mix of commercial and government opportunities. Additionally, we have started transitioning several key clients from the process development phase into full-scale manufacturing, enabling an additional revenue stream and marking a significant shift in our operational focus.
We believe that Scorpius is now exceptionally well-positioned to service new and existing clients, expand its service offering and achieve positive cash flow in the near future. Given these overarching goals, we are taking steps to align senior executive compensation with our growth objectives, contingent on meeting sales targets and booking goals.
We’ve built and staffed a state-of-the-art CDMO with a scalable and high-margin business model. Scorpius’ profile and reputation for quality biomanufacturing is indeed growing in the industry. With the closing of this financing, we are now well positioned to deliver significant returns to our shareholders in the years to come."
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 https://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 continuing to position the Company to take a lead role in catering to the rapidly growing biologic and cell therapy markets, the current sales pipeline now including more than $100 million in weighted opportunities across the biopharmaceutical and government sectors, the funds raised enabling the Company to better service its existing clients as well as attract larger prospective customers the Company being well-positioned to service new and existing clients, expand its service offering and achieve positive cash flow in the near future and being well positioned to deliver significant returns to the Company’s shareholders in the years to come. Important factors that could cause actual results to differ materially from current expectations include, among others, 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
mailto://ir@scorpiusbiologics.com
Paulness
5 월 전
NEWS -- Scorpius Holdings Achieves 16% Year-Over-Year Increase in Revenue for the Second Quarter of 2024
Reduces operating expenses by 25%
Pipeline surpasses $100 million in weighted opportunities across the government and manufacturing sectors
DURHAM, N.C., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today provided strategic, financial, and operational updates for the second quarter ended June 30, 2024.
Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, “We are extremely proud of the progress Scorpius achieved in the second quarter of 2024. Despite facing a quarter with significant working capital challenges, our revenues still increased by 16% and we reduced our operating expenses by 25% over the same period last year. With our recently completed financing, we now have a much stronger balance sheet to capitalize on a number of exciting projects in front of us. We anticipate this funding will not only allow us to accelerate our revenue growth but should enable us to achieve our goal of positive cash flow.”
“Our success this year highlights the significant progress we’ve made in both innovation and customer-focused program management across our service platforms. This progress is most clearly reflected in the strength of our pipeline, which now surpasses $100 million in weighted opportunities across the government and manufacturing sectors. We anticipate closing many of these opportunities by year’s end. As we look ahead, we are confident in our ability to sustain this momentum as we continue to execute our strategic initiatives and deliver value to our shareholders.”
Second Quarter 2024 Financial Results
For the three months ended June 30, 2024, the Company recognized $0.8 million of revenue, primarily from process development, compared to $0.7 million of process development revenue recognized in the 2023 comparable quarter. The increase in process development revenue is attributable to the completion of services over a larger number of customer contracts.
Cost of revenues were $0.8 million and $0.4 million for the three months ended June 30, 2024, and 2023, respectively, and primarily consisted of the direct cost of labor, overhead and material costs at Scorpius. The increase in cost of revenues is due to the expanded service offerings and completed milestone work on multiple CDMO contracts.
Research and development expenses were $3.6 million for the three months ended June 30, 2024, compared to $5.2 million for the three months ended June 30, 2023.
Selling, general and administrative expenses were $5.0 million and $7.0 million for the three months ended June 30, 2024, and 2023, respectively. The decrease of $2.0 million was primarily due to decreases in consultant services of $1.1 million, professional services of $0.4 million, sales and marketing of $0.2 million, and stock-based compensation of $0.3 million.
For the three months ended June 30, 2024, there was no change in fair value of contingent earn-out receivable, related party.
Total non-operating expense was ($0.6) million for the three months ended June 30, 2024, which primarily consisted of $0.6 million from the loss on disposal of leasehold improvements, $0.2 million of interest expense on finance leases, partially offset by $0.2 million from gain on partial extinguishment of debt. Total non-operating expense was ($0.2) million for the three months ended June 30, 2023, which primarily consisted of ($0.2) million of interest expense, ($0.1) million of loss on disposal of equipment, partially offset by ($0.1) million of interest income.
Net loss attributable to Scorpius was approximately $8.9 million, or ($26.98) per basic and diluted share, for the three months ended June 30, 2024, compared to approximately $13.9 million, or ($106.67) per basic and diluted share, for the three months ended June 30, 2023.
As of June 30, 2024, the Company had approximately $1.5 million in cash and cash equivalents and short-term investments. As of August 19, 2024, the Company’s cash and cash equivalents and short-term investments were approximately $13.2 million.
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 https://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 being able to capitalize on a number of exciting projects in front of the Company, the funding allowing the Company to accelerate its revenue growth and enable it to achieve its goal of positive cash flow, the Company’s pipeline, surpassing $100 million in weighted opportunities across the government and manufacturing sectors, the closing of many of the pipeline opportunities by year’s end, and the Company’s ability to sustain the momentum as it continues to execute its strategic initiatives and deliver value to its shareholders. Important factors that could cause actual results to differ materially from current expectations include, among others, 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
mailto://ir@scorpiusbiologics.com
Paulness
5 월 전
NEWS -- Scorpius Holdings, Inc. Announces Closing of Public Offering
Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the closing of its underwritten public offering of 14,375,000 shares of common stock (and/or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof), including full exercise of the underwriter’s over-allotment option. Each share of common stock (or Pre-Funded Warrant) was offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price), for gross proceeds of $14,375,000, before deducting underwriting discounts and offering expenses.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity acted as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887) relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus has been filed with the SEC and is available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule 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 https://www.scorpiusbiologics.com.
Forward-Looking Statements
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 regarding the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q 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 press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
Paulness
6 월 전
NEWS -- Scorpius Holdings, Inc. Announces Pricing of Public Offering
DURHAM, N.C., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the new pricing of an underwritten public offering of 12,500,000 shares of common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The gross proceeds to the Company from the offering are expected to be approximately $12,500,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,875,000 shares of common stock and/or Pre-Funded Warrants solely to cover over-allotments, if any. As previously announced, the Company had terminated the pricing of its underwritten public offering that it had announced on August 6, 2024. Subsequently, the Company requested, and the NYSE American approved, a financial viability exception to the NYSE American stockholder approval rules that would allow the Company to proceed with the closing of the underwritten public offering upon the terms set forth above.
The offering is expected to close on August 19, 2024, subject to satisfaction of customary closing conditions and trading of the Company’s common stock on the NYSE American is expected to resume that same day.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule 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 https://www.scorpiusbiologics.com.
Forward-Looking Statements
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 regarding the timing and completion of the proposed offering, the timing that trading will resume and the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q 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 press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
Paulness
6 월 전
NEWS -- Scorpius Holdings, Inc. Provides Update on its Previously Announced Public Offering
August 09 2024 - 3:38PM
Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced a delay in its previously announced public offering. The Company has requested, and the NYSE has approved, a financial viability exception to the NYSE American shareholder approval rules that would allow it to proceed with the closing of an underwritten public offering. The Company intends to pursue the sale of 12,500,000 shares of common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof, exclusive of the over-allotment option) at a price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The underwriting agreement was terminated in connection with the previously announced offering and a new underwriting agreement will be entered into if the offering is consummated. There can be no assurance that the Company will be able to consummate an offering under these terms or otherwise. The Company will adhere to all applicable provisions relating to the exemption, as outlined in Section 710 of the NYSE American Company Guide, and a closing is intended to occur ten days following the mailing of a notification letter to the Company’s shareholders.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule 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 https://www.scorpiusbiologics.com.
Forward-Looking Statements
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 regarding the repricing of the offering, the ability to consummate an offering under the specified terms or otherwise the timing and completion of the proposed offering and the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q 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 press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
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