Latest news with #JeffWolf
Business Wire
14-05-2025
- Business
- Business Wire
Tivic Health Enters GMP Manufacturing Validation Agreement with Scorpius BioManufacturing in Preparation for FDA Submission
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing to complete the GMP manufacturing validation of the lead candidate from its TLR5 program, Entolimod™, for treatment of Acute Radiation Syndrome, or ARS, in preparation for filing a Biological Licensing application, or BLA, with the U.S. Food & Drug Administration. Scorpius BioManufacturing, Inc. is an integrated contract development and manufacturing organization (CDMO) and subsidiary of Scorpius Holdings Inc. (OTC:SCPX), which will be the primary U.S. manufacturer for Entolimod™. Scorpius plans to utilize its scientific and technical expertise to validate the commercial manufacturing process for Tivic's lead candidate, Entolimod™. The GMP Validation Program is valued at approximately $4.1 million and is inclusive of the following activities: cell line verification, legacy process verification, GMP scale-up production, drug product fill and finish, analytical development and qualification, and finally upstream and downstream optimization of the process. All of these activities are designed to ensure Tivic submits to the FDA a complete CMC (chemistry, manufacturing, and control) package for its Entolimod BLA. Jennifer Ernst, CEO of Tivic, commented, 'We believe that Scorpius' specialized focus on manufacturing of biologicals and its experience with Department of Defense programs makes them the perfect partner for completing our GMP manufacturing validation for our FDA BLA filing as well as for commercial production, subject to FDA approval.' Scorpius plans to validate the manufacturing process for Entolimod™ utilizing its facility in San Antonio, Texas. The use of this domestic facility offers a leaner supply chain, ensures the end product is manufactured in the U.S., and provides a streamlined path toward the goal of commercial success. Tivic believes that Entolimod is uniquely positioned for ARS and follow-on applications, as it is potentially the only therapy that can prevent and treat radiation-related damage to both human hematopoietic and gastrointestinal cells. 'We welcome the opportunity to contribute our scientific and technical expertise to delivering the successful manufacture of this important therapy,' said Jeff Wolf, CEO of Scorpius. 'We look forward to working closely with Tivic and reinforcing Scorpius' reputation as a trusted and innovative biomanufacturing partner.' About Tivic Health Systems, Inc. Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation for the vagus nerve to deliver meaningful improvements in clinically relevant measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ to treat ARS, has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: Scorpius BioManufacturing, Inc. Scorpius BioManufacturing, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit Forward-Looking Statements This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and include statements regarding Scorpius serving as the primary U.S. manufacturer for Entolimod; Scorpius utilizing its scientific and technical expertise to validate the commercial manufacturing process for Tivic's lead candidate, Entolimod; Scorpius' plans to validate the manufacturing process for Tivic's lead candidate utilizing its facility in San Antonio, TX; the use of the domestic facilities enabling leaner supply chains; Entolimod being uniquely positioned to be the only therapy that can potentially prevent and treat damage to human hematopoietic and gastrointestinal cells due to radiation exposure; Tivic's ability to realize near-term value for their shareholders and patients. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the ability of Scorpius to successfully manufacture Entolimod; Tivic Health's interactions with and receipt of guidance from the FDA; potential failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; Tivic Health's future development of Entolimod and Entolasta; changes to the companies' business strategies timing and success of clinical trials and study results; regulatory requirements and pathways for approval; consummation of any strategic transactions; Tivic Health's need for, and ability to secure when needed, additional working capital; and Tivic Health's ability to maintain its Nasdaq listing. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading 'Risk Factors', as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law.
The Sun
05-05-2025
- Business
- The Sun
US-based Scorpius exploring halal-compliant biomanufacturing facility in Malaysia
KUALA LUMPUR: Scorpius Holdings Inc, a United States-based integrated contract development and manufacturing organisation, is exploring the establishment of a halal-compliant biomanufacturing facility in Malaysia as part of its international expansion strategy. In a statement, the company said discussions with key Malaysian stakeholders and regulatory authorities are underway to potentially set up a local subsidiary aimed at serving regional and global demand for halal-certified biopharmaceutical products. This initiative aimed to address a critical gap in access to halal-certified biologics for the global Muslim population, which is significantly underserved. Its CEO, Jeff Wolf, said the move is part of Scorpius' broader strategic restructuring to improve operational efficiency and drive long-term growth. 'We have proactively implemented structural changes to right-size our operations, including workforce reductions and the closing of our North Carolina facilities to consolidate operations in one location,' he said. The restructuring, which includes a 28% reduction in headcount and the realignment of non-core expenditure, is expected to generate over US$6 million (RM25.2 million) in annualised cost savings. Meanwhile, Science, Technology and Innovation Minister Chang Lih Kang welcomed the initiative, noting its alignment with Malaysia's ambition to become a global hub for halal biopharmaceutical innovation. To support this global push, Scorpius has appointed prominent Malaysian entrepreneur Tan Sze Thuan to its Board of Directors. Tan is World Total Logistics Sdn Bhd founder and CEO, and his experience in Southeast Asia's logistics and regulatory environment is expected to aid the company's regional expansion efforts. Scorpius continues to provide biologics manufacturing, process development, and analytical services to global clients while pursuing strategic alternatives to enhance shareholder value. – Bernama
Yahoo
05-05-2025
- Business
- Yahoo
Scorpius Holdings Announces Corporate Update Including Cost Optimization Initiatives, Strategic Corporate Developments, and Potential Opportunities for Expansion into Southeast Asia
Operational Realignment Expected to Deliver Over $6 Million in Annual Cost Savings Company Exploring CDMO Expansion Opportunities in Southeast Asia San Antonio, TX, May 04, 2025 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (OTC: SCPX) ('Scorpius' or 'the Company'), an integrated contract development and manufacturing organization ("CDMO'), today provided a corporate update highlighting key strategic initiatives, including cost optimization measures expected to yield over $6 million in annualized savings and the Company's exploration of opportunities to expand operations into Southeast Asia through a potential biomanufacturing presence in Malaysia. Major Operational Cost Optimization Program Initiated Scorpius has launched a strategic restructuring initiative designed to streamline operations, improve capital efficiency, and position the Company for long-term sustainable growth. This initiative includes a 28% reduction in headcount and the realignment of select non-core expenditures. These actions are expected to generate over $6 million in annualized cost savings while preserving the Company's ability to deliver high-quality services to its client base. 'We have proactively implemented structural changes to right-size our operations, including workforce reductions and the closing of our North Carolina facilities to consolidate operations in one location,' said Jeff Wolf, Chief Executive Officer of Scorpius Holdings. 'While these decisions are difficult, we believe they are essential to accelerating our path to profitability.' Scorpius Exploring Opportunities to Establish a Halal-Certified Biomanufacturing Presence in Malaysia As part of its international business strategy, Scorpius is seeking to establish operations in Malaysia focused on delivering halal-compliant biomanufacturing and CDMO services. The Company is in preliminary discussions with key Malaysian stakeholders and regulatory authorities to explore the formation of a Malaysian subsidiary that would support regional and global distribution of biologics manufactured in accordance with halal standards. This initiative seeks to address a critical unmet need within the 2-billion-person global Muslim population, which remains significantly underserved in access to halal-certified biopharmaceutical products. Scorpius believes that its differentiated approach could meet the growing demand across Southeast Asia and other Muslim-majority markets. 'We are encouraged by the potential opportunity to bring our CDMO expertise to Southeast Asia and collaborate with the Malaysian government to develop halal-compliant biomanufacturing capabilities,' said Mr. Wolf. 'This expansion, if realized, would position Scorpius as a first mover in a critically underserved yet rapidly growing segment of the biopharma industry.' YB Chang Lih Kang, Malaysia's Minister of Science, Technology and Innovation (MOSTI), commented, 'We look forward to working closely with Scorpius Holdings as they aim to bring their expertise in biomanufacturing to Malaysia. There is an urgent need for regional access to high-quality biologics—especially those produced to halal standards. This collaboration underscores Malaysia's commitment to becoming a global hub for halal biopharmaceutical innovation.' All forward-looking statements regarding the Company's potential operations in Malaysia are subject to customary regulatory, legal, and commercial approvals. Scorpius intends to pursue these opportunities in full compliance with local ownership laws and applicable government incentives and policies. New Board Appointment to Support Growth and Global Expansion Scorpius has strengthened its Board of Directors with the appointment of Tan Sze Thuan, a prominent Malaysian entrepreneur. Mr. Tan is the Founder and Chief Executive Officer of World Total Logistics Sdn Bhd, a leading logistics company in Malaysia offering integrated solutions in shipping, freight forwarding, trucking, warehousing, and distribution. Under his leadership, the firm has become a key player in the nation's logistics and supply chain landscape. Mr. Tan's extensive operational and business development experience across Southeast Asia uniquely positions him to support Scorpius's global expansion strategy, especially in navigating partnerships, infrastructure development, and regulatory engagement. 'This appointment aligns with our commitment to building a world-class board capable of guiding Scorpius through its next chapter of growth, including the potential for international expansion,' added Mr. Wolf. Advancing Biotech Leadership with a Global Vision Scorpius continues to serve clients in biologics manufacturing, process development, and analytical services. The Company believes that expanding these capabilities into Southeast Asia—while embedding halal standards from the ground up—could unlock access to new global markets and serve critical healthcare needs in a culturally aligned and commercially scalable manner. At the same time, the Company continues to explore a variety of potential strategic alternatives aimed at maximizing shareholder value. Scorpius Holdings, Inc. Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit Forward-Looking StatementThis 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 Company's potential opportunities for expansion into Southeast Asia; the operational realignment delivering over $6 million in annual cost savings; exploring opportunities to expand operations into Southeast Asia through a biomanufacturing presence in Malaysia; the strategic initiative streamlining operations; improving capital efficiency; and positioning the Company for long-term sustainable growth;; preserving the Company's ability to deliver high-quality services to its client base; accelerating the Company's path to profitability; establishing operations in Malaysia focused on delivering halal-compliant biomanufacturing and CDMO services; forming a Malaysian subsidiary that would support regional and global distribution of biologics manufactured in accordance with halal standards; addressing a critical unmet need within the global Muslim population; meeting the growing demand across Southeast Asia and other Muslim-majority markets; bringing the Company's CDMO expertise to Southeast Asia and collaborating with the Malaysian government to develop halal-compliant biomanufacturing capabilities; positioning the Company as a first mover in a critically underserved yet rapidly growing segment of the biopharma industry; pursuing opportunities in Malaysia in full compliance with local ownership laws and applicable government incentives and policies, building a world-class board capable of guiding the Company through its next chapter of growth, including the potential for international expansion; the expected contribution of Mr. Tan;; expanding the Company's biologics manufacturing, process development, and analytical services into Southeast Asia while embedding halal standards from the ground up and unlocking access to new global markets and serving critical healthcare needs in a culturally aligned and commercially scalable manner; and the Company continuing to explore a variety of potential strategic alternatives aimed at maximizing shareholder value. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to effect its strategic operational realignment as planned and achieve its expected results; the Company's ability to accelerate its path to profitability; the Company's ability to establish operations in Malaysia focused on delivering halal-compliant biomanufacturing and CDMO services; the ability to maximize shareholder value; the ability of Mr. Tan to assist the Company as expected; the Company's ability to unlock access to new global markets and serve critical healthcare needs in a culturally aligned and commercially scalable manner; 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 CDMO; and other factors described in the Company's most recent annual report on Form 10-K, 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 ContactDavid Waldman+1 919 289 4017ir@ in to access your portfolio
Yahoo
05-05-2025
- Business
- Yahoo
Scorpius Holdings Provides 2024 Year-End Business Update; Implements Strategic Cost Reductions and Operational Streamlining
SAN ANTONIO, April 30, 2025 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (OTC: SCPX) ('Scorpius' or 'the Company'), an integrated contract development and manufacturing organization ("CDMO'), today provided strategic, financial, and operational updates for the year ended December 31, 2024. Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, "The current biotech funding environment has created real headwinds for many of our clients, particularly when it comes to advancing drug development and clinical trials. In response, we took decisive steps to streamline our operations, reduce our cost structure, and refocus on our core CDMO capabilities. While the delay in our Form 10-K filing was not ideal, it was driven in part by the internal realignment necessary to secure our long-term success. With the filing now complete, we are focused on executing our business strategy and driving value for shareholders." 2024 Financial Results For the year ended December 31, 2024, the Company recognized $6.0 million of contract revenue and $0.2 million of National Institutes of Health grant revenue from continuing operations. For the year ended December 31, 2023, revenue consisted of $6.6 million of contract revenue and $0.3 million of National Institutes of Health grant revenue, and $0.1 million or royalty revenue from continuing operations. The revenue does not reflect any revenue derived from Elusys Therapeutics, which was divested in December 2023 and reported in discontinued operations. The decrease in contract revenue is primarily due to less revenue from one customer that migrated to a larger CDMO for commercial manufacture of their product during 2024. For the year ended December 31, 2024, the Company recognized $3.2 million of cost of revenues from product sales as compared to $2.7 million for the year ended December 31, 2023. The increase of $0.5 million was due to expanding our biomanufacturing capabilities and executing on CDMO contracts. Selling, general and administrative expenses for the years ended December 31, 2024, and 2023 were $21.6 million and $26.2 million, respectively. The decrease of $4.6 million was primarily due to decreases in consultants and contract labor of $2.8 million; marketing expenses of $1.6 million; stock-based compensation of $1.3 million; and legal expenses of $0.7 million, which decreases were partially offset by an increase of $0.8 million related to rent expense and an increase of $0.4 million related to public company expenses. Net loss attributable to Scorpius was approximately $32.8 million, or ($13.04) per basic and diluted share, for the year ended December 31, 2024, compared to approximately $45.2 million, or ($347.50) per basic and diluted share, for the year ended December 31, 2023. As of December 31, 2024, the Company had approximately $1.2 million in cash, cash equivalents, and short-term investments. Pursuant to the disclosure requirements of the NYSE American Company Guidelines Sections 401(h) and 610(b), Scorpius reports that its audited financial statements for the year ended December 31, 2024 and 2023, included in its 2024 annual report on Form 10-K, contain an audit opinion from its independent registered public accounting firm that includes an explanatory paragraph related to the Company's ability to continue as a going concern due to the fact that the Company has suffered recurring losses from operations and has not generated significant revenue or positive cash flows from operations. Scorpius Holdings, Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit Forward-Looking StatementThis 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 actions to streamline the Company's operations, reduce its cost structure, and refocus on its core CDMO capabilities; and the Company driving value for shareholders. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to scale rapidly as market conditions improve; the Company's ability to achieve its expected results; the Company's ability to accelerate its path to 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 CDMO; and other factors described in the Company's most recent annual report on Form 10-K, 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 ContactDavid Waldman+1 919 289 4017ir@ in to access your portfolio
Yahoo
05-05-2025
- Business
- Yahoo
Scorpius Holdings Announces Corporate Update Including Cost Optimization Initiatives, Strategic Corporate Developments, and Potential Opportunities for Expansion into Southeast Asia
Operational Realignment Expected to Deliver Over $6 Million in Annual Cost Savings Company Exploring CDMO Expansion Opportunities in Southeast Asia San Antonio, TX, May 04, 2025 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (OTC: SCPX) ('Scorpius' or 'the Company'), an integrated contract development and manufacturing organization ("CDMO'), today provided a corporate update highlighting key strategic initiatives, including cost optimization measures expected to yield over $6 million in annualized savings and the Company's exploration of opportunities to expand operations into Southeast Asia through a potential biomanufacturing presence in Malaysia. Major Operational Cost Optimization Program Initiated Scorpius has launched a strategic restructuring initiative designed to streamline operations, improve capital efficiency, and position the Company for long-term sustainable growth. This initiative includes a 28% reduction in headcount and the realignment of select non-core expenditures. These actions are expected to generate over $6 million in annualized cost savings while preserving the Company's ability to deliver high-quality services to its client base. 'We have proactively implemented structural changes to right-size our operations, including workforce reductions and the closing of our North Carolina facilities to consolidate operations in one location,' said Jeff Wolf, Chief Executive Officer of Scorpius Holdings. 'While these decisions are difficult, we believe they are essential to accelerating our path to profitability.' Scorpius Exploring Opportunities to Establish a Halal-Certified Biomanufacturing Presence in Malaysia As part of its international business strategy, Scorpius is seeking to establish operations in Malaysia focused on delivering halal-compliant biomanufacturing and CDMO services. The Company is in preliminary discussions with key Malaysian stakeholders and regulatory authorities to explore the formation of a Malaysian subsidiary that would support regional and global distribution of biologics manufactured in accordance with halal standards. This initiative seeks to address a critical unmet need within the 2-billion-person global Muslim population, which remains significantly underserved in access to halal-certified biopharmaceutical products. Scorpius believes that its differentiated approach could meet the growing demand across Southeast Asia and other Muslim-majority markets. 'We are encouraged by the potential opportunity to bring our CDMO expertise to Southeast Asia and collaborate with the Malaysian government to develop halal-compliant biomanufacturing capabilities,' said Mr. Wolf. 'This expansion, if realized, would position Scorpius as a first mover in a critically underserved yet rapidly growing segment of the biopharma industry.' YB Chang Lih Kang, Malaysia's Minister of Science, Technology and Innovation (MOSTI), commented, 'We look forward to working closely with Scorpius Holdings as they aim to bring their expertise in biomanufacturing to Malaysia. There is an urgent need for regional access to high-quality biologics—especially those produced to halal standards. This collaboration underscores Malaysia's commitment to becoming a global hub for halal biopharmaceutical innovation.' All forward-looking statements regarding the Company's potential operations in Malaysia are subject to customary regulatory, legal, and commercial approvals. Scorpius intends to pursue these opportunities in full compliance with local ownership laws and applicable government incentives and policies. New Board Appointment to Support Growth and Global Expansion Scorpius has strengthened its Board of Directors with the appointment of Tan Sze Thuan, a prominent Malaysian entrepreneur. Mr. Tan is the Founder and Chief Executive Officer of World Total Logistics Sdn Bhd, a leading logistics company in Malaysia offering integrated solutions in shipping, freight forwarding, trucking, warehousing, and distribution. Under his leadership, the firm has become a key player in the nation's logistics and supply chain landscape. Mr. Tan's extensive operational and business development experience across Southeast Asia uniquely positions him to support Scorpius's global expansion strategy, especially in navigating partnerships, infrastructure development, and regulatory engagement. 'This appointment aligns with our commitment to building a world-class board capable of guiding Scorpius through its next chapter of growth, including the potential for international expansion,' added Mr. Wolf. Advancing Biotech Leadership with a Global Vision Scorpius continues to serve clients in biologics manufacturing, process development, and analytical services. The Company believes that expanding these capabilities into Southeast Asia—while embedding halal standards from the ground up—could unlock access to new global markets and serve critical healthcare needs in a culturally aligned and commercially scalable manner. At the same time, the Company continues to explore a variety of potential strategic alternatives aimed at maximizing shareholder value. Scorpius Holdings, Inc. Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit Forward-Looking StatementThis 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 Company's potential opportunities for expansion into Southeast Asia; the operational realignment delivering over $6 million in annual cost savings; exploring opportunities to expand operations into Southeast Asia through a biomanufacturing presence in Malaysia; the strategic initiative streamlining operations; improving capital efficiency; and positioning the Company for long-term sustainable growth;; preserving the Company's ability to deliver high-quality services to its client base; accelerating the Company's path to profitability; establishing operations in Malaysia focused on delivering halal-compliant biomanufacturing and CDMO services; forming a Malaysian subsidiary that would support regional and global distribution of biologics manufactured in accordance with halal standards; addressing a critical unmet need within the global Muslim population; meeting the growing demand across Southeast Asia and other Muslim-majority markets; bringing the Company's CDMO expertise to Southeast Asia and collaborating with the Malaysian government to develop halal-compliant biomanufacturing capabilities; positioning the Company as a first mover in a critically underserved yet rapidly growing segment of the biopharma industry; pursuing opportunities in Malaysia in full compliance with local ownership laws and applicable government incentives and policies, building a world-class board capable of guiding the Company through its next chapter of growth, including the potential for international expansion; the expected contribution of Mr. Tan;; expanding the Company's biologics manufacturing, process development, and analytical services into Southeast Asia while embedding halal standards from the ground up and unlocking access to new global markets and serving critical healthcare needs in a culturally aligned and commercially scalable manner; and the Company continuing to explore a variety of potential strategic alternatives aimed at maximizing shareholder value. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to effect its strategic operational realignment as planned and achieve its expected results; the Company's ability to accelerate its path to profitability; the Company's ability to establish operations in Malaysia focused on delivering halal-compliant biomanufacturing and CDMO services; the ability to maximize shareholder value; the ability of Mr. Tan to assist the Company as expected; the Company's ability to unlock access to new global markets and serve critical healthcare needs in a culturally aligned and commercially scalable manner; 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 CDMO; and other factors described in the Company's most recent annual report on Form 10-K, 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 ContactDavid Waldman+1 919 289 4017ir@
