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NEWS -- Scorpius Holdings, Inc. Announces Closing of Public Offering
DURHAM, N.C., May 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 closing of its underwritten public offering of 60,000,000 common units and/or pre-funded units in lieu thereof. Each common (or pre-funded) unit was offered at a public offering price of $0.10 per unit (inclusive of the pre-funded warrant exercise price) and consists of one share of common stock (or pre-funded warrant to purchase one share of common stock in lieu thereof) and a common warrant, for gross proceeds of $6,000,000, before deducting underwriting discounts and offering expenses. The warrants have an exercise price of $0.12 per share and are immediately exercisable upon issuance for a period of five years following the date of issuance. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 9,000,000 shares of common stock (and/or pre-funded warrants) and/or up to an additional 9,000,000 common warrants solely to cover over-allotments, if any.
The Company intends to use the net proceeds of the offering to fund working capital, general corporate purposes, and the repayment of a $750,000 non-convertible promissory note, plus accrued and unpaid interest.
ThinkEquity acted as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-279092) relating to the shares of common stock, pre-funded warrants, common warrants, and the shares of common stock underlying such warrants was filed with the Securities and Exchange Commission (“SEC”) and became effective on May 13, 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.
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 factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023 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
NEWS -- Scorpius Holdings Commends Congress on Bipartisan Legislative Action Aimed at Bolstering U.S. Biomanufacturing
Urges Congress to Immediately Pass the BIOSECURE Act
DURHAM, N.C., May 16, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization providing state-of-the-art large molecule contract development and manufacturing organization (“CDMO”), today applauded on-going legislative efforts within the United States Congress to bolster domestic biomanufacturing in the face of vulnerabilities from America’s adversaries.
The most notable legislative effort is the recent introduction of the BIOSECURE Act, which would mark a significant step forward in strengthening America’s pharmaceutical supply chain and reducing dependency on foreign manufacturers. The BIOSECURE Act is now seeing significant bipartisan momentum in Congress, advancing out of the House Oversight Committee this week, setting the stage for a possible vote and final passage by the end of the year.
Other notable efforts include recent legislative and policy measures that prioritize U.S. Government investment and development for U.S.-based biomanufacturing, as well as the launch of the BioMaP Consortium within the Biomedical Advanced Research and Development Authority, of which Scorpius is a member.
Over the past year, Scorpius has proactively expanded its production facilities, all within the United States, investing heavily in state-of-the-art technologies to support scalable and secure manufacturing processes. This expansion not only enhances the Company's capacity to meet growing demand but also aligns seamlessly with the objectives of the newly proposed legislative measures.
Scorpius continues to support ongoing work on behalf of U.S. Government-backed pharmaceutical programs and recently hosted several visits to its San Antonio facility from U.S. Government representatives in which these efforts were discussed.
Jeff Wolf, CEO of Scorpius, praised the pending Congressional action, but urged its final passage, stating, “We are at a critical juncture in ensuring the health security of our nation. The recent legislative developments, including the BIOSECURE Act, are commendable as they align with our vision of a robust, self-reliant American biomanufacturing infrastructure. We urge Congress to immediately pass the BIOSECURE Act, to ensure that America’s drug supply chain is no-longer beset with vulnerabilities from our nation’s adversaries. We are also closely engaged in the reauthorization of the Pandemic and All-Hazards Preparedness Act, and strongly urge Congress to pass this critical legislation that bolsters preparedness in the face of threats. From cancer treatments to biodefense, it is imperative that we have control over our pharmaceutical supply chain to protect and provide for the American people.”
“Scorpius is committed to working with lawmakers, industry partners, and drug developers to implement the BIOSECURE Act and other initiatives aimed at onshoring drug production. By leveraging our enhanced production capabilities and deep expertise in biomanufacturing, Scorpius stands ready to support the nation’s healthcare needs while fostering American economic growth and innovation,” concluded Mr. Wolf.
Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated CDMO focused on manufacturing biologic and cell therapy programs for our clients. 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 marking a significant step forward in strengthening America’s pharmaceutical supply chain and reducing dependency on foreign manufacturers, a possible vote and final passage of the BIOSECURE Act by the end of the year. by the end of the year, continuing to support on-going work on behalf of U.S. Government-backed pharmaceutical programs. Important factors that could cause actual results to differ materially from current expectations include, among others, the passage of the BIOSECURE Act and its impact on the Company, Company’s ability to expand its large molecule biomanufacturing CDMO services, attract new customers, the ability to capture a meaningful market share; 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, 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
NEWS -- Scorpius Holdings Achieves Major Milestone with cGMP Facility Validation for Microbial Manufacturing
Scorpius Holdings, Inc.
Gaining operating efficiency through transition to an internal environmental monitoring team
DURHAM, N.C., May 15, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the successful validation of its microbial facilities, marking a significant milestone in the Company's operations. This validation signifies that Scorpius’ microbial cleanrooms are now officially approved to manufacture current Good Manufacturing Practice (cGMP) microbial biologic drugs, underscoring the Company's commitment to quality and regulatory compliance.
Scorpius facilities have already garnered considerable interest, with a backlog of bookings from client programs. This achievement not only demonstrates Scorpius' capability to meet the regulatory and client driven high standards required for contract manufacturing of microbial biologics but also highlights the trust and confidence its clients place in its services.
In conjunction with the facility qualifications, Scorpius is also streamlining its operations by transitioning environmental monitoring responsibilities to internal teams, while it migrates from the previous reliance on third-party services. This shift is expected to allow for greater efficiency, further enhancing the Company's robust ability to deliver high-quality biomanufacturing services.
“Scorpius has experienced strong interest in our microbial capabilities, and we continue to add additional opportunities to our pipeline for 2024 and 2025,” stated Jeff Wolf, CEO of Scorpius Holdings. “This validation confirms our commitment to high-quality, state-of-the-art microbial production. We are dedicated to leveraging our advanced capabilities to support our clients' needs and contributing to the advancement of breakthrough therapies.”
“This validation is a testament to Scorpius’ rigorous quality standards and our dedication to supporting the development and manufacturing of microbial products. With this achievement, Scorpius is poised to further solidify its position as a leader in clinical scale microbial manufacturing, offering our clients unparalleled quality and service,” concluded Wolf.
Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit 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 transition of environmental monitoring responsibilities from third-parties to internal teams being expected to allow for greater efficiency, further enhancing the Company's robust ability to deliver high-quality biomanufacturing services; continuing to add additional opportunities to the Company’s pipeline for 2024 and 2025; Scorpius being poised to further solidify its position as a leader in clinical scale microbial manufacturing, offering our clients unparalleled quality and service. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to continue to validate its microbial facilities; expand its large molecule biomanufacturing CDMO services and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Scorpius Holdings, Inc. Announces Pricing of Public Offering
DURHAM, N.C., May 14, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the pricing of its underwritten public offering of 60,000,000 common units and/or pre-funded units in lieu thereof. Each common (or pre-funded) unit is being offered at a public offering price of $0.10 per unit (inclusive of the pre-funded warrant exercise price) and consists of one share of common stock (or pre-funded warrant to purchase one share of common stock in lieu thereof) and a common warrant to purchase one share of common stock. The common warrants will have an exercise price of $0.12 per share and will be immediately exercisable upon issuance for a period of five years following the date of issuance. The gross proceeds to the Company from the offering are expected to be approximately $6,000,000, 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 9,000,000 shares of common stock (and/or pre-funded warrants) and/or up to an additional 9,000,000 common warrants solely to cover over-allotments, if any. All of the shares of common stock (and/or pre-funded warrants) and associated common warrants are being offered by the Company. The offering is expected to close on May 16, 2024, subject to satisfaction of customary closing conditions.
The Company intends to use the net proceeds of the offering to fund working capital, general corporate purposes, and the repayment of a $750,000 non-convertible promissory note, plus accrued and unpaid interest.
ThinkEquity is acting as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-279092), 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 May 13, 2024. This offering is being made only by means of a prospectus. Copies of the preliminary prospectus and 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 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 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
NEWS -- Scorpius Holdings Appoints New VP of Business Development Shari Udoff-McDonald
Biopharma industry veteran joins Scorpius’ leadership team
DURHAM, N.C., May 07, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX) (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the appointment of Shari Udoff-McDonald as VP of Business Development. She brings more than 25 years of experience in biopharma business development and management.
Prior to joining Scorpius, Ms. Udoff-McDonald spent 17 years at BioReliance Corporation, part of MilliporeSigma. She was most recently Head of Commercial, North America, East with interim oversight of half of the European market. Her role included commercial oversight of biologics, vaccines, cell and gene therapies, ADCs, and mRNA GMP testing services for sponsors and CDMOs.
Joe Payne, Scorpius’ President and COO, said, “Shari has the unique combination of experience in the field, at the account-level, and in leadership roles. This wide breadth of business development experience will help Scorpius continue to grow its customer base. I’m confident that Shari will have an immediate, positive impact on our current and future clients.”
Ms. Udoff-McDonald will oversee the business development, marketing, and proposals teams, which are addressing the strong demand for flexible mammalian and microbial biomanufacturing services. Scorpius’ facility in San Antonio, Texas, has available capacity for mammalian and microbial programs, which are supported by on-site process and analytical development services.
“I’m thrilled to join Scorpius BioManufacturing at this key growth stage,” said Ms. Udoff-McDonald. “Scorpius is committed to being a transparent, flexible, and responsive CDMO partner. I am impressed by their technical and scientific capabilities and am even more impressed by the passion and enthusiasm displayed by the team. I look forward to working with current and future clients to bring their large molecule drugs to market.”
Ms. Udoff-McDonald and the Scorpius business development team will be at the BIO International Convention in San Diego on June 3-6. To schedule a meeting, visit https://www.scorpiusbiologics.com/contact-us.
About Scorpius Holdings
Scorpius BioManufacturing Inc. is a wholly owned subsidiary of Scorpius Holdings Inc., 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 contributions to be made by Shari Udoff-McDonald including her business development experience helping Scorpius continuing to grow its customer base and working with current and future clients to bring their large molecule drugs to market. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of Shari Udoff-McDonald to make contributions to Scorpius, the Company’s ability to regain compliance with the NYSE American continued listing standards, expand its large molecule biomanufacturing CDMO services and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s most recent 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 & Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Scorpius Holdings Provides 2023 Year-End Business Update; Reports 570% Sequential Increase in Revenue for the Fourth Quarter of 2023
DURHAM, N.C., April 29, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (‘Scorpius” or “the Company”), an integrated contract development and manufacturing organization providing state-of-the-art large molecule contract development and manufacturing organization (“CDMO”), today provided strategic, financial, and operational updates for the year ended December 31, 2023.
Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, “We are executing our plan to augment sales and drive revenue, as evidenced by the $4.8 million of revenue from continuing operations that we reported in the fourth quarter of 2023. This represents a 570% increase from the third quarter of 2023, and a 226% increase compared to revenue for the first nine months of the year. To date, Scorpius’s successful business development efforts have resulted in the recording of more than $20 million of contract bookings. We believe our bookings, coupled with the strong interest in our microbial and mammalian capabilities and promising pipeline of new opportunities, positions us well for significant growth in 2024 and beyond.”
"As the large molecule drug substance CDMO market is projected to grow from $10 billion in 2023 to $21 billion by 20301, there is a substantial need for enhanced industry capacity. With our scalable business model and the rising demand for our large molecule CDMO services, we believe that we are well-positioned to capture a meaningful share of this market. Moreover, we expect Scorpius’ growth to accelerate in 2024 and remain optimistic about becoming cash flow positive by early 2025. With the completion of our facility and divestiture of our research and non-core assets, we substantially reduced our operating expenses in the fourth quarter of 2023. As a result, we believe the future for Scorpius could not be brighter as our 60,000+ sq. ft. campus provides us sufficient capacity to grow our business with minimal additional capex requirements, which we believe is the key to maximizing profits and returns for our shareholders,” concluded Mr. Wolf.
2023 Financial Results
NEWS -- Scorpius Holdings Announces Receipt of Filing Delinquency Notification
Reaffirms commitment to regaining compliance with the NYSE American continued listing standards
DURHAM, N.C., April 22, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), an integrated contract development and manufacturing organization (CDMO), received an official notice of noncompliance (the “NYSE American Notice”) from NYSE Regulation stating that the Company is not in compliance with NYSE American LLC (“NYSE American” or the “Exchange”) continued listing standards (the “Filing Delinquency Notification”) under the timely filing criteria included in Section 1007 of the NYSE American Company Guide (the "Company Guide") due to the failure to timely file the Company’s Form 10-K for the period ended December 31, 2023 (the “Delinquent Report”) by the filing due date of April 16, 2024 (the “Filing Delinquency”).
As previously reported in the Company’s Notification of Late Filing on Form 12b-25 filed with the SEC on April 1, 2024, the Company was unable to file its Annual Report on Form 10-K for the year ended December 31, 2023, within the prescribed period because of delays experienced by the Company in preparing its consolidated financial statements. The delays relate to recent finance staff turnover of those directly involved in preparing the Delinquent Report, and the need for additional time to complete the calculation of revenue recognition for certain contracts for the year ended December 31, 2023.
Jeff Wolf, CEO of Scorpius, stated, “We regret the delay in filing our Form 10-K, due in part to substantive changes within our organization. We expect to file our year-end financial results in short order. Most importantly, we remain committed to maintaining the highest standards of financial reporting and corporate governance.”
The Company is now subject to the procedures and requirements set forth in Section 1007 of the NYSE American Company Guide. Within five days of the date of the Filing Delinquency Notification, the Company was required to (a) contact the Exchange to discuss the status of the Delinquent Report and (b) issue a press release disclosing the occurrence of the Filing Delinquency, the reason for the Filing Delinquency and, if known, the anticipated date such Filing Delinquency will be cured via the filing or refiling of the applicable report, as the case may be.
During the six-month period from the date of the Filing Delinquency (the "Initial Cure Period"), the NYSE will monitor the Company and the status of the Delinquent Report and any subsequent delayed filings, including through contact with the Company, until the Filing Delinquency is cured. If the Company fails to cure the Filing Delinquency within the Initial Cure Period, the Exchange may, in the Exchange’s sole discretion, allow the Company’s securities to be traded for up to an additional six-month period (the "Additional Cure Period") depending on the Company’s specific circumstances. If the Exchange determines that an Additional Cure Period is not appropriate, suspension and delisting procedures will commence in accordance with the procedures set out in Section 1010 of the NYSE American Company Guide. If the Exchange determines that an Additional Cure Period of up to six months is appropriate and the Company fails to file its Delinquent Report and any subsequent delayed filings by the end of that period, suspension and delisting procedures will generally commence. An issuer is not eligible to follow the procedures outlined in Section 1009 with respect to these criteria.
Notwithstanding the foregoing, however, the Exchange may in its sole discretion decide (i) not to afford an issuer any Initial Cure Period or Additional Cure Period, as the case may be, at all or (ii) at any time during the Initial Cure Period or Additional Cure Period, to truncate the Initial Cure Period or Additional Cure Period, as the case may be, and immediately commence suspension and delisting procedures if the Company is subject to delisting pursuant to any other provision of the Company Guide, including if the Exchange believes, in the NYSE’s sole discretion, that continued listing and trading of an issuer's securities on the Exchange is inadvisable or unwarranted in accordance with Sections 1001-1006 hereof.
The Company intends to regain compliance with the NYSE American continued listing standards. There can be no assurance that the Company will ultimately regain compliance with all applicable NYSE American continued listing standards.
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 Company’s expectation to expand the scope of the agreement to include Phase 1 clinical manufacturing, the Company’s ability to file its Annual Report on Form 10-K during the Initial Cure Period and its ability to regain compliance with the NYSE American continued listing standards Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to regain compliance with the NYSE American continued listing standards, expand its large molecule biomanufacturing CDMO services and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s 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 Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Scorpius Holdings Awarded Contract in Excess of $1 Million with NIH-Funded Researcher at a Major University
DURHAM, N.C., March 19, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), an integrated contract development and manufacturing organization (CDMO), today announced that it has been awarded a contract in excess of $1 million with an NIH-funded researcher at a major university.
The program involves process optimization and development of a therapeutic antibody, which Scorpius will manufacture for preclinical studies. The work will be conducted in the Company’s state-of-the-art process development lab and cGMP cleanrooms in its Mammalian Building, which is ideally suited for early-stage programs using CHO cell lines. Following process optimization and development, the Company expects to expand the scope of the agreement to include Phase 1 clinical manufacturing.
Jeff Wolf, CEO of Scorpius, stated, "Scorpius is excited to begin work with another nationally renowned university. Our selection by this leading researcher highlights our unique process development, bioanalysis, and manufacturing capabilities, which we have the ability to leverage into much larger projects as the programs progress through clinical stages and eventually into commercialization. There is a tremendous amount of innovative research being conducted at academic institutions, and Scorpius is well-suited to provide these clients with the attention and responsiveness they otherwise would not receive from a CDMO. Overall, we could not be more excited about the outlook for the business and the traction we are gaining.”
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 Company’s expectation to expand the scope of the agreement to include Phase 1 clinical manufacturing, the Company’s ability to leverage its process development, bioanalysis, and manufacturing capabilities into larger projects as the programs progress through clinical stages and into commercialization and future traction that the Company is gaining. 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 and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, 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
NEWS -- Scorpius Holdings Accepted as a Member of the US Government’s BioMaP-Consortium
Provides Access to Growth Funding and Enhanced Access to Federal Projects
DURHAM, N.C., March 14, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), an integrated contract development and manufacturing organization (CDMO), today announced that it has been accepted into the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), a part of the National Biopharmaceutical Manufacturing Partnership. The BioMap-Consortium has a $20 billion funding ceiling, through which it provides growth funding, as well as streamlined access to servicing government-funded manufacturing programs.
The BioMaP-Consortium supports the Biomedical Advanced Research and Development Authority (BARDA) and is comprised of industry partners across the drug and vaccine manufacturing supply chain, including manufacturers of raw materials and consumables, developers of innovative manufacturing technologies, and suppliers of fill finish services. This consortium seeks to expand the industrial and manufacturing base for medical countermeasures to include the requisite capabilities, flexibilities, and strategies to secure needed medical supplies to meet the nation’s public health preparedness and response requirements.
Jeff Wolf, CEO of Scorpius, stated, "We are honored to be accepted as a member of the BioMaP-Consortium, which provides Scorpius opportunities to support biomanufacturing programs focused on the nation’s medical countermeasure programs, while providing biomanufacturing capacity and capabilities to defend against pandemics and other emerging threats. We look forward to building upon our track record of supporting infectious disease and biodefense programs on behalf of BARDA, the U.S. Department of Health & Human Services, and the U.S. Department of 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 the Company’s opportunities to support biomanufacturing programs focused on the nation’s medical countermeasure programs, while providing biomanufacturing capacity and capabilities to defend against pandemics and other emerging threats and supporting infectious disease and biodefense programs on behalf of BARDA, HHS and the DoD. 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 and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure-play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, 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
NEWS -- Scorpius Holdings, Inc. Announces Closing of Public Offering
DURHAM, N.C., March 12, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the closing of its previously announced public offering of 10,000,000 shares of its common stock at a public offering price of $0.15 per share, for gross proceeds of $1,500,000, before deducting underwriting discounts and offering expenses.
The Company intends to use the proceeds from the offering for working capital and general corporate purposes.
ThinkEquity acted as sole book-running manager for the offering.
The offering was made pursuant to an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (the “SEC”), including the base prospectus therein, as supplemented by the final prospectus relating to the offering filed with the SEC on March 11, 2024, all of which are available on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004, Attention: Prospectus Department.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other 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 use of proceed from the offering. Important factors that could cause actual results to differ materially from current expectations include those factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, 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 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
NEWS -- Scorpius Holdings, Inc. Announces Pricing of Public Offering
DURHAM, N.C., March 08, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the pricing of its underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $0.15 per share, for aggregate gross proceeds of $1,500,000, before deducting underwriting discounts, commissions and offering expenses. All of the shares of common stock were offered by the Company. The offering is expected to close on March 12, 2024, subject to satisfaction of customary closing conditions.
The Company intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
The securities were offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-251255), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 10, 2020 and declared effective on December 22, 2020. The offering was made only by means of a written prospectus. A preliminary prospectus supplement and the accompanying base prospectus describing the terms of the offering was filed with the SEC on its website at www.sec.gov. A final prospectus supplement and the accompanying base prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.
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. Important factors that could cause actual results to differ materially from current expectations include, among others, the timing of closing of the offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, 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 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
NEWS -- Scorpius Holdings, Inc. Announces Proposed Public Offering of Common Stock
DURHAM, N.C., March 07, 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 intends to offer to sell shares of its common stock to the public in an underwritten public offering. All of the shares of common stock are to be sold by the Company.
ThinkEquity is acting as sole book-running manager for the offering.
The Company intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.
The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-251255), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 10, 2020 and declared effective on December 22, 2020. The offering will be made only by means of a written prospectus. A preliminary prospectus supplement and the accompanying base prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying base prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference into such preliminary prospectus supplement and the accompanying base prospectus, which provide more information about the Company and such offering
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of 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. 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, 2022, 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 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
NEWS -- Scorpius Holdings Estimates Greater than 375% Sequential Increase in Revenue for the Fourth Quarter of 2023 Compared to the Third Quarter of 2023
Estimates Sequential Reduction in the Fourth Quarter of 2023 Operating Loss by Over $3.3 Million or Approximately 30% Compared to the Third Quarter of 2023
Achieves Record Backlog of $9.3 Million
DURHAM, N.C., March 07, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc., (“Scorpius”) (NYSE American: SCPX), an integrated contract development and manufacturing organization (CDMO), today reported preliminary, unaudited financial results for the fourth quarter of 2023.
Jeff Wolf, CEO of Scorpius, stated, “We are firing on all cylinders and currently estimate our preliminary, unaudited revenue for the fourth quarter of 2023 to be in the range of $3.4 million to $3.6 million, which would represent a greater than 375% sequential increase over the third quarter of 2023. Our contract bookings of over $20 million in 2023 and strong business development efforts in the first quarter of 2024 have produced a record current backlog of $9.3 million. This backlog, along with a strong pipeline of new opportunities, gives us tremendous confidence in our growth trajectory for 2024. In addition, I am pleased to report that we estimate our preliminary, unaudited operating losses for the fourth quarter declined by over $3.3 million, or approximately 30%, compared to the third quarter of 2023, as almost all of our upfront investments in the new facility are now behind us. Most notably, we have built a highly scalable operation, and as revenue continues to grow, we expect to become cash flow positive by early 2025 due to the high incremental margins in our business.”
Mr. Wolf continued, “We are witnessing increasing demand for our state-of-the-art large molecule CDMO services, which has been compounded by the significant shortage of dedicated clinical-scale manufacturing capacity within the industry. Moreover, the large molecule drug substance CDMO market is projected to grow from over $10 billion in 2023 to $21 billion by 20301, highlighting the need for additional industry capacity. Our capabilities, seamless execution, and flexibility to meet the needs of our customers has allowed us to attract premier biopharma and biotech companies, as well as leading research institutions. We typically onboard these customers at the early stages of clinical development, which provides us the opportunity to expand our scope of work as their therapies progress through clinical trials and, ultimately, into full-scale commercial production. Our unique 40,000+ sq. ft. campus, with investments totaling over $65 million to date, provides us sufficient capacity to grow our throughput with minimal additional capex requirements, which we believe is the key to maximizing profits and returns for our shareholders.”
Based upon a preliminary, unaudited review, the Company currently estimates revenue in the range of $3.4 million to $3.6 million for the fourth quarter of 2023. The increase in revenue reflects the completion of contract milestones primarily in the microbial facility and process development work. Additionally, the Company estimates that our operating loss will decline by over $3.3 million, or approximately 30%, as a result of primary completion of qualification and validation processes. The Company expects to report its complete 2023 audited financial results on or before March 28, 2024.
The estimated revenue and operating loss results for 2023 are preliminary and unaudited and are subject to completion of the Company’s financial closing procedures. The Company’s independent registered public accounting firm has not conducted an audit or review of and does not express an opinion or any other form of assurance with respect to, the preliminary unaudited revenue results. It is possible that the Company or its independent registered public accounting firm may identify items that require the Company to make adjustments to the preliminary estimates of revenue and/or operating loss set forth in the press release and those changes could be material. Accordingly, undue reliance should not be placed on the preliminary estimates.
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 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 preliminary, unaudited revenue for the fourth quarter of 2023 being in the range of $3.4 million to $3.6 million, representing a greater than 375% sequential increase over the third quarter of 2023, operating losses for the fourth quarter declining by over $3.3 million, having tremendous confidence in our growth trajectory for 2024, preliminary, unaudited operating losses for the fourth quarter declined by over $3.3 million, or approximately 30% compared to the third quarter of 2023; our expectation to become cash flow positive by early 2025 due to the high incremental margins in the Company’s business, the large molecule drug substance CDMO market being projected to grow from over $10 billion in 2023 to $21 billion by 2030 highlighting the need for additional industry capacity, expand the Company’s scope of work as our customers’ therapies progress through clinical trials and, ultimately, into full-scale commercial production, the Company’s 40,000+ sq. ft. campus providing it with sufficient capacity to grow its throughput with minimal capex requirements, such capacity being the key to maximizing profits and returns for the Company’s shareholders and reporting the Company’s complete 2023 audited financial results on or before March 28, 2024. There can be no assurance that the Company’s actual full-year 2023 financial and operating results will not differ, perhaps substantially, from the preliminary financial and operating results and expectations contained in this press release. In addition, the Company has not completed its fourth quarter and full-year 2023 closing and review process, and the final results for the full-year 2023 may differ, perhaps substantially, from the statements made in this press release. During the course of preparing the Company’s financial statements and during the review process, management may identify items that would require adjustments that may be material to the amounts described in this press release. In addition, 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 and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed; the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements; regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO; and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this press release 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.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
1 SkyQuest Large Molecule Industry Forecast, February 2024
NEWS -- NightHawk Biosciences Completes Name Change to Scorpius Holdings; Trading to Commence Under “SCPX” Effective at the Market Open Today
DURHAM, N.C., Feb. 06, 2024 (GLOBE NEWSWIRE) -- NightHawk Biosciences / Scorpius Holdings, Inc. (NYSE American: NHWK; SCPX), an integrated contract development and manufacturing organization (CDMO), today announced that it had completed its name change from NightHawk Biosciences, Inc. to Scorpius Holdings, Inc., to better reflect the Company’s successful shift into a pure-play, large molecule biomanufacturing CDMO. In connection with the name change, the Company’s ticker will change to “SCPX” effective today, February 6, 2024. The name and symbol changes do not affect the Company's share structure or the rights of the Company's shareholders, and no further action will be required by existing shareholders.
Jeff Wolf, CEO of Scorpius, stated, "Changing our name to Scorpius Holdings reflects our evolution into a revenue-generating biomanufacturing company and expansion of our CDMO services. The biopharmaceutical sector is currently grappling with a severe shortage of clinical-scale biologic manufacturing capacity, a situation exacerbated by the rising demand for large molecule CDMO services. Our cutting-edge San Antonio, Texas facility is strategically positioned to fill this critical void. The feedback from our key biotech and pharmaceutical customers has been overwhelmingly positive, as reflected in our enhanced sales pipeline. We are eager to advance these initiatives under the Scorpius banner."
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 Company’s successful shift into a pure-play, large molecule biomanufacturing CDMO; the rising demand for large molecule CDMO services; the Company’s cutting-edge San Antonio, Texas facility being strategically positioned to fill the critical shortage of clinical-scale biologic manufacturing capacity in the biopharmaceutical sector; the Company’s enhanced sales pipeline; and advancing the Company’s initiatives under the Scorpius banner. 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 and continue to grow revenue; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2022, 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
NEWS -- NightHawk’s Scorpius BioManufacturing Subsidiary Announces the Promotion of Joe Payne to President and Chief Operating Officer
DURHAM, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK) (“NightHawk” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the promotion of Joe Payne to President and Chief Operating Officer (COO) of its Scorpius BioManufacturing subsidiary.
Payne joined Scorpius in 2023 as VP of Quality and Regulatory Affairs. With a biopharma and pharmaceutical career spanning over 20 years, Payne’s recent experience includes leadership roles at CDMOs Tergus Pharma and Alcami Corporation. He has participated in 40+ regulatory inspections and has extensive knowledge of global regulatory agency requirements. In his role as President and COO, Payne will oversee quality, manufacturing, process sciences, and commercial operations.
Jeff Wolf, CEO of NightHawk Biosciences, commented, “Joe has seen nearly 100 different pharmaceutical facilities and has interacted with thousands of industry professionals at all levels. His expertise and experience will greatly benefit Scorpius during its next phase of growth. Joe has deep experience in developing and implementing quality production processes within large and small CDMO’s. Joe’s appointment reflects our focus on quality biomanufacturing throughout our organization. I’m confident Joe will ensure our clients have the smoothest path from the lab to the clinic to commercialization.”
Joe Payne further noted, “When I joined Scorpius in 2023, I was focused on building a robust quality operation. I was impressed by the team’s commitment, from the leadership all the way to our floor-level operators. I’m truly grateful for the faith that Jeff, the board, and the entire organization have placed in me, and I look forward to working with current and future clients to bring their biologic innovations to patients as efficiently and safely as possible.”
Mr. Wolf, Mr. Payne and the Scorpius commercial team will be at DCAT Week in New York City on March 18-21 to meet with clients and prospects about analytical testing, process development, and manufacturing services.
NightHawk Biosciences, Inc.
NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, 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.nighthawkbio.com or 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 Mr. Payne’s contribution to Scorpius including his expertise and experience greatly benefitting Scorpius during its next phase of growth and Mr. Payne ensuring clients have the smoothest path from the lab to the clinic to commercialization.. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to derive the contributions to Scorpius anticipated from Mr. Payne, the ability to generate future revenue from manufacturing contracts, the Company’s ability to continue its strategy and to grow revenue, leverage fixed costs and achieve long-term profitability; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace, the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the ability to obtain regulatory approval 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, 2022, 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://investorrelations@nighthawkbio.com
NEWS -- NightHawk Receives Proceeds of $3.25 Million in Connection with Sale of Non-Core Intellectual Property and Issuance of a Low Interest Bearing Note
DURHAM, N.C., Jan. 30, 2024 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK) (“NightHawk” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced it has sold additional none-core IP. Additionally, the Company received proceeds of $2.25 million from a note issued pursuant to the terms of the previously announced divestiture of non-core assets ( the “Note”). The Note bears interest at an annual rate of 1% and, subject to stockholder approval, would be convertible into shares of NightHawk’s common stock at $0.39281 per share, an 8% premium to the closing price of the Company’s common stock on January 29, 2024.
Jeff Wolf, CEO of NightHawk Biosciences, commented, “Receipt of these funds is particularly timely as it strengthens our balance sheet and provides us additional working capital to further accelerate our growth. The sale of this intellectual property is consistent with our strategy to divest non-core assets in order to focus on our Scorpius BioManufacturing subsidiary, which is gaining significant traction in the market.”
Additional details related to the sale of the IP and the Note are included in the Company’s Form 8-K, which has been filed with the Securities and Exchange Commission.
NightHawk Biosciences, Inc.
NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, 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 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.nighthawkbio.com or https://www.scorpiusbiologics.com, and also follow us on Twitter.
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 further accelerating the Company’s growth and Scorpius BioManufacturing gaining significant traction in the market . Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to generate future revenue from manufacturing contracts, the Company’s ability to continue its strategy and to grow revenue, leverage fixed costs and achieve long-term profitability; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace, the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the ability to obtain regulatory approval 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, 2022, 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://investorrelations@nighthawkbio.com
NEWS -- NightHawk’s Scorpius BioManufacturing Subsidiary Awarded Multimillion- Dollar Contract with a Publicly Traded Biotech Company to Support its Phase 2 Clinical Program
Project to benefit from Scorpius’ comprehensive services in process development, bioanalysis, and cGMP manufacturing
DURHAM, N.C., Jan. 25, 2024 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK) (“NightHawk” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced its Scorpius BioManufacturing subsidiary has been awarded a multimillion-dollar contract to provide process development, analytical, and cGMP manufacturing services for a publicly traded biotech company’s Phase 2 clinical program.
Jeff Wolf, CEO of NightHawk Biosciences, commented, “We are proud to have been selected to help advance this potentially lifesaving therapy through the clinic. Scorpius has multiple clients with Orphan Drug Designations from the FDA, and our San Antonio facility is especially well-suited to advance these important programs. This new client, needing biologic manufacturing for a Phase 2 clinical program under cGMP guidelines, will benefit from Scorpius' comprehensive services in process development, bioanalysis, and manufacturing. The client, transitioning from a large CDMO, chose Scorpius to assist in this Phase 2 program based on our adaptability, dedicated service, and commitment to meeting project timelines. The scope of work, which includes producing a monoclonal antibody (mAb) in Scorpius' mammalian facility, is expected to be completed in 2024. We are extremely pleased with the success and traction Scorpius gained in 2023, our first full year in operation, and we are excited to see this momentum continue as we witness rising demand for our mammalian and microbial biomanufacturing services.”
NightHawk Biosciences, Inc.
NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, 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 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.nighthawkbio.com or https://www.scorpiusbiologics.com, and also follow us on Twitter.
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 advancing the potentially lifesaving therapy through the clinic, the San Antonio facility being especially well-suited to advance programs with Orphan Drug Designations from the FDA, the scope of work being completed in 2024 and seeing the momentum continue as demand rises for Scorpius’ mammalian and microbial biomanufacturing services. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to complete the work as planned, the Company’s ability to generate future revenue from manufacturing contracts, the Company’s ability to continue to grow revenue, leverage fixed costs and achieve long-term profitability,; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace, the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the ability to obtain regulatory approval 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, 2022, 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://investorrelations@nighthawkbio.com
NEWS -- NightHawk’s Scorpius BioManufacturing Subsidiary Commences Work on Preclinical Program for New Client
NightHawk Biosciences (NYSE American: NHWK) (“NightHawk” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced its Scorpius BioManufacturing subsidiary has been awarded a project to support a preclinical program for a U.S. based biotech company. The initial project value exceeds one million dollars, with the potential to exceed several million dollars over the next two years.
Jeff Wolf, CEO of NightHawk, commented, “We are pleased to have been awarded this competitive bid due to the versatility of our biologics facility, manufacturing readiness, and commitment to quality. This award reflects our growing reputation in the industry, as well as our track record advancing early stage clinical programs. A key element of this project is Scorpius’ specialized analytical and process development laboratories where the client benefits from our expertise in biologics and, in particular, microbial fermentation, which is garnering significant attention in the industry. Although the work outlined in this contract is anticipated to be completed in 2024, our intent is to expand the scope of the project as they prepare for phase 1 clinical trials and beyond.”
NightHawk Biosciences, Inc.
NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, 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 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.nighthawkbio.com or https://www.scorpiusbiologics.com, and also follow us on Twitter.
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 potential to exceed several million dollars over the life of the project, completing the work outlined in the contract by 2024 and building a long-term relationship with the client in order to expand the scope of the project as they prepare for phase 1 clinical trials and beyond. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to complete the work outlined in 2024 and to expand the scope of the project, the Company’s ability to generate future revenue from manufacturing contracts , the Company’s ability to continue to grow revenue, leverage fixed costs and achieve long-term profitability; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace; 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 successfully operate as a CDMO the ability to obtain regulatory approval 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, 2022, 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://investorrelations@nighthawkbio.com
NEWS -- NightHawk Biosciences Announces Planned Name Change to Scorpius Holdings, Reflecting Successful Transition to a Large Molecule Biomanufacturing CDMO
Announces senior leadership appointments to further support client programs and growing sales pipeline
DURHAM, N.C., Jan. 08, 2024 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK; NHWK), an integrated contract development and manufacturing organization (CDMO), today announced that it is changing the name of the Company to Scorpius Holdings, Inc. (“Scorpius”) to better reflect the Company’s successful shift into a pure-play, large molecule biomanufacturing CDMO. The Company will continue to operate its CDMO within the Scorpius BioManufacturing subsidiary.
In connection with the name change, the Company’s ticker will change to SCPX as well. The name and symbol changes will not affect the Company's share structure or the rights of the Company's shareholders, and no further action will be required by existing shareholders.
In addition, the Company announced that it has bolstered its leadership team with the promotions of Brian O’Mara to VP of Process Sciences and Steve Lavezoli to VP of Commercial Operations, as well as the additions of Juan Lagos as Senior Director of Cell-Based Technologies and Ania Szymanska as Site Head of Quality.
Jeff Wolf, CEO of Nighthawk, commented, “Our rebranding to Scorpius Holdings is a testament to our successful transition and the growth of our CDMO operations. The industry faces a critical shortage of clinical-scale biologic manufacturing capacity, driven by increasing demand for large molecule CDMO services. Our state-of-the-art facility in San Antonio, Texas ideally positions us to address this gap in CDMO manufacturing capacity and services. The response from major biotech companies and leading research institutions to our CDMO capabilities has been positive, as evidenced by the expansion of our sales pipeline."
Mr. Wolf further noted, “To better service increasing demand for our specialized CDMO services, we have expanded our team with key hires to support our growing client base. Each of these team members brings extensive industry experience and will help ensure that we continue to provide our clients with exceptional service. Given the investments in both our facility and operations, we now have significant capacity to scale our operations, which we expect will generate high incremental margins and attractive returns for our shareholders in the years ahead."
Senior Promotions and Appointments
Brian O’Mara - VP of Process Sciences. Mr. O’Mara joined Scorpius in June 2022 as the Senior Director, Manufacturing Science & Technology. He has more than 20 years of industrial biotechnology experience in downstream process development of early- and late-stage protein therapeutics from mammalian and microbial expression systems. He also has extensive experience in the development and scale-up of protein conjugates, including antibody-drug conjugates (ADCs), bi-specifics, and PEGylated molecules, as well as experience in technology transfer, CDMO management, process characterization, preparation and oversight of PPQ campaigns, and associated CMC regulatory filings. Brian earned a BS in Biology from Binghamton University and an MS in Chemistry from Lehigh University.
Steve Lavezoli - VP of Commercial Operations. Mr. Lavezoli joined Scorpius in December 2022 as the Regional VP of Business Development for the central region. He now oversees Scorpius’ business development, proposals, and marketing strategy. He brings extensive experience in various roles throughout business development and marketing. He spent 12 years in the industrial gasses industry with Linde Gas, as well as W.L. Gore in their Startup Biopharmaceutical division working on a Commercial Business/Market Development role for Bulk Drug Substance Single-Use items. He also spent 3 years with Catalent Biologics, focused on Drug Substance Business Development in the US for early-stage clinical programs with clients to bring life-changing therapies to the market. Steve holds a BS in Chemical Engineering from Pennsylvania State University and an MBA in Marketing from Robert Morris University.
Juan Lagos - Senior Director of Cell-Based Technologies. Mr. Lagos brings more than 20 years of experience in cell culture and upstream process development from lab bench to cGMP manufacturing and leads Scorpius’ cell-based technologies team, which is responsible for analytical and cell therapy processes. Before joining Scorpius, he was the Associate Director MS&T / LVV Suspension Process Development at Rocket Pharmaceuticals. His industry experience includes director-level and senior engineering roles at Allakos and Bristol Myers Squibb, as well as experience at biopharma service providers like WuXi Apptec and Patheon. He holds a dual B.S. in Computer Science and Chemical Engineering from Rutgers University, where he continues to pursue a Ph.D. in Biochemical Engineering.
Ania Szymanska - Site Head of Quality. Ms. Szymanska brings over 19 years of leadership and management experience in Quality Control, Quality Assurance, and Compliance at pharmaceutical and biotech companies. She joined Scorpius from Marker Therapeutics, Inc. where she was Vice President of Quality and built the Quality Management Systems. She played a critical role in the design, construction, and qualification of their state-of-the-art cell therapy GMP manufacturing facility and Quality Control laboratories. Prior to Marker, she served as Director of Quality Control for Bellicum Pharmaceuticals, Inc. where she developed its Quality Control department and was responsible for aseptic facility qualification. She also served as Quality Validation Specialists of Opexa Therapeutics, Inc. and in roles of increasing responsibility at Woodfield Pharmaceutical, LLC (formerly Pernix Manufacturing, LLC), most recently as Director of Microbiology. Ms. Szymanska earned an M.S. in Microbiology from the University of Warsaw.
NightHawk Biosciences, Inc.
NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, 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 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.nighthawkbio.com or https://www.scorpiusbiologics.com, and also follow us on Twitter.
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 generating high incremental margins and attractive returns for our shareholders in the years ahead. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to generate, high incremental margins and attractive returns for our shareholders in the years ahead, the Company’s ability to continue to grow revenue, leverage fixed costs and achieve long-term profitability; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace; 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 successfully operate as a CDMO the ability to obtain regulatory approval 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, 2022, 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://investorrelations@nighthawkbio.com
NEWS -- NightHawk Biosciences Commences Work on Multi-Million-Dollar Development and Manufacturing Agreement For a Leading National University
Scorpius subsidiary to manufacture novel biologic targeting substance use disorder
DURHAM, N.C., Jan. 03, 2024 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK) (“NightHawk” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced its Scorpius BioManufacturing subsidiary (“Scorpius”) has commenced work on a contract that it was awarded by a leading university to develop and manufacture a novel biologic targeting substance use disorder, which includes drug, alcohol and opioid addiction.
Jeff Wolf, CEO of NightHawk, commented, “We are honored to have been awarded this multi-million dollar contract by one of the foremost research universities in the United States. Scorpius was selected due to its process development and large molecule manufacturing expertise, as well as its flexibility and dedication to customer service. We are off to a strong start and look forward to expanding this relationship into additional programs in 2024 and beyond. Overall, we could not be more excited by the traction and growing pipeline within Scorpius.”
NightHawk Biosciences, Inc.
NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, 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 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.nighthawkbio.com or https://www.scorpiusbiologics.com, and also follow us on Twitter.
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 expanding the relationship with the university into additional programs in 2024 and beyond Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to generate future revenue from manufacturing contracts, the Company’s ability to continue to grow revenue, leverage fixed costs and achieve long-term profitability; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace; 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 successfully operate as a CDMO the ability to obtain regulatory approval 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, 2022, 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://investorrelations@nighthawkbio.com
NHWK......................................................https://stockcharts.com/h-sc/ui?s=NHWK&p=W&b=5&g=0&id=p86431144783
NEWS -- NightHawk Biosciences Announces Completion of Demonstration Run for a Top-Tier NIH and DTRA Funded Research University
Next phase of multi-million-dollar project to include scaling up cGMP manufacturing for phase 1 trial targeting infectious disease
CDMO services attracting considerable interest as state-of-the-art San Antonio facility helps address industry-wide scarcity for large molecule manufacturing
DURHAM, N.C., Dec. 21, 2023 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK) (“NightHawk” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced its Scorpius BioManufacturing subsidiary (“Scorpius”) completed a demonstration run in the Company’s process development lab for a microbial vaccine program developed by a top-tier research university that is NIH and DTRA (Defense Threat Reduction Agency) funded.
Jeff Wolf, CEO of NightHawk, commented, “This first phase of a multi-million-dollar project was particularly noteworthy, as we achieved a successful demonstration run following a prior failed attempt by a competitor CDMO. The complexity of the project led this top-tier university to choose Scorpius, drawn by our more engaged management approach and accelerated development timeline. The successful completion of this demonstration run showcases our team's dedication and expertise, and represents an important step in advancing our relationship with this nationally renowned university. The next phase of this project will include scaling up to cGMP manufacturing to support a phase 1 infectious disease trial. Our CDMO services continue to attract considerable interest, thanks to our extraordinary team, state-of-the-art facilities, and the industry-wide scarcity of capacity for large molecule manufacturing.”
NightHawk Biosciences, Inc.
NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, 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 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.nighthawkbio.com or https://www.scorpiusbiologics.com, and also follow us on Twitter.
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 recognizing revenue from the agreement during 2024, expanding our scope of work and revenue potential of this agreement and the CDMO activities holding the potential to generate meaningful revenue and cash flow Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to generate future revenue from manufacturing contracts booked in 2023 the Company’s ability to continue to grow revenue, leverage fixed costs and achieve long-term profitability; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace; 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 successfully operate as a CDMO, he continued maintenance and growth of the Company’s and its subsidiaries’ patent estates the ability to obtain regulatory approval 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, 2022, 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://investorrelations@nighthawkbio.com
NHWK: It's an interesting Firm, to say the least --- with strange price action yesterday. BEST OF LUCK with your gambit!!
I bought some yesterday
NHWK: Trying to scratch its way GREEN right now in the Post-M, after big crash at the Close; had nice news, yesterday.
https://www.nighthawkbio.com/ (Cute website, too!!)
NEWS -- NightHawk Biosciences Announces Major Milestone with Completion of Manufacturing Run for a Premier U.S.-Based Biopharmaceutical Company
Manufacturing run at Scorpius’ state-of-the-art San Antonio microbial facility sets the stage for commercial manufacturing
Advances multi-million dollar biomanufacturing contract awarded earlier this year; set to expand upon client’s regulatory filing and start of commercial manufacturing
DURHAM, N.C., Dec. 18, 2023 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK) (“NightHawk” or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced its Scorpius BioManufacturing subsidiary initiated its first manufacturing run for a premier U.S.-based biopharmaceutical company in the Company’s new, state-of-the-art microbial manufacturing facility.
Jeff Wolf, CEO of NightHawk, commented, “We are generating strong interest in our CDMO services, given our state-of-the-art facility and the industry-wide lack of available capacity for large molecule manufacturing. This demonstration run in our new microbial facility marks a major milestone, as it represents the first at-scale production run with a premier biopharmaceutical company and reflects positively upon our manufacturing readiness, as well as our ability to meet their stringent product requirements. Importantly, this milestone enables us to build upon the initial multi-million-dollar contract with this client, which we expect to recognize as revenue during 2024. We also look forward to further expanding our scope of work and revenue potential of this agreement, as we work with our client to submit the necessary regulatory filings to commence commercial-scale production. We appreciate their trust in Scorpius to ensure this important product gets to patients as safely and quickly as possible.”
Mr. Wolf added, “This demonstration run and expansion of this agreement is further validation of our recent decision to streamline the organization through the divestiture of non-core assets to double-down on our CDMO activities, which we believe hold the potential to generate meaningful revenue and cash flow. We are witnessing growing interest in the industry as we build our track record and enhance our reputation. This is reflected in our rapidly expanding sales pipeline that now includes a number of premier biopharma companies, as well as leading government and academic research institutes.”
NightHawk Biosciences, Inc.
NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, 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 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.nighthawkbio.com or https://www.scorpiusbiologics.com, and also follow us on Twitter.
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 recognizing revenue from the agreement during 2024, expanding our scope of work and revenue potential of this agreement and the CDMO activities holding the potential to generate meaningful revenue and cash flow Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to generate future revenue from manufacturing contracts booked in 2023 the Company’s ability to continue to grow revenue, leverage fixed costs and achieve long-term profitability; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace; 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 successfully operate as a CDMO, he continued maintenance and growth of the Company’s and its subsidiaries’ patent estates the ability to obtain regulatory approval 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, 2022, 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://investorrelations@nighthawkbio.com
NEWS -- NightHawk Biosciences Announces Strategic Shift into a Pure-Play Large Molecule Biomanufacturing CDMO to Capitalize on Rapid Growth in Sales Pipeline along with Divestiture of Non-Core Assets
DURHAM, N.C., Dec. 12, 2023 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK) today (“NightHawk” or the “Company”) announced its strategic shift into a pure-play biomanufacturing Contract Development & Manufacturing Organization (CDMO), as well as the divestiture of certain non-core assets, in order to focus on the growing sales within its Scorpius BioManufacturing subsidiary (“Scorpius”). The Company has booked contracts thus far in 2023, Scorpius’ first full year of operation, that are expected to generate over $20 million in revenue, a substantial portion of which will be recognized in 2024. To facilitate this strategic shift, the Company has divested its Elusys subsidiary and related assets, and has eliminated most of its R&D and associated expenses to focus its resources on growing and expanding Scorpius.
The assets will be acquired by a private company established by Jeff Wolf, CEO of NightHawk, which will assume Elusys’ contracted financial commitments, currently estimated at over $40 million. Under the terms of the transaction, the private company will also provide an upfront payment of $500,000, a note for $2.25 million that is convertible into shares of NightHawk’s common stock subject to receipt of stockholder approval, and royalties of 3% on all of Elusys’ gross sales until June 30, 2031. The royalties are subject to a mandatory minimum payment of $5 million during the first five years of the royalty term. The divestiture of Elusys and R&D cuts are expected to reduce the Company’s annual operating expenses by over $13 million and fully eliminate the need for NightHawk to raise capital to support Elusys’ programs.
Jeff Wolf, Chief Executive Officer of NightHawk and Elusys following the closing, commented, “Given the strength of our CDMO operations at Scorpius, we have made the strategic decision to refocus our efforts around those activities that hold the potential to generate meaningful cash flow while substantially reducing non-core costs and associated overhead. Scorpius booked $3 million in contracted sales in 2022, which has grown to over $20 million in contracted sales thus far in 2023. As contracted sales are generally recognized as revenue as work is performed, we expect to recognize substantial revenue on these booked contracts in 2024. We also have a very significant and growing sales pipeline, which includes contracts from premier pharma and biotech companies, as well as leading research institutes. We expect to close a number of new contracts before year-end and believe the growth in our sales pipeline is strong validation of the meaningful investments we have made in our Scorpius subsidiary. As we continue to grow our revenue and leverage our fixed costs, we expect our CDMO business to generate high margins and long-term profitability.”
Mr. Wolf added, “There is a significant shortage of clinical scale biologic manufacturing capacity within the industry as a result of growing demand for large molecule CDMO services. In turn, this has led to significant M&A activity within the sector. We believe we are extremely well positioned to capitalize on these trends given our state-of-the-art facility, experienced and dedicated team, broad service offering, and robust sales pipeline.”
John Prendergast, Ph.D., NightHawk’s lead director stated, “The divestiture of our non-core assets enables NightHawk to focus its resources on growing its Scorpius subsidiary, and will result in the immediate elimination of approximately $40 million of contractual obligations and reduction of over $13 million in operating expenses per year. Moreover, NightHawk will receive an upfront cash payment, as well as a $2.25 million convertible loan and at least $5 million in royalties on future Elusys gross payment receipts for approximately 7.5 years. This was vetted and approved by an independent committee of the board to be in the best long-term interests of NightHawk and its shareholders. As a pure-play CDMO, the board of NightHawk believes that NightHawk now has the opportunity to create substantial shareholder value in an underserved marketplace.”
Mr. Wolf further noted, “The senior management team and board of directors are laser-focused on transforming our company into a revenue-generating CDMO. We have shuttered most all of our research, substantially cut costs and divested our non-core assets to achieve this. Our goals are clear; provide the highest quality manufacturing services to our CDMO customers and focus on driving near and long-term revenue. We believe this strategic shift and divestiture of non-core assets will not only enhance our balance sheet and cashflow, but also drive meaningful returns to our shareholders for years to come.”
NightHawk Biosciences, Inc.
NightHawk Biosciences, through its Scorpius BioManufacturing subsidiary, 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 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.nighthawkbio.com or https://www.scorpiusbiologics.com, and also follow us on Twitter.
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 booking over $20 million in booked contracts in 2023 alone; the Elusys divestiture and research and development cuts to eliminating over $40M of commitments and reducing annual operating expenses by more than $13 million; recognizing substantial revenue on contracts next year; closing a number of new contracts before year-end; the growth in the Company’s sales pipeline being strong validation of the meaningful investments it has made in its Scorpius subsidiary; the CDMO business generating high margins and achieving long-term profitability; being extremely well positioned to capitalize on trends given the Company’s state-of-the-art facility, broad service offering, and robust sales pipeline; the the reduction in personnel and other expenses substantially reducing the Company’s operating expenses; transforming the Company into a revenue-generating CDMO; providing the highest quality manufacturing services to CDMO customers and driving near and long-term revenue; and the strategic shift into a pure-play, large molecule CDMO and divestiture of non-core assets, enhancing the Company’s balance sheet and cashflow and also helping to drive meaningful returns for shareholders for years to come. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to generate over $20 million in future revenue from manufacturing contracts booked in 2023; the Company’s ability to close on a number of new CDMO contracts before year-end; the Company’s ability to continue to grow revenue, leverage fixed costs and achieve long-term profitability; the Company’s ability to create substantial shareholder value as a pure-play CDMO in an underserved marketplace; 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 successfully operate as a CDMO, he continued maintenance and growth of the Company’s and its subsidiaries’ patent estates the ability to obtain regulatory approval 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, 2022, 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://investorrelations@nighthawkbio.com
NEWS -- NightHawk Biosciences Provides Q3 2023 Business Update
NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative therapies, today provided strategic, financial, and operational updates for the quarter ended September 30, 2023.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We are very pleased with the progress of our Scorpius San Antonio facility where operations are advancing well and the feedback from our customers has been extremely positive. As a result, we are currently evaluating a variety of strategic options to maximize the potential of the business. We look forward to providing further updates on our efforts in the near future.”
Third Quarter 2023 Financial Results
NEWS -- NightHawk Biosciences Provides Q2 2023 Business Update
DURHAM, N.C., Aug. 14, 2023 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative medical countermeasures that combat unmet and emerging biothreats, today provided strategic, financial, and operational updates for the quarter ended June 30, 2023.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “Development of our biomanufacturing operations, continues to progress. Specifically, we continue to invest in our San Antonio facilities and are currently evaluating a variety of strategic options to advance these operations. In parallel, we are continuing our R&D activities, and are highly encouraged by the latest preclinical data. Towards this end, our strategy is to further develop these potential therapies through key milestones, with a focus on licensing or partnering these assets to maximize value for shareholders. We look forward to providing updates on these programs.”
Second Quarter 2023 Financial Results
Do some dd and you will see! Lazy one
NEWS -- NightHawk Biosciences Provides Q1 2023 Business Update
DURHAM, N.C., May 15, 2023 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company specializing in the end-to-end development, manufacturing, and commercialization of innovative medical countermeasures that combat unmet and emerging biothreats, today provided strategic, financial, and operational updates for the quarter ended March 31, 2023.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We continue to invest in and advance our research and biomanufacturing efforts, including our San Antonio and Manhattan, Kansas biologics manufacturing facilities. We are making steady progress and look forward to providing further updates.”
2023 Financial Results
I see another R/S coming … my money is already gone your crazy to invest in this one
My goodness what a total joke of a company
NEWS -- NightHawk Biosciences Appoints Stephan Kutzer, Ph.D. as Interim Chief Executive Officer of Scorpion Biological Services
DURHAM, N.C., June 13, 2022 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced the appointment of Stephan Kutzer, Ph.D. as Interim Chief Executive Officer of Scorpion Biological Services. Dr. Kutzer currently serves on Scorpion’s advisory board.
Dr. Kutzer brings more than 25 years of experience in the pharmaceutical and biotech industries, building and managing successful contract development and manufacturing organizations. He previously served as President and Chief Executive Officer of Alcami Corporation, a leading provider of development, analytical testing and manufacturing services to the pharmaceutical and biotech industries. Prior to this, he served as President, Divisional CEO and Chief Operating Officer of the Pharma Biotech & Customer Manufacturing division of Lonza Group AG, a multinational manufacturing company for the pharmaceutical and biotechnology sectors, where he had full oversight of the division, which generated over $1.6 billion in annual sales. He also served as a member of the Executive Management Board of Lonza Group AG; President of Lonza Biologics Inc; Chairman of the Board of Directors of Lonza Singapore Inc; Chairman of the Board of Directors of Teva-Lonza TL Biopharmaceuticals AG; Chairman of the Board of Directors of Lonza Biologics plc.; and President and Chairman of Lonza Inc. Dr. Kutzer previously served as an Executive Director on the board of directors for the Drug, Chemical & Associated Technologies Association (DCAT). Dr. Kutzer earned a master’s degree in Chemical and Process Engineering and a Ph.D. in Engineering Sciences from the Technical University of Munich, Germany.
Jeff Wolf, CEO of NightHawk and Chairman of Scorpion, commented, “Given the dynamic evolution of Scorpion and rapid progress with construction of our San Antonio and Manhattan, Kansas biomanufacturing facilities, we are delighted to welcome Stephan on board. Throughout his more than 25 years in the biomanufacturing space, Stephan has built and managed several successful contract development and global manufacturing organizations. We tapped Stephan from Scorpion’s advisory board to lead Scorpion through its next phase of growth, and we believe his proven track record will be invaluable to our future success.”
Commenting on his appointment, Dr. Kutzer stated, “This is an exciting time at Scorpion as we seek to build a robust and fully integrated CDMO. I am honored to have this opportunity and look forward to supporting Scorpion through this next phase of growth.”
About Scorpion Biological Services
Scorpion Biological Services is a contract research, and contract development and manufacturing organization (CDMO) focused on cell- and gene-based therapies and large molecule biologics. Scorpion provides a broad array of clinical-scale biomanufacturing, analytical and R&D services to pharmaceutical and biotech companies from its San Antonio, Texas facilities. Scorpion also plans to offer commercial-scale biomanufacturing from its newly announced site in Manhattan, Kansas. Additional information is available at: https://www.scorpionbio.com/.
NightHawk Biosciences, Inc.
NightHawk Biosciences is a fully integrated biopharmaceutical company focused on the development of new drugs from discovery through commercialization. The Company leverages its integrated ecosystem of subsidiaries to accelerate the development of novel therapies that arm the immune system, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility.
For more information on the Company and is subsidiaries, please visit: https://www.nighthawkbio.com, and also follow us on Twitter.
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 Stephan Kutzer’s proven track record being invaluable to our future success Important factors that could cause actual results to differ materially from current expectations include, among others, the contribution to be made by Stephan Kutzer, the ability to progress the company’s efforts under the NightHawk banner, whether the combined business of NightHawk and Elusys will be successful, NightHawk’s ability to successfully operate as a CDMO, NightHawk’s and its subsidiaries’ ability to maintain license agreements, the continued maintenance and growth of NightHawk’s and its subsidiaries’ patent estates, NightHawk’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, the ability to initiate clinical trials and if initiated, the ability to complete them on time and achieve the desired results and benefits continuing enrollment as expected, the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to NightHawk’s ability to promote or commercialize its product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of NightHawk’s products, developments by competitors that render such products obsolete or non-competitive, and other factors described in NightHawk’s annual report on Form 10-K for the year ended December 31, 2021, subsequent quarterly reports on Form 10-Qs and any other filings NightHawk makes with the SEC. The information in this presentation is provided only as of the date presented, and NightHawk 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://investorrelations@heatbio.com
NEWS -- NightHawk Biosciences Provides First Quarter 2022 Business Update
DURHAM, N.C., May 16, 2022 (GLOBE NEWSWIRE) -- NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today provided strategic, financial, and operational updates for the first quarter ended March 31, 2022.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, “We are extremely proud of the progress we have made this quarter to transition NightHawk into a fully-integrated biopharmaceutical company. On the business front, this month we announced the name change to NightHawk Biosciences to better reflect our evolution towards a fully integrated ecosystem that enables more rapid delivery of medical innovations with increased quality and efficiency. The NightHawk ecosystem includes an expanded development pipeline and enhanced manufacturing capabilities around five key subsidiaries: Skunkworx Bio, Heat Biologics, Pelican Therapeutics, Elusys Therapeutics and Scorpion Biological Services.”
“Moreover, we recently closed the strategic acquisition of Elusys Therapeutics (Elusys), which significantly expands our foothold in the biodefense space. The addition of Elusys’ ANTHIM®, a treatment for inhalation anthrax, complements our infectious disease product portfolio, which includes our RapidVax® platform, which is designed to target emerging biological threats. Shortly after the completion of the Elusys acquisition, we finalized our first international contract with the Canadian government to deliver ANTHIM® to their national stockpile. We are now pursuing additional opportunities to expand ANTHIM® distribution abroad.”
“At the same time, we continue to expand our biomanufacturing and bioanalytic capabilities. We recently unveiled plans for a new 500,000 square foot commercial/biodefense biomanufacturing facility in Manhattan, Kansas. In addition to servicing our own product pipeline, we plan to operate as a full-service Contract Development and Manufacturing Organization (CDMO) to support other biopharma companies. Moreover, we remain on track for the grand opening of our San Antonio facility in Q2/22.”
Mr. Wolf added, “The NightHawk ecosystem is truly unique among small biopharmaceutical companies. We look forward to providing further updates on our progress later this year.”
First Quarter 2022 Financial Results
agree with that
Ya do another reverse split and screw the shareholders again.
When are they going to make R/S illegal it’s such a terrible thing they are able to do . Here’s and idea run the company properly so you can stay on the indexes without having to do that
just might hit .25 like it did years back. POS
NEWS -- NightHawk Biosciences to Present at the 4th Annual Treg Directed Therapies Summit on PTX-35
NightHawk Biosciences (NYSE American: NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Matthew Seavey, Ph.D., MBA, NightHawk’s Vice President of Research will be presenting data on PTX-35, and serving on an expert panel discussing modes of Treg activation, at the 4th Annual Treg Directed Therapies Summit (https://treg-directed-therapies.com/) being held on May 17-19th in Boston.
PTX-35 is a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be utilized to expand regulatory T-cell subsets for auto/inflammatory indications. PTX-35 is the Company's first antibody-based product and is currently in a Phase 1 clinical trial for the treatment of patients with solid tumors.
Presentation Date/Time: Day-1, Wednesday, May 18th at 4:30 PM ET
Presentation Title: Agonizing Over Treg Expansion to Treat Human Disease: An Update on Our TNFRSF25-Agonist, PTX-35
Expert Panel Date/Time: Day-2, Thursday, May 19th at 11:30 AM ET
Expert Panel Title: Optimizing Routes of Administration & Delivery Mechanisms to Induce Timely Treg Specific Activation
Discussion Highlights:
NEWS -- Heat Biologics Completes Name Change to NightHawk Biosciences; Trading to Commence Under “NHWK” Effective at the Market Open Today
DURHAM, N.C., May 03, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. / NightHawk Biosciences (NYSE American: HTBX; NHWK), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that it has completed its name change from Heat Biologics, Inc. to NightHawk Biosciences, Inc. to better reflect the Company’s evolution, including expansion of the therapeutic pipeline, vertical integration of capabilities from drug discovery to manufacturing and commercialization, as well as the Company’s new biodefense capabilities. In connection with the name change, the Company’s ticker will change to “NHWK,” effective today, May 3, 2022. The name and symbol changes do not affect the Company's share structure or the rights of the Company's shareholders, and no further action is required by existing shareholders.
Jeff Wolf, CEO of Nighthawk, commented, “The NightHawk brand better reflects our evolution towards a fully integrated ecosystem, designed to efficiently move drugs from discovery through commercialization. The NightHawk ecosystem includes an expanded development pipeline, new biodefense capabilities and enhanced manufacturing capabilities. As a result, we have organized the Company around five key subsidiaries: Skunkworx Bio, Heat Biologics, Pelican Therapeutics, Elusys Therapeutics and Scorpion Biological Services. NightHawk is laser focused on addressing key industry challenges, including the slow pace and high cost of new drug development through a fully integrated ecosystem of drug discovery, preclinical testing and manufacturing. We look forward to progressing these efforts under the NightHawk banner.”
NightHawk Biosciences, Inc.
NightHawk Biosciences is a fully integrated biopharmaceutical company focused on the development of new drugs from discovery through commercialization. The Company leverages its integrated ecosystem of subsidiaries to accelerate the creation and manufacture of novel therapies that arm the immune system, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility.
For more information on the Company and is subsidiaries, please visit: https://www.nighthawkbio.com, and also follow us on Twitter.
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 progressing the company’s efforts under the NightHawk banner. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to progress the company’s efforts under the NightHawk banner, the ability to complete to successfully integrate the changes being made, whether the combined business of NightHawk and Elusys will be successful, NightHawk’s and its subsidiaries’ ability to maintain license agreements, the continued maintenance and growth of NightHawk’s and its subsidiaries’ patent estates, NightHawk’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, the ability to initiate clinical trials and if initiated, the ability to complete them on time and achieve the desired results and benefits continuing enrollment as expected, the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to NightHawk’s ability to promote or commercialize its product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of NightHawk’s , developments by competitors that render such products obsolete or non-competitive, and other factors described in NightHawk’s annual report on Form 10-K for the year ended December 31, 2021, subsequent quarterly reports on Form 10-Qs and any other filings NightHawk makes with the SEC. The information in this presentation is provided only as of the date presented, and NightHawk 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://investorrelations@heatbio.com
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