Paulness
5 days ago
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
Paulness
1 month ago
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
Paulness
1 month ago
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
Paulness
2 months ago
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
Paulness
2 months ago
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
Paulness
2 months ago
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
Paulness
2 months ago
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
Paulness
3 months ago
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
Paulness
3 months ago
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
Paulness
3 months ago
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
Paulness
3 months ago
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
Paulness
3 months ago
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
Paulness
4 months ago
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
Paulness
4 months ago
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
Paulness
4 months ago
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
Paulness
4 months ago
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
Paulness
5 months ago
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
Over $20 million in signed manufacturing contracts which include premier biotech/pharma companies and research institutesElusys divestiture and R&D cuts expected to eliminate over $40 million in commitments and reduce operating expenses by more than $13 million per yearDURHAM, 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
Paulness
5 months ago
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
In August, the Company determined to make available for sale the equity interests of Elusys Therapeutics, Inc. Therefore, the results of operations have been reclassified as discontinued operations on a retrospective basis for all periods presented.For the three months ended September 30, 2023 we recognized $6.7 million of revenue from product sales, which is included in discontinued operations, $0.6 million of revenue from process development and $0.1 million from service revenue. For the three months ended September 30, 2022 we recognized $5.98 million of product sales revenue, which is included in discontinued operations, and $0.5 million of grant revenue. The increase in product sales revenue is due to the completion of the manufacturing conversion of ANTHIM® and the increase in process development revenue is attributable to the operations of the San Antonio CDMO facility. No grant revenue was recognized in 2023 as the CPRIT grant has ended.Cost of revenues were $2.7 million for the three months ended September 30, 2023. $2.2 million of these expenses primarily reflect the manufacturing conversion costs from the sale of ANTHIM® which are included in discontinued operations. The remaining $0.5 million primarily consists of direct cost of labor, overhead and material costs at Scorpius. We recognized $6.4 million of product cost of revenues for the three months ended September 30, 2022, driven by the sale of ANTHIM® to Canada which is included in discontinued operations.
Research and development expenses decreased approximately 3.7% to $5.2 million for the three months ended September 30, 2023, compared to $5.4 million for the three months ended September 30, 2022. The components of R&D expense are as, in millions: HS-110 expense decreased by $0.1 million primarily due to the discontinuation of the clinical trial in 2022; HS-130 expense decreased to $0.0 from $0.1 million due to the de-prioritization of our oncology assets; PTX-35 expense decreased by $0.5 million primarily due to the discontinued clinical trial and development of the product candidate in the third quarter of 2022; other programs expense stayed consistent at $0.3 million and primarily relate to close out costs of our R&D facility; and unallocated research expenses increased by $0.5 million primarily due to increased personnel costs, depreciation expense, amortization expense and scientific hardware and software.Selling, general and administrative expenses were $6.1 million and $4.8 million for the three months ended September 30, 2023 and 2022, respectively. The increase was primarily due to increases in marketing expense of $0.6 million, personnel expense of $0.4 million, depreciation and amortization of $0.2 million, and rent expense of $0.2 million, offset by a decrease in insurance expense of $0.1 million.As of September 30, 2023, the Company had approximately $9.5 million in cash, cash equivalents, and short-term investments of which $3.3 million is in current assets held for sale.NightHawk Biosciences, Inc.
NightHawk Biosciences leverages its integrated ecosystem of subsidiaries to streamline the advancement of novel therapies, 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 its 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 the evaluation of a variety of strategic options to maximize the potential of the Scorpius San Antonio operations and providing updates on the Company’s efforts in the near future. Important factors that could cause actual results to differ materially from current expectations include, among others, , NightHawk’s ability to successfully maximize the potential of its operations, NightHawk’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, 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, , the ability to obtain required regulatory approval 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 and services in the marketplace and the successful development, marketing or sale of NightHawk’s services and products, developments by competitors that render such products or services obsolete or non-competitive, and other factors described in NightHawk’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 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
Paulness
8 months ago
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
For the three months ended June 30, 2023 we recognized $0.7 million of revenue from process development. For the three months ended June 30, 2022 we recognized $0.05 million of service revenue. The increase in process development revenue is attributable to the operations of the San Antonio CDMO facility.Research and development expenses increased approximately 21.3% to $5.7 million for the three months ended June 30, 2023 compared to $4.7 million for the three months ended June 30, 2022. The components of R&D expense are as follows, in millions: HS-110 expense increased by $0.3 million primarily due to site close out fees; HS-130 expense decreased to $0 from $0.1 million due to the de-prioritization of our oncology assets; PTX-35 expense decreased by $0.4 million primarily due to the discontinued clinical trial and development of the product candidate in the third quarter of 2022; ANTHIM was not acquired until the second quarter of 2022 and the 2023 expense primarily relates to fill finish; other programs expense decreased by $0.3 million primarily due to a decrease in laboratory supplies expense related to preclinical R&D expenses; and unallocated research expenses increased by $0.9 million primarily due to increased personnel costs, including stock-based compensation from stock awards, contractor expense and supplies purchased for discovery projects.Cost of revenues were $0.4 million for the three months ended June 30, 2023. These expenses primarily reflect direct cost of labor, overhead and material costs. There was no cost of revenues for the three months ended June 30, 2022 as the Scorpius facility was not operational.Selling, general and administrative expenses were $7.4 million and $4.9 million for the three months ended June 30, 2023 and 2022, respectively. The increase was primarily due to increases in consulting and other professional expenses of $0.7 million, personnel expense of $0.5 million, marketing expense of $0.5 million, facility expense of $0.3 million, rent expense of $0.2 million, depreciation and amortization of $0.3 million, insurance and taxes of $0.2 million, offset by a decrease in supplies expense of $0.2 million.Net loss attributable to NightHawk Biosciences was approximately $13.9 million, or ($0.53) per basic and diluted share, for the three months ended June 30, 2023, compared to approximately $6.8 million, or ($0.27) per basic and diluted share, for the three months ended June 30, 2022.As of June 30, 2023, the Company had approximately $18.6 million in cash, cash equivalents, and short-term investments.NightHawk Biosciences, Inc.
NightHawk Biosciences is focused on the discovery and commercialization of innovative medical countermeasures to defend against emerging biothreats. The Company leverages its integrated ecosystem of subsidiaries to streamline the advancement of novel therapies, 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 its 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 continuing to invest in the Company’s San Antonio facilities, continuing our R&D activities, further developing potential therapies through key milestones, with a focus on licensing or partnering these assets to maximize value for shareholders providing further updates and the Company’s evolving strategy unlocking significant value for stockholders. Important factors that could cause actual results to differ materially from current expectations include, among others, NightHawk’s ability to continue to invest in and advance its research and biomanufacturing efforts, including its San Antonio facility, NightHawk’s ability to successfully develop potential therapies through key milestones, NightHawk’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, 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, 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, 2022, 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
Paulness
11 months ago
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
For the three months ended March 31, 2023 we recognized $0.1 million of revenue from a licensing agreement with Shattuck Labs and $0.7 million of revenue from Scorpius biomanufacturing services. For the three months ended March 31, 2022 we recognized $0.2 million of grant revenue for qualified expenditures under the CPRIT grant. The decrease in grant revenue in the current-year period is due to the fact that we have recognized all $15.2 million of CPRIT grant revenue. As of March 31, 2023, we had a grants receivable balance of $1.5 million for the final CPRIT tranche, and received those funds in April 2023. . We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.Research and development expenses increased approximately 79.5% to $7.0 million for the three months ended March 31, 2023 compared to $3.9 million for the three months ended March 31, 2022. The components of R&D expense are as follows: HS-110 expense decreased $0.1 million primarily due to a decrease in consultants and contract labor expense; HS-130 expense decreased to $0 from $0.5 million due to the deprioritization of the oncology assets; PTX-35 expense increased by $0.3 million primarily due to the expensing of prepaid expenses associated with the discontinued clinical trials and development of the product candidate in the third quarter of 2022;ANTHIM® (obiltoxaximab) was not acquired until the second quarter of 2022 and the 2023 expense primarily relates to fill finish; other programs expense increased by $0.4 million primarily due to increase in laboratory supplies expense related to preclinical R&D expenses and the operations of the CDMO facility; Unallocated research expenses increased by $2.7 million primarily due to increased personnel costs, including stock-based compensation from stock awards, contractor expense and supplies purchased for discovery projects;Cost of revenues were $0.6 million for the three months ended March 31, 2023. These expenses primarily reflect direct cost of labor, overhead and material costs for Scorpius biomanufacturing services. There was no cost of revenues for the three months ended March 31, 2022 as the Scorpius facility was not operational.Selling, general and administrative expenses were $6.8 million and $3.8 million for the three months ended March 31, 2023 and 2022, respectively. The increase was primarily due to an increase of $1.9 million for consulting and other professional expenses to manage the business and increased personnel costs of $1.0 million, and to a lesser extent, an increase in rent expense of $0.3 million, offset by a decrease in stock-based compensation expense of $0.1 million.Net loss attributable to NightHawk Biosciences was approximately $12.8 million, or ($0.49) per basic and diluted share, for the three months ended March 31, 2023, compared to approximately $8.1 million, or ($0.32) per basic and diluted share, for the three months ended March 31, 2022.As of March 31, 2023, the Company had approximately $28.6 million in cash, cash equivalents, and short-term investments.About ANTHIM
Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.
ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.
Indications and Usage
ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.
IMPORTANT SAFETY INFORMATION Including BOXED WARNING
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.
WARNINGS AND PRECAUTIONS
Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.
ADVERSE REACTIONS
The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.
USE IN SPECIFIC POPULATIONS
Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.
To see the complete prescribing information for ANTHIM, click here.
NightHawk Biosciences, Inc.
NightHawk Biosciences is a fully-integrated biopharmaceutical company focused on the discovery and commercialization of innovative medical countermeasures to defend against emerging biothreats. The Company leverages its integrated ecosystem of subsidiaries to streamline the advancement of novel therapies, 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 its 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 continuing to invest in and advance NightHawk’s research and biomanufacturing efforts, including its San Antonio and Manhattan, Kansas biologics manufacturing facilities, and making steady progress and providing further updates. Important factors that could cause actual results to differ materially from current expectations include, among others, NightHawk’s ability to continue to invest in and advance its research and biomanufacturing efforts, including its San Antonio and Manhattan, Kansas biologics manufacturing facilities, NightHawk’s ability to increase sales of ANTHIM® (obiltoxaximab) including distribution abroad, NightHawk’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, NightHawk’s ability to commence operation in Kansas when anticipated and to successfully operate as a CDMO in San Antonio and Kansas, 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, 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, 2022, 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
Paulness
2 years ago
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
Paulness
2 years ago
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
Recognized $0.2 million of grant revenue for qualified expenditures under the CPRIT grant for the quarter ended March 31, 2022 compared to $0.5 million for the quarter ended March 31, 2021. The decrease in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of March 31, 2022, we had a grant receivable balance of $1.5 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.Research and development expenses were $3.9 million for the three months ended March 31, 2022 compared to $3.4 million for the three months ended March 31, 2021. The increase was primarily due to regulatory consulting and investigator site payments for the ongoing Phase 1 clinical trial for HS-130 as well as unallocated research expenses related to personnel costs, including stock-based compensation from stock awards.General and administrative expense was $3.8 million and $4.8 million for the quarters ended March 31, 2022 and 2021. The decrease was due to a decrease in stock-based compensation expense of $2.0 million, partially offset by increased personnel costs of $0.2 million, and increases of $0.3 million for consulting and other professional expenses to manage the business.Net loss attributable to NightHawk Biosciences was approximately $8.1 million, or ($0.32) per basic and diluted share for the three months ended March 31, 2022 compared to a net loss of approximately $7.5 million, or ($0.31) per basic and diluted share for the three months ended March 31, 2021.As of March 31, 2022, the Company had approximately $84.1 million in cash, cash equivalents and short term investments.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 the RapidVax® platform targeting emerging biological threats, NightHawk pursuing additional opportunities to expand ANTHIM® distribution abroad, NightHawk operating as a full-service Contract Development and Manufacturing Organization (CDMO) to support other biopharma companies, remaining on track for the grand opening of the San Antonio facility in Q2/22, providing further updates on NightHawk’s progress later this year, and continuing efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs. 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 successfully integrate Elusys and expand ANTHIM® distribution abroad, 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
Paulness
2 years ago
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:
Describing a clinical-stage Treg immunomodulator with utility in both oncology and auto/inflammationpDemonstrating preclinical efficacy in several possible, clinical indications including transplantation, autoimmunity, and metabolic diseasesExpanding plans for new indications and modalities, as well as opportunities for partnershipsThe Hanson Wade 4th Annual Treg Directed Therapies Summit is focused on targeting and translating Treg modifying therapies and brings together executives and leading researchers from large pharma, biotech and academia to discuss developments in Treg therapies.
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.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
Paulness
2 years ago
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
Paulness
2 years ago
NEWS -- Heat Biologics (NightHawk Biosciences) Announces that its Elusys Therapeutics Subsidiary has Executed a Contract to Deliver ANTHIM® to the Canadian Government
New contract marks the first international sale of ANTHIM® and follows recent acquisition of Elusys by NightHawk
DURHAM, N.C., April 27, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (NYSE American: HTBX) (to be renamed “NightHawk Biosciences”), a fully integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced to shareholders that its Elusys Therapeutics subsidiary has finalized a contract with the Canadian government to deliver ANTHIM® (obiltoxaximab for injection), a treatment for inhalation anthrax, for use against a potential anthrax attack.
ANTHIM® will be delivered to Canada’s National Emergency Strategic Stockpile under a procurement contract totaling CAD $7.9 million i. The goal of this program is to establish a Canadian supply of Anthim for use as a medical countermeasure against natural and man-made anthrax biothreats.
Jeff Wolf, CEO of Nighthawk and its Elusys subsidiary, commented, “We are excited to announce this first international contract to supply ANTHIM® to Canada, which is particularly timely given the growing global geopolitical uncertainty and emerging threats. This agreement follows our recent acquisition of Elusys, which complements our broader biodefense initiatives. We are focused on expanding sales of ANTHIM®, abroad and this first international contract is an important validation of our strategy.”
According to the United States Centers for Disease Control and Prevention (CDC), if a bioterrorist attack were to happen, bacillus anthracis, the bacteria that causes anthrax, would be one of the biological agents most likely to be used, since these spores are easily found in nature, can be produced in a lab, and may remain in the environment for a prolonged period. In recent Congressional testimony, Gerald Parker, Associate Dean of Texas A&M’s College of Veterinary Medicine & Biomedical Sciences, indicated that the top three bioterrorist threats were “anthrax, anthrax, and anthrax.”
Elusys has previously established a successful track record collaborating with U.S. government agencies including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), the Strategic National Stockpile (SNS) and the Department of Defense (DOD). To date, Elusys has been awarded over $400 million in research and development grants, contracts and procurement orders from BARDA and SNS through ongoing, multi-year partnerships with the U.S. government.
This latest award follows NightHawk’s recent announcement of its planned 500,000+ square foot biodefense-focused biologics biomanufacturing facility in Manhattan, Kansas, which is being designed to scale production of ANTHIM®, among other uses.
About ANTHIM®
Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.
ANTHIM® (obiltoxaximab for injection) is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. ANTHIM® is indicated for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate. The effectiveness of ANTHIM® is based solely on efficacy studies in animal models of inhalational anthrax.
About Elusys Therapeutics
Elusys Therapeutics is focused on the development of antibody therapeutics for the treatment of infectious disease. ANTHIM®(obiltoxaximab), the company’s monoclonal antibody (mAb) anthrax antitoxin, received market clearance by the U.S. Food and Drug Administration (FDA) in March 2016. In July 2020, Health Canada approved ANTHIM’s Extraordinary Use New Drug Submission for the treatment of inhalation anthrax. ANTHIM has also received marketing approved in the E.U. and the U.K., under the trade name of Obiltoxaximab SFL. For more information, please visit https://www.elusys.com.
About Heat Biologics, Inc. / NightHawk Biosciences, Inc.
Heat Biologics (to become “NightHawk Biosciences”) is a fully integrated biopharmaceutical company focused on the development of new drugs from discovery through biomanufacturing. The Company leverages its integrated ecosystem of subsidiaries to accelerate the creation 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 regarding establishing an initial Canadian supply of Anthim for use as a medical countermeasure against natural and man-made anthrax biothreats and planned 500,000+ square foot biodefense-focused biologics biomanufacturing facility in Manhattan, Kansas, which is being designed to scale production of ANTHIM®. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to fulfill the contract and supply Anthim to Canada, the ability to complete the biologics biomanufacturing facility in Manhattan, Kansas, whether the combined business of Heat and Elusys will be successful, Heat’s and Elusys’ ability to maintain license agreements, the continued maintenance and growth of Heat’s and Elusys’ patent estate, Heat’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 Heat’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 Heat’s, developments by competitors that render such products obsolete or non-competitive, and other factors described in Heat’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 Heat makes with the SEC. Heat can give no assurance that the conditions to the Merger will be satisfied. The information in this presentation is provided only as of the date presented, and Heat 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
i As this contract involved the sale of preexisting ANTHIM® inventory, 80% of the net proceeds of the contract will be tendered to the former shareholders of Elusys.
Paulness
2 years ago
NEWS -- Scorpion Biological Services Announces New Kansas Commercial Biomanufacturing Facility
MANHATTAN, Kan., April 26, 2022 /PRNewswire/ -- Biopharmaceutical contract development and manufacturing organization (CDMO) Scorpion Biological Services (Scorpion) today announced a planned development partnership with a private developer, the State of Kansas, and local and university affiliates, which will support the construction of a new biodefense-focused large molecule and biologics biomanufacturing facility in Manhattan, Kansas.
The 500,000 sq. ft. commercial biomanufacturing facility will service up to 144,000L cGMP capacity across 48 bioreactors
The $650 million commercial-scale facility, which will service approximately 144,000 liters of biomanufacturing capacity across 48 bioreactors, is being designed for large molecule biologics manufacturing.
The design and engineering of the facility is being led by CRB Group, a nationally recognized firm focused on designing and building biomanufacturing facilities. Realty Trust Group (RTG), a leading healthcare / life sciences real estate advisory and development firm, is serving as the lead developer on the project.
After considering locations in 23 states, the Scorpion leadership team selected Manhattan, Kansas, largely as a result of the city's concentration of biodefense organizations, including Kansas State University's Biosecurity Research Institute (BRI) and the National Bio and Agro-Defense Facility (NBAF) — the U.S. government's agricultural biothreat research laboratory. One specific goal of the facility will be to help scale production of ANTHIM®, an antitoxin against anthrax, which could be employed in defense against a potential anthrax attack.
To meet Biomedical Advanced Research and Development Authority (BARDA) and Department of Defense requirements for the Strategic National Stockpile (SNS), Scorpion intends to start manufacturing ANTHIM by mid-2024. As such, the company is planning a phased building approach to complete the production train for ANTHIM first –– by April 2024 — with plans to complete a new train every 15 months thereafter. Scorpion projects that the Manhattan facility will be complete, fully functional and staffed by April 2027.
The facility is being designed to be as flexible and versatile as possible. The majority of the facility will be dedicated to commercial CDMO services, but the company is exploring the design of trains focused on other products for the SNS, among others, given that 70% of the drug products in the SNS will expire over the next four years. Where possible, Scorpion plans to use a U.S.-based supply chain, beginning with the decision to install Pall bioreactors.
David Halverson, President of Scorpion, said, "We are very excited to break ground on this new facility. There is a strong demand for world-class biomanufacturing, which we expect to continue well into the future. The 500,000 square foot Manhattan facility is being designed to service up to 144,000 liters across 48 bioreactors –– powered by an excellent Kansas workforce. We're looking forward to rapidly growing and expanding Scorpion, and Manhattan is the perfect location for our newest facility."
Upon completion, Scorpion projects that the facility will have a billion-dollar impact on the State of Kansas, and employ over 500 individuals, largely from the local Kansas talent pool. The company has begun a project to transfer bioprocessing programs from Texas A&M to Kansas State University and the Manhattan Area Technical College at the associate's, bachelor's, and graduate level to help train Scorpion's future workforce.
"We are thrilled and excited that Scorpion has chosen Kansas for this game-changing facility that will have a massive positive impact in our state," said Governor Laura Kelly. "Being in the center of the country, with quick access to either coast, there is no better state for Scorpion to locate in order to address potential threats to public health."
About Scorpion Biological Services
Scorpion Biological Services is working to expand the reach of precision medicine to more people within multiple therapeutic areas. Its team is comprised of experts in bioanalytics, cell biology, virology, translational biology, biomanufacturing, and drug development. Scorpion's services are designed to support a myriad of biologic drugs from conception through clinical trials and commercial production, to bring new drugs to market faster and more reliably. For more information, visit https://www.scorpionbio.com and follow us on LinkedIn.
Contact:
Kenna Harris
Head of Sales and Marketing
Email: mailto://Hello@scorpionbio.com
Tel.: +1 (858) 472 1969
SOURCE Scorpion Biological Services
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