HTBX HEAT BIOLOGICS INC

NightHawk Biosciences Announces Major Milestone with Completion of Manufacturing Run for a Premier U.S.-Based Biopharmaceutical Company

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) -- (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:  or , and also follow us on .

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



 



EN
18/12/2023

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