NHWK Nighthawk Biosciences Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (date of earliest event reported): January 16, 2024

 

NightHawk Biosciences, Inc.

(Exact name of registrant as specified in charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

001-35994	26-2844103
(Commission File Number)	(IRS Employer Identification No.)

 

627 Davis Drive, Suite 300

Morrisville, North Carolina 27560

(Address of principal executive offices and zip code)

 

(919) 240-7133

(Registrant’s telephone number including area code)

 

N/A

(Former Name and Former Address)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:

 

¨

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨

Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)

 

¨

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0002 par value per share	NHWK	NYSE American LLC
Common Stock Purchase Rights	None	NYSE American LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  ¨

 

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

Item 7.01.   Regulation FD Disclosure.

 

NightHawk Biosciences, Inc. (the “Company”) will be making several presentations to investors over the next several weeks. In connection with the presentations, the Company intends to discuss the investor presentation, which is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 7.01 and in the investor presentation furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

The investor presentation furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.

 

Item 8.01 Other Items

On January 16, 2024, the Company updated its corporate presentation. The updated presentation highlights the Company’s focus on its contract development and manufacturing organization (“CDMO”) business, which is operated by the Company’s subsidiary, Scorpius Biomanfacturing, Inc. (“Scorpius”). Since inception, Scorpius has signed 12+ development and manufacturing contracts (representing over $20 million in potential revenue) with customers that include premier biopharma and emerging biotech companies.

Item 9.01 Financial Statements and Exhibits.

(d)	Exhibits.
	Exhibit Number			Description
	99.1			Corporate Presentation dated January 2024
	104			Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

 

 

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated:  January 16, 2024	NightHawk Biosciences, Inc.
	By:	/s/ Jeff Wolf
	Name:	Jeff Wolf
	Title:	Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

NightHawk Biosciences A rapidly growing, highly scalable biologics Contract Development & Manufacturing Organization (CDMO) Investor Presentation - January 2024 NYSE: NHWK

 

 

 

This presentation includes statements that are, or may be deemed, “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, these forward - looking statements can be identified by the u se of forward - looking terminology, including the terms “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may” , “could”, “might”, “will”, “should”, “approximately” or, in each case, their negative or other variations thereon or comparable termino log y, although not all forward - looking statements contain these words. They appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations, concerning, am ong other things, the demand for contract development & manufacturing organization services growing, our recognizing revenue in 2 024 from over $20M in Scorpius signed manufacturing contracts, expected high margins and long - term profitability, leveraging fixed costs as revenue continues to grow resulting in high margins and long - term profitability, the industry in which we operate and t he trends that may affect the industry or us. By their nature, forward - looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward - looking statement contained in this presentation, we caution you that forward - looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of th e i ndustry in which we operate may differ materially from the forward - looking statements contained in this presentation as a result of, am ong other factors, the factors referenced in the “Risk Factors” section of our Annual Report on Form 10 - K for the year ended Decembe r 31, 2022, our quarterly reports on Form 10 - Q for the subsequent quarters and our other subsequent filings with the Securities an d Exchange Commission (collectively, our “SEC Filings”). In addition, even if results of operations, financial condition and li qui dity, and the development of the industry in which we operate are consistent with the forward - looking statements contained in this presentation, they may not be predictive of results or developments in future periods. Any forward - looking statements that we m ake in this presentation speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this presentation, except as required by law. Forward Looking Statements Forward Looking Statement

 

 

Full - Service CDMO Focused on Biologic Production for the Middle Market Scorpius seeks to differentiate itself from competitors with a comprehensive mix of service offerings and a nimble, “boutique” approach to project planning and execution

 

 

 

Investment Highlights x Growing demand for Contract Development & Manufacturing Organization (CDMO) services and significant shortage of dedicated clinical - scale manufacturing capacity within the industry x Pure - play biologics CDMO offering a comprehensive range of services from process and analytical development through clinical - stage and small - scale commercial cGMP manufacturing x Began 2023 with $3M signed contracts, which has grown to over $20M in signed contracts , with recognized revenue from a substantial number of these contracts expected in 2024 x Installed capacity to support a large and growing pipeline and backlog that is being driven by new customer acquisition and existing customer/program expansion x Customers include many premier biopharma and emerging biotech companies , as well as leading research institutions x Ability to leverage fixed costs as revenue continues to grow; expected to result in high margins and long - term profitability Investment Highlights

 

 

 

Refocused and Recharged Recently divested non - core assets and contractual obligations to focus on Scorpius BioManufacturing operations » Terminated major in - house research activities » Divested non - core assets » Slashed non - core liabilities and burn rate These efforts have eliminated approximately $40M of contractual obligations and reduced operating expenses by over $13M per year Now laser - focused on driving revenue and cash flow through our Scorpius operations

 

 

 

Increased Biologic Demand Driving Rapid Growth in CDMO Segment Large Molecule Drug Substance CDMO Market size is poised to grow from $10.86B in 2022 to $21B by 2030, growing at a CAGR of 8.6% in the forecast period (2023 - 2030)* * SkyQuest Large Molecule Industry Forecast, July 2023 Over the last decade, R&D spending has steadily shifted from its focus on small molecules to the growing biologics segment » This shift has resulted in significantly higher demand for pharma services providers to assist in advancing these large molecules through the clinic » An increasing number of FDA approvals for biologics - based drugs has further validated interest in the space » It takes years of investment to establish complex facilities with talented teams, strong quality management and operating procedures up to regulatory standards » Already - established CDMOs, like Scorpius, are well - positioned to develop relationships with biotech clients ahead of future competition **Coherent Market Insights, July 2021, Biologics Market Analysis.

 

 

Business History Nov ’20: Scorpius BioManufacturing is founded Aug ’21: Broke ground on San Antonio, TX facility 2H ’22: Onboarded key execs and industry experts to build out management team Q4 ’22: Onboarded first client for microbial commercial contract Oct ’22: Opened San Antonio facility 2H ‘21 1H ‘22 2H ‘22 1H ‘23 2H ‘23 2H ‘20 1H ‘21 In the two years since breaking ground, Scorpius has generated revenue and is currently executing on a diverse pipeline of CDMO contracts Q1’24: Substantial pipeline with preparation for first GMP batches underway Worked with industry - leading advisors to design and build state - of - the - art, co - located mammalian and microbial facilities 1H ‘24 Q1’24: Over $20M in signed contracts with substantial revenue from these contracts anticipated in 2024 Since inception, Scorpius has signed 12+ development and manufacturing agreements with various pharma and biotech clients

 

Scorpius Snapshot Clinical - scale biomanufacturing in San Antonio, TX located in the heart of a thriving innovation district Highly skilled scientific and manufacturing leadership team US - sourced supply chain with US and international customers In - house process development and analytical services including Microbial fermentation, MAbs , Cell Therapy products

 

San Antonio Facility Overview Expertise in Mammalian and Microbial Manufacturing 40,000+ sq. ft. footprint includes – Brand new, state - of - the - art 40,000 sq. ft. facility with: • ~5,400 sq. ft. Mammalian / Cell Therapy manufacturing space • ~3,200 sq. ft. Microbial manufacturing space • ~2,000 sq. ft. of analytical development / QC space • ~2,000 sq. ft. of process development space – Additional 20,000 sq. ft. warehouse space – Large molecule manufacturing capabilities span preclinical through mid - late clinical scale and small - scale commercial: • Mammalian (250 mL development – 500 L manufacturing) • Microbial (250 mL development – 200 L manufacturing) – Clinical - scale development for third - party clients started in Oct ’22 – First client GMP batches planned for Q1 ’2 4 – 80+ employees, including a veteran management team with deep experience and tenure in the CDMO space

 

Supported Drug Modalities Phase - Appropriate Process Development Clinical - Scale Manufacturing Small - Scale Commercial Manufacturing Mammalian Cell Culture • Antibody Production • Monoclonals, Bi - Specifics • Recombinant Therapeutic Proteins • Allogeneic and Autologous Cell Therapy • Fc Fusions • Cells, Exosomes, Secretome Microbial Fermentation • Recombinant Therapeutic Proteins & Enzyme Products • Bacterial Subunit Vaccines

 

Financial Profile Robust Pipeline Supported by Streamlined Marketing Approach » Since inception, Scorpius has signed 12+ development and manufacturing agreements , establishing strong brand recognition » Over $20M in signed contracts with substantial revenue from these contracts anticipated in 2024 » Rapidly expanding pipeline with several near - term opportunities » ~$32M of direct facility investment (PP&E, etc.) » $50M+ revenue/ yr capacity in current San Antonio facility configuration, with substantial expansion possibilities

 

Balance Sheet Highlights » Over $20 million of PP&E acquired without term debt (as of 09/30/23) » No term debt » ROU assets and liabilities represent all Scorpius facilities ($22M) and leased specialized equipment ($2.5M) (as of 09/30/23) » Capital investment into facility and equipment completed in Q3, 2023 » Clean capital structure » ~26.1 million common shares outstanding (as of 01/15/24) » No warrants outstanding (as of 01/15/24)

 

2024 Goals Plans to grow market share through several initiatives in 2024: » Deliver seamless execution on signed manufacturing contracts » Expand pipeline with target biotech, pharma, and research customers » Streamline operations to deliver at scale » Bolster and strengthen in - house development and analytical services » Develop talent and culture, creating a team that can win long - term Focused on driving revenue and cash flow

 

Leadership Team Joe Payne VP, Quality & Regulatory 20+ Years Of Experience Alcami , Tergus , Teva Brian O’Mara VP, Process Sciences 20+ Years Of Experience Ambrx , Bristol - Myers Squibb, Genencor, Wyeth Stephan Kutzer Senior Advisor 25+ Years Of Experience Alcami , Lonza Matt LeClair VP, Manufacturing Operations 30+ Years Of Experience Abzena, Takeda Steve Lavezoli VP, Business Development 20+ Years Of Experience Catalent, W.L. Gore Bill Ostrander Chief Financial Officer 20+ Years Of Experience KBI Jeff Wolf Founder & CEO 30+ Years Of Experience Avigen , TyRx Pharma, EluSys Tx Ania Szymanska Site Quality Head 25+ Years Of Experience Opex Tx, Bellicum , Marker Tx

Summary x Growing demand for Contract Development & Manufacturing Organization (CDMO) services and significant shortage of dedicated clinical - scale manufacturing capacity within the industry x Scorpius began 2023 with $3M of signed manufacturing contracts, which has grown to over $20M in signed manufacturing contracts, with recognized revenue from a substantial number of these contracts expected in 2024 x Customers include many premier pharma and biotech companies, as well as leading research institutions x Recently divested non - core assets to focus on CDMO operations; eliminated approximately $40M of contractual obligations and reduced operating expenses by over $13M per year x Ability to leverage fixed costs as revenue continues to grow; expected to result in higher margins and long - term profitability

 

 

A Full - Service CDMO Focused on Biologic Production for the Middle Market

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

v3.23.4

Cover	Jan. 16, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 16, 2024
Entity File Number	001-35994
Entity Registrant Name	NightHawk Biosciences, Inc.
Entity Central Index Key	0001476963
Entity Tax Identification Number	26-2844103
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	627 Davis Drive
Entity Address, Address Line Two	Suite 300
Entity Address, City or Town	Morrisville
Entity Address, State or Province	NC
Entity Address, Postal Zip Code	27560
City Area Code	(919)
Local Phone Number	240-7133
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Common Stock [Member]
Common Stock	Common Stock, $0.0002 par value per share
Trading Symbol	NHWK
Security Exchange Name	NYSEAMER
Common Stock Purchase Rights [Member]
Common Stock	Common Stock Purchase Rights
Trading Symbol	None
Security Exchange Name	NYSEAMER

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