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 year ended December 31, 2022.
Jeff Wolf, Chief Executive Officer of NightHawk,
commented, “We are making progress on our transition towards
biodefense and biomanufacturing through our Elusys and Scorpion
subsidiaries as we wind down our HS-110 and PTX-35 oncology
programs. Pursuant to this, we are investing in our
biomanufacturing technologies and capabilities, including our San
Antonio and Manhattan, Kansas biologics manufacturing facilities,
which we believe will position us well in the future. The
manufacturing capabilities associated with these facilities are
designed to streamline the development and delivery of life-saving
medical countermeasures, while enabling us to offer excess capacity
to third parties on a fee-for-service model.”
2022 Financial Results
- For the year ended December 31,
2022, the Company recognized revenue of $6.4 million, which
included $6.0 million of product sales revenue, $0.1 million of
contract revenue, and $0.3 million of CPRIT grant revenue. For the
year ended December 31, 2021, the Company recognized revenue of
$2.1 million for qualified expenditures under the CPRIT grant. The
increase in product sales revenue was due to the sale of ANTHIM®
(obiltoxaximab) to the Canadian government. The decrease in grant
revenue was due to the fact that the Company recognized all $15.2
million of CPRIT grant revenue. For the year ended December 31,
2022, the Company had a grants 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.
- For the year ended December 31,
2022, the Company recognized $6.4 million of cost of sales. No
product sales were recognized for the year ended December 31, 2021,
and thus no cost of sales was recorded. The increase was due to the
cost of sales related to the ANTHIM® (obiltoxaximab) sale to the
Canadian government. Cost of sales includes $5.9 million of
inventory, $0.3 million of pre-acquisition backlog, and $0.2
million of shipping and fulfillment expenses.
- Selling, general and administrative
(“SGA”) expenses for the years ended December 31, 2022 and 2021
were $21.1 million and $16.8 million, respectively. The increase of
$4.3 million was primarily due to an increase in consulting and
other professional expenses to manage the business of $3.2 million,
an increase in facilities expense of $1.2 million primarily due to
the opening of the Company’s San Antonio facility, an increase in
personnel expense of $0.8 million due to an increase in headcount,
an increase in rent expense of $0.5 million, an increase in
insurance expense of $0.3 million, an increase in depreciation of
$0.3 million, an increase in marketing expenses of $0.2 million, an
increase in software expense of $0.2 million offset by a decrease
in stock-based compensation of $2.4 million.
- Research and development expenses
increased to $23.5 million from $16.5 million for the years ended
December 31, 2022 and 2021, respectively. HS-110 R&D expense
decreased by $1.2 million, HS-130 expense decreased by $0.2
million, and PTX-35 expense decreased by $0.3 million, all due to a
decrease in site and investigator fees as a result of the closing
of the clinical trials. ANTHIM® (obiltoxaximab) expenses increased
due to the Company’s acquisition of Elusys in April 2022. Other
program expenses decreased by $0.7 million, including preclinical
costs associated with the RapidVax program, T-cell costimulatory
programs, and laboratory supplies. Unallocated research expenses
increased by $8.2 million primarily from license fees, sponsored
research agreements for preclinical research, as well as increased
clinical and CMC consulting expenses and Skunkworx lab and
personnel costs.
- Net loss attributable to NightHawk
Biosciences was approximately $43.4 million, or ($1.70) per basic
and diluted share, for the year ended December 31, 2022, compared
to approximately $35.1 million, or ($1.41) per basic and diluted
share, for the year ended December 31, 2021.
- As of December 31, 2022, the
Company had approximately $44.3 million in cash, cash equivalents,
and short-term investments.
Pursuant to the disclosure requirements of the
NYSE American Company Guidelines Sections 401(h) and 610(b),
NightHawk reports that its audited financial statements for the
year ended December 31, 2022, included in the 2022 Form 10-K,
contain an audit opinion from its independent registered public
accounting firm that includes an explanatory paragraph related to
the Company’s ability to continue as a going concern due to the
fact that the Company has suffered recurring losses from operations
and has not generated significant revenue or positive cash flows
from operations.
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
ANAPHYLAXISHypersensitivity 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: www.nighthawkbio.com, and also
follow us on Twitter.
Forward Looking StatementThis
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. In some cases
forward-looking statements can be identified by terminology such as
"may," "should," "potential," "continue," "expects," "anticipates,"
"intends," "plans," "believes," "estimates," and similar
expressions, and include statements such as continuing to make
progress in our biodefense and biomanufacturing efforts through
NightHawk’s Elusys and Scorpion subsidiaries, investing in
biomanufacturing technologies and capabilities, including
NightHawk’s San Antonio and Manhattan, Kansas biologics
manufacturing facilities, positioning NightHawk well in the future,
the manufacturing capabilities associated with these facilities
streamlining the development and delivery of life-saving medical
countermeasures while enabling us to offer excess capacity to third
parties on a fee-for-service model. Important factors that could
cause actual results to differ materially from current expectations
include, among others, the ability to continue to make progress in
NightHawk’s biodefense and biomanufacturing efforts through Elusys
and Scorpion subsidiaries, the ability to expand ANTHIM®
(obiltoxaximab) distribution abroad, 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 most recent annual
report on Form 10-K, 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 ContactDavid
Waldman+1 919 289 4017investorrelations@heatbio.com
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