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
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 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 ContactDavid
Waldman+1 919 289 4017investorrelations@heatbio.com
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