SAB Biotherapeutics Provides Company Update for Q3 2022 Financial Results
16 November 2022 - 12:30AM
SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage
biopharmaceutical company with a novel immunotherapy platform that
produces specifically targeted, high-potency, fully-human
polyclonal antibodies without the need for human donors, today
reported financial results for the third quarter ended September
30, 2022, and provided a company update.
“We continue to utilize our capabilities and
infrastructure to advance our development pipeline in
immunotherapeutics directed at unmet medical needs in respiratory
diseases and in gastrointestinal disease with our Clostridioides
difficile (C. diff) program and have discovery programs in
autoimmune disease and oncology. During the quarter we were able to
show data that further validates our platform at targeted medical
conferences. Additionally, we signed a contract manufacturing
agreement with Emergent BioSolutions, one of the few companies
experienced in both human and animal plasma fractionation and
purification uniquely qualified to manufacture SAB’s novel
fully-human polyclonal antibody products,” said Eddie J. Sullivan,
Ph.D., Co-Founder, President, and Chief Executive Officer of SAB
Biotherapeutics.
Pipeline Updates and Anticipated
Milestones
SAB continues to execute on its strategy to
build a proprietary immunology pipeline addressing respiratory and
gastrointestinal diseases that disproportionately affect patients
who are immunocompromised or have autoimmune disorders. Below are
some key highlights and milestones from the quarter:
- During the quarter, the company
presented an overview of its DiversitAb™ polyclonal platform and
data on SAB-176 and SAB-185 at the 2022 Plasma Product
Biotechnology Conference in Limassol, Cyprus. The data presented
showed the benefits of fully-human polyclonal antibodies derived
from SAB’s Transchromosomic (Tc) Bovine™ over plasma derived
antibodies from humans. The SAB fully-human polyclonal antibody
platform maintains its efficacy against multiple variants of
several highly mutating viruses.
- The company also presented at a
conference hosted by the International Society for Influenza and
other Respiratory Virus Diseases (ISIRV) in Belfast, Northern
Ireland. The data presented showed its fully-human polyclonal
antibody platform maintains its efficacy against multiple variants
of several highly mutating viruses. The Phase 2a challenge trial
showed that SAB-176 reduced the viral load in subjects exposed to
pandemic H1N1 influenza virus, improved symptoms by day four, and
shortened the timeframe for viral shedding. The data also showed
that SAB-185 COVID-19 polyclonal antibody therapeutic candidate was
effective in animal models against all tested SARS-CoV2 variants,
including some of the recently evolving Omicron variants. “Both of
these programs show the power of polyclonal antibodies to broadly
neutralize highly mutating viruses and the differentiation of SAB’s
novel therapeutic products vs monoclonal biologic therapies,” Dr.
Sullivan said. “These data highlight that our technology produces
neutralizing antibodies that create an envisioned evergreen
therapeutic aimed to maintain efficacy against rapidly mutating
pathogens.”
- SAB-176, the Company’s
anti-influenza human polyclonal therapeutic, will move into
advanced Phase 2b development, and SAB-195, the Company’s anti-C.
diff. human polyclonal antibody therapeutic, will move to
IND-enabling activities and IND filing.
- In October, the company announced
it has entered into an exclusive manufacturing services agreement
with Emergent BioSolutions Inc. Emergent will provide contract
development and manufacturing (CDMO) services to produce SAB’s
fully-human polyclonal antibody products. Under the terms of the
agreement, Emergent will provide end-to-end Good Manufacturing
Practice (cGMP) manufacturing services to SAB, including process
development and manufacturing clinical investigational drug product
to support SAB’s clinical programs, and commercial manufacturing
services upon regulatory approval of SAB’s therapeutics. The
agreement also provides the opportunity for Emergent to utilize
SAB’s novel DiversitAb™ platform, the only one in the world that
produces fully-human polyclonal antibodies without the need for
human donors.
Q3 2022 Financial Results
- Financial
Guidance: SAB received $8.6 million from the DoD
contract on November 10, 2022, for work performed.
Additionally, SAB and the DoD continue to engage in a
comprehensive negotiation over several million dollars claimed by
SAB as contract closeout costs. Based on its current operating
plans, SAB reaffirms that it expects its existing business plan,
cash and cash equivalents, and anticipated cash flows will be
sufficient to fund its operating expenses and capital expenditure
requirements through July 2023.
- Cash
Position: Cash and cash equivalents were $8.3 million
as of September 30, 2022, compared to $16.6 million on June 30,
2022, which was driven primarily by SAB’s third quarter cash
operating loss of $7.1 million.
- Research and Development
(R&D) Expenses: R&D expenses were $7.4
million for three months ended September 30, 2022, compared to
$15.1 million for the three months ended September 30, 2021. The
decrease was primarily due to decreases in laboratory supplies,
contract manufacturing costs, clinical trial expense, and outside
lab services due to a decrease in work performed.
- General and Administrative
(G&A) Expenses: G&A expenses were $4.0
million for the three months ended September 30, 2022, compared to
$3.6 million for the three months ended September 30, 2021. The
increase was primarily due to increased compensation costs and
increased insurance and compliance costs associated with being a
public company.
- Net
Income: Net loss was $7.1 million for the three
months ended September 30, 2022, for an earnings per basic and
diluted share of $(0.16), as compared to a net loss of $4.1 million
for the three months ended September 30, 2021, for an earnings per
basic and diluted share of $(0.16).
About SAB Biotherapeutics,
Inc.
SAB Biotherapeutics, Inc. (SAB) We are a
clinical-stage biopharmaceutical company focused on the development
of powerful and proprietary immunotherapeutic polyclonal human
antibodies to treat and prevent infectious diseases and immune and
autoimmune disorders. Our development programs include infectious
diseases resulting from outbreaks and pandemics, as well as
immunological, gastroenterological, and respiratory diseases that
have significant mortality and health impacts on immune compromised
patients. SAB has applied advanced genetic engineering and antibody
science to develop Transchromosomic (Tc) Bovine™. Our versatile
DiversitAb™ platform is applicable to a wide range of serious unmet
needs in human diseases. It produces natural, specifically
targeted, high-potency, fully-human polyclonal immunotherapies
without the need for human donors. SAB currently has multiple drug
development programs underway and collaborations with the US
government and global pharmaceutical companies. For more
information on SAB, visit: https://www.SAb.bio/ and follow SAB on
Twitter and LinkedIn.
Forward-Looking Statements
Certain statements made herein that are not
historical facts are forward-looking statements for purposes of the
safe harbor provisions under The Private Securities Litigation
Reform Act of 1995. Forward-looking statements generally are
accompanied by words such as “believe,” “may,” “will,” “estimate,”
“continue,” “anticipate,” “intend,” “expect,” “should,” “would,”
“plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook”
and similar expressions that predict or indicate future events or
trends or that are not statements of historical matters. These
forward-looking statements include, but are not limited to,
statements regarding future events, including the development and
efficacy of our influenza program, C. diff. program, Type 1
Diabetes program, and other discovery programs, the likelihood that
a patent will issue from any patent application, the results,
including timing, of the development of SAB-176, SAB-185 and
SAB-195 (including any IND filing or proposed clinical trials),
financial projections and future financial and operating results
(including estimated cost savings and cash runway), the outcome of
and potential future government and other third-party
collaborations or funded programs (including negotiations with the
DoD).
These statements are based on the current
expectations of SAB and are not predictions of actual performance,
and are not intended to serve as, and must not be relied on, by any
investor as a guarantee, prediction, definitive statement, or an
assurance, of fact or probability. These statements are only
current predictions or expectations, and are subject to known and
unknown risks, uncertainties and other factors which may be beyond
our control. Actual events and circumstances are difficult or
impossible to predict, and these risks and uncertainties may cause
our or our industry’s results, performance, or achievements to be
materially different from those anticipated by these
forward-looking statements. A further description of risks and
uncertainties can be found in the sections captioned “Risk Factors”
in our most recent annual report on Form 10-K, subsequent quarterly
reports on Form 10-Q, and other filings with or submissions to, the
U.S. Securities and Exchange Commission, which are available at
https://www.sec.gov/. Except as otherwise required by law, SAB
disclaims any intention or obligation to update or revise any
forward-looking statements, which speak only as of the date they
were made, whether as a result of new information, future events,
or circumstances or otherwise.
CONTACTS
Investor Relations:SAbIR@westwicke.com
Media Relations:SAbPR@westwicke.com
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