SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage
biopharmaceutical company with a novel immunotherapy platform that
produces specifically targeted, high-potency, fully-human
immunoglobulin (hIgG) antibodies, also known as fully-human
polyclonal antibodies, without the need for human donors, today
reported financial results for the full year ended December 31,
2022, and provided a company update.
“I am pleased to share the meaningful progress
SAB has made this past year advancing our groundbreaking,
proprietary immunotherapy platform, a powerful approach and the
only one in the world that generates targeted and fully-human
immunoglobulin antibodies without the need for human donors. We
continue to use this platform to create first-of-its-kind
approaches and set new standards in developing differentiated
treatments for a myriad of complex diseases. SAB’s clinically
validated platform has the potential to deliver new treatments for
patients with unmet medical needs, including potential for a highly
desired disease-modifying approach in difficult-to-treat chronic
autoimmune disorders, where we’ve made tremendous progress in our
type 1 diabetes program. Our Clostridioides difficile Infection, or
C. diff, investigational product is the first and only to deliver a
multi-targeted approach to the entire complex lifecycle of the C.
diff pathogen. C. diff is a devastating disease recognized by the
CDC as an urgent antibiotic resistance threat,” said Eddie J.
Sullivan, Ph.D., Co-Founder, President, and Chief Executive Officer
of SAB Biotherapeutics. “Our focus remains on enhancing patient
outcomes while also generating long-term value for our
shareholders.”
Pipeline Milestones and
Updates
SAB continues to execute its strategy to build a
proprietary immunology pipeline addressing complex immune disorders
and respiratory and gastrointestinal diseases that
disproportionately affect immunocompromised patients, including the
elderly. Below are some key highlights and milestones from the year
2022:
- Advanced our
SAB-142 type 1 diabetes program and completed numerous pre-clinical
activities, including an IND-enabling GLP toxicology study, which
was completed in early 2023.
- Expanded our
pipeline with SAB-195, a new, differentiated research program to
treat C. diff, a potentially terminal gastrointestinal infectious
disease with few effective treatments.
- Announced new
clinical data for SAB’s Influenza Phase 2a challenge trial,
validating SAB-176’s proof of concept in reducing viral load and
improving symptoms of influenza, while also reinforcing the ability
to generate broadly neutralizing antibodies to H1N1 pandemic strain
as well as all tested viral variants of influenza A and B.
- Presented new
pre-clinical data for SAB-185 demonstrating the therapeutic
candidate to be effective against the majority of SARS-CoV-2
variants, including Omicron.
- Announced results
from a project collaborating with global biotechnology leader CSL,
confirming that SAB’s DiversitAb™ polyclonal platform can generate
functional and fully-human anti-idiotype polyclonal antibodies to
effectively target and neutralize autoantibodies associated with
autoimmune diseases.
- Forged an exclusive
manufacturing services agreement with Emergent BioSolutions Inc. to
provide contract development and manufacturing services to produce
SAB’s fully-human IgG antibody products.
- Welcomed Alexandra
Kropotova, M.D., to be the company’s new Chief Medical Officer. Dr.
Kropotova brings to SAB more than 20 years of experience in all
phases of global clinical development, translational medicine and
medical affairs. Prior to joining SAB, Dr. Kropotova was the
Therapeutic Area Head of Global Specialty R&D at Teva
Pharmaceuticals, where she led innovative drug development focused
on delivering on a broad portfolio of immunology, respiratory, and
immuno-oncology assets spanning from pre-IND to BLA/NDA filing of
biologics and complex drug-device combination products and was
instrumental in clinical development of Dupixent at Sanofi.
- Announced the
appointment of Rear Admiral (RADM), retired, Scott Giberson, a
former Assistant U.S. Surgeon General and two-star admiral with the
U.S. Public Health Service and current President of AMI Health to
SAB’s Board of Directors
- Negotiated
settlement with the US Government in October 2022 and received
first payment of $8.6 million in November 2022, with a second and
final payment of $8.2 million in January 2023, to close out work
for manufacturing of SAB-185, the company’s clinical stage
therapeutic candidate for COVID-19.
- Raised $7.9 million
in a private placement of common stock to advance our pipeline of
first-in-class therapeutic candidates and fund working
capital.
- Presented an
overview of the Company’s DiversitAb™ Platform and data showing
benefits of fully-human IgG antibody products derived from cows vs.
human-derived plasma and highlighted data on SAB-176 for seasonal
and pandemic influenza and SAB-185 for COVID-19 at the 2022 Plasma
Product Biotechnology Conference in Cyprus.
- Presented “Novel
Biologic Therapeutics for Infectious Diseases,” focusing on
SAB-176, a novel pan-influenza immunotherapeutic, SAB-195, an
immunotherapeutic for Clostridioides difficile Infection, and
SAB-185, a broadly neutralizing COVID-19 treatment, at the Pharma
Partnering Conference in Boston.
Financial Guidance
- Financial Guidance:
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 December
2023.
- Cash Position: Cash
and cash equivalents were $15.0 million as of December 31, 2022,
compared to $33.2 million on December 31, 2021.
- The company reduced
its annualized anticipated net cash consumption from $60 million to
$18 million.
Restatement of 2021 Financial
Results
The Company will restate its previously issued
consolidated financial statements for the fiscal year ended
December 31, 2021. The Company determined that it is necessary to
correct the presentation of a financed insurance premium resulting
in offsetting increases to current assets, current liabilities, and
the associated presentation on the Company’s statement of cash
flows. Investors should no longer rely upon the Company’s
consolidated financial statements contained in its Form 10-K for
the year ended December 31, 2021, and the Company's previously
issued interim financial statements included in the Forms 10-Q for
the 2022 fiscal year. The Company will restate its prior period
financial results in its Annual Report on Form 10-K for the fiscal
year ended December 31, 2022. Such restatement is an error related
to accounting presentation; as such it will not result in any net
increase or reduction in the Company’s income, nor adjustment in
historical or anticipated cash flows.
As previously disclosed by SAB in a Form 12b-25 filed with the
Securities and Exchange Commission on March 31, 2023, SAB has
delayed filing its Form 10-K because SAB and its independent
auditors require additional time to complete procedures surrounding
the restatement of prior period financials.
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, SAB-142
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
SAB Biotherapeutics (NASDAQ:SABSW)
Historical Stock Chart
From Jul 2024 to Aug 2024
SAB Biotherapeutics (NASDAQ:SABSW)
Historical Stock Chart
From Aug 2023 to Aug 2024