SEC 8-K filings with transcript text
Mar 29, 2024
Mar 31, 2023
sabs20230330_8k.htm
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Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 30, 2023
(Exact name of Registrant as Specified in Its Charter)
Delaware
001-39871
85-3899721
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
2100 East 54th Street North
Sioux Falls, South Dakota
57104
(Address of Principal Executive Offices)
(Zip Code)
Registrant’s Telephone Number, Including Area Code: 605 679-6980
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the 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 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, $0.0001 par value per share
The NASDAQ Stock Market LLC
Warrants, each exercisable for one share of Common Stock at an exercise price of $11.50 per share
The NASDAQ Stock Market 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 check mark 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 2.02. Results of Operations and Financial Condition.
On March 31, 2023, SAB Biotherapeutics, Inc., a Delaware corporation (the “Company”) issued a press release announcing its financial results for the year ended 2022. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated by reference herein.
The information furnished pursuant to this “Item 2.02 - Results of Operations and Financial Condition”, including Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”) or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing made by us under the Exchange Act or Securities Act of 1933, as amended, regardless of any general incorporation language in any such filing, except as shall be expressly set forth by specific reference in such filing.
Item 4.02. Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review.
On March 30, 2023, the audit committee (the “Audit Committee”) of the board of directors of the Company, and the Company’s management concluded that the Company’s previously issued audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “Prior Year Financial Statements”), and the Company's previously issued interim financial statements included in the Company's Quarterly Reports on Forms 10-Q for the three months ended March 31, 2022, the six months ended June 30, 2022, and nine months ended September 30, 2022 (the “Prior Period Interim Financial Statements”), should no longer be relied upon as a result of the following accounting errors:
●
The Company concluded that it did not correctly account for a financed insurance premium whereby a third-party lender prepaid the Company's annual insurance premiums to our insurance companies in exchange for a short-term interest bearing note (the “Insurance Financing Agreement”). The Company previously recognized, on its consolidated balance sheet, a current prepaid asset for the amount paid by the Company under the Insurance Financing Agreement in excess of the total amortized value of the prepaid insurance policy. The Company reassessed its accounting for the Insurance Financing Agreement and determined that the Insurance Financing Agreement should be classified as a current note payable with the full amount of the insurance premium recognized as cu
Nov 22, 2021
2 ex99-1.htm
Exhibit 99.1
SAB Biotherapeutics Reports Third Quarter 2021 Financial Results and Provides Company Update
Advanced SAB-185 to Phase 3 in NIH-Sponsored ACTIV-2 Trial for treatment of COVID-19 following positive DSMB recommendation at interim analysis
Awarded additional $60.5 million from DoD in expanded scope for advancement of SAB-185
Strengthened leadership team through appointment of Russell Beyer as Chief Financial Officer
Sioux Falls, S.D., November 22, 2021 – 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, 2021 and provided a company update.
“We entered the next stage of our growth with our recent debut as a public company, highlighted by the completion of our business combination with Big Cypress Acquisition Corp. in October,” said Eddie J. Sullivan, PhD, co-Founder, President, and Chief Executive Officer of SAB Biotherapeutics. “Our pipeline of potent and scalable human polyclonal antibodies leveraging our novel DiversitAb™ platform continues to advance, and our clinical programs for SAB-185 and SAB-176 show strong therapeutic potential as they progress through clinical trials. We have built a strong team with exceptional experience and knowledge, enabling us to drive forward the development of highly-efficacious human polyclonal therapies with the potential to address the emergence, mutation, and diversity of modern health challenges.”
Recent Developments and Upcoming Milestones
Pipeline Updates:
● Infectious Disease Pipeline:
○
a polyclonal antibody therapeutic candidate for the treatment of COVID-19 is currently being evaluated in the ongoing Phase 3 ACTIV-2 trial in collaboration with the US National Institutes of Health (NIH) for the treatment of non-hospitalized patients with mild to moderate COVID-19
– In September, announced that an independent Data Safety Monitoring Board (DSMB) recommended advancement to Phase 3 following a prespecified interim analysis data review of the safety and efficacy of SAB-185 in the Phase 2 portion of the ACTIV-2 trial
– Awarded an additional $60.5 million in September for expanded scope from U.S. Department of Defense (DoD) for advanced clinical development through licensure and commercial manufacturing; SAB has announced four awards currently totaling more than $203 million since March of 2020
– Dosed the first patient in Phase 3 trial in October 2021
○
a quadrivalent polyclonal antibody therapeutic candidate currently being evaluated in an ongoing Phase 2a challenge study for the treatment of seasonal influenza
– Phase 2a topline data are expected in the fourth quarter of this year
● Autoimmune Diseases Pipeline:
○
a human polyclonal antibody therapeutic candidate for type 1 diabetes and organ transplantation (induction/rejection) currently in preclinical development
– IND-enabling studies expected to begin in the first quarter of 2022
Business Highlights
● Successfully closed business combination with Big Cypress Acquisition Corp. The business combination, which closed in October 2021, resulted in gross proceeds to SAB of approximately $30 million. SAB now trades on the Nasdaq under the ticker “SABS.”
● In September 2021, appointed Russell Beyer to the Company’s leadership team as Chief Financial Officer. Russell brings more than 30 years of experience overseeing financial functions at pharmaceutical and other Fortune 100 firms.
Nine Months to Date 2021 Financial Results
● Cash Position – As a result of the closing of the business combination with Big Cypress on October 22, 2021, cash and cash equivalents, on a proforma basis, were $30 million. Cash and cash equivalents on September 30, 2021 were $10.8 million as compared to $13.5 million as of September 30, 2020.
● Research and Development (R&D) Expenses – R&D expenses were $46.5 million for the nine months to date September 30, 2021, compared to $12.6 million for the same period in 2020. The increase was primarily due to the advancement of SAB-185 for COVID-19.
● General and Administrative (G&A) Expenses – G&A expenses were $9.3 million for the nine months ended September 30, 2021, compared to $4.9 million for the same period in 2020. The increase was primarily due to services in support of company growth.
● Net Loss – Net loss was $5.6 million, for the nine months ended September 30, 2021, compared to Net Income of $11.7 million, for the same period in 2020.
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. SAB has applied advanced genetic engineering and antibody science to develop transchromosomic (Tc) Bovine™ that produ
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