Item 1.01 Entry into a Material Definitive Agreement
On September 2, 2022, Statera Biopharma, Inc. (the "Company") entered a Binding
Letter of Intent ("LOI") with Lay Sciences, Inc. ("Lay"), pursuant to which the
Company will manufacture, and test IgY polyclonal antibody products created by
Lay. The LOI provides for an exclusivity period of ninety (90) days (the
"Exclusivity Period") for negotiating and finalizing a definitive agreement (the
"Definitive Agreement"). During the Exclusivity Period, which begins from the
date of the LOI, Lay will not engage in activities with any third party in
relation to the acquisition of the Company.
Pursuant to the LOI, (i) Lay shall complete technology transfer to the Company;
and (ii) the Company shall (A) assist Lay in testing its current and future
products for activity and purity, In consideration of the manufacturing right
granted to the Company by Lay, the Company shall (i) issue 500,000 shares of
preferred stock of the Company to Lay and (ii) pay up to $500,000 to Lay within
30 days of the execution of the LOI.
The foregoing description of the LOI does not purport to be complete and is
qualified in its entirety by reference to the full text of the LOI, a copy of
which is filed as Ex. 10.1 to this report and is incorporated by reference
herein.
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or
Standard; Transfer of Listing.
On September 1, 2022, the Company was notified by the Listing Qualifications
Staff (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") that the Company's
common stock would be subject to delisting due to the Company's non-compliance
with the filing requirement set forth in Nasdaq Listing Rule 5250(c)(1) unless
the Company timely requested a hearing before the Nasdaq Hearings Panel (the
"Panel"). The Company has not yet filed the Form 10-K for the fiscal year ended
December 31, 2021 ("Form 10-K"), or the Forms 10-Q for the quarterly periods
ended March 31, 2022 and June 30, 2022 (collectively, "Form 10-Qs") with the
Securities and Exchange Commission. The Company intends to timely request a
hearing before the Panel, which request will stay any further action by Nasdaq
at least pending the issuance of a decision by the Panel and the expiration of
any extension the Panel may grant to the Company following the hearing.
The Company is diligently working to evidence compliance with the filing
requirement; however, there can be no assurance that the Panel will determine to
continue the Company's listing or that the Company will be able to evidence
compliance with the applicable listing criteria within the period of time that
may be granted by the Panel.
The Company expects and intends to submit the Form 10-K and the Form 10-Qs and
intends to file the Form 10-K and Form 10-Qs as soon as practicable.
Item 3.02 Unregistered Sales of Equity Securities.
The information contained above in Item 1.01 is hereby incorporated by reference
into this Item 3.02 in its entirety. The Company intends to issue shares of
preferred stock to Lay pursuant to the exemption from the registration
requirements of the Securities Act of 1933, as amended (the "Securities Act"),
available under Section 4(a)(2) and/or Rule 506(b) of Regulation D promulgated
thereunder.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On September 2, 2022, the Board of Directors of the Company appointed John
Kallassy as a director of the Company, effective September 2, 2022, to fill the
vacancy created by Randy Saluck's resignation. Mr. Kallassy will serve in such
position until his successor is elected and qualified or until his earlier
death, resignation, or removal. Mr. Kallassy will serve as a member of the
Board's audit committee, compensation committee, and nominating and corporate
governance committee. The Board has affirmatively determined that Mr. Kallassy
is "independent" within the meaning of the listing standards of The Nasdaq Stock
Market ("Nasdaq"). In addition, Mr. Kallassy is independent under Nasdaq's
heightened independence standards applicable to audit committee and compensation
committee members. The Board also appointed Mr. Kallassy as an "audit committee
financial expert" as defined in Item 407(d)(5) of Regulation S-K and Chairperson
of the Audit Committee of the Board.
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Mr. Kallassy currently serves as Chief Executive Officer and Board Chairman of
biotech company Bactana Corp and Chief Financial Officer of animal health
biologics company Torigen Pharmaceuticals, Inc. Mr. Kallassy has more than 25
years' experience in finance and biotech innovation, including roles as CEO of
Siemens spinoff Zargis Medical Corp and chief financial officer of Jaguar
Health, which he supported through its Nasdaq IPO in 2015. Mr. Kallassy received
his bachelor's degree in biology from the State University of New York at
Brockport, studied pharmacology at the University of Leeds, and received his MBA
from Cornell's Johnson Graduate School of Management.
The Company confirms that (1) there is no family relationship between Mr.
Kallassy and any director or executive officer of the Company, (2) there was no
arrangement or understanding between Mr. Kallassy and any other person pursuant
to which he was elected to his position with the Company, and (3) there is no
transaction between Mr. Kallassy and the Company that would require disclosure
under Item 404(a) of Regulation S-K.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements that are
based on management's beliefs and assumptions and on information currently
available to the Company's management. Forward-looking statements include
statements regarding the Company's intention to enter into a Definitive
Agreement, the Company's intention to request a hearing before the Panel, the
Company's ability to file the Form 10-K and the Form 10-Qs with the SEC.
Forward-looking statements include statements that are not historical facts and
can be identified by terms such as "anticipate," "believe," "could," "estimate,"
"expect," "intend," "may," "plan," "potential," "predict," "project," "seek,"
"should," "will," "would" or similar expressions and the negatives of those
terms. The Company's actual results and the timing of events could materially
differ from those anticipated in such forward-looking statements as a result of
certain risks and uncertainties including those described in more detail in the
Company's most recent Annual Report on Form 10-K and other documents on file
with the SEC, each of which can be found on the SEC's website, www.sec.gov, or
the investor relations portion of the Company's website,
https://ir.staterabiopharma.com/financial-information/sec-filings. Except as
required by law, the Company assumes no obligation to update these
forward-looking statements, or to update the reasons actual results could differ
materially from those anticipated in these forward-looking statements, even if
new information becomes available in the future.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
Binding Letter of Intent, dated September 2, 2022, by and between
10.1 Statera Biopharma, Inc. and Lay Sciences, Inc.
Cover Page Interactive Data File (embedded within the Inline XBRL
104 document).
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