cbli20220527_8k.htm
false 0001318641 0001318641 2022-04-18 2022-04-18
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
 
FORM 8-K
 
 
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
 
Date of Report (Date of Earliest Event Reported): April 18, 2022
 
 
Statera Biopharma, Inc.
(Exact Name of Registrant as Specified in Charter)
 
 
Delaware
001-32954
20-0077155
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
 
2537 Research Boulevard, Suite 201
Fort Collins, CO 80526
(Address of Principal Executive Offices and zip code)
 
(888) 613-8802
(Registrant's Telephone Number, Including Area Code)
 
Securities registered or to be 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, par value $0.005
STAB
NASDAQ Capital Market
 
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))
 
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 1.01 Entry into a Material Definitive Agreement
 
On April 18, 2022, Statera Biopharma, Inc. (the “Company”) entered a “Forbearance and Second Amendment to Loan Documents,” (“Forbearance Agreement”) regarding the Loan Agreement between Avenue Venture Opportunities Fund, L.P. (“Avenue”) and the Company, with respect to the Loan and Security Agreement, dated as of April 26, 2021, between Avenue and the Company.
 
The description and terms of the Forbearance Agreement are stated in Item 2.04 and are hereby incorporated by reference.
 
Item 2.04. Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement.
 
As previously reported in its Current Report on Form 8-K filed with the SEC on March 31, 2022, Statera Biopharma, Inc. (the “Company”) received a letter (the “Letter”) from Avenue Venture Opportunities Fund, L.P. (“Avenue”) regarding alleged events of default with respect to the Loan and Security Agreement, dated as of April 26, 2021, between the Company and Avenue (the “Loan Agreement”). In the Letter, Avenue alleges that certain events of default under the Loan Agreement have occurred and continue to exist. Specifically, Avenue alleged that the Company was in violation of certain provisions of the Loan Agreement as a result of which, Avenue purported to exercise its rights to suspend further loans or advances to the Company under the Loan Agreement and to accelerate the amount due under the Loan Agreement, which it asserts to be approximately $11.2 million, inclusive of fees of penalties. Avenue further states in the letter that interest will continue to accrue on the outstanding amounts at the default rate of 5.0%. In furtherance of the allegations set forth in the Letter, Avenue foreclosed on approximately $4.8 million of the Company’s cash.
 
In response to the Letter, on April 18, 2022, Avenue and the Company entered into a “Forbearance and Second Amendment to Loan Documents,” (“Forbearance Agreement”) regarding the Loan Agreement, whereby the parties agreed to the following terms:
 
On March 25, 2022, Avenue exercised certain of its remedies under the Loan Agreement with respect to the Existing Defaults (as defined below), by sweeping cash from Company’s accounts, totaling Four Million Eight Hundred Twenty-Seven Thousand Two Hundred Ninety and 22/110 Dollars ($4,827,290.22), which Avenue applied to the then-outstanding Obligations under the Loan Agreement. The principal balance outstanding under the Loan Agreement, before giving effect to the Forbearance Agreement, is Five Million Seven Hundred Eleven Thousand Forty-Nine and 14/100 Dollars ($5,711,049.14), plus accrued and unpaid interest, fees (including the Prepayment Fee) and expenses (including but not limited to legal fees and costs).
 
Subject to the terms of the Forbearance Agreement, Avenue agrees that, from the effective date of the Agreement until May 31, 2022 (the “Forbearance Period”), it will refrain and forbear from exercising certain remedies arising out of the Existing Defaults or any other present or future Event of Default under the Loan Agreement or Supplement. Under the Forbearance Agreement, Avenue shall not seize, sweep, or by any means take control of, directly or indirectly, any funds from any of the Company’s bank accounts; and (ii) during the Forbearance Period, the Loans may be prepaid in whole or in part at any time, subject to the repayment and prepayment terms of the Loan Documents.
 
In addition to the terms of the Forbearance Agreement, certain terms of the Loan Agreement were amended, including changing the Agreement Effective Date to April 18, 2022, and revisions to certain definitions of Agreement terminology.
 
A copy of the Forbearance Agreement is attached as Exhibit 1.1 and is incorporated herein.
 
Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
 
On April 19, 2022, Statera Biopharma, Inc. (the “Company”) received a letter from the Listing Qualifications Department of The Nasdaq Stock Market (“NASDAQ”) stating that, because the Company has not yet filed its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the “Form 10-K”) with the Securities and Exchange Commission (the “SEC”), the Company is not in compliance with NASDAQ Listing Rule 5250(c)(1) for continued listing. Pursuant to the NASDAQ letter, the Company is required to submit a plan to regain compliance by June 20, 2022. If the plan is accepted by NASDAQ, the Company must implement the plan to regain compliance by the date that is 180 days after the due date of the Form 10-K, or October 17, 2022. The Company submitted the plan to NASDAQ to regain compliance on May 27, 2022 and is currently awaiting NASDAQ acceptance.
 
 

 
Subsequently, on May 18, 2022, the Company received an additional letter from NASDAQ stating that because the Company remains delinquent in filing its Form 10-K, and subsequently has failed to timely file its Quarterly Report on Form 10-Q for the period ended March 31, 2022 (the “Form 10-Q”), the Company does not comply with NASDAQ Listing Rules for continued listing. NASDAQ reiterated that the Company had until June 20, 2022 to submit a plan to regain compliance with respect to the delinquent Form 10-K and Form 10-Q. Please note that any Staff exception to allow the Company to regain compliance, if granted, will be limited to a maximum of 180 calendar days from the due date of the Form 10-K, or October 17, 2022. As noted above, the Company submitted the plan to NASDAQ to regain compliance on May 27, 2022 and is currently awaiting NASDAQ acceptance.
 
As previously reported by the Company in its Current Report on Form 8-K filed with the SEC on March 25, 2022, on March 23, 2022, the Company received written notice from NASDAQ indicating that because the minimum bid price of the Company’s common stock has closed below $1.00 per share for the last 30 consecutive business days, the Company no longer meets the requirements of Listing Rule 5550(a)(2), which requires the Company to maintain a minimum bid price of $1.00 per share (the “Bid Price Rule”). The NASDAQ Listing Rules provide the Company with a compliance period of 180 calendar days in which to regain compliance with the Bid Price Rule. Accordingly, the Company will regain compliance if at any time during this 180-day period the closing bid price of the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days.
 
In the event the Company does not regain compliance by the end of the 180-day compliance period on September 19, 2022, but meets certain other applicable standards, the Company may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for NASDAQ, with the exception of the Bid Price Rule, and will need to provide written notice of the Company’s intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, NASDAQ will inform the Company that it has been granted an additional 180 calendar days to regain compliance with the Bid Price Rule. However, if it appears to NASDAQ that the Company will not be able to cure the deficiency, or if it is otherwise not eligible, NASDAQ will provide notice that the Company’s common stock will be subject to delisting. At that time, the Company may appeal the delisting determination to a hearings panel.
 
The Company intends to monitor the bid price of its common stock and consider available options if its common stock does not trade at a level likely to result in the Company regaining compliance with the Bid Price Rule by September 19, 2022. There can be no assurance that the Company will be able to regain compliance with the Bid Price Rule or that the Company will otherwise be compliant with the other NASDAQ listing standards.
 
Also as previously reported by the Company in its Current Report on Form 8-K filed with the SEC on March 31, 2022, as amended by the Current Report on Form 8-K/A filed with the SEC on April 13, 2022, on March 25, 2022, Randy Saluck and Lea Verny, each a member of the board of directors (the “Board”) of the Company, resigned from their positions as members of Board, effective immediately. At the time of their resignations, Mr. Saluck and Ms. Verny each served on the audit, nominating and corporate governance and compensation committees of the Board. As a result of these resignations, the Company is no longer in compliance with several of NASDAQ governance rules.
 
First, under NASDAQ Listing Rule 5605(b)(1), a majority of the directors on the Board must be independent directors, as defined under the NASDAQ rules. As of the effective time of the resignations of Mr. Saluck and Ms. Verny, the Board is comprised of one director who is independent under the NASDAQ Listing Rules and two directors who are not independent.
 
Second, under NASDAQ Listing Rule 5605(c)(2)(A), the audit committee of the Board must be comprised of at least three independent directors, as defined under the NASDAQ rules. As of the effective time of the resignations of Mr. Saluck and Ms. Verny, the audit committee of the Board is comprised of one director who is independent under the NASDAQ Listing Rules.
 
Third, under NASDAQ Listing Rule 5605(d)(2)(A), the compensation committee of the Board must be comprised of at least three independent directors, as defined under the NASDAQ Rules. As of the effective time of the resignations of Mr. Saluck and Ms. Verny, the compensation committee of the Board is comprised of only one director who is independent under the NASDAQ Listing Rules.
 
 
Item 7.01 Regulation FD Disclosure.
 
On April 22, 2022, the Company issued a press release announcing that on April 19, 2022, NASDAQ sent a letter to the Company indicating that, because the Company had not yet filed the Form 10-K, the Company is not in compliance with NASDAQ Listing Rule 5250(c)(1) for continued listing. A copy of the April 22, 2022 press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
 
On May 23, 2022, the Company issued a press release announcing that the Company received a letter from the Listing Qualifications Department of NASDAQ on May 18, 2022 indicating that, because the Company was delinquent in filing the Form 10-Q, the Company had not complied with Nasdaq Listing Rule 5250(c)(1) for continued listing. A copy of the May 23, 2022 press release is attached as Exhibit 99.2 to this Current Report on Form 8-K.
 
The information in this Item 7.01 of Form 8-K, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), except as shall be expressly set forth by specific reference. The press releases attached as Exhibit 99.1 and Exhibit 99.2 shall not be incorporated by reference into any filing or other document pursuant to the Securities Act, except as shall be expressly set forth by specific reference in such filing or document.
 
 

 
Forward-Looking Statements
 
This Current Report on Form 8-K contains forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties, many of which are beyond the Company’s control, that may cause actual results or events to differ materially from those projected. These risks and uncertainties include risks described in the section entitled “Risk Factors” and elsewhere in the Company’s Annual Report on Form 10-K filed with the SEC on March 22, 2021 and in its other filings with the SEC, including, without limitation, its reports on Forms 8-K and 10-Q, and the prospectus supplement filed with the SEC on March 23, 2022, all of which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
 
Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits.
 
The following exhibits are filed or furnished with this Current Report on Form 8-K:
 
Exhibit
   
Number
 
Description
     
1.1
99.1
99.2
 
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. 
 
 
STATERA BIOPHARMA, INC.
 
       
       
May 27, 2022
By:
/s/ Peter Aronstam
 
   
Name: Peter Aronstam
Title: Chief Financial Officer
 
 
 
Image Exhibit

Exhibit 1.1

 

 

 

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ex_381429.htm

Exhibit 99.1

 

https://cdn.kscope.io/57ba44cddb959df4056154e52e4a87b6-a01.jpg

 

 

Statera Biopharma Receives Notification Letter from Nasdaq Regarding Form 10-K Filing

 

FORT COLLINS, CO., April 22, 2022 /Globe Newswire/ — Statera Biopharma (Nasdaq: STAB) (the “Company”), a biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) on April 19, 2022 indicating that, because the Company has not yet filed its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the “Form 10-K”), the Company does not comply with Nasdaq Listing Rule 5250(c)(1) for continued listing.

 

On March 31, 2022, the Company filed a Form 12b-25 Notification of Late Filing (the “Form 12b-25”) with the Securities and Exchange Commission (the “SEC”) and issued a press release announcing, among other things, that the Company was unable to file its Form 10-K within the prescribed time period. The Company indicated that it was unable to complete its financial statements for the full year 2021 due to a delay experienced in completing its financial statements and other disclosures in the Annual Report.

 

As previously disclosed, Nasdaq granted an exception giving the Company a new deadline of April 15, 2022 to file its Form 10-K.

 

As a result of this additional delinquency, the Company must submit to Nasdaq a plan to regain compliance by June 20, 2022. If the plan is accepted by Nasdaq, the Company must implement the plan to regain compliance by the date that is 180 days after the due date of the Form 10-K or October 17, 2022. The Company intends to submit a timely plan. There is no assurance, however, that the Company’s plan will be accepted by Nasdaq nor that the Company will successfully implement its plan. If the Company does not regain compliance with the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq may provide notice that the Company’s common stock will be subject to delisting.

 

Further on April 13, 2022, the Company announced it was no longer in compliance with several of the Nasdaq Stock Market’s rules. Details of this non-compliance is set out below.


On March 25, 2022, Randy Saluck and Lea Verny, each a member of the board of directors (the “Board”) of the Company, resigned from their positions as members of Board, effective immediately. At the time of their resignations, Mr. Saluck and Ms. Verny each served on the audit, nominating and corporate governance and compensation committees of the Board.

 

First, under Nasdaq Listing Rule 5605(b)(1), a majority of the directors on the Board must be independent directors, as defined under the Nasdaq rules. As of the effective time of the resignations of Mr. Saluck and Ms. Verny, the Board is comprised of one director who is independent under the Nasdaq Listing Rules and two directors who are not independent.

 

Second, under Nasdaq Listing Rule 5605(c)(2)(A), the audit committee of the Board must be comprised of at least three independent directors, as defined under the Nasdaq rules. As of the effective time of the resignations of Mr. Saluck and Ms. Verny, the audit committee of the Board is comprised of one director who is independent under the Nasdaq Listing Rules.

 

 

 

https://cdn.kscope.io/57ba44cddb959df4056154e52e4a87b6-a01.jpg

 

 

Third, under Nasdaq Listing Rules 5605(d)(2)(A) and 5605(d)(5), the compensation committee of the Board must be comprised of at least two independent directors, as defined under the Nasdaq Rules. As of the effective time of the resignations of Mr. Saluck and Ms. Verny, the compensation committee of the Board is comprised of only one director who is independent under the Nasdaq Listing Rules.

 

On March 28, 2022, the Company provided formal notice to Nasdaq disclosing the Company’s noncompliance with Nasdaq’s governance requirements as described above. Under Nasdaq’s rules, because the Company has only one independent director and one independent audit committee member, there is no available cure period within which the Company can regain compliance with the rules pertaining to the composition of the Board and the audit committee of the Board. Instead, the Company has until May 19, 2022 to submit a plan to Nasdaq to regain compliance. If Nasdaq accepts the plan, Nasdaq can grant an extension of up to 180 calendar days from April 4, 2022, the date of Nasdaq’s letter to the Company regarding this noncompliance matter, to evidence compliance. The Company intends to submit a plan to Nasdaq to regain compliance by or before May 19, 2022.

 

In accordance with Nasdaq Listing Rule 5605(d)(4), the Company is granted a cure period to regain compliance with the rules pertaining to the composition of the compensation committee of the Board, which cure period will expire upon the earlier of the Company’s next annual stockholders’ meeting or March 25, 2023; provided, however, that if the Company’s next annual stockholders’ meeting is held before September 21, 2022, then the Company must evidence compliance no later than September 21, 2022. The Board intends to appoint one or more new independent directors to fill the vacancies on the compensation committee of the Board prior to the expiration of such cure period in order to regain compliance with Nasdaq Listing Rule 5605(d)(2)(A) pertaining to the compensation committee of the Board.

 

Further on April 15, 2022, the Company announced that on April 11, 2022, Tuner, Stone & Company, LLP (“TSC”) advised the Audit Committee of the Board of Directors (the “Audit Committee”) of Statera Biopharma, Inc., a Delaware corporation (the “Company”) of TSC’s resignation as the Company’s independent registered public accounting firm, effective on that date. The Audit Committee did not request, recommend or approve the resignation of TSC.  In its letter of resignation, TSC indicated that based on information that had come to its attention, TSC was resigning and would no longer be able to provide auditing services. The resignation was not the result of a disagreement between the Company and the TSC on accounting principles or practices, financial statement disclosure, or auditing scope or procedure during the two most recently completed fiscal years.

 

The Company has begun a search process to identify a new independent registered public accounting firm. The Company will disclose its engagement of a new independent registered public accounting firm in accordance with SEC rules and regulations once the process has been completed.

 

There can be no assurance that the Company will be able to regain compliance with the Nasdaq listing criteria or will otherwise be in compliance with the NASDAQ listing criteria.

 

 

 

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About Statera Biopharma

 

Statera Biopharma (formerly Cytocom, Inc.) is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. Statera has one of the largest platforms of toll-like receptor (TLR) agonists in the biopharmaceutical industry with TLR4 and TLR9 antagonists, and the TLR5 agonists, Entolimod and GP532. TLRs are a class of protein that plays a key role in the innate immune system. Statera is developing therapies designed to directly elicit within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Statera has clinical programs for Crohn’s disease (STAT-201), hematology (Entolimod), pancreatic cancer (STAT-401) and COVID-19 (STAT-205) in addition to potential expansion into fibromyalgia and multiple sclerosis. To learn more about Statera Biopharma, please visit www.staterabiopharma.com.

 

Forward Looking Statements

 

This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this press release, including statements regarding the Companys expected clinical development timeline for the Companys product candidates, future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations, are forward-looking statements. The words anticipate, believe, continue, should, estimate, expect, intend, may, plan, project, will, and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on the current expectations about future events held by management. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond the Companys control. The companys actual future results may differ materially from those discussed here for various reasons. The Company discusses many of these risks under the heading Risk Factors in the proxy statement/prospectus filed with the SEC on June 10, 2021, as updated by the companys other filings with the SEC. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger between Cleveland BioLabs and Cytocom; unexpected costs, charges or expenses resulting from the merger; the Companys need for additional financing to meet the Companys business objectives; the Companys history of operating losses; the Companys ability to successfully develop, obtain regulatory approval for, and commercialize the Companys products in a timely manner; the Companys plans to research, develop and commercialize the Companys product candidates; the Companys ability to attract collaborators with development, regulatory and commercialization expertise; the Companys plans and expectations with respect to future clinical trials and commercial scale-up activities; the Companys reliance on third-party manufacturers of the Companys product candidates; the size and growth potential of the markets for the Companys product candidates, and the Companys ability to serve those markets; the rate and degree of market acceptance of the Companys product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of the Companys third-party suppliers and manufacturers; the success of competing therapies that are or may become available; the Companys ability to attract and retain key scientific or management personnel; the Companys historical reliance on government funding for a significant portion of the Companys operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over the Companys company by the Companys largest individual stockholder; the impact of the novel coronavirus (COVID-19) pandemic on the Companys business, operations and clinical development; the geopolitical relationship between the United States and the Russian Federation as well as general business, legal, financial and other conditions within the Russian Federation; the Companys ability to obtain and maintain intellectual property protection for the Companys product candidates; the Companys potential vulnerability to cybersecurity breaches; and other factors discussed in the Companys SEC filings, including the Companys Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed under the heading Risk Factors in the proxy statement/prospectus the company filed in connection with the merger on June 10, 2021.

 

 

 

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Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.

 

 

Contacts:

 

Statera Biopharma

Nichol Ochsner

Executive V.P. Investor Relations and Corporate Communications

+1.732.754.2545

nichol.ochsner@staterabiopharma.com

 

FINN Partners

Glenn Silver

+1.973.818.8198

glenn.silver@finnpartners.com

 

FINN Partners
David Carey (IR)
+1.212. 867.1768
David.carey@finnpartners.com

 

 
ex_381430.htm

Exhibit 99.2

 

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Statera Biopharma Receives Notification Letter from Nasdaq Regarding Form 10-Q Filing

 

FORT COLLINS, CO., May 23, 2022 /Globe Newswire/ — Statera Biopharma (Nasdaq: STAB) (the “Company”), a biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) on May 18, 2022 indicating that, because the Company was delinquent in filing its quarterly report on Form 10-Q on May 15, 2022 for the first quarter ended March 31, 2022, the Company had not complied with Nasdaq Listing Rule 5250(c)(1) for continued listing.

 

Statera is searching to identify a new independent registered public accounting firm. The Company will disclose the engagement of the new firm in accordance with SEC rules and regulations once the process has been completed. The Company recently restructured to reduce cash burn and conserve resources. The Company is also working to complete the previously announced transactions with Coeptis Therapeutics, Inc. and Immune Therapeutics, Inc. to out-license certain assets. In addition, the Company has the potential to reinvirogate its pipeline with certain assets from Lay Sciences, Inc. as previously announced.

 

On April 19, 2022, the Company received notification from Nasdaq that it had failed to comply with Nasdaq Listing Rule 5250(c)(1) because it was delinquent in filing its Annual Report on Form 10-K for the period ending December 31, 2021.   In a subsequent letter dated May 18, 2022 the Company received further notification from Nasdaq that it had failed to comply with Nasdaq Listing Rule 5250(c)(1) because it was delinquent in filing its Quarterly Report on Form 10-Q for the three-month period ending March 31, 2022.

 

In accordance with Nasdaq’s letters dated April 19, 2022 and May 18, 2022, the Company has until June 20, 2022 to submit a plan to regain compliance with respect to the delinquencies described in this announcement. Any Nasdaq exception to allow the Company to regain compliance, if granted, will be limited to a maximum of 180 calendar days from the due date of the initial delinquent filing of the Company’s 2021 Form 10-K, or October 17, 2022. The Company intends to submit a timely plan.

 

There can be no assurance that the Company will be able to regain compliance with the Nasdaq listing criteria or will otherwise be in compliance with the Nasdaq listing criteria.

 

About Statera Biopharma

 

Statera Biopharma (formerly Cytocom, Inc.) is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. Statera has one of the largest platforms of toll-like receptor (TLR) agonists in the biopharmaceutical industry with TLR4 and TLR9 antagonists, and the TLR5 agonists, Entolimod and GP532. TLRs are a class of protein that plays a key role in the innate immune system. Statera is developing therapies designed to directly elicit within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Statera has clinical programs for Crohn’s disease (STAT-201), hematology (Entolimod), pancreatic cancer (STAT-401) and COVID-19 (STAT-205) in addition to potential expansion into fibromyalgia and multiple sclerosis. To learn more about Statera Biopharma, please visit www.staterabiopharma.com.

 

 

 

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Forward Looking Statements

 

This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this press release, including statements regarding the Companys expected clinical development timeline for the Companys product candidates, future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations, are forward-looking statements. The words anticipate, believe, continue, should, estimate, expect, intend, may, plan, project, will, and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on the current expectations about future events held by management. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond the Companys control. The companys actual future results may differ materially from those discussed here for various reasons. The Company discusses many of these risks under the heading Risk Factors in the proxy statement/prospectus filed with the SEC on June 10, 2021, as updated by the companys other filings with the SEC. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger between Cleveland BioLabs and Cytocom; unexpected costs, charges or expenses resulting from the merger; the Companys need for additional financing to meet the Companys business objectives; the Companys history of operating losses; the Companys ability to successfully develop, obtain regulatory approval for, and commercialize the Companys products in a timely manner; the Companys plans to research, develop and commercialize the Companys product candidates; the Companys ability to attract collaborators with development, regulatory and commercialization expertise; the Companys plans and expectations with respect to future clinical trials and commercial scale-up activities; the Companys reliance on third-party manufacturers of the Companys product candidates; the size and growth potential of the markets for the Companys product candidates, and the Companys ability to serve those markets; the rate and degree of market acceptance of the Companys product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of the Companys third-party suppliers and manufacturers; the success of competing therapies that are or may become available; the Companys ability to attract and retain key scientific or management personnel; the Companys historical reliance on government funding for a significant portion of the Companys operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over the Companys company by the Companys largest individual stockholder; the impact of the novel coronavirus (COVID-19) pandemic on the Companys business, operations and clinical development; the geopolitical relationship between the United States and the Russian Federation as well as general business, legal, financial and other conditions within the Russian Federation; the Companys ability to obtain and maintain intellectual property protection for the Companys product candidates; the Companys potential vulnerability to cybersecurity breaches; and other factors discussed in the Companys SEC filings, including the Companys Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed under the heading Risk Factors in the proxy statement/prospectus the company filed in connection with the merger on June 10, 2021.

 

 

 

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Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.

 

Contacts:

 

Statera Biopharma

Nichol Ochsner

Executive V.P. Investor Relations and Corporate Communications

+1.732.754.2545

nichol.ochsner@staterabiopharma.com

 

FINN Partners

Glenn Silver

+1.973.818.8198

glenn.silver@finnpartners.com

 

FINN Partners
David Carey (IR)
+1.212. 867.1768
David.carey@finnpartners.com