ICCC ImmuCell Corporation

 

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) June 28, 2023

 

ImmuCell Corporation

(Exact name of registrant as specified in its charter)

 

DE		001-12934		01-0382980
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

56 Evergreen Drive Portland, Maine		04103
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code 207-878-2770

 

(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: None

 

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 7.01.  Regulation FD Disclosure

 

On June 28, 2023 ImmuCell Corporation (the “Company”) issued a press release announcing a change in the timing of its anticipated FDA submission with respect to its product Re-Tain^®.

 

The information shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits

 

(d)

Exhibits.

 

The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed:

 

99.1		Press Release of ImmuCell Corporation dated June 28, 2023.
104		Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

 

 

SIGNATURE

 

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.

 

	IMMUCELL CORPORATION
Date: June 28, 2023	By:	/s/ Michael F. Brigham
		Michael F. Brigham
		President, Chief Executive Officer and Principal Financial Officer

 

 

Exhibit Index

 

Exhibit No.		Description
99.1		Press Release of ImmuCell Corporation dated June 28, 2023
104		Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

 

3

 

Exhibit 99.1

 

ImmuCell Announces Change in Timing of Anticipated FDA Submission

 

PORTLAND, Maine, June 28, 2023 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically proven and practical products that improve the health and productivity of dairy and beef cattle, today announced a change to its anticipated FDA submission schedule.

 

“Although we had planned to make our next FDA submission during the second quarter of this year, we have decided to add one additional month to the projected regulatory development process for Re-Tain^®,” commented Michael F. Brigham, President and CEO of ImmuCell. “The CMC Technical Section is ready for submission at this time, but we are going to use this extra time to optimize our readiness for the related pre-approval re-inspection.”

 

About ImmuCell: 

 

ImmuCell Corporation’s (Nasdaq: ICCC) purpose is to create scientifically proven and practical products that improve the health and productivity of dairy and beef cattle. ImmuCell manufactures and markets First Defense^®, providing Immediate Immunity™ to newborn dairy and beef calves, and is in the late stages of developing Re-Tain^®, a novel treatment for subclinical mastitis in dairy cows without a milk discard requirement that provides an alternative to traditional antibiotics. Press releases and other information about the Company are available at: http://www.immucell.com.

 

Contacts:

Michael F. Brigham, President and CEO ImmuCell Corporation (207) 878-2770 Joe Diaz, Robert Blum and Joe Dorame Lytham Partners, LLC (602) 889-9700 iccc@lythampartners.com

 

Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement):

 

This Press Release contains or may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and will often include words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts”, “seeks” and similar words and expressions. Such statements include, but are not limited to, any forward-looking statements relating to: our plans and strategies for our business; projections of future financial or operational performance; the scope and timing of ongoing and future product development work and commercialization of our products; the timing and completeness of any regulatory submissions or milestones and possible regulatory approval of any of our products (including Re-Tain^®) and any other statements that are not historical facts. These statements are intended to provide management’s current expectation of future events as of the date of this Press Release, are based on management’s estimates, projections, beliefs and assumptions as of the date hereof; and are not guarantees of future performance. Such statements involve known and unknown risks and uncertainties that may cause the Company’s actual results, financial or operational performance or achievements to be materially different from those expressed or implied by these forward-looking statements, including, but not limited to, those risks and uncertainties detailed from time to time in filings we make with the Securities and Exchange Commission (SEC), including our Quarterly Reports on Form 10-Q, our Annual Reports on Form 10-K and our Current Reports on Form 8-K. In addition, there can be no assurance that future risks, uncertainties or developments affecting us will be those that we anticipate. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

v3.23.2

Cover	Jun. 28, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jun. 28, 2023
Entity File Number	001-12934
Entity Registrant Name	ImmuCell Corporation
Entity Central Index Key	0000811641
Entity Tax Identification Number	01-0382980
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	56 Evergreen Drive
Entity Address, City or Town	Portland
Entity Address, State or Province	ME
Entity Address, Postal Zip Code	04103
City Area Code	207
Local Phone Number	878-2770
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false

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