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: December 11, 2018
(Date of earliest event reported)
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 Number) | ||
| 56 Evergreen Drive Portland, Maine | 04103 | |||
| (Address of principal executive offices) | (Zip Code) | |||
207-878-2770
(Registrant's telephone number, including area code)
Not
Applicable
(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 obligations 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
8.01 Other Events.
On December 11, 2018, ImmuCell announced that it has received USDA licensure of Dual-Force™ First Defense®. Dual-Force™ in a single-dose oral syringe provides guaranteed levels of E. coli and coronavirus antibodies to prevent scours in newborn calves.
Additional information is provided in today’s press release that is attached as Exhibit 99.1 to this Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release of ImmuCell Corporation, dated December 11, 2018. |
| 1 |
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: December 11, 2018 | By: | /s/ Michael F. Brigham |
| Michael F. Brigham | ||
| President and Chief Executive Officer | ||
| 2 |
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press Release of ImmuCell Corporation, dated December 11, 2018. |
| 3 |
Exhibit 99.1
ImmuCell
ImmuCell Announces USDA Approval of
Dual-Force™ First Defense®
For Immediate Release
PORTLAND, Maine – December 11, 2018 – 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 that the USDA has issued a product license for Dual-Force™ First Defense®.
Dual-Force™ in a single-dose oral syringe provides guaranteed levels of E. coli and coronavirus antibodies to prevent scours in newborn calves. The gel tube delivery format is a preferred administration route for some, as an alternative to the Company’s longstanding First Defense® capsule.
“Our goal is to formulate our efficacious colostrum antibodies into a variety of formats so that our customers can choose the option that works best for their operations,” commented Michael F. Brigham, President and CEO. “This regulatory validation should help us compete more effectively in the market and grow sales.”
“Quicker and easier administration is what we were aiming for when we made the decision to formulate our E. coli and coronavirus antibodies into a gel tube,” added Ms. Bobbi Jo Brockmann, Vice President of Sales and Marketing. “This product offers a non-digestible blue dye that serves as a marker, turning the calf’s first stool after administration neon blue-green to help detect and prevent protocol drift.”
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 has developed products that provide Immediate Immunity™
to newborn dairy and beef livestock. The Company is developing a novel treatment for mastitis, the most significant cause of economic
loss to the dairy industry. Press releases and other information about the Company are available at: http://www.immucell.com.
Cautionary Note Regarding Forward-Looking Statements (Safe Harbor Statement):
This Press Release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to: our plans and strategies for our business; projections of future financial performance; the value of our deferred tax assets; projections about depreciation expense and its impact on income for book and tax return purposes; the scope and timing of ongoing and future product development work and commercialization of our products; future costs of product development efforts; the estimated prevalence rate of subclinical mastitis; the expected efficacy of new products; estimates about the market size for our products; future market share of and revenue generated by current products and products still in development; our ability to increase production output and reduce costs of goods sold associated with our new product, Tri-Shield First Defense®; the future adequacy of our own manufacturing facilities or those of third parties with which we have contractual relationships to meet demand for our products on a timely basis; the continuing availability to us on reasonable terms of third party providers of critical products or services; the robustness of our manufacturing processes and related technical issues; estimates about our production capacity; the future adequacy of our working capital and the availability and cost of third party financing; the timing and outcome of pending or anticipated applications for regulatory approvals; future regulatory requirements relating to our products; future expense ratios and margins; future compliance with bank debt covenants; future cost of our variable interest rate exposure on most of our bank debt; costs associated with sustaining compliance with current Good Manufacturing Practice (cGMP) regulations in our current operations and attaining such compliance for the facility to produce the Drug Substance; factors that may affect the dairy and beef industries and future demand for our products; implementation of international trade tariffs could reduce the export of dairy products, which could weaken the price received by our customers for their products; our effectiveness in competing against competitors within both our existing and our anticipated product markets; the cost-effectiveness of additional sales and marketing expenditures and resources; anticipated changes in our manufacturing capabilities and efficiencies; anticipated competitive and market conditions; and any other statements that are not historical facts. Forward-looking statements can be identified by the use of words such as “expects”, “may”, “anticipates”, “aims”, “intends”, “would”, “could”, “should”, “will”, “plans”, “believes”, “estimates”, “targets”, “projects”, “forecasts”, “seeks” and similar words and expressions. In addition, there can be no assurance that future developments affecting us will be those that we anticipate. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of our products (including Drug Substance and Drug Product manufacturing), competition within our anticipated product markets, customer acceptance of our new and existing products, product performance, alignment between our manufacturing resources and product demand, our potential reliance upon third parties for financial support, products and services, changes in laws and regulations, decision making by regulatory authorities, possible dilutive impacts on existing stockholders from any equity financing transactions in which we may engage, currency values and fluctuations and other risks detailed from time to time in filings we make with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q, our Annual Reports on Form 10-K and our Current Reports on Form 8-K. Such statements involve risks and uncertainties and are based on our current expectations, but actual results may differ materially due to various factors, including the risk factors summarized above.
| 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 | ||