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): May 17, 2021
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
| | ||||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
(650 ) 306-1650
(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 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 | ||||||
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 May 17, 2021, Landec Corporation (the “Company”) issued a press release announcing the receipt by Heron Therapeutics, Inc. (“Heron”) of U.S. regulatory approval for a new treatment of postoperative pain, for which Lifecore Biomedical, Inc. (“Lifecore”) provided CDMO support. The press release is furnished herewith as Exhibit 99.1.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and 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 of that Section. The information in this Current Report, including Exhibit 99.1, shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |||||||
| 104 | Cover Page Interactive Data File – the cover page XBRL tags are embedded within the Inline XBRL document. | |||||||
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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.
Date: May 17, 2021
LANDEC CORPORATION | |||||||||||
| By: | /s/ John Morberg | ||||||||||
John Morberg | |||||||||||
| Chief Financial Officer | |||||||||||
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Exhibit 99.1
Lifecore to Manufacture New Innovative Drug for Treatment of Postoperative Pain Following Customer’s FDA Approval
Lifecore Expands its Aseptic Production of Pharmaceutical Drugs
CHASKA, MN, May 17, 2021 (GLOBE NEWSWIRE) – Lifecore Biomedical, Inc., a fully-owned subsidiary of Landec Corporation (Nasdaq: LNDC), today announced the receipt by Heron Therapeutics (“Heron”), one of Lifecore’s customers, of U.S. Food and Drug Administration (FDA) approval for its ZYNRELEF™ (formerly known as HTX-011) candidate on May 13, 2021, for which for Lifecore provides CDMO support.
Heron received FDA approval for ZYNRELEF (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. ZYNRELEF, the first and only extended-release dual-acting local anesthetic (DALA), delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. The synergy between bupivacaine and meloxicam in ZYNRELEF has resulted in patients experiencing less pain, including severe pain, and fewer patients requiring opioids (opioid-free) after surgery as compared to bupivacaine solution, the current standard-of-care.
Dr. Albert Bolles, Landec’s Chief Executive Officer, commented, “We congratulate Heron on their approval and are proud of Lifecore’s efforts in supporting the development of this innovative new opioid-free drug for overcoming postoperative pain. This is an excellent example of how Lifecore’s unique capabilities can help advance product commercialization for innovative drug therapies that improve patient lives.”
Jim Hall, President of Lifecore, continued, “We are excited about this approval and congratulate the Heron team on achieving this major regulatory milestone. The commercial scale manufacturing process of ZYNRELEF was successfully developed and validated at Lifecore and provides another example of Lifecore’s quality systems and manufacturing engineering excellence that we provide to our partners. We greatly appreciate Heron’s long-standing partnership and are pleased to be part of their ongoing commercial success.”
The approval of ZYNRELEF adds to Lifecore’s growing portfolio of partnerships and products, and further demonstrates Lifecore’s capabilities to support the development services and manufacturing of products that must comply with the stringent clinical and regulatory standards in the pharmaceutical marketplace. Lifecore is focused on continuing to work with its partners to develop, formulate and fill pharmaceutical drugs, medical devices and combination products.
About Landec Corporation (Lifecore Biomedical)
Landec Corporation (Nasdaq: LNDC) is a leading innovator of diversified health and wellness solutions with two operating businesses: Lifecore Biomedical, Inc. and Curation Foods, Inc. Landec designs, develops, manufactures and sells products for the food and biopharmaceutical industry. Lifecore Biomedical is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes and vials. As a leading manufacturer of premium, injectable grade Hyaluronic Acid, Lifecore brings 35 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. Curation Foods is focused on innovating and distributing plant-based foods with 100% clean ingredients to retail, club and foodservice channels throughout North America. Curation Foods is able to maximize product freshness through its geographically dispersed family of growers, refrigerated supply chain and patented BreatheWay® packaging technology. Curation Foods brands include Eat Smart® fresh packaged vegetables and salads, O Olive Oil & Vinegar® premium artisan products and Yucatan® and Cabo Fresh® avocado products. For more information about the Company, visit Landec’s website at www.landec.com.
Important Cautions Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the timing and expenses associated with operations, the ability to achieve acceptance of the Company’s new products in the market place. For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in our most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K. Forward-looking statements represent management’s current expectations and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.
Contact Information:
Investor Relations
Jeff Sonnek
(646) 277-1263
jeff.sonnek@icrinc.com