UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
FORM 8-K CURRENT REPORT
Pursuant to Section 13 or 15(d) of the |
Date of Report: May 23, 2016
(Date of earliest event reported)
Stellar Biotechnologies, Inc.
(Exact name of registrant as specified in its charter)
British Columbia, Canada
(State or other jurisdiction
of incorporation)
000-54598
(Commission File Number)
N/A
(IRS Employer
Identification Number)
332 E. Scott Street Port Hueneme, California
(Address of principal executive offices)
93041
(Zip Code)
(805) 488-2800
(Registrant's telephone number, including area code)
Not Applicable
(Former Name or Former Address, if changed since last report)
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Item 8.01. Other Events On May 23, 2016, Stellar Biotechnologies, Inc. (the Company) issued a press release announcing the appointment of Michael L. Klein, Ph.D. as Vice President of Chemistry, Manufacturing and Controls (CMC). A copy of the press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
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.
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Dated: May 23, 2016 |
STELLAR BIOTECHNOLOGIES, INC.
By: /s/ Kathi Niffenegger |
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| Exhibit No. | Description |
| 99.1 | Press Release of Stellar Biotechnologies, Inc. dated May 23, 2016 |
PORT HUENEME, CA -- (Marketwired - May 23, 2016) - Stellar Biotechnologies, Inc. ("Stellar" or "Company") (NASDAQ: SBOT), the leader in sustainable manufacture of Keyhole Limpet Hemocyanin ("KLH"), today announced the appointment of Michael L. Klein, Ph.D. as Vice President of Chemistry, Manufacturing and Controls ("CMC"). Dr. Klein will assume management responsibility for the Company's pharmaceutical manufacturing and product development functions and serve as the Company's representative on all activities related to CMC.
Dr. Klein joins Stellar as a seasoned executive with over 26 years of scientific, regulatory, and operational experience in the biopharmaceutical industry with specialization in protein chemistry. Dr. Klein's background includes leadership of numerous therapeutic biologics development projects, scientific oversight for CMC development and GLP/cGMP manufacturing and testing, management of manufacturing contracts and negotiation, and technology transfer. His past experience includes operational team leadership for over thirty therapeutic biologic products across all stages of development, and served as an author on successful regulatory filings for many proteins entering clinical trials including direct defense of filings with the FDA. Dr. Klein received his Bachelor's and Master's degrees in Biochemistry from the University of Rochester, and a Ph.D. in Biological Chemistry from UCLA. He also served as a postdoctoral fellow in the Division of Immunology at the Beckman Research Institute of the City of Hope.
"Mike's extensive experience in pharmaceutical manufacturing management, and especially his work with novel biological products at all stages of development, will be a great asset given Stellar's expansion plans," said Frank Oakes, President, CEO and Chairman of Stellar Biotechnologies, Inc. "Our customer base is growing and there is a pipeline of new KLH-based immunotherapies in development which are anticipated to drive higher demand for Stellar KLH™. We are very pleased to have Mike join our operations team at this exciting time in the Company's evolution."
About Stellar Biotechnologies, Inc.:
Stellar Biotechnologies, Inc. (NASDAQ: SBOT) is the leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets. KLH is both an active pharmaceutical ingredient (API) in many new immunotherapies (targeting cancer, immune disorders, Alzheimer's and inflammatory diseases) as well as a finished product for measuring immune status. Stellar Biotechnologies is unique in its proprietary methods, facilities, and KLH technology. We are committed to meeting the growing demand for commercial-scale supplies of GMP grade KLH, ensuring environmentally sound KLH production, and developing KLH-based active immunotherapies.
Visit www.stellarbiotech.com and the KLH knowledge base www.klhsite.org.
Forward Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions. Readers should not place undue reliance on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or future events to differ materially from the forward-looking statements. Such risks include, but may not be limited to: general economic and business conditions; technology changes; competition; changes in strategy or development plans; availability of funds and resources; governmental regulations and the ability or failure to comply with governmental regulations; the timing of the Company's or its partners' anticipated results, including in connection with clinical trials; the ability to meet the goals of the Company's joint ventures and strategic partnerships; and other factors referenced in the Company's filings with securities regulators. For a discussion of further risks and uncertainties related to the Company's business, please refer to the Company's public company reports filed with the B.C. Securities Commission and the U.S. Securities and Exchange Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such statements. This press release does not constitute an offer or solicitation of an offer for sale of any securities in any jurisdiction, including the United States.
Stellar Biotechnologies Company Contact: Mark A. McPartland Vice President of Corporate Development and Communications Telephone: +1 (805) 488-2800 ext. 103 Email: markmcp@stellarbiotech.com www.stellarbiotech.com