ISR IsoRay Inc

 

United States Securities And Exchange Commission
Washington, DC 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): January 6, 2016

 

ISORAY, INC.

(Exact name of registrant as specified in its charter)

 

Minnesota	001-33407	41-1458152
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

 

350 Hills Street, Suite 106, Richland, Washington 99354

(Address of principal executive offices) (Zip Code)

 

(509) 375-1202

(Registrant's telephone number)

 

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))

 

 

ITEM 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

 

On January 6, 2016, Dwight Babcock, Chairman and CEO of IsoRay, Inc. (the "Company"), informed the Board of his retirement from all positions held with the Company and its subsidiaries, including from Board service, effective as of January 7, 2016. There was no disagreement, as defined in 17 CFR 240.3b-7, between the Company and Mr. Babcock at the time of Mr. Babcock's notification of his impending retirement from the Board of Directors.

 

In connection with his retirement, on January 6, 2016, Mr. Babcock entered into a Severance Agreement, Waiver and Release (the "Agreement") with the Company and its subsidiaries. Pursuant to the Agreement, Mr. Babcock will continue to receive his base salary through January 6, 2017, and Mr. Babcock has agreed to a waiver and release of claims. In accordance with federal law, Mr. Babcock is entitled to revoke his acceptance of the Agreement within seven (7) days of its execution. If he revokes his acceptance, the Agreement will be of no further force or effect and Mr. Babcock will not be entitled to the benefits described above.

 

Pending locating an ultimate successor CEO, the Board has appointed William Cavanagh III, the Company’s Vice President, Research and Development, as interim CEO, and has elected Thomas LaVoy, Chair of the Audit Committee, as Chairman, each of whom took office on January 7, 2016.

 

Mr. Cavanagh, age 50, joined IsoRay Medical, Inc. in January 2010 and has served as Vice President, Research and Development since that time. Immediately prior to joining IsoRay Medical, Mr. Cavanagh was engaged in the research and development of dendritic cell therapies for cancer and infectious diseases. He served as Chief Scientific Officer for Sangretech Biomedical, LLC for the six years prior to joining IsoRay Medical. At Sangretech, he oversaw the design and implementation of a novel cancer therapy. Mr. Cavanagh began his extensive career in cancer treatment technologies in the early 1990s, when he helped lead research and development of a therapy involving the insertion of radioactive sources directly into the prostate for the treatment of prostate cancer (prostate brachytherapy). He has designed several cancer treatment-related studies, is listed as an author on 34 peer-reviewed publications, and is the listed inventor on a U.S. patent application detailing a novel treatment for cancer. Mr. Cavanagh has also served as Director of the Haakon Ragde Foundation for Advanced Cancer Studies in Seattle, Washington, where he led the research foundation in the selection of viable research projects directed at treating advanced cancers. Mr. Cavanagh holds a B.S. in Biology from the University of Portland (Oregon) and attended two years of medical school before beginning his career in research management.

 

Neither the Company nor any of its subsidiaries has entered into any transactions with Mr. Cavanagh described in Item 404(a) of Regulation S-K other than in connection with his existing employment with the Company. Mr. Cavanagh was not appointed pursuant to any arrangement or understanding between Mr. Cavanagh and any other person. There are no family relationships between Mr. Cavanagh and any director or executive officer of the Company. In connection with Mr. Cavanagh's appointment as interim CEO, the Company did not enter into or materially amend any plan, contract, or arrangement that Mr. Cavanagh will participate in as interim CEO. However, Mr. Cavanagh did receive a salary increase of $17,000 and one time bonus of $10,000 effective as of January 7, 2016.

 

Item 8.01

Other Events

 

On January 7, 2016, IsoRay, Inc. issued a press release announcing Mr. Babcock’s planned retirement, the text of which is attached hereto as Exhibit 99.1.

  

Item 9.01

Financial Statements and Exhibits

 

(d)

Exhibits

 

Exhibit	Description
99.1	Press release issued by IsoRay, Inc., dated January 7, 2016.

 

  

SIGNATURES

 

In accordance with 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.

 

Dated:  January 12, 2016
	IsoRay, Inc., a Minnesota corporation
	By:	/s/ Brien Ragle
		Brien Ragle, CFO

 

 

Exhibit 99.1

 

 

IsoRay Chairman and CEO Dwight Babcock to Retire;

Tom LaVoy Elected New Chairman & Bill Cavanagh Appointed Interim CEO

 

Richland, WA—January 7, 2016–IsoRay Inc. (NYSE:ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for the treatment of prostate, brain, lung, head and neck and gynecological cancers, announced today that Dwight Babcock has informed the Board that he intends to retire effective today. Mr. Babcock began serving on IsoRay’s Board in March 2006 and was appointed as Chairman and interim CEO in 2008, and then CEO in 2009.

 

While the Company conducts a search for a new CEO, Bill Cavanagh will serve as interim CEO. Mr. Cavanagh has served as the Company’s Vice President, Research and Development since 2010. Tom LaVoy, Chair of the Company’s Audit Committee, was appointed the new Chairman of the Board.

 

Mr. LaVoy commented, “We want to thank Dwight for his years of service and his outstanding contributions to IsoRay. We wish him well in his future endeavors. As we move forward, we are very fortunate to be able to rely on the significant knowledge and experience of Bill Cavanagh, our new interim CEO, and other members of the dedicated management team.”

 

“After nearly ten years with IsoRay, I look forward to working with the Board and management to transition leadership of IsoRay to a new CEO,” said Mr. Babcock. “I’ve been privileged to lead this Company through some challenging times for the prostate brachytherapy industry as a whole, and to spearhead the ever-increasing use of Cesium-131 in treating other cancers.”

 

During Mr. Babcock’s tenure as CEO, IsoRay:

 

·

Expanded international distribution efforts;

 

·

Received FDA and foreign regulatory approvals for GliaSite® and liquid Cs-131;

 

·

Supported studies resulting in peer-reviewed publications;

 

·

Raised over $25 million in capital through public offerings; and

 

·

Began selling IsoRay products for use in treating head and neck, lung, colorectal, chest wall, brain, and gynecological cancers.

 

  

About IsoRay

IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of GliaSite® and Cesium-131 by visiting www.isoray.com. Join us on Facebook/Isoray. Follow us on Twitter @Isoray.

 

Safe Harbor Statement

Statements in this news release about IsoRay’s future expectations, including: the advantages of our products and their delivery systems, whether interest in and use of our products will increase or continue, whether we will be successful in locating qualified candidates to serve as a permanent CEO, and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases beyond prostate, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay’s reports filed with the SEC. Unless required to do so by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

 

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