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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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.
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 |
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 |
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IsoRay, Inc., a Minnesota corporation |
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By: |
/s/ Brien Ragle |
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Brien Ragle, CFO |
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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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