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): July 9, 2018

ISORAY, INC.

(Exact name of registrant as specified in its charter)

Minnesota
(State or other jurisdiction
of incorporation)

001-33407
(Commission
File Number)

41-1458152
(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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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 1.01      Entry into a Material Definitive Agreement .

 

The information set forth under Item 3.03 of this Current Report on Form 8-K is incorporated into this Item 1.01 by reference. 

 

Item 3.03      Material Modification to Rights of Security Holders .

 

On July 9, 2018, the Board of Directors of IsoRay, Inc. (the “Company”) resolved to amend the Share Rights Agreement (the “Amendment”), dated as of February 1, 2007, as amended, between the Company and Computershare Trust Company, N.A., as Rights Agent, in order to exempt any purchaser of common stock of the Company pursuant to those certain Securities Purchase Agreements dated July 9, 2018, between the Company and the respective purchasers named therein or any of such purchaser’s affiliates and associates from being considered an “Acquiring Person” (as defined in the Share Rights Agreement) unless and until the purchaser together with such purchaser’s affiliates and associates becomes the beneficial owner of more than 15% of the voting power of the voting capital stock of the Company then outstanding.

 

The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment. A copy of the Amendment is attached hereto as Exhibit 4.1 and is incorporated herein by reference.

 

Item 8.01      Other Events .

 

On July 11, 2018, the Company issued a press release announcing the closing of the sale of common stock of the Company to certain institutional investors, the text of which is attached hereto as Exhibit 99.1.

 

Item 9.01       Financial Statements and Exhibits.

 

(d)      Exhibits

 

 

4.1

Amendment, dated July 9, 2018, to the Share Rights Agreement, dated as of February 1, 2007, between IsoRay, Inc. and Computershare Trust Company, N.A., as Rights Agent.

 

99.1

Press release issued by IsoRay, Inc., dated July 11, 2018.

 

 
 

 

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: July 12, 2018

 

IsoRay, Inc., a Minnesota corporation

 

 

 

By: /s/ Lori A. Woods

       Lori A. Woods, Interim CEO

Exhibit 4.1

 

EIGHTH AMENDMENT

TO

SHARE RIGHTS AGREEMENT

 

This Eighth Amendment dated July 9, 2018 (the “Eighth Amendment”), amends the Share Rights Agreement, dated February 1, 2007 (the “Rights Agreement”), as previously amended by the First Amendment, dated November 22, 2010, as further amended by the Second Amendment, dated October 13, 2011, as further amended by the Third Amendment, dated July 11, 2012, as further amended by the Fourth Amendment, dated August 28, 2013, as further amended by the Fifth Amendment, dated August 28, 2013, as further amended by the Sixth Amendment, dated March 20, 2014, as further amended by the Amendment, dated February 2, 2017, between IsoRay, Inc., a Minnesota corporation (the “Company”) and Computershare Trust Company N.A. (the “Rights Agent”).

 

Except as modified herein, terms defined in the Rights Agreement shall have the same definitions herein.

On page 2 of the Rights Agreement the following is added to the end of the definition of “Acquiring Person”:

 

“Notwithstanding anything herein to the contrary, in no event shall any purchaser of common stock pursuant to those certain Securities Purchase Agreements dated July 9, 2018, between the Company and the respective “Purchasers” named therein (each, a “Purchaser”) or any of such Purchaser’s Affiliates and Associates be considered an Acquiring Person unless and until the Purchaser together with such Purchaser’s Affiliates and Associates has become the Beneficial Owner of in excess of 15% of the voting power of the Voting Capital Stock then outstanding."

 

Except as set forth in this Eighth Amendment, the Rights Agreement, as previously amended, remains in full force and effect.

 

IN WITNESS WHEREOF, the undersigned has executed this Eighth Amendment pursuant to the authorization of the Company's Board of Directors, which has the power to amend the Rights Agreement given it in Section 27 of the Rights Agreement.

 

ISORAY, INC.

 

 

By: /s/ Lori A. Woods                

       Lori A. Woods, Interim CEO

 

 

Exhibit 99.1

 

 

IsoRay , Inc. Closes $8,250,000 Registered Direct Offering

 

RICHLAND, Wash., July 12, 2018 (GLOBE NEWSWIRE) -- IsoRay, Inc. (NYSE American: 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 it closed its previously announced $8,250,000 registered direct offering with several institutional investors (the “Offering”) of 11,000,000 shares of its common stock at a price of $0.75 per share. Additionally, IsoRay has also issued to the investors unregistered warrants to purchase up to 5,500,000 shares of common stock. The warrants have an exercise price of $0.75 per share of common stock, are exercisable commencing six months following the issuance date, and expire five and one-half years from the issuance date. IsoRay intends to use the net proceeds from the Offering, estimated at approximately $7,600,000, after deducting the placement agent fees and estimated offering expenses, for working capital and general corporate purposes, with particular focus on marketing the brain applications and Build Blu™ delivery system for real-time prostrate brachytherapy.

 

H.C. Wainwright & Co. acted as the exclusive placement agent for the Offering.

 

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were sold by IsoRay pursuant to a "shelf" registration statement on Form S-3 that was originally filed on August 25, 2015 and declared effective by the Securities and Exchange Commission ("SEC") on November 23, 2015 and the base prospectus contained therein (File No. 333-206559).

 

A final prospectus supplement and accompanying base prospectus relating to the shares of common stock has been filed with the SEC. Copies of the final prospectus supplement and accompanying base prospectus may be obtained on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at placements@hcwco.com .

 

The warrants described above were sold in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

 

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

 

About IsoRay, Inc.

IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-Blu 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 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 use of proceeds of the registered direct offering, the advantages of our products and their delivery systems including the Build-Blu™ delivery system, whether interest in and use of the GammaTile™ Therapy and the Build-Blu™ delivery system will increase or continue as anticipated, our ongoing relationship with GT Medical Technologies, Inc., the success of continued development of GammaTile™, the viability and efficacy of the Build-Blu™ delivery system, the timing of product launch of the Build-Blu™ delivery system, continued positive industry data fueling renewed interest in brachytherapy patient results from use of GammaTile™ Therapy and the Build-Blu™ delivery system, the perception by patients of quality of life outcomes, 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, including GammaTile™ and the Build-Blu™ delivery system, our ability to successfully manufacture the GammaTile™ product and the Build-Blu™ delivery system in sufficient quantities to meet demand within required delivery time periods while meeting quality control standards for both companies involved, 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 GammaTile™ and the Build-Blu™ delivery system 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, successful completion of future research and development activities, including those related to the GammaTile™ product and the Build-Blu™ delivery system, 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, changes in laws and regulations applicable to our products, the use of competitors’ products in lieu of GammaTile™ and the Build-Blu™ delivery system, and other risks detailed from time to time in IsoRay’s reports filed with the U.S. Securities Exchange Commission. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

Contacts:

IsoRay, Inc.

info@isoray.com

(509) 375-1202

 

Investors:

Stephanie Prince, Managing Director

PCG Advisory Group

sprince@pcgadvisory.com

(646) 762-4518