0001354488-14-001095.txt : 20140310 0001354488-14-001095.hdr.sgml : 20140310 20140310160129 ACCESSION NUMBER: 0001354488-14-001095 CONFORMED SUBMISSION TYPE: 424B3 PUBLIC DOCUMENT COUNT: 4 FILED AS OF DATE: 20140310 DATE AS OF CHANGE: 20140310 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OXYGEN BIOTHERAPEUTICS, INC. CENTRAL INDEX KEY: 0000034956 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 262593535 STATE OF INCORPORATION: DE FISCAL YEAR END: 0430 FILING VALUES: FORM TYPE: 424B3 SEC ACT: 1933 Act SEC FILE NUMBER: 333-187466 FILM NUMBER: 14680842 BUSINESS ADDRESS: STREET 1: ONE COPLEY PARKWAY STREET 2: SUITE 490 CITY: MORRISVILLE STATE: NC ZIP: 27560 BUSINESS PHONE: 919-806-4414 MAIL ADDRESS: STREET 1: ONE COPLEY PARKWAY STREET 2: SUITE 490 CITY: MORRISVILLE STATE: NC ZIP: 27560 FORMER COMPANY: FORMER CONFORMED NAME: SYNTHETIC BLOOD INTERNATIONAL INC DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: SINEQUANON CORP DATE OF NAME CHANGE: 19901219 FORMER COMPANY: FORMER CONFORMED NAME: FEDERATED FRANCHISES INC DATE OF NAME CHANGE: 19760907 424B3 1 oxbt_8k.htm CURRENT REPORT oxbt_8k.htm
Filed pursuant to Rule 424(b)(3)
Registration No. 333-187466

PROSPECTUS SUPPLEMENT NO. 16
(to Prospectus dated July 21, 2013)


5,369 Shares of Series C 8% Convertible Preferred Stock
 
(and 2,753,348 Shares of Common Stock Underlying the Series C 8% Convertible Preferred Stock)
 
Warrants to Purchase up to 2,753,348 Shares of Common Stock
 
(and 2,753,348 Shares of Common Stock Issuable From Time to Time Upon Exercise of Warrants)
 
This prospectus supplement modifies and supplements the prospectus of Oxygen Biotherapeutics, Inc. (the “Company”) dated July 21, 2013 (as supplemented on July 25, 2013, July 31, 2013, August 13, 2013, August 23, 2013, August 26, 2013, September 17, 2013, October 25, 2013, November 8, 2013, November 19, 2013, December 9, 2013, December 17, 2013, December 20, 2013, December 23, 2013 and January 22, 2014) relating to 5,369 shares of Series C 8% Convertible Preferred Stock (and 2,753,348 shares of common stock issuable upon conversion of the Series C 8% Convertible Preferred Stock) and warrants exercisable for 2,753,348 shares of common stock at an exercise price of $2.60 per share (and 2,753,348 shares of common stock issuable upon exercise of the warrants).

This prospectus supplement should be read in conjunction with, and may not be delivered or utilized without, the prospectus. This prospectus supplement is qualified in its entirety by reference to the prospectus, except to the extent that the information in this prospectus supplement supersedes the information contained in the prospectus.

This prospectus supplement includes the attached Current Report on Form 8-K as filed with the Securities and Exchange Commission (the “SEC”) on March 6, 2014.

NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY OF THIS PROSPECTUS SUPPLEMENT. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

The date of this prospectus supplement is March 6, 2014.

 
 

 


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): February 28, 2014

Oxygen Biotherapeutics, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-34600
 
26-2593535
(State or other jurisdiction of incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)

ONE Copley Parkway, Suite 490
Morrisville, NC 27560
(Address of principal executive offices) (Zip Code)

919-855-2100
(Registrant’s telephone number, including area code)

N/A
(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))
 


 
 
 
 
 
Item 8.01    Other Events.

On February 28, 2014, Oxygen Biotherapeutics, Inc. (the “Company”) was orally notified by the U.S. Food and Drug Administration (the “FDA”) that the agency has completed its review of the Company’s September 2013 nonclinical submission and has lifted the clinical hold on Oxycyte.

On March 4, 2014, the Company issued a press release regarding the FDA action described above.  A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.
 
Description
     
 
Press Release dated March 4, 2014.

 
 
2

 
 
SIGNATURES

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: March 6, 2014
Oxygen Biotherapeutics, Inc.
 
     
     
 
By:  /s/ Michael B. Jebsen
 
 
Michael B. Jebsen
 
 
Chief Financial Officer
 
 
 

 
3

 
 
Exhibit Index
 
Exhibit No.
 
Description
     
 
Press Release dated March 4, 2014.

 
 
 
 
 
 
4

 
EX-99.1 2 oxbt_ex991.htm PRESS RELEASE oxbt_ex991.htm
Exhibit 99.1
 
 
Oxygen Biotherapeutics Inc. Provides an Update on Communication
with the FDA Regarding Oxycyte Development Program
 
Morrisville, NC, March 3, 2014 – Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, announced today that it has been notified by the U.S. Food and Drug Administration (the “FDA”) that the agency has completed its review of the September 2013 nonclinical submission and has lifted the clinical hold on Oxycyte® .   Lifting of the clinical hold clears the company to proceed with the clinical development program in the US.  The FDA communicated this information to the company during a conference call with the FDA on Friday, February 28, 2014.  Written confirmation of the FDA’s decision is expected to be received within 30 days.
 
On September 23, 2013, the company announced that it had submitted to the FDA results from two series of animal studies designed to address FDA concerns regarding the use of Oxycyte in treating traumatic brain injury (TBI) patients. These studies were conducted to probe both the interactions between Oxycyte and the immune system, as well as assess the PFC-based emulsion’s potential to increase the risk of intracerebral hemorrhage (ICH). This submission has formed the basis for the FDA’s decision to lift the clinical hold. “We are pleased that the FDA has responded favorably to the data provided and removed the clinical hold to allow further clinical development of Oxycyte,” said John Kelley, CEO.
 
Prior to the initiation of any human clinical studies using Oxycyte in the US, the company will need to develop an FDA approved protocol which will incorporate  FDA input on the design and safety measures to be utilized in such studies.    Oxygen is currently enrolling patients outside of the US in a Phase II-b study to evaluate the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI).  The study is currently enrolling patients in the second cohort of a three cohort trial, with active enrollment sites located in Israel  and additional sites anticipated to soon begin enrollment in Switzerland, France and Spain.
 
About Oxygen Biotherapeutics
 
Oxygen Biotherapeutics, Inc. is developing medical products for the critical care market. The company recently acquired the North American rights to develop and commercialize levosimendan. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to a Phase 3 protocol design under Special Protocol Assessment (SPA), and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. The company also has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke.
 
Caution Regarding Forward-Looking Statements
 
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, receipt of written confirmation of the FDA’s decision to lift the clinical hold on Oxycyte, our ability to successfully develop a protocol for the use of Oxycyte in human clinical studies that satisfies the FDA, matters beyond the company's control that could lead to delays in the clinical studies, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its quarterly report on Form 10-Q filed on December 17, 2013, and annual report on Form 10-K filed on June 26, 2013, as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
 
Contact:
 
IRTH Communications
 
Robert Haag, 1-866-976-4784
 
oxbt@irthcommunications.com
 

 

 
 
 
 
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