0000912282-17-000161.txt : 20170725 0000912282-17-000161.hdr.sgml : 20170725 20170725131818 ACCESSION NUMBER: 0000912282-17-000161 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20170725 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170725 DATE AS OF CHANGE: 20170725 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AntriaBio, Inc. CENTRAL INDEX KEY: 0001509261 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 273440894 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-54495 FILM NUMBER: 17980065 BUSINESS ADDRESS: STREET 1: 1450 INFINITE DRIVE CITY: LOUISVILLE STATE: CO ZIP: 80027 BUSINESS PHONE: 650-847-1919 MAIL ADDRESS: STREET 1: 1450 INFINITE DRIVE CITY: LOUISVILLE STATE: CO ZIP: 80027 FORMER COMPANY: FORMER CONFORMED NAME: FITS MY STYLE INC DATE OF NAME CHANGE: 20110104 8-K 1 antriabio8k_072417.htm


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): July 25, 2017
 
ANTRIABIO, INC.
(Name of registrant in its charter)

Delaware
000-54495
27-3440894
(State or jurisdiction
(Commission File
(IRS Employer
of incorporation or
Number)
Identification No.) 
organization) 
 
 

1450 Infinite Drive
Louisville, CO 80027
 (Address of principal executive offices)

(303) 222-2128
 (Registrant's telephone number)

 (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 7.01. Regulation FD Disclosure.
 
On July 25, 2017, we issued the press release attached hereto as Exhibit 99.1.  In accordance with General Instruction B.2 of Form 8-K, the information set forth herein and in the press release is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934, as amended.  The information set forth in Item 7.01 of this Current Report on Form 8-K shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.


Item 9.01 Financial Statements and Exhibits
 
EXHIBIT
DESCRIPTION
99.1
Press Release of AntriaBio, Inc. dated July 25, 2017 **

** The following exhibit relating to Item 7.01 is intended to be furnished to, not filed with, the SEC pursuant to Regulation FD.



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.
 
  
ANTRIABIO, INC.
  
 
  
  
 
  
DATE:  July 25, 2017
By:
/s/ Morgan Fields         
 
 
Morgan Fields
Chief Accounting Officer



EXHIBIT INDEX
 
EXHIBIT
DESCRIPTION
99.1
Press Release of AntriaBio, Inc. dated July 25, 2017 **
   

** The following exhibit relating to Item 7.01 is intended to be furnished to, not filed with, the SEC pursuant to Regulation FD.

 


EX-99.1 2 ex99_1.htm PRESS RELEASE

EXHIBIT 99.1
 

AntriaBio Announces First Patient Dosed in Phase 1 Clinical Study of AB101

LOUISVILLE, CO – (Marketwired) – July 25, 2017 – AntriaBio, Inc. (“AntriaBio or the “Company”) (OTCQB: ANTB), a biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with diabetes and metabolic diseases, announced today the dosing of the first patient in a Phase 1 first-in-human clinical trial of its lead product candidate, AB101.

“The successful filing of the IND followed by initiation of the first-in-human clinical trial for AB101, are significant milestones for our company, as these events validate our robust preclinical results and bring us to the doorstep of being able to demonstrate clinical proof-of-concept for AB101 as a once weekly insulin,” stated Brian Roberts, M.D., Vice President of Clinical Development at AntriaBio. “Based on animal data, AB101 has the potential to improve overall glycemic control in patients with diabetes, while offering a more convenient injection regimen compared to currently available basal insulins.  The availability of such a therapy could optimize insulin initiation and adherence, and provide an important treatment option for patients and providers, at a time when diabetes continues to increase to historic proportions.”

The Phase 1 clinical trial is a first-in-human single ascending dose study to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of AB101 in patients with type 1 diabetes mellitus.

The first study part will be sequential cohort dose ranging of AB101, while an optional second study part will compare one or more tested doses of AB101 from part 1 to active comparator Lantus® (insulin glargine).  In addition to safety and pharmacokinetic assessments, the time-action pharmacology of AB101 (onset, peak, and end of action) will be evaluated using several measures of glycemic response, including the hyperinsulinemic euglycemic clamp technique, continuous glucose monitoring, and background insulin use.

Following the completion of the first part of the study, the Company expects to review data and announce high-level results as early as Q4, 2017.



About AntriaBio, Inc. 
AntriaBio is a biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with diabetes and metabolic diseases. AntriaBio's lead product candidate is AB101, an injectable once-weekly basal insulin for type 1 and type 2 diabetes that addresses a >$10 billion market where the current standard of care is a once-daily basal insulin injection. For more information visit: www.antriabio.com.

Forward-Looking Statements
This release, like many written and oral communications presented by AntriaBio, Inc., and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies 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. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, AntriaBio undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.

AntriaBio, Inc. Contact:

investor-relations@antriabio.com


Source: AntriaBio Inc.



 
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