<SEC-DOCUMENT>0000912282-17-000005.txt : 20170105
<SEC-HEADER>0000912282-17-000005.hdr.sgml : 20170105
<ACCEPTANCE-DATETIME>20170105132529
ACCESSION NUMBER:		0000912282-17-000005
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20170105
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20170105
DATE AS OF CHANGE:		20170105

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:		17509859

	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
</SEC-HEADER>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">UNITED STATES</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">SECURITIES AND EXCHANGE COMMISSION</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">WASHINGTON, D.C. 20549</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">FORM 8-K</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">CURRENT REPORT</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">Date of Report (Date of earliest event reported): January 5, 2017</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center"><u>ANTRIABIO, INC.</u></div>

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<div style="TEXT-ALIGN: center"><u>Delaware</u></div>
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<div style="TEXT-ALIGN: center"><u>000-54495</u></div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">organization)&#160;</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">1450 Infinite Drive</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">Louisville, CO 80027</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">&#160;(Address of principal executive offices)</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">(303) 222-2128</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center">&#160;(Former name or former address, if changed since last report)</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">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:</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">Item 7.01. Regulation FD Disclosure.</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">&#160;</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">On January 5, 2017, we issued a shareholder letter attached hereto as Exhibit 99.1.&#160;&#160;In accordance with General Instruction B.2 of Form 8-K, the information set forth herein is deemed to be &#8220;furnished&#8221; and shall not be deemed to be &#8220;filed&#8221; for purposes of the Securities Exchange Act of 1934, as amended.&#160;&#160;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.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">Item 9.01 Financial Statements and Exhibits</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">DESCRIPTION</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">99.1</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Shareholder Letter of AntriaBio, Inc. dated January 5, 2017 **</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">** The following exhibit relating to Item 7.01 is intended to be furnished to, not filed with, the SEC pursuant to Regulation FD.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">SIGNATURES</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">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.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">ANTRIABIO, INC.</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">DATE:&#160;&#160;January 5, 2017</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">By:</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">/s/ Morgan Fields&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Morgan Fields</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Chief Accounting Officer</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center">EXHIBIT INDEX</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">DESCRIPTION</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">99.1</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Shareholder Letter of AntriaBio, Inc. dated January 5, 2017 **</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">** The following exhibit relating to Item 7.01 is intended to be furnished to, not filed with, the SEC pursuant to Regulation FD.</div>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ex99_1.htm
<DESCRIPTION>SHAREHOLDER LETTER DATED JANUARY 4, 2017
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<div style="FONT-WEIGHT: bold; TEXT-ALIGN: right">EXHIBIT 99.1</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">January 5, 2017</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Dear Shareholders:</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">We are writing to highlight a few recent developments in the competitive landscape of the once-weekly basal insulin market. AntriaBio closely tracks the progress of companies with pipeline products that we view as potential competition to AB101 market share. The three programs management believes are the most relevant are the weekly insulin programs from Hanmi Pharmaceutical Co., Ltd. (<sup style="vertical-align: text-top; line-height: 1; font-size: smaller">LAPS</sup>Insulin 115), PhaseBio Pharmaceuticals (PE0139) and Novo Nordisk (LAI287). We believe AB101 is in a position to be a differentiated product as it is the only product that uses native, unmodified insulin in its drug substance. This may confer a safety and regulatory advantage over all three of our competitors whose weekly basal insulin candidates are insulin analogs or modified forms of insulin.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Late last week, Hanmi announced it was amending the licensing agreement it signed with Sanofi in November 2015. Under the original agreement, Sanofi licensed the development and commercialization rights for three of Hanmi&#8217;s long-acting diabetes products: efpeglenatide (weekly/monthly GLP-1 agonist), <sup style="vertical-align: text-top; line-height: 1; font-size: smaller">LAPS</sup>Insulin 115 (weekly basal insulin) and <sup style="vertical-align: text-top; line-height: 1; font-size: smaller">LAPS</sup>Insulin Combo (GLP-1 agonist + basal insulin combination). The agreement stipulated that Hanmi would receive an upfront payment of 400 million euros and up to 3.5 billion euros in development, registration and sales milestones, in addition to double-digit royalties on net sales.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Under the terms of the revised licensing agreement, Sanofi returned development rights for <sup style="vertical-align: text-top; line-height: 1; font-size: smaller">LAPS</sup>Insulin 115 to Hanmi. As a result, Hanmi will return 196 million euros to Sanofi by December 2018 and Sanofi&#8217;s commercial milestone payments to Hanmi have been reduced by 798 million euros. Hanmi will also now be responsible for part of the development expenses for efpeglenatide and receive reduced milestone payments for the drug.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">In 2014, Hanmi terminated their lead clinical stage weekly insulin compound, HM12460A, for failing to meet the target product profile of a once-weekly subcutaneous injection. </font>Though Hanmi initiated Phase 1 clinical studies of their follow-on compound, <sup style="vertical-align: text-top; line-height: 1; font-size: smaller">LAPS</sup>Insulin 115 in February 2015, neither Hanmi nor Sanofi has announced or presented data from these trials.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Based on the preclinical PK/PD data Hanmi presented at the American Diabetes Association 74<sup style="vertical-align: text-top; line-height: 1; font-size: smaller">th</sup> Scientific Sessions<sup style="vertical-align: text-top; line-height: 1; font-size: smaller">&#174;</sup> in San Francisco in 2014, we believe <sup style="vertical-align: text-top; line-height: 1; font-size: smaller">LAPS</sup>Insulin 115 fails to meet the target product profile of a once-weekly subcutaneous injection. We believe the data showed an acute release of insulin with significant glucose lowering within the first 24 hours. Peak insulin levels and glucose lowering occurred at Day 2-3 and resolved by Day 5-6, which leads us to believe that the <sup style="vertical-align: text-top; line-height: 1; font-size: smaller">LAPS</sup>Insulin 115 formulation may fall short of once-weekly dosing. <font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">We believe any issues related to the efficacy of </font><sup style="vertical-align: text-top; line-height: 1; font-size: smaller">LAPS</sup>Insulin 115<font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">, if they exist, are unique to </font><sup style="vertical-align: text-top; line-height: 1; font-size: smaller">LAPS</sup>Insulin 115 and are not <font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">applicable to all once-weekly insulin therapies</font>.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">In contrast, single dose and repeat weekly dose preclinical studies of AB101 in multiple animal species demonstrated no acute insulin release or glucose reduction and also demonstrated slow onset, sustained insulin increases and corresponding glucose reductions over the entire course of the weekly dosing interval.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left"><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">AntriaBio continues to believe in the promise of the once-weekly insulin class to deliver a basal insulin with fewer side effects and greater accessibility to patients needing insulin, given the right formulation and product. </font>Due to its potential safety advantages and consistent weekly profile in animals, we believe AB101 is uniquely positioned to meet this promise. <font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">Recent events strengthen our competitive advantage</font>. In addition to our view of AB101 as a best in class therapy, we also believe AB101 remains in a position to be first in class to take share of the current ~$11 billion basal insulin market. We look forward to commencing our first clinical study this year and we are optimistic we will demonstrate human proof of concept for AB101 as a once-weekly insulin therapy.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Best Regards,</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">Noopur Liffick</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">Vice President, Corporate Development</div>

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<div style="FONT-SIZE: 8pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left">Forward-Looking Statements</div>

<div style="FONT-SIZE: 8pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left">This shareholder letter, 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.</div>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
