<SEC-DOCUMENT>0001079973-12-000760.txt : 20120927
<SEC-HEADER>0001079973-12-000760.hdr.sgml : 20120927
<ACCEPTANCE-DATETIME>20120926175910
ACCESSION NUMBER:		0001079973-12-000760
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20120926
ITEM INFORMATION:		Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20120927
DATE AS OF CHANGE:		20120926

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			AspenBio Pharma, Inc.
		CENTRAL INDEX KEY:			0001167419
		STANDARD INDUSTRIAL CLASSIFICATION:	IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]
		IRS NUMBER:				841553387
		STATE OF INCORPORATION:			CO
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33675
		FILM NUMBER:		121111659

	BUSINESS ADDRESS:	
		STREET 1:		1585 S. PERRY STREET
		CITY:			CASTLE ROCK
		STATE:			CO
		ZIP:			80104
		BUSINESS PHONE:		(303) 794-2000

	MAIL ADDRESS:	
		STREET 1:		1585 S. PERRY STREET
		CITY:			CASTLE ROCK
		STATE:			CO
		ZIP:			80104

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ASPENBIO INC
		DATE OF NAME CHANGE:	20020213
</SEC-HEADER>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">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 (see General Instruction A.2. below):</font></div>

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<div align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.</font></div>
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<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">On September 26, 2012, Douglas Hepler, Ph.D., Michael Merson, Gregory Pusey and Mark Ratain, M.D. resigned as directors of AspenBio Pharma, Inc. (the &#8220;Company&#8221;).&#160;&#160;Such resignations were tendered and accepted in connection with a strategic reorganization and re-alignment of the Company that began in mid-2011, and were also based on time commitment constraints for some of the departing directors.&#160;&#160;The focus of the Company&#8217;s strategic re-alignment are its efforts to convert the Company&#8217;s principal product in development, AppyScore&#8482; to a multi-marker diagnostic test, and to progress with the receipt of regulatory clearance for and commercialization of AppyScore.&#160;&#160;The Company has closed two financing transactions, one in December 2011 ($1,600,000 in gross proceeds to the Company) and the other in June 2012 ($12,200,000 in gross proceeds to the Company), designed to raise funds to finance such product development completion work.&#160;&#160;The Company further continued this corporate re-alignment with the recent consummation of the transaction to exclusively license the Company&#8217;s animal health assets to a third party.&#160;&#160;This transaction provides the Company with the potential for additional milestone and royalty income from its animal health assets while allowing the Company to focus its resources on its AppyScore product development efforts.&#160;&#160;As part of such Company re-organization, the Company also evaluated the alignment, with the Company&#8217;s current business focus, of the qualifications, skills and experience of the members of its Board of Directors, as well as assessing the impact of their other professional responsibilities and activities on the time that could be committed to service on the Company&#8217;s Board of Directors.&#160;&#160;Dr. Hepler, Mr. Merson and Dr. Ratain were independent non-employee directors, and Mr. Pusey, was an employee-director.&#160;&#160;Mr. Pusey remains with the Company in his role as Vice President.</font></div>

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<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">None of such directors resigned because of any disagreements with the management or direction of the Company.</font></div>

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<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">On September 27, 2012, the Company issued a press release titled &#8211; &#8220;AspenBio Plans to Initiate Pivotal Study in Fourth Quarter.&#8221;&#160;&#160;This press release is filed as Exhibit 99.1 to this Form 8-K.</font></div>

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<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">On September 27, 2012, the Company hosted an investor update call.&#160;&#160;The script for this investor call is filed as Exhibit 99.2 to this Form 8-K.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">Press release dated September 27, 2012, issued by AspenBio Pharma, Inc. titled &#8220;AspenBio Plans to Initiate Pivotal Study in Fourth Quarter.&#8221;</font></div>

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<TYPE>EX-99.1
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<div style="TEXT-ALIGN: right">Exhibit 99.1</div>

<div>&#160;</div>

<div>&#160;</div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&#160;FDA Meeting Held; Advancing Toward Commercialization in U.S. and EU</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Clinical and Business Update Conference Call Scheduled Today at 8:30 a.m. ET</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-WEIGHT: bold">CASTLE ROCK, Colo., September 27, 2012</font><font style="DISPLAY: inline; FONT-SIZE: 10pt"> &#8212; </font><font style="DISPLAY: inline; FONT-WEIGHT: bold">AspenBio Pharma, Inc.</font> (Nasdaq: <font style="DISPLAY: inline; TEXT-DECORATION: underline">APPY</font>), an <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostic company, today provided its shareholders and the broader investment community with an update on its clinical and business activities.&#160;&#160;The Company announced that it plans to initiate a pivotal study in the fourth quarter of 2012 for its blood-based appendicitis test designed to assist emergency room clinicians in ruling out acute appendicitis.&#160;&#160;The Company is moving ahead with its plans following its recent productive meeting with the U.S. Food and Drug Administration (&#8220;FDA&#8221;).&#160;&#160;In addition to seeking approval in the U.S., the Company plans to obtain CE Mark before the end of the year and to introduce the product in Europe shortly thereafter.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Steve Lundy, President and CEO of AspenBio, stated, &#8220;We are very pleased with the recent progress we have made in executing on our key development objectives.&#160;&#160;Most importantly, after meeting with the FDA, we plan to initiate our pivotal study in the U.S. during the fourth quarter.&#160;&#160;We are currently modifying the study protocol in accordance with the FDA&#8217;s constructive feedback, and we continue to engage hospitals across the U.S. for participation in our study.&#160;&#160;In parallel, we are preparing to launch the product in Europe once we obtain a CE Mark, which we anticipate receiving during the fourth quarter.&#8221;</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">In addition to the Company&#8217;s clinical advancements, AspenBio announced that progress continues for its out-licensed animal health assets.&#160;&#160;To date, cumulative consideration achieved under the exclusive license agreement is approximately $1.3 million, including license fees and milestone payments.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Finally, the Company outlined strategic changes designed to further position AspenBio for success.&#160;&#160;The Board of Directors is being restructured in alignment with the strategic focus of the Company and certain board members have stepped down voluntarily from their positions.&#160;&#160;These Board members are Greg Pusey, Doug Hepler, Mark Ratain and Michael Merson.&#160;&#160;AspenBio is in the process of identifying potential new board members with the desired skills, qualifications and experience to guide the Company&#8217;s refocused strategy, but ultimately intends to have a smaller sized Board.&#160;&#160;Additionally, a rebranding of the Company is underway and is expected to include the evaluation of new company and product names, as well as associated logos.&#160;&#160;The Company intends to propose a new company name later this year and such change will require shareholder approval.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Mr. Lundy concluded, &#8220;As we move ahead with a balance sheet strengthened by funding from our recent public offering and by the out-licensing of our animal health assets, we are confident that we have the capital resources to continue executing on our clinical and business objectives.&#160;&#160;We believe we are taking important steps to position the Company strategically for our future as a successful commercial <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostics company.&#8221;</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Conference Call and Webcast Information</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Interested participants and investors may access the conference call by dialing 800-860-2442 (U.S.); 866-605-3852 (Canada); or 412-858-4600 (international).&#160;&#160;An audio webcast will be accessible via the Investors Relations section of the AspenBio web site, www.aspenbiopharma.com.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">A telephonic replay of the call will be available for two weeks beginning at 9:30 a.m. ET on September 27, 2012.&#160;&#160;Access numbers for this replay are 877-344-7529 (U.S./Canada) and 412-317-0088 (international); conference ID: 10018947.&#160;&#160;The webcast replay will remain available in the Investors Relations section of the AspenBio web site for 30 days.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">About AspenBio Pharma</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">AspenBio Pharma, Inc. is an <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostic company focused on the clinical development and commercialization of its blood-based appendicitis test.&#160;&#160;The unique appendicitis test has projected high sensitivity and negative predictive value and is designed to aid in the identification of patients at low risk for acute appendicitis, allowing for more conservative patient management.&#160;&#160;The test is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the highest risk for appendicitis and has the highest risk of long-term health effects associated with CT imaging.&#160;&#160;For more information, visit <font style="DISPLAY: inline; TEXT-DECORATION: underline">www.aspenbiopharma.com</font>.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Forward-Looking Statements</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">This press release includes "forward-looking statements" of AspenBio Pharma, Inc. ("AspenBio") as defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact, included in this press release that address activities, events or developments that AspenBio believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors AspenBio believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of AspenBio. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including our ability to successfully complete required product development and modifications in a timely and cost effective manner, complete clinical trial activities for the appendicitis test required for FDA submission, obtain FDA clearance or approval, complete and obtain CE Mark, cost effectively manufacture and generate revenues from the appendicitis test, execute agreements required to successfully advance the company's objectives, retain the management team to advance the products, overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property rights, and realize value of intangible assets. Furthermore, AspenBio does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this press release should be considered in conjunction with the risk factors contained in AspenBio's recent filings with the SEC, including its Final Prospectus filed on June 20, 2012.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">For Investors &amp; Media:</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Joshua Drumm, Ph.D. / Jason Rando</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Tiberend Strategic Advisors, Inc.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">(212) 827-0020</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">jdrumm@tiberend.com</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">jrando@tiberend.com</font></div>
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<DOCUMENT>
<TYPE>EX-99.2
<SEQUENCE>3
<FILENAME>ex99x2.htm
<DESCRIPTION>EXHIBIT 99.2
<TEXT>
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<div style="TEXT-ALIGN: right">Exhibit 99.2</div>

<div style="TEXT-ALIGN: right">&#160;</div>

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<div>&#160;</div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 36pt; MARGIN-RIGHT: 0pt" align="right"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">AspenBio September 2012 Update Conference Call Script</font></div>

<div style="TEXT-ALIGN: right; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">September 27, 2012</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; TEXT-DECORATION: underline">SPEAKER: Jason Rando &#8211; Tiberend Strategic Advisors, Inc.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Thank you, Operator.&#160;&#160;And thank you all for joining us this morning for AspenBio&#8217;s clinical and business update.&#160;&#160;With me on today&#8217;s call are Steve Lundy, President and Chief Executive Officer; Jeff McGonegal, Chief Financial Officer; and Don Hurd, Senior Vice President and Chief Commercial Officer.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">This morning, AspenBio issued a news release that provided an overview of some recent clinical and business developments.&#160;&#160;We encourage everyone to read today&#8217;s news release as well as AspenBio&#8217;s quarterly report on Form 10-Q, for the six months ended June 30, 2012, which was filed in August of this year and is available on the Company&#8217;s website at www.aspenbiopharma.com.&#160;&#160;If you need a copy of the press release, please call Tiberend Strategic Advisors at 212-827-0020 and we will e-mail you one.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">At the end of the prepared remarks, we will open the call for a question-and-answer session where Steve, Jeff, and Don will be available to take your questions.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">SAFE HARBOR LANGUAGE:</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Please note that certain of the information discussed on the call today is covered under the Safe Harbor Provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, AspenBio management will be making forward-looking statements.&#160;&#160;Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the Company&#8217;s business. These forward-looking statements are qualified by the cautionary statements contained in AspenBio&#8217;s news releases and SEC filings, including its Final Prospectus filed on June 20, 2012.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, Thursday, September 27, 2012.&#160;&#160;AspenBio undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the date of this conference call.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Now, I would like to turn the call to Steve Lundy, President and Chief Executive Officer of AspenBio.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; TEXT-DECORATION: underline">SPEAKER: Steve Lundy</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Thank you, Jason, and thanks to everyone for joining us today.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">I want to start by reminding everyone quickly of what we achieved during the last year.&#160;&#160;On the development front, we completed a major conversion from a single marker test to a new multi-biomarker blood-based test.&#160;&#160;We also completed a 500-patient pilot study that demonstrated significantly improved performance of the multi-marker test configuration over the previous single-marker configuration.&#160;&#160;The success of this study, in large part, has driven the proposed design of our upcoming pivotal study, which was discussed with the FDA at our recent meeting, and which I will discuss in some detail in a few moments.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">In June we raised capital to fund our clinical and market development initiatives by completing an equity financing that generated approximately 12 million dollars in gross proceeds.&#160;&#160;The balance sheet was also strengthened by the successful out-licensing of our animal health assets.&#160;&#160;Importantly, we believe that we have the cash resources we need to complete the planned pivotal trial and file our submission with the FDA, as well as launch the product in Europe.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">We&#8217;ve also added expertise to the organization by hiring talented executives in key roles.&#160;&#160;Optimizing the infrastructure of our Company in alignment with our strategic value drivers is an important and ongoing process.&#160;&#160;As we emerge as a pure-play, commercial-stage <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostics company, we will continue to make efforts that ensure our internal organization parallels our ability to achieve our goals.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">As a team, we have demonstrated a strong track record of successfully executing our milestones.&#160;&#160;Today&#8217;s announcement reflects this and further highlights our commitment to build the company successfully.&#160;&#160;At the end of this call, I will outline the anticipated milestones for the next 12 months, which will provide a roadmap for our shareholders to track our progress as we execute on the many important events occurring in the coming quarters.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">As you read in this morning&#8217;s news release, we recently completed a meeting with the FDA regarding our planned regulatory path, including the design of the pivotal study.&#160;&#160;To quickly remind everyone how this meeting came about: On August 7<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">th</font> we filed our pre-Investigational Device Exemption (or IDE) package, which contained key information regarding our intended use and plans for a pivotal clinical study, including our proposed study protocol, as well as our statistical approach and risk analysis plan.&#160;&#160;At the time of submission, we also requested a follow-up meeting with the FDA, which occurred recently as scheduled.&#160;&#160;We were pleased by the outcome of this meeting, during which the FDA gave us valuable input that we are currently incorporating into our study plans.&#160;&#160;Most importantly, based on this FDA meeting, we plan to initiate the pivotal study in the fourth quarter of this year.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The FDA meeting was a significant milestone for us, and we look forward to enrolling our first patients in the study in the coming months.&#160;&#160;Right now, we are focusing the majority of our efforts on incorporating modifications to our study protocol based on the FDA&#8217;s feedback, as well as continuing to engage at hospital sites across the U.S. anticipated to participate in the study.&#160;&#160;We expect to have about 25 study sites on-line for the pivotal study. In parallel with our clinical efforts in the U.S., we have continued to make significant progress towards our product launch in Europe.&#160;&#160;Our Chief Commercial Officer Don Hurd has been investing significant time and energy in market development. He has been back and forth to various territories in Europe, meeting and negotiating with potential distributors as well as key opinion leaders (KOL&#8217;s).&#160;&#160;Thanks to his efforts, we believe we will be well positioned for a successful EU introduction, pending CE Mark.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Moving on, I&#8217;m pleased to say that we continue to execute on our business objectives.&#160;&#160;We announced this morning that progress continues following the successful out-licensing of our animal health assets.&#160;&#160;To date, we have achieved approximately 1.3 million dollars in cumulative consideration under the exclusive license agreement, including license fees and milestone payments.&#160;&#160;I&#8217;ll remind everyone that we may receive up to approximately 3.7 million dollars in additional milestone payments as part of the licensing agreement, as well as low double-digit royalties on potential sales of products developed using these animal health assets.&#160;&#160;Successful monetization of our animal health assets was a critical step in completing our strategic shift toward <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostics.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Keeping in line with that strategic focus, we determined, as part of the Board of Directors&#8217; annual self-evaluation, that a realignment of the skills, background and experience of our Board members with our strategic focus was warranted.&#160;&#160;In addition, each of our Board members re-evaluated his or her professional commitments and the impact of such commitments on his or her ability to devote significant time to participation on our Board of Directors.&#160;&#160;This morning we announced that the composition of our Board of Directors is changing.&#160;&#160;Four of our current board members have stepped down from their positions.&#160;&#160;They are Greg Pusey, Doug Hepler, Mark Ratain and Mike Merson.&#160;The recent out-licensing of our animal health assets was also a consideration.&#160;&#160;We&#8217;re currently identifying potential new board members with the skills, qualifications and experience we are seeking, but ultimately, we intend to keep the size of our board smaller than it had been previously.&#160;&#160;&#160;Collectively, we feel a smaller board is more appropriate for a company of our size and stage of development.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Before we open it up to Q&amp;A I want to lay out the milestones we have upcoming within the next 12 months:</font></div>

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<div style="TEXT-INDENT: 0pt; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">We are continuing to scale up manufacturing for the start of the trial and this process is also on track.</font></div>
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<div style="TEXT-INDENT: 0pt; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">We plan to complete the pivotal study, file for marketing clearance with the FDA, and, upon receipt of such clearance, launch the product in the U.S. in 2013.</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">To conclude our clinical and corporate update, I want to reiterate that we are committed to positioning the Company as a successful <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostics company.&#160;&#160;In line with these efforts, we believe that our corporate and product identity should not be overlooked.&#160;&#160;That is why we announced this morning that we plan to move forward with a corporate rebranding strategy that is expected to include a company and product name changes.&#160;&#160;We are currently evaluating such changes and expect to propose a new company name and product names later this year.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">We hope you share in our enthusiasm that the many important events coming up over the next 12 months will hopefully generate significant shareholder value.&#160;&#160;We thank you for your continued support and look forward to taking your questions.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Once again I&#8217;d like to thank everyone for joining us today.&#160;&#160;We look forward to speaking with you on our next call.</font></div>

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