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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
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<p style="text-align:center;margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">UNITED STATES</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SECURITIES AND EXCHANGE COMMISSION</p>
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<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">FORM 8-K </p>
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<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">CURRENT REPORT </p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 </p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Date of Report (Date of earliest event reported): August 13, 2015 </p>
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<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#;font-size:24pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">KEMPHARM, INC.</font></p>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">of Incorporation)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Identification No.)</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">2656 Crosspark Road, Suite 100</font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">Coralville, IA</font></p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:12pt;">&nbsp;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">52241</font></p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Address of Principal Executive Offices)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(Zip Code)</p></td>
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<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Registrant&#8217;s Telephone Number, Including Area Code: <font style="Background-color:#FFFFFF;color:#;">(319) 665-2575</font></p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Not Applicable </p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Former Name or Former Address, if Changed Since Last Report) </p>
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<p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 Instructions A.2. below): </p>
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<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </font></p></td></tr></table></div>
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<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </font></p></td></tr></table></div>
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<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </font></p></td></tr></table></div>
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<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </font></p></td></tr></table></div>
<p style="text-align:center;margin-top:4pt;line-height:1pt;border-top:Solid 0.75pt #000000;padding-top:0pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
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<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>

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<p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU2"></a><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Section 2 - Financial Information</font></p>
<p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item 2.02 Results of Operations and Financial Condition.</p>
<p style="text-align:justify;margin-top:12pt;margin-bottom:0pt;text-indent:7.69%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On August 13, 2015, KemPharm, Inc., a Delaware corporation, or KemPharm, issued a press release announcing its corporate and financial results for the quarter ended June 30, 2015, as well as information regarding a conference call to discuss these corporate and financial results.&nbsp;&nbsp;The press release is attached hereto as Exhibit&#160;99.1, which is furnished under Item 2.02 of this report and shall not be deemed to be &#8220;filed&#8221; for purposes of Section&#160;18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any of KemPharm&#8217;s filings under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.</p>
<p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Section 8 &#8211; Other Events</p>
<p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item 8.01 Other Events</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On August 13, 2015, KemPharm issued a press release with respect to data from the first of two intranasal human abuse liability clinical trials of KP201 in accordance with KemPharm&#8217;s broader KP201/APAP human abuse liability program. KP201/APAP, KemPharm&#8217;s most advanced product candidate currently being developed for the treatment of acute moderate to moderately severe pain, consists of KP201 formulated in combination with acetaminophen, or APAP. This first intranasal trial, or KP201.A03, was conducted with KP201, a prodrug of hydrocodone and the active ingredient, or API, in KP201/APAP.&nbsp;&nbsp;This single-center, cross-over pharmacokinetic study was designed to measure the amount of hydrocodone released from the API, KP201, when insufflated (i.e., snorted) without APAP, as compared directly to hydrocodone bitartrate, or HB. KP201 demonstrated a statistically significant lowering in peak hydrocodone exposure (C<font style="font-size:7pt;">max</font>), and a delay in the time to achieve peak exposure (T<font style="font-size:7pt;">max</font>), as well as a significant decrease in total exposure to hydrocodone (AUC<font style="font-size:7pt;">last</font> and AUC <font style="font-size:7pt;">0-4h</font>) especially in the early time points typically associated with increased drug liking and abuse.&nbsp;&nbsp;Secondary endpoints related to drug liking, pupillometry and ease of snorting also showed significant differences between KP201 and HB with KP201 demonstrating lower drug liking, less pupil dilation and higher difficulty of snorting than HB. </p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Results from the KP201.A03 trial included:</p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">36% decrease in peak hydrocodone exposure (C</font><font style="font-size:7pt;font-family:Times New Roman;">max</font><font style="font-family:Times New Roman;">) for KP201 compared to HB when taken intranasally;</font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Time to peak hydrocodone exposure (T</font><font style="font-size:7pt;font-family:Times New Roman;">max</font><font style="font-family:Times New Roman;">) delayed by one hour;</font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Decreased overall exposure to hydrocodone released from KP201 vs. HB especially in early time points (82% decrease in AUC</font><font style="font-size:7pt;font-family:Times New Roman;">0-0.5h</font><font style="font-family:Times New Roman;"> and 63% decrease in AUC</font><font style="font-size:7pt;font-family:Times New Roman;">0-1.5h</font><font style="font-family:Times New Roman;"> ); and</font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-size:10pt;font-family:'Symbol';font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#183;</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Significantly lower drug liking and pupil dilation for KP201 as well as a greater difficulty in snorting KP201 vs. HB.&nbsp;&nbsp;</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">A second intranasal human abuse liability trial, or KP201.A02, is currently ongoing and is intended to assess the intranasal abuse potential of KP201/APAP.&nbsp;&nbsp;KemPharm anticipates reporting data from the KP201.A02 trial in the third quarter of 2015.&nbsp;&nbsp;The KP201.A03 and KP201.A02 trials are part of a broader human abuse liability program designed by KemPharm to assess key abuse-deterrence criteria as specified by the U.S. Food and Drug Administration, or FDA. </p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU3"></a><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Remaining components of the </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">KP201/APAP </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">huma</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">n abuse liability program include three nonclinical studies to evaluate the tamper resistance of KP201/APAP (whether the active ingredient can be extracted physically or chemically, abused intravenously or smoked) and KP201.A02. Results from these studies </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">are expected in the third quarter of 2015.&nbsp;&nbsp;</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">KemPharm anticipates submitting </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">a New Drug Application</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for KP201/APAP to</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">the FDA in the fourth quarter of 2015.</font></p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Caution Concerning Forward Looking Statements</p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">This Current Report may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21 E of the Securities Exchange Act of 1934, as amended.&nbsp;&nbsp;Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as &#8220;may,&#8221; &#8220;will,&#8221; &#8220;expect,&#8221; &#8220;project,&#8221; &#8220;estimate,&#8221; &#8220;anticipate,&#8221; &#8220;plan,&#8221; &#8220;believe,&#8221; &#8220;potential,&#8221; &#8220;should,&#8221; &#8220;continue&#8221; or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the timing of filing of KemPharm&#8217;s anticipated New Drug Application with the FDA and the expected timing of completion of additional clinical trials.&nbsp;&nbsp;These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm&#8217;s financial resources and whether they will be sufficient to meet KemPharm&#8217;s business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by KemPharm&#8217;s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. KemPharm&#8217;s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm&#8217;s business are described in additional detail in KemPharm&#8217;s Registration Statement on Form S-1 (Registration No. 333-202660) declared effective April 15, 2015, and KemPharm&#8217;s other Periodic and Current Reports filed with the Securities and Exchange Commission.&nbsp;&nbsp;KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item 9.01 Financial Statements and Exhibits.</p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="OLE_LINK7"></a><a name="OLE_LINK8"></a>Press Release titled &#8220;KemPharm, Inc. Announces Positive Data from Intranasal Human Abuse Liability Study of KP201/APAP; Reports Q2 2015 Results&#8221; dated August 13, 2015.</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU4"></a><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES </font></p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:7.69%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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. </p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-variant: small-caps;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;">KemPharm, Inc.</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Press Release titled &#8220;KemPharm, Inc. Announces Positive Data from Intranasal Human Abuse Liability Study of KP201/APAP; Reports Q2 2015 Results&#8221; dated August 13, 2015.</p></td>
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kmph-8k_20150813.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): August 13, 2015
KEMPHARM, INC.
(Exact name of Registrant as Specified in Its Charter)
Delaware
001-36913
20-5894398
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
2656 Crosspark Road, Suite 100
Coralville, IA
52241
(Address of Principal Executive Offices)
(Zip Code)
Registrant's Telephone Number, Including Area Code:
(319) 665-2575
Not Applicable
(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 (see General Instructions A.2. below):
¨
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))
Section 2 - Financial Information
Item 2.02 Results of Operations and Financial Condition.
On August 13, 2015, KemPharm, Inc., a Delaware corporation, or KemPharm, issued a press release announcing its corporate and financial results for the quarter ended June 30, 2015, as well as information regarding a conference call to discuss these corporate and financial results.  The press release is attached hereto as Exhibit 99.1, which is furnished under Item 2.02 of this report and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any of KemPharm's filings under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
Section 8 – Other Events
Item 8.01 Other Events
On August 13, 2015, KemPharm issued a press release with respect to data from the first of two intranasal human abuse liability clinical trials of KP201 in accordance with KemPharm's broader KP201/APAP human abuse liability program. KP201/APAP, KemPharm's most advanced product candidate currently being developed for the treatment of acute moderate to moderately severe pain, consists of KP201 formulated in combination with acetaminophen, or APAP. This first intranasal trial, or KP201.A03, was conducted with KP201, a prodrug of hydrocodone and the active ingredient, or API, in KP201/APAP.  This single-center, cross-over pharmacokinetic study was designed to measure the amount of hydrocodone released from the API, KP201, when insufflated (i.e., snorted) without APAP, as compared directly to hydrocodone bitartrate, or HB. KP201 demonstrated a statistically significant lowering in peak hydrocodone exposure (C
max
), and a delay in the time to achieve peak exposure (T
max
), as well as a significant decrease in total exposure to hydrocodone (AUC
last
and AUC
0-4h
) especially in the early time points typically associated with increased drug liking and abuse.  Secondary endpoints related to drug liking, pupillometry and ease of snorting also showed significant differences between KP201 and HB with KP201 demonstrating lower drug liking, less pupil dilation and higher difficulty of snorting than HB.
Results from the KP201.A03 trial included:
·
36% decrease in peak hydrocodone exposure (C
max
) for KP201 compared to HB when taken intranasally;
·
Time to peak hydrocodone exposure (T
max
) delayed by one hour;
·
Decreased overall exposure to hydrocodone released from KP201 vs. HB especially in early time points (82% decrease in AUC
0-0.5h
and 63% decrease in AUC
0-1.5h
); and
·
Significantly lower drug liking and pupil dilation for KP201 as well as a greater difficulty in snorting KP201 vs. HB.
A second intranasal human abuse liability trial, or KP201.A02, is currently ongoing and is intended to assess the intranasal abuse potential of KP201/APAP.  KemPharm anticipates reporting data from the KP201.A02 trial in the third quarter of 2015.  The KP201.A03 and KP201.A02 trials are part of a broader human abuse liability program designed by KemPharm to assess key abuse-deterrence criteria as specified by the U.S. Food and Drug Administration, or FDA.
Remaining components of the
KP201/APAP
huma
n abuse liability program include three nonclinical studies to evaluate the tamper resistance of KP201/APAP (whether the active ingredient can be extracted physically or chemically, abused intravenously or smoked) and KP201.A02. Results from these studies
are expected in the third quarter of 2015.
KemPharm anticipates submitting
a New Drug Application
under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for KP201/APAP to
the FDA in the fourth quarter of 2015.
Caution Concerning Forward Looking Statements
This Current Report may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21 E of the Securities Exchange Act of 1934, as amended.  Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as "may," "will," "expect," "project," "estimate," "anticipate," "plan," "believe," "potential," "should," "continue" or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the timing of filing of KemPharm's anticipated New Drug Application with the FDA and the expected timing of completion of additional clinical trials.  These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. KemPharm's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm's business are described in additional detail in KemPharm's Registration Statement on Form S-1 (Registration No. 333-202660) declared effective April 15, 2015, and KemPharm's other Periodic and Current Reports filed with the Securities and Exchange Commission.  KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No.
Description
99.1
Press Release titled "KemPharm, Inc. Announces Positive Data from Intranasal Human Abuse Liability Study of KP201/APAP; Reports Q2 2015 Results" dated August 13, 2015.
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.
KemPharm, Inc.
Date: August 13, 2015
By:
/s/ R. LaDuane Clifton
R. LaDuane Clifton
Chief Financial Officer
EXHIBIT INDEX
Exhibit
Number
Description
99.1
Press Release titled "KemPharm, Inc. Announces Positive Data from Intranasal Human Abuse Liability Study of KP201/APAP; Reports Q2 2015 Results" dated August 13, 2015.