KEMPHARM, INC. (NASDAQ:KMPH) Files An 8-K Regulation FD Disclosure

Item 7.01Regulation FD Disclosure.

On December 14, 2016, KemPharm, Inc., or the Company, issued a
press release announcing the resultsof its Phase I
proof-of-concept clinical trial of KP415, the Companys prodrug,
extended release, or ER,d-threo-methylphenidate, or d-MPH,
product candidate for the treatment of attention deficit
hyperactivity disorder, or ADHD.

A copy of the press release is furnished as Exhibit 99.1 to this
Current Report on Form 8-K. The information set forth in this
Item 7.01 and contained in the press release furnished as Exhibit
99.1 shall not be deemed filed for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or the Exchange Act,
and is not incorporated by reference into any of the Companys
filings under the Securities Act of 1933, as amended, or the
Securities Act, or the Exchange Act, whether made before or after
the date hereof, except as shall be expressly set forth by
specific reference in any such filing.

Item 8.01Other
Events.

In the press release described above, onDecember 14, 2016, the
Company announced the resultsof its Phase I proof-of-concept
clinical trial of KP415, or KP415.101. KP415.101 was designed to
assess the relative pharmacokinetic, or PK, of 32 mg of KP415
compared with 36 mg of Concerta after oral administration under
fasted conditions. Twenty-four healthy volunteers were enrolled
in and completedthis open-label, single-dose, two-treatment,
two-period, cross-over PK clinical trial. Dosing levels in each
treatment did not contain equivalent amounts of d-MPH: 36 mg
Concerta contains approximately 12% more d-MPH than 32 mg KP415.

After KP415 dosing, the mean peak plasma concentration, or Cmax,
of d-MPH was similar to Concerta at a median time to Cmax, or
Tmax, of 3 hours for KP415 and 6 hours for Concerta. When the
area under curve,was normalized for dose differences of d-MPH
content, they were nearly identical between treatments. The mean
terminal elimination plasma half-life of d-MPH was 12 hours for
KP415 versus 4 hours for Concerta.

Plasma concentrations of the inactive, intact KP415 molecule were
measured after oral administration, which may contribute to the
early d-MPH levels and the ER profile of KP415-derived d-MPH.
Both treatments were generally well-tolerated and there were no
serious adverse events.

Data from thestudy indicated that KP415demonstrated PK properties
that produce earlier d-MPH exposure followed by a slower extended
release of d-MPH relative to the comparator, Concerta.

Caution Concerning Forward Looking Statements

ThisCurrent Report on Form 8-Kmay contain forward-looking
statements made in reliance upon the safe harbor provisions of
Section 27A of the Securities Act and Section 21E of the Exchange
Act. 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 expected features, characteristics,
development timelineandpotential submission of an NDA for KP415.
These forward-looking statements are not guarantees of future
actions or performance. These forward-looking statements are
based on information currently available tothe Companyand 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: the Companys financial
resources and whether they will be sufficient to meet the
Companys 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 the Companys intellectual property; risks
related to the drug discovery and the regulatory approval
process; the impact of competitive products and technological
changes;obligations to third parties regarding the potential
commercialization or sale of KP415;and the FDA approval process,
including without limitation any timelines for related approval.
The Companys 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 the
Companys business are described in additional detail in the
CompanysQuarterly Report on Form 10-Q for thequarter
endedSeptember 30, 2016, and the Companys other Periodic and
Current Reports filed with the Securities and Exchange
Commission.The Companyis 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.

About KEMPHARM, INC. (NASDAQ:KMPH)

KemPharm, Inc. is a clinical-stage specialty pharmaceutical company. The Company is engaged in the discovery and development of prodrugs. The Company uses its Ligand Activated Therapy (LAT) platform technology to create prodrugs. The Company’s product candidate, KP201/APAP, consists of KP201, its prodrug of hydrocodone, which is combined with acetaminophen (APAP). The Company is developing KP201/APAP as an immediate release (IR), a product candidate for the short-term, or no longer than 14 days for the management of acute pain. The Company has designed KP201/APAP with abuse-deterrent properties to address the epidemic of opioid abuse in the United States. The Company also focuses on developing the pipeline of additional prodrug product candidates that targets pain and attention deficit hyperactivity disorder (ADHD). The Company’s products include KP201/IR (APAP-free), KP511/ER, KP415, KP606/IR and KP746.

KEMPHARM, INC. (NASDAQ:KMPH) Recent Trading Information

KEMPHARM, INC. (NASDAQ:KMPH) closed its last trading session down -0.10 at 3.45 with 83,070 shares trading hands.