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

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 8.01 Other Events.

In the press release described above, onJanuary 9, 2017, the
Company announced the resultsof Study KP511.A01,its Phase I,
double-blind, single-dose, 2-treatment, 2-period, randomized,
crossover studyof KP511. Study KP511.A01 was designed to assess
the pharmacokinetics, safety and exploratory abuse potential of
KP511 API compared to hydromorphone APIafter intranasal
administration in twenty-six nondependent recreational opioid
users who reported prior insufflation experience. The primary
endpoint was pharmacokinetic evaluation of hydromorphone released
from KP511 API and HM API. The secondary endpoint was safety. The
exploratory endpoint was the abuse potential.

Mean peak hydromorphone exposure, or Cmax, was reduced by
approximately 63% and median Tmax for hydromorphone was delayed
by 30 minutes after insufflation of KP511 API when compared to HM
API. Mean overall hydromorphone exposure with KP511 API was
approximately 58% and 48% lower as measured by AUClast and
AUCinf, respectively. In addition, mean cumulative hydromorphone
exposures at time points following intranasal administration of
KP511 were decreased from approximately 56% to 100% (higher
reduction at earlier time points) with negligible hydromorphone
plasma concentration prior to the 30-minute time point. The
results demonstrated that KP511 prodrug may release hydromorphone
at a significantly slower rate and lower extent after intranasal
administration when compared to HM API. KemPharm believes the
statistically significant reduction in hydromorphone exposure
translated into statistically significant differences in the
exploratory pharmacodynamic measures. Mean maximum scores, or
Emax, of Drug Liking and Feeling High for KP511 were
approximately 11.4 and 23.4 points lower, respectively.
Additionally, mean Overall Drug Liking and Take Drug Again scores
collected at 24hours post-dose were approximately 16.0 and 13.3
points lower, respectively. Abuse measures were assessed on
bipolar and unipolar (Feeling High only) visual analog scales.

In a retrospective assessment of drug preference after the last
treatment, a significant majority of subjects (17 out of 26)
preferred HM API over KP511 API indicating that KP511 may be less
attractive for intranasal abuse. Several endpoints related to
intranasal irritation including nasal burning, need to blow nose,
nasal discharge and facial pain were higher (i.e., more severe)
for KP511 versus HM API.

Also onJanuary 9, 2017, the Company made available on the
Companys website at www.kempharm.com,an investor
presentation that includes, among other things, an update
regarding the Companys product candidate pipeline. Management of
the Company intends to deliver the presentation at investor
meetings inJanuary 2017. A copy of the presentation is filed as
Exhibit 99.2 to this Current Report on Form 8-K, the contents of
which are incorporated herein by reference. The information
contained in this Current Report on Form 8-K speaks only as the
date hereof. While the Company may elect to update the
information in this Current Report on Form 8-K in the future, the
Company disclaims any obligation to do so except to the extent
required by applicable law.

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 NDAs for KP511/ER
and KP511/IR. 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 KP511/ER or KP511/IR;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 -0.15 at 3.20 with 13,202 shares trading hands.