KemPharm, Inc. (NASDAQ:KMPH) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD
Disclosure.
OnJune 28, 2017, KemPharm, Inc., or the Company, issued a press
release announcing two significant advances involving its prodrug
development pipeline for the treatment of attention deficit
hyperactivity disorder, or ADHD. These advances include the
development of a new prodrugproduct candidateof
d-threo-methylphenidate, KP484, for ADHD indications that may
benefit from a super-extended duration of treatment and the
successful completion of an End-of-Phase 1 meeting with theU.S.
Food and Drug Administration, or FDA, for KP415. A copy of the
press release is furnished as Exhibit 99.1 to this Current Report
on Form 8-K.
Also onJune 28, 2017, the Company conducted a conference call and
live audio webcast to discuss these matters. A copy of the slide
presentation used in connection with this conference call is
furnished as Exhibit 99.2 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 and the slide
presentation furnished as Exhibit 99.2 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.
Caution Concerning Forward Looking Statements
ThisCurrent Report on Form 8-K and the materials furnished
herewithmay 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 and characteristics of KP415 and KP484, and the
anticipated timelines for any Investigational New Drug
applicationor New Drug Application submission or the availability
of clinical trial results. 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 or
KP484; 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 Companys Quarterly Report
on Form 10-Q for the period ended March 31, 2017, 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.
|
(d) |
Exhibits |
|
ExhibitNo. |
Description |
|
|
99.1 |
Press Release titled KemPharm Strengthens ADHD Prodrug |
|
| 99.2 |
Presentation titled ADHD Prodrug Pipeline Update datedJune 28, 2017. |
KEMPHARM, INC ExhibitEX-99.1 2 ex99-1.htm EXHIBIT 99.1 ex99-1.htm EXHIBIT 99.1 KemPharm Strengthens ADHD Prodrug Pipeline with Development of KP484,…To view the full exhibit click here 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.