Conference Call and Live Audio Webcast with Slide
Presentation Scheduled for Today at 4:30 p.m. ET
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company engaged in the discovery and development of
proprietary prodrugs, today reported its corporate and financial
results for the second quarter ended June 30, 2017, including an
update on clinical and regulatory events involving its prodrug
development pipeline.
“The second quarter was highlighted by key
advances to our ADHD prodrug portfolio, including the completion of
the KP415 End-of-Phase 1 meeting with the FDA and the requisite
Phase 1 pharmacokinetics trial, the data of which was announced
today and has provided us additional support of the potential early
onset and extended duration of therapy that may be provided by
KP415,” said Travis C. Mickle, Ph.D., President and Chief Executive
Officer of KemPharm. “We believe these two events keep us on
schedule for the initiation of the pivotal efficacy study and human
abuse liability program prior to year-end.”
“Importantly, we also were able to announce the
development of a new ADHD prodrug product candidate, KP484, a
super-extended release d-threo-methylphenidate. We now expect to
file the Investigational New Drug (IND) application for KP484 as
early as the third quarter of 2017, after which we anticipate
initiating an expedited clinical development program in 2018,” Dr.
Mickle continued. “Should we continue to advance our ADHD
prodrug portfolio as expected, KemPharm foresees submitting New
Drug Applications (NDAs) for KP415 and KP484 in 2018 and 2019,
respectively, enabling the Company to potentially introduce two
highly differentiated products to the ADHD market in close
succession. Altogether, these completed and anticipated milestones
have strengthened our conviction that our ADHD prodrug portfolio is
not only KemPharm’s most valuable asset, but also has the potential
to address important treatment needs across the ADHD patient
spectrum.”
“In addition to the significant activity with
our ADHD portfolio, we anticipate the completion of the Formal
Dispute Resolution Request (FDRR) process for Apadaz™, our product
candidate combining KP201with APAP, with the FDA in the near future
as well,” Dr. Mickle concluded. “Collectively, we believe
these internal opportunities may add significant value to KemPharm
in 2017 and 2018, while serving to highlight the potential of our
Ligand Activated Therapy (LAT) prodrug platform. We will
continue to leverage this drug discovery engine, which is designed
to enhance the performance of an active pharmaceutical ingredient
and increase the marketability of the parent drug.”
Q2 2017 Financial Results:
KemPharm’s reported net loss of $6.5 million, or
$0.44 per basic and diluted share for Q2 2017, compared to net
income of $9.8 million, or net income per basic share of $0.59 and
net loss per diluted share of $0.58, for the same period in 2016.
Net loss for the Q2 2017 was driven primarily by a loss from
operations of $8.2 million, and net interest expense and other
items of $1.8 million; these expenses were partially offset by fair
value adjustment income of $3.5 million. Loss from operations was
$9.3 million for the same period in 2016. The decrease in loss from
operations for Q2 2017 compared to the same quarter in 2016 was
primarily due to a decrease in general and administrative costs
related to overhead and personnel spending.
As of June 30, 2017, total cash, cash
equivalents, restricted cash, marketable securities, and long-term
investments was $65.8 million, which reflected a decrease of $6.6
million compared to March 31, 2017. Based on the Company’s
current forecast, existing resources are expected to fund operating
expenses and capital expenditure requirements through Q2 2019.
Conference Call
Information:
The company will host a conference call and live
audio webcast with slide presentation on Thursday, August 10, 2017,
at 4:30 p.m. ET, to discuss its corporate and financial results for
the second quarter 2017. Interested participants and investors may
access the conference call by dialing either:
- (866) 395-2480 (U.S.)
- (678) 509-7538 (international)
- Conference ID: 63587183
The live webcast with accompanying slides will
be accessible via the Investor Relations section of the KemPharm
website http://investors.kempharm.com/. An archive of the
webcast and presentation will remain available for 90 days
beginning at approximately 5:00 p.m. ET, on August 10, 2017.
Second Quarter 2017 Activities:
- Initiated Development of KP484, A New, Super-Extended
Release ADHD Methylphenidate Product Candidate 1On June
28, 2017, KemPharm announced the development of a new prodrug
product candidate of d-threo-methylphenidate (d-MPH), KP484, for
ADHD indications that may benefit from a super-extended duration of
treatment. The new therapeutic application was developed
during a data analysis of the KP415 Phase 1 study, in which
KemPharm observed that the prodrug molecule demonstrated an ability
to produce a longer duration release of d-MPH relative to
comparator products available on the market today. As a
result, KemPharm is now planning to initiate clinical development
of KP484 and anticipates filing an IND application for KP484 as
early as the third quarter of 2017. KemPharm expects to
leverage data from certain clinical and nonclinical trials of KP415
to expedite the development of KP484. KemPharm believes this may
enable it to realize key cost and R&D efficiencies and target
an NDA submission as soon as 2019.
- Completed KP415 End-of-Phase 1 Meeting with
FDAAlso on June 28, 2017, KemPharm announced the
successful completion of an End-of-Phase 1 (EOP1) meeting with the
FDA for KP415. KemPharm held the EOP1 meeting with the FDA to
discuss the data from the Phase 1 proof-of-concept clinical trial
of KP415 (KP415.101), additional nonclinical and manufacturing data
sets, and the proposed clinical and nonclinical programs required
for eventual submission of an NDA for KP415. Additionally,
KemPharm and the FDA discussed the proposed commercial formulation
of KP415, which KemPharm plans to develop with a co-formulated
product of methylphenidate and the prodrug of KP415 to potentially
support a superior early onset profile. Based on the feedback
from the FDA, KemPharm believes that its ongoing and anticipated
research of KP415, including the pivotal efficacy trial planned to
initiate in the second half of 2017, remains on schedule and in
alignment with a potential NDA submission as soon as late
2018.
- Announced First Patent Grant for KP746, a Prodrug of
OxymorphoneOn June 26, 2017, KemPharm announced the
addition of a patent for KP746, a prodrug of oxymorphone.
KemPharm was granted U.S. Patent No. 9,682,076 from the United
States Patent and Trademark Office for its patent application
titled, “Benzoic acid, benzoic acid derivatives and heteroaryl
carboxylic acid conjugates of oxymorphone, prodrugs, methods of
making and use thereof.” The patent, which extends through
2035, provides compositions of matter for treating moderate to
severe pain, specifically comprising a compound and compositions of
oxymorphone conjugated to 6-diflunisal.
- Presented Clinical Data for KP511 at the International
Conference on OpioidsOn June 11, 2017, KemPharm presented
clinical data from KP511 KemPharm’s prodrug of hydromorphone, at
the International Conference on Opioids Annual Meeting. The
poster, titled, “Pharmacokinetics and Abuse Potential of KP511, a
Novel Prodrug of Hydromorphone, after Intranasal Administration in
Recreational Drug Users,” reported the results of a study designed
to assess the pharmacokinetics and abuse potential of equimolar
doses of KP511 hydrochloride active pharmaceutical ingredient (API)
(16.1 mg) compared with hydromorphone (HM) hydrochloride (HCl) API
(8 mg) following intranasal administration in the studied
non-dependent, recreational opioid users. Intranasal KP511
demonstrated favorable pharmacokinetics marked by reduced plasma
drug exposure compared to HM HCl, as well as statistically
significant reductions in FDA-recommended endpoints relating to
abuse potential, including “at-the-moment” Drug Liking and Feeling
High measures and retrospective measures of Take Drug Again and
Overall Drug Liking.
- Promoted Andrew Barrett, Ph.D., to Vice President,
Scientific AffairsOn June 1, 2017, KemPharm announced the
promotion of Dr. Andrew Barrett as Vice President, Scientific
Affairs. Dr. Barrett has contributed to KemPharm’s scientific
research and development since early 2016, playing a significant
role in the clinical/regulatory development of the company’s
pipeline assets and communicating key scientific findings to the
medical and investor communities. As Vice President, Scientific
Affairs, Dr. Barrett is responsible for leading KemPharm’s medical
communications strategies, while continuing to contribute to
clinical/regulatory efforts.
About KemPharm
KemPharm is a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs to treat serious medical conditions through
its LATTM (Ligand Activated Therapy) platform technology.
KemPharm utilizes its LATTM platform technology to generate
improved prodrug versions of FDA-approved drugs in the high need
areas of pain, ADHD and other central nervous system disorders.
KemPharm’s co-lead clinical development candidates are KP415 and
KP484, both based on a prodrug of methylphenidate, but with
differing extended-release profiles for the treatment of ADHD, and
KP201/IR, an acetaminophen-free formulation of the company’s
immediate release abuse deterrent hydrocodone product candidate,
KP201. For more information on KemPharm and its pipeline of
prodrug product candidates visit www.kempharm.com.
Caution Concerning Forward Looking
Statements
This press release 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
21E 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 expected features and characteristics of
KP415, KP484, KP201/IR and KP511, the expected timing of the
initiation and completion of any clinical trials for the Company’s
product candidates and the expected timing for any submission of an
New Drug Application with the FDA for any of the Company’s product
candidates. 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; the impact of competitive products and
technological changes; and the FDA approval process under the
Section 505(b)(2) regulatory pathway, including without limitation
any timelines for related approval. 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 Annual Report on Form 10-K for the year ended
December 31, 2016, 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.
KEMPHARM, INC. |
UNAUDITED CONDENSED STATEMENTS OF
OPERATIONS |
(in thousands, except share and per share
amounts) |
|
|
|
Three months endedJune 30, |
|
|
Six months ended June
30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
4,650 |
|
|
|
4,988 |
|
|
|
8,764 |
|
|
|
8,222 |
|
General
and administrative |
|
|
3,574 |
|
|
|
4,287 |
|
|
|
6,840 |
|
|
|
8,023 |
|
Total
operating expenses |
|
|
8,224 |
|
|
|
9,275 |
|
|
|
15,604 |
|
|
|
16,245 |
|
Loss from
operations |
|
|
(8,224 |
) |
|
|
(9,275 |
) |
|
|
(15,604 |
) |
|
|
(16,245 |
) |
Other (expense)
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on
extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(4,740 |
) |
Interest
expense related to amortization of debt issuancecosts and
discount |
|
|
(390 |
) |
|
|
(393 |
) |
|
|
(780 |
) |
|
|
(835 |
) |
Interest
expense on principal |
|
|
(1,443 |
) |
|
|
(1,475 |
) |
|
|
(2,884 |
) |
|
|
(2,625 |
) |
Fair
value adjustment |
|
|
3,523 |
|
|
|
20,763 |
|
|
|
(3,693 |
) |
|
|
31,041 |
|
Interest
and other income, net |
|
|
13 |
|
|
|
144 |
|
|
|
114 |
|
|
|
246 |
|
Total other
(expense) income |
|
|
1,703 |
|
|
|
19,039 |
|
|
|
(7,243 |
) |
|
|
23,087 |
|
(Loss) income before
income taxes |
|
|
(6,521 |
) |
|
|
9,764 |
|
|
|
(22,847 |
) |
|
|
6,842 |
|
Income tax benefit
(expense) |
|
|
4 |
|
|
|
4 |
|
|
|
8 |
|
|
|
(8 |
) |
Net (loss) income |
|
$ |
(6,517 |
) |
|
$ |
9,768 |
|
|
$ |
(22,839 |
) |
|
$ |
6,834 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.44 |
) |
|
$ |
0.59 |
|
|
$ |
(1.56 |
) |
|
$ |
0.41 |
|
Diluted |
|
$ |
(0.44 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares of common stockoutstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
14,649,586 |
|
|
|
14,597,449 |
|
|
|
14,648,291 |
|
|
|
14,546,576 |
|
Diluted |
|
|
14,649,586 |
|
|
|
15,435,322 |
|
|
|
14,648,291 |
|
|
|
15,583,390 |
|
KEMPHARM, INC. |
CONDENSED BALANCE SHEETS |
(in thousands, except share and par value amounts) |
|
|
|
As of June 30, |
|
|
As ofDecember 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
12,386 |
|
|
$ |
16,762 |
|
Restricted cash |
|
|
1,100 |
|
|
|
1,100 |
|
Marketable securities |
|
|
41,107 |
|
|
|
51,003 |
|
Trade
date receivables |
|
|
— |
|
|
|
5,003 |
|
Prepaid
expenses and other current assets |
|
|
771 |
|
|
|
489 |
|
Total
current assets |
|
|
55,364 |
|
|
|
74,357 |
|
Property and equipment,
net |
|
|
2,148 |
|
|
|
1,970 |
|
Long-term
investments |
|
|
11,215 |
|
|
|
8,200 |
|
Other long-term
assets |
|
|
321 |
|
|
|
360 |
|
Total assets |
|
$ |
69,048 |
|
|
$ |
84,887 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' deficit |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
6,303 |
|
|
$ |
6,444 |
|
Current
portion of capital lease obligation |
|
|
177 |
|
|
|
157 |
|
Other
current liabilities |
|
|
112 |
|
|
|
41 |
|
Total
current liabilities |
|
|
6,592 |
|
|
|
6,642 |
|
Convertible notes,
net |
|
|
91,950 |
|
|
|
91,170 |
|
Derivative and warrant
liability |
|
|
8,311 |
|
|
|
4,618 |
|
Other long-term
liabilities |
|
|
1,472 |
|
|
|
1,153 |
|
Total liabilities |
|
|
108,325 |
|
|
|
103,583 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies (Note D) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
deficit: |
|
|
|
|
|
|
|
|
Common
stock, $0.0001 par value, 250,000,000 shares authorized,
14,657,430shares issued and outstanding as of June 30, 2017
(unaudited); 14,646,982shares issued and outstanding as of December
31, 2016 |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
104,901 |
|
|
|
102,643 |
|
Preferred
stock, $0.0001 par value, 10,000,000 shares authorized, no
sharesissued or outstanding as of June 30, 2017 (unaudited) and
December 31, 2016 |
|
|
— |
|
|
|
— |
|
Accumulated deficit |
|
|
(144,179 |
) |
|
|
(121,340 |
) |
Total
stockholders' deficit |
|
|
(39,277 |
) |
|
|
(18,696 |
) |
Total liabilities and
stockholders' deficit |
|
$ |
69,048 |
|
|
$ |
84,887 |
|
Investor Contacts:
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com
Media Contact:
Daniel L. Cohen
Executive VP, Government and Public Relations
KemPharm, Inc.
202-329-1825
dcohen@kempharm.com
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