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 third quarter ended September 30, 2017, including
an update on development and regulatory events involving its
prodrug development pipeline.
“We continued to reach key milestones for our
company during the third quarter that we believe, collectively,
showcase the value potential of our prodrug pipeline and our Ligand
Activated Therapy (LAT™) discovery platform,” said Travis C.
Mickle, Ph.D., President and Chief Executive Officer of
KemPharm. “During the quarter, we filed the Investigational
New Drug (IND) application for KP484, our super-extended release
prodrug for the treatment of attention deficit hyperactivity
disorder (ADHD), and last week, we were pleased to report that the
FDA completed its review of the KP484 IND application, enabling us
to proceed to the clinic. This advancement, coupled with the
ongoing development of KP415, our lead ADHD prodrug candidate,
positions KemPharm to potentially have two late-stage product
candidates designed to address important unmet treatment needs in
ADHD.”
“The third quarter was also highlighted by the
completion of the Formal Dispute Resolution Request (FDRR) process
with the U.S. Food and Drug Administration (FDA) for Apadaz™
(benzhydrocodone and acetaminophen),” Dr. Mickle continued.
“Initiated approximately a year ago, the FDRR process provided us
an opportunity to discuss appropriate labeling language for
Apadaz™. Based on the discussions, we replied to the June
2016 Complete Response Letter from the FDA by submitting an amended
Apadaz™ New Drug Application (NDA), for which the FDA assigned a
Prescription Drug User Fee Act (PDUFA) date of February 23,
2018.”
“Additionally, we entered into a technology
licensing and assignment agreement with Genco Sciences with the
goal of building on their technology to develop a new prodrug
product for the treatment of pediatric Tourette’s syndrome when
accompanied by ADHD,” Dr. Mickle continued. “Although still
in discovery phase, we are very excited by the opportunity to
harness our LAT™ prodrug discovery platform to potentially
develop a new product candidate for an orphan-drug area. This
agreement is the first of what we hope will be replicated as a
model for our strategy to leverage our LAT™ to potentially
enhance the performance of an active pharmaceutical ingredient and
increase the marketability of the parent drug.”
“We anticipate that the fourth quarter and early
2018 will be a very active period for KemPharm. We anticipate
multiple clinical and regulatory milestone announcements, including
initiating the pivotal efficacy study for KP415, completing the
combined intravenous (IV) human abuse liability study for KP415 and
KP484, and, as noted previously, the PDUFA decision for
Apadaz™ in February,” Dr. Mickle concluded.
Q3 2017 Financial Results:
KemPharm’s reported net loss was $10.0 million,
or $0.68 per basic and diluted share, for the three months ended
September 30, 2017, compared to net loss of $13.4 million, or $0.92
per basic and diluted share, for the same period in 2016. Net loss
for the Q3 2017 was driven primarily by a loss from operations of
$9.6 million, and net interest expense and other items of $1.7
million; these expenses were partially offset by non-cash fair
value adjustment income of $1.3 million. Loss from operations
decreased $0.8 million from $10.4 million in Q3 2016 to $9.6
million in Q3 2017. The decrease in loss from operations for Q3
2017 compared to the same quarter in 2016 was primarily due to
severance expense recognized in Q3 2016 of $3.0 million which did
not recur in Q3 2017. This decrease was partially offset by
increased research and development and general and administrative
spending of $2.0 million and $0.2 million, respectively, period
over period.
As of September 30, 2017, total cash and
security-related amounts, which is comprised of cash, cash
equivalents, restricted cash, marketable securities, trade date
receivables and long-term investments, was $55.6 million, which
reflected a decrease of $10.2 million compared to June 30,
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, November 9,
2017, at 4:30 p.m. ET, to discuss its corporate and financial
results for the third 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: 3698227
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 November 9, 2017.
Recent and Third Quarter 2017 Activities:
- Entered into Licensing and Assignment Agreement with
Genco Sciences to Develop Prodrug-Based Therapy for Potential Rare
Pediatric Indications of Tourette’s Syndrome with
ADHD
On October 4, 2017, KemPharm entered into a
technology licensing and assignment agreement with Genco Sciences,
LLC (Genco) whereby KemPharm anticipates utilizing Genco’s early
research-stage proprietary nano-particulate amphetamine technology
to devise a unique prodrug to be developed as a treatment for
pediatric Tourette’s syndrome when accompanied by ADHD. Under terms
of the agreement, KemPharm will be responsible for financing and
managing all product development.
- Filed IND for KP484 for the Treatment of ADHD, An
Investigational Prodrug of Methylphenidate
On September 20, 2017, KemPharm announced that
it filed an IND application with the FDA to begin human clinical
trials of KP484, the Company’s prodrug product candidate of
“super-extended” release methylphenidate for the treatment of
ADHD. KemPharm’s IND proposal is to develop KP484 along a
similar clinical trial pathway as KP415, with efficacy studies of
KP484 expected to initiate in 2018.
- Announced FDRR Process Completion and Resubmission of
the Apadaz™ NDA
On September 19, 2017, KemPharm announced
completion of the FDRR process with the FDA for Apadaz
(benzhydrocodone and acetaminophen). Based on the FDRR
discussions, KemPharm replied to the CRL by submitting an amended
Apadaz NDA. The FDA notified KemPharm with the determination that
the resubmitted NDA application is complete and assigned February
23, 2018, as the expected date by which an approval decision will
be determined.
- Announced Preliminary Pharmacokinetic Phase I Trial
Results for KP415
On August 10, 2017, KemPharm announced
preliminary results for KP415.109, our proposed co-formulation of
our proprietary extended release (ER) KP415 d-methylphenidate
prodrug together with immediate release (IR) d-MPH, demonstrated
expected PK parameters in this Phase I trial and is now being
readied for further development in a safety and efficacy clinical
trial later this year. This Phase I trial was designed to assess
the relative pharmacokinetics (PK) of three different formulations
of KP415 vs. a methylphenidate-containing comparator product
(Concerta ®) at both single and multiple dose conditions.
KP415 is KemPharm’s co-lead ADHD product candidate.
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 proprietary LAT™ (Ligand Activated Therapy) platform
technology. KemPharm utilizes its proprietary
LAT™ platform technology to generate improved prodrug versions
of FDA-approved drugs in the high need areas of ADHD, pain 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. In addition, the company is
advancing Apadaz™, an immediate-release, abuse-deterrent
hydrocodone/acetaminophen combination product candidate, 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
any product candidates developed under the Genco license agreement,
KP415, KP484, Apadaz™ and KemPharm’s other product candidates,
the expected timing of the initiation and completion of any
clinical trials for KemPharm’s product candidates, the expected
timing and outcome from the resubmission of KemPharm’s Apadaz NDA
with the FDA, and KemPharm’s current forecast that existing
resources are expected to fund operating expenses and capital
expenditure requirements through Q2 2019. 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.
Investor
Contacts: |
Media
Contact: |
Jason Rando / Joshua
Drumm, Ph.D.Tiberend Strategic Advisors, Inc.212-375-2665 /
2664jrando@tiberend.comjdrumm@tiberend.com |
Daniel L.
CohenExecutive VP, Government and Public RelationsKemPharm,
Inc.202-329-1825dcohen@kempharm.com |
|
KEMPHARM, INC. |
UNAUDITED CONDENSED STATEMENTS OF
OPERATIONS |
(in thousands, except share and per share
amounts) |
|
|
|
Three months ended September
30, |
|
Nine months ended September
30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
6,293 |
|
|
|
4,287 |
|
|
|
15,057 |
|
|
|
12,509 |
|
General
and administrative |
|
|
3,319 |
|
|
|
3,104 |
|
|
|
10,159 |
|
|
|
11,127 |
|
Severance
expense |
|
|
— |
|
|
|
3,010 |
|
|
|
— |
|
|
|
3,010 |
|
Total
operating expenses |
|
|
9,612 |
|
|
|
10,401 |
|
|
|
25,216 |
|
|
|
26,646 |
|
Loss from
operations |
|
|
(9,612 |
) |
|
|
(10,401 |
) |
|
|
(25,216 |
) |
|
|
(26,646 |
) |
Other (expense)
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on
extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(4,740 |
) |
Interest
expense related to amortization of debt issuance costs and
discount |
|
|
(391 |
) |
|
|
(390 |
) |
|
|
(1,171 |
) |
|
|
(1,225 |
) |
Interest
expense on principal |
|
|
(1,448 |
) |
|
|
(1,441 |
) |
|
|
(4,332 |
) |
|
|
(4,066 |
) |
Fair
value adjustment |
|
|
1,312 |
|
|
|
(1,299 |
) |
|
|
(2,381 |
) |
|
|
29,742 |
|
Interest
and other income, net |
|
|
154 |
|
|
|
98 |
|
|
|
268 |
|
|
|
344 |
|
Total other
(expense) income |
|
|
(373 |
) |
|
|
(3,032 |
) |
|
|
(7,616 |
) |
|
|
20,055 |
|
Loss before income
taxes |
|
|
(9,985 |
) |
|
|
(13,433 |
) |
|
|
(32,832 |
) |
|
|
(6,591 |
) |
Income tax benefit |
|
|
4 |
|
|
|
19 |
|
|
|
12 |
|
|
|
11 |
|
Net loss |
|
$ |
(9,981 |
) |
|
$ |
(13,414 |
) |
|
$ |
(32,820 |
) |
|
$ |
(6,580 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
(0.68 |
) |
|
$ |
(0.92 |
) |
|
$ |
(2.24 |
) |
|
$ |
(0.45 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares of common stock outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
14,657,430 |
|
|
|
14,646,982 |
|
|
|
14,651,371 |
|
|
|
14,580,289 |
|
|
KEMPHARM, INC. |
CONDENSED BALANCE SHEETS |
(in thousands, except share and par value amounts) |
|
|
|
|
|
|
|
|
|
As of September
30, |
|
|
As of December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
7,829 |
|
|
$ |
16,762 |
|
Restricted cash |
|
|
1,100 |
|
|
|
1,100 |
|
Marketable securities |
|
|
37,412 |
|
|
|
51,003 |
|
Trade
date receivables |
|
|
2,503 |
|
|
|
5,003 |
|
Prepaid
expenses and other current assets |
|
|
1,354 |
|
|
|
489 |
|
Total
current assets |
|
|
50,198 |
|
|
|
74,357 |
|
Property and equipment,
net |
|
|
2,086 |
|
|
|
1,970 |
|
Long-term
investments |
|
|
6,717 |
|
|
|
8,200 |
|
Other long-term
assets |
|
|
313 |
|
|
|
360 |
|
Total assets |
|
$ |
59,314 |
|
|
$ |
84,887 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' deficit |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
6,355 |
|
|
$ |
6,444 |
|
Current
portion of capital lease obligation |
|
|
180 |
|
|
|
157 |
|
Other
current liabilities |
|
|
112 |
|
|
|
41 |
|
Total
current liabilities |
|
|
6,647 |
|
|
|
6,642 |
|
Convertible notes,
net |
|
|
92,341 |
|
|
|
91,170 |
|
Derivative and warrant
liability |
|
|
6,999 |
|
|
|
4,618 |
|
Other long-term
liabilities |
|
|
1,427 |
|
|
|
1,153 |
|
Total liabilities |
|
|
107,414 |
|
|
|
103,583 |
|
|
|
|
|
|
|
|
|
|
Stockholders’
deficit: |
|
|
|
|
|
|
|
|
Common
stock, $0.0001 par value, 250,000,000 shares authorized, 14,657,430
shares issued and outstanding as of September 30, 2017
(unaudited); 14,646,982 shares issued and outstanding as of
December 31, 2016 |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
106,059 |
|
|
|
102,643 |
|
Preferred
stock, $0.0001 par value, 10,000,000 shares authorized, no shares
issued or outstanding as of September 30, 2017 (unaudited) and
December 31, 2016 |
|
|
— |
|
|
|
— |
|
Accumulated deficit |
|
|
(154,160 |
) |
|
|
(121,340 |
) |
Total
stockholders' deficit |
|
|
(48,100 |
) |
|
|
(18,696 |
) |
Total liabilities and
stockholders' deficit |
|
$ |
59,314 |
|
|
$ |
84,887 |
|
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