CUPERTINO, Calif., March 14, 2017 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) announced today financial results for the three
months and year ended December 31,
2016 and provided a corporate update.
- Total revenues were $3.5 million
and net loss was $8.8 million for the
three months ended December 31, 2016
as compared to total revenues of $5.2
million and net loss of $5.8
million for the three months ended December 31, 2015.
- Total revenues were $14.0 million
and net loss was $34.5 million for
the year ended December 31, 2016,
compared to total revenues of $19.1
million and net loss of $22.7
million for the year ended December
31, 2015.
- At December 31, 2016, cash and
investments were $25.2 million,
compared to cash and investments of $29.3
million at December 31, 2015.
Debt at December 31, 2016 was
$19.9 million.
"For DUR-928, our novel epigenetic regulator which has potential
for broad utility in metabolic disorders, acute organ injury and
inflammatory conditions, we have completed six Phase 1 clinical
trials to date, including dosing over 140 healthy volunteers and
patients," stated James E. Brown,
D.V.M., President and CEO of DURECT. "We are pleased with the
excellent safety profile of DUR-928 in these trials as well as
certain promising biomarker data seen in NASH patients. We
look forward to presenting this data at the upcoming EASL
meeting. We are also announcing today that we are
investigating the use of DUR-928 as a topical agent for the
potential treatment of psoriasis. In PERSIST, the POSIMIR pivotal
Phase 3 clinical trial in post-operative pain, enrollment rates
support completion of dosing in the third quarter of 2017 which
would put us in position to obtain top-line results this year."
Expected milestones in 2017:
- Reporting of DUR-928 Phase 1b and other data at scientific
meetings, including the AASLD Emerging Trends Conference (March)
and EASL (April)
- Commencing at least one Phase 2 trial with DUR-928, with
primary sclerosing cholangitis (PSC) likely the first oral
indication to be pursued
- Selecting lead topical formulations for DUR-928 that will be
taken into a proof-of-concept clinical trial in psoriasis
patients
- Completing enrollment in the Phase 3 POSIMIR clinical trial
(PERSIST) in post-operative pain and announcing top-line
results
- Potentially establishing a commercial partner for POSIMIR
- Reporting on top-line results from the Phase 3 trial with
ORADUR®-Methylphenidate in Taiwan conducted by our partner Orient
Pharma
Update on Selected Programs:
Epigenetic Regulator Program. DUR-928, our
Epigenetic Regulator Program's lead product candidate, is an
endogenous, small molecule, new chemical entity (NCE), which may
have broad applicability in several metabolic diseases such as
nonalcoholic steatohepatitis (NASH) and other disorders of the
liver, in acute organ injuries such as acute kidney injury, and in
autoimmune/inflammatory disorders such as psoriasis.
Oral Formulation
- Our first patient trial utilizing DUR-928 was an open-label,
single-ascending-dose safety and pharmacokinetic (PK) Phase 1b
trial in liver function impaired (NASH) patients and matched
control subjects. This study was conducted in Australia, evaluating single-dose levels
(first a low dose and then a high dose) of orally administered
DUR-928 in successive cohorts. Twenty subjects with NASH and 12
matched control subjects received DUR-928.
- We observed a dose dependent reduction of certain biomarkers
after a single oral dose of DUR-928. In both cohorts, IL-18, an
inflammatory mediator implicated in both liver and kidney diseases,
decreased hours after DUR-928 dosing, with the effect greater in
the NASH patients. Full length CK-18 (a generalized cell death
marker) and cleaved CK-18 (a cell apoptosis marker) were both
greatly reduced after low and high doses of DUR-928, with the
effect, again, more pronounced in NASH patients.
- An abstract for this study has been accepted and data from the
study will be presented at the International Liver Congress™ 2017
organized by the European Association for the Study of the Liver
(EASL) in Amsterdam, April 19-23, 2017.
- An abstract describing our two STAM™ NASH mouse
model studies has been accepted at the AASLD Emerging Trends
Conference 2017: Emerging Trends in Non-alcoholic Fatty Liver
Disease in Washington, DC. That
data will be presented on March 17,
2017.
- We will be participating in and presenting at 4:40 pm at the H.C. Wainwright NASH Investor
Conference taking place on April 3,
2017 at the St. Regis Hotel in New
York.
- We are actively working towards a Phase 2 trial in Primary
Sclerosing Cholangitis (PSC), with an oral formulation of DUR-928.
PSC is a chronic liver disease characterized by a progressive cause
of cholestasis (decrease in bile flow) with inflammation and
fibrosis of bile ducts. It is an orphan medical condition for which
there is no established medical treatment.
Injectable Formulation
- Our second Phase 1b study with DUR-928, also being conducted in
Australia, is an open-label,
single-ascending-dose safety and pharmacokinetic study in patients
with impaired kidney function (stage 3 and 4 chronic kidney
disease) and matched control subjects.
- This study is being conducted in successive cohorts evaluating
single-dose levels (first a low dose and then a high dose) of
DUR-928 administered by intramuscular injection. The low dose
cohort consisted of 6 kidney function impaired patients and 3
matched control subjects.
- Data from the low dose cohort showed the PK parameters between
the kidney function impaired patients and the matched control
subjects were comparable. After a PK/safety review of this cohort,
patients are now being enrolled in the high dose cohort, utilizing
a dose four times larger than the low dose cohort.
- We are working closely with expert advisors to design Phase 2
trials in one or more indications with an injectable formulation of
DUR-928.
Topical Formulation
- We conducted an initial exploratory Phase 1b trial in psoriasis
patients (n = 9 evaluable patients) in Australia. The
decision to proceed with clinical testing in psoriasis was based on
the anti-inflammatory and cell survival properties of DUR-928,
including the downregulation of IL-17, full length CK-18, cleaved
CK-18, as well as the results of a psoriasis study with DUR-928 in
mice.
- The Phase 1b trial was conducted with intradermal micro
injections of DUR-928, and we feel the results warrant further
investigation. As a result, we have developed several topical
formulations of DUR-928 that we are evaluating for a topical
application microplaque trial which we expect to commence this
year. We believe that there is a large unmet medical
need for new topical drugs for psoriasis for use prior to systemic
biologic treatments which often have significant associated side
effects.
POSIMIR (SABER®-Bupivacaine) Post-Operative
Pain Relief Depot. POSIMIR is our investigational
post-operative pain relief depot that utilizes our patented SABER
technology and is intended to deliver bupivacaine to provide up to
3 days of pain relief after surgery. We are in negotiations
with a number of potential partners regarding licensing development
and commercialization rights to POSIMIR, for which we hold
worldwide rights.
- We expect to finish dosing patients in PERSIST, a POSIMIR Phase
3 clinical trial consisting of patients undergoing laparoscopic
cholecystectomy (gallbladder removal) surgery, in the third quarter
of 2017 and to have top-line results this year.
- In a previous clinical trial of 50 patients in the same
surgical model (laparoscopic cholecystectomy), POSIMIR was compared
with the active control bupivacaine HCl, against which POSIMIR
demonstrated in a post hoc analysis an approximately 25% reduction
in pain intensity on movement for the first 3 days after surgery
(p=0.024) and for the first 2 days after surgery (p=0.0198), using
the same statistical methodology specified for the current trial.
There can be no assurance that the PERSIST trial will replicate
these results.
REMOXY® ER (oxycodone)
Extended-Release Capsules CII. Based on our ORADUR
technology, the investigational drug REMOXY ER is a unique
long-acting formulation of oxycodone designed to discourage common
methods of tampering associated with opioid misuse and abuse.
- In September 2016, Pain
Therapeutics (our licensee) received a Complete Response Letter
from the FDA for REMOXY ER. Based on its review, the FDA has
determined that the NDA cannot be approved in its present form and
specifies additional actions and data that are needed for drug
approval.
- We understand from its public disclosures that Pain
Therapeutics had a meeting with the FDA in February 2017 to discuss the regulatory path
forward for REMOXY ER, and that Pain Therapeutics will provide
details of the FDA meeting after receipt of the final meeting
minutes.
ORADUR-ADHD Program. ORADUR-Methylphenidate is an
investigational drug that has the potential for rapid onset of
action, long duration with once-a-day dosing, utilizes a small
capsule size relative to the leading existing long-acting products
on the market and incorporates our ORADUR anti-tampering
technology. Orient Pharma, our licensee in defined Asian and
South Pacific countries, has completed dosing a Phase 3 study in
Taiwan and anticipates obtaining
top-line results from that study in the second quarter of
2017. We retain rights to all other markets in the world,
notably including the U.S., Europe
and Japan.
Feasibility Projects and Other Activities. During
the fourth quarter of 2016 and in 2017, we continued work on
feasibility projects funded by large pharmaceutical companies as a
means of demonstrating that our technologies can achieve the drug
delivery objectives set forth by our collaborators and are worthy
of further development.
Earnings Conference Call
A live audio webcast
of a conference call to discuss fourth quarter 2016 results and
provide a corporate update will be broadcast live over the internet
at 4:30 p.m. Eastern Time on
March 14 and is available by
accessing DURECT's homepage at www.durect.com and clicking
"Investor Relations." If you are unable to participate during the
live webcast, the call will be archived on DURECT's website under
Audio Archive in the "Investor Relations" section.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing new
therapeutics based on its Epigenetic Regulator Program and
proprietary drug delivery platforms. DUR‑928, a new chemical
entity in Phase 1 development, is the lead candidate in DURECT's
Epigenetic Regulator Program. An endogenous, orally
bioavailable small molecule, DUR-928 has been shown in preclinical
studies to play an important regulatory role in lipid homeostasis,
inflammation, and cell survival. Human applications may
include acute organ injury, chronic metabolic disorders such as
nonalcoholic fatty liver disease (NAFLD), nonalcoholic
steatohepatitis (NASH) and other disorders of the liver both broad
and orphan, and inflammatory conditions such as psoriasis.
DURECT's advanced oral, injectable, and transdermal delivery
technologies are designed to enable new indications and enhanced
attributes for small-molecule and biologic drugs. One
late-stage product candidate in this category is
POSIMIR® (SABER®-Bupivacaine), an
investigational analgesic product intended to address key unmet
needs in postoperative pain management. Another late stage
product candidate is REMOXY® ER (oxycodone), an
investigational extended release pain relief drug based on DURECT's
ORADUR® technology. For more information, please
visit www.durect.com.
NOTE: POSIMIR®, SABER®, and
ORADUR® are trademarks of DURECT Corporation. Other
referenced trademarks belong to their respective owners.
POSIMIR, DUR-928, REMOXY ER and ORADUR-Methylphenidate are drug
candidates under development and have not been approved for
commercialization by the U.S. Food and Drug Administration or other
health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential
benefits and uses of our drug candidates, including the potential
use of DUR-928 to treat NASH, other disorders of the liver,
kidney diseases or psoriasis or other inflammatory
conditions, the potential use of POSIMIR to treat pain, the
potential abuse deterrent properties of REMOXY ER and the potential
use of ORADUR-ADHD to treat ADHD, clinical trial plans for DUR-928,
POSIMIR and our other product candidates (including timing and
potential results), potential reporting of Phase 3 results for
ORADUR-methylphenidate, potential regulatory approvals of POSIMIR
and REMOXY ER, potential markets for our product candidates,
potential plans to license commercialization rights for POSIMIR and
Pain Therapeutics' plans for REMOXY ER are forward-looking
statements involving risks and uncertainties that can cause actual
results to differ materially from those in such forward-looking
statements. Potential risks and uncertainties include, but are not
limited to, the risks that future clinical trials of DUR-928 do not
demonstrate the safety or efficacy of DUR-928 in a statistically
significant manner, that the PERSIST clinical trial of POSIMIR will
take longer to conduct than anticipated or result in data that will
not support a successful NDA resubmission or product approval, that
Pain Therapeutics may not be able to adequately address all of
FDA's concerns regarding the REMOXY ER NDA or that there could be a
delay in addressing such concerns, the potential that FDA may not
grant regulatory approval of REMOXY ER, the risks of obtaining
marketplace acceptance of REMOXY ER, if approved, the risk of
delays in the commencement, enrollment or completion of other
clinical trials, the risk that prior clinical trials (including
prior trials of POSIMIR in laparoscopic cholecystectomy
patients and Phase 1b trials of DUR-928) will not be confirmed in
subsequent trials, the potential failure of clinical trials to meet
their intended endpoints, the risk that Pain Therapeutics or Orient
Pharma will discontinue development of REMOXY ER or
ORADUR-Methylphenidate, respectively, or be delayed in development
or regulatory submissions, the risk of adverse decisions by
regulatory agencies or delays and additional costs due to
requirements imposed by regulatory agencies, additional time and
resources that may be required for development, testing and
regulatory approval of DUR-928, potential adverse effects arising
from the testing or use of our drug candidates, our potential
failure to maintain our collaborative agreements with third parties
or consummate new collaborations and risks related to our ability
to obtain capital to fund operations and expenses. Further
information regarding these and other risks is included in DURECT's
Form 10-Q filed on November 1, 2016
under the heading "Risk Factors."
DURECT
CORPORATION
|
|
CONDENSED
STATEMENTS OF COMPREHENSIVE LOSS (in thousands, except
per share amounts) (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
|
Twelve months
ended
|
|
|
|
December
31
|
|
|
December
31
|
|
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
$
738
|
|
$
2,264
|
|
|
$
1,880
|
|
$
7,832
|
Product revenue,
net
|
2,779
|
|
2,903
|
|
|
12,145
|
|
11,292
|
|
Total
revenues
|
3,517
|
|
5,167
|
|
|
14,025
|
|
19,124
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
955
|
|
993
|
|
|
5,290
|
|
3,905
|
|
Research and
development
|
7,992
|
|
6,658
|
|
|
29,274
|
|
24,317
|
|
Selling, general and
administrative
|
2,832
|
|
2,845
|
|
|
11,825
|
|
11,566
|
Total operating
expenses
|
11,779
|
|
10,496
|
|
|
46,389
|
|
39,788
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(8,262)
|
|
(5,329)
|
|
|
(32,364)
|
|
(20,664)
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest and other
income
|
31
|
|
43
|
|
|
143
|
|
237
|
|
Interest and other
expense
|
(580)
|
|
(559)
|
|
|
(2,288)
|
|
(2,236)
|
Net other income
(expense)
|
(549)
|
|
(516)
|
|
|
(2,145)
|
|
(1,999)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ (8,811)
|
|
$ (5,845)
|
|
|
$(34,509)
|
|
$(22,663)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
(0.06)
|
|
$
(0.05)
|
|
|
$
(0.26)
|
|
$
(0.19)
|
|
Diluted
|
|
$
(0.06)
|
|
$
(0.05)
|
|
|
$
(0.26)
|
|
$
(0.19)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share
|
|
|
|
|
|
|
|
|
|
Basic
|
|
139,636
|
|
120,911
|
|
|
133,163
|
|
118,523
|
|
Diluted
|
|
139,636
|
|
120,911
|
|
|
133,163
|
|
118,523
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
$ (8,819)
|
|
$ (5,925)
|
|
|
$(34,498)
|
|
$(22,764)
|
DURECT
CORPORATION
|
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
|
December 31,
2016
|
|
December 31,
2015(1)
|
|
|
|
(unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
5,404
|
|
$
3,583
|
|
Short-term investments
|
|
19,600
|
|
25,457
|
|
Accounts receivable
|
|
1,154
|
|
2,222
|
|
Inventories
|
|
3,782
|
|
3,917
|
|
Prepaid expenses and other current assets
|
|
2,486
|
|
3,142
|
|
Total current
assets
|
|
32,426
|
|
38,321
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
1,297
|
|
1,566
|
|
Goodwill
|
|
6,399
|
|
6,399
|
|
Long-term restricted
Investments
|
|
150
|
|
250
|
|
Other long-term
assets
|
|
236
|
|
236
|
|
Total
assets
|
|
$
40,508
|
|
$
46,772
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
2,086
|
|
$
1,286
|
|
Accrued liabilities
|
|
5,060
|
|
4,970
|
|
Contract research liability
|
|
783
|
|
575
|
|
Deferred revenue, current portion
|
|
968
|
|
616
|
|
Term loan, current portion, net
|
|
19,853
|
|
-
|
|
Total current
liabilities
|
|
28,750
|
|
7,447
|
|
|
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
|
1,879
|
|
2,269
|
|
Term loan, noncurrent
portion, net
|
|
-
|
|
19,684
|
|
Other long-term
liabilities
|
|
1,541
|
|
2,489
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
8,338
|
|
14,883
|
|
Total liabilities and
stockholders' equity
|
|
$
40,508
|
|
$
46,772
|
|
|
|
|
|
|
|
(1) Derived
from audited financial statements.
|
|
|
|
|
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SOURCE DURECT Corporation