CUPERTINO, Calif., Aug. 1, 2019 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced financial results for the three
months ended June 30, 2019 and
provided a corporate update.
- Total revenues were $4.0 million
and net loss was $7.2 million for the
three months ended June 30, 2019 as
compared to total revenues of $3.4
million and net loss of $7.0
million for the three months ended June 30, 2018.
- At June 30, 2019, cash and
investments were $38.1 million,
compared to cash and investments of $34.5
million at December 31, 2018.
Subsequent to the end of the quarter, in July DURECT received
a $25 million payment from Gilead
relating to an exclusive license agreement for DURECT's
SABER® technology. Debt at June 30, 2019 was $20.8
million, which included partial accrual for the final
payment of our term loan.
"The second quarter was very productive, with multiple important
milestones achieved, including announcing compelling preliminary
data from the first 10 alcoholic hepatitis (AH) patients,
announcing that the preliminary data from the completed 90 mg
severe cohort was consistent with the first 10 patients, and
proceeding to the 150 mg severe cohort in the ongoing DUR-928
alcoholic hepatitis trial," stated James E.
Brown, D.V.M., President and CEO of DURECT. "We
also successfully submitted a full response to the
POSIMIR® CRL seeking FDA approval, and received a user
fee goal date for FDA response of December
27, 2019. In addition, in July we executed an
exclusive license agreement with Gilead for a long-acting
injectable HIV investigational product utilizing DURECT's
SABER® technology, entailing an upfront fee of
$25 million, up to $145 million in additional milestone payments
plus royalties and an exclusive option to license additional
SABER-based products directed to HIV and HBV for an additional
$150 million per product in upfront
and milestones plus royalties."
Update on Selected Programs and Transactions:
Epigenetic Regulator Program. DUR-928, the lead product
candidate in the Company's Epigenetic Regulator Program, is an
endogenous, first-in-class small molecule, which may have broad
applicability in acute organ injuries such as AH and acute kidney
injury (AKI), in chronic liver diseases such as non-alcoholic
steatohepatitis (NASH), and in inflammatory skin disorders such as
psoriasis and atopic dermatitis.
Clinical Trials
Alcoholic Hepatitis (AH)
- As reported on May 7 and 8, 2019
through a press release and key opinion leader conference call,
preliminary clinical data from the first 10 AH patients dosed with
DUR-928 demonstrated statistically significant reductions from
baseline of serum bilirubin levels and MELD scores. Additionally,
Lille scores in patients treated
with DUR-928 were statistically lower than historical controls.
DUR-928 was well tolerated and PK parameters were not affected by
the severity of the disease.
- In June, we completed dosing the 90 mg cohort (n=4) in severe
AH patients and, following approval by the Dose Escalation
Committee (DEC), initiated dosing for the 150 mg cohort in severe
AH patients. Preliminary data from the 90 mg severe cohort was
consistent with the first 10 patients.
- We are now enrolling moderate AH patients in the 90 mg cohort
and severe AH patients in the 150 mg cohort.
- About the AH Trial: DURECT is conducting a Phase 2a clinical
trial with intravenously administered DUR-928 in patients with
AH. This is an open label, dose escalation (30, 90 and 150
mg), multi-center U.S. study that includes patients with moderate
and severe AH (as determined by initial MELD score). Dose
escalation requires approval by the Dose Escalation Committee (DEC)
following its review of safety and pharmacokinetic (PK) results
from the prior dose level. The target number of patients for the
study is 4 moderate and 4 severe per dose. The objectives of this
study include assessment of safety, PK and pharmacodynamic (PD)
signals, including liver chemistry, and biomarkers. Additional
information on the trial design, including eligibility criteria and
site locations, can be found at www.clinicaltrials.gov using
the NCT Identifier 03432260.
- In parallel with our ongoing trial, we are supporting Professor
Craig McClain, MD (Chief of Research
Affairs, Division of Gastroenterology, Hepatology and Nutrition,
University of Louisville) in his
efforts to initiate an NIH-funded study of DUR-928 in AH patients
at the University of Louisville.
- AH is a syndrome of progressive inflammatory liver injury
associated with long-term heavy intake of alcohol, and encompasses
a spectrum that ranges from mild injury to severe, life threatening
liver damage. The prevalence of AH is estimated to occur in
10-35% of heavy drinkers. According to an article in the
Journal of Clinical Gastroenterology (2015 July;
49(6):506-511), there were over 320,000 hospitalizations
related to alcoholic hepatitis in the U.S. in 2010, resulting in
hospitalization costs of nearly $50,000 per patient. The cost of a liver
transplant exceeds $800,000.
Non-Alcoholic Steatohepatitis (NASH)
- In March 2019, we began enrolling
patients in a Phase 1b randomized and
open-label clinical study being conducted in the U.S. to evaluate
safety, pharmacokinetics and signals of biological activity of
DUR-928 in NASH patients with stage 1-3 fibrosis.
DUR-928 (at doses of 50 mg QD, 150 mg QD or 300 mg BID) is
administered orally for 28 consecutive days with approximately 20
patients per dose group for a total of approximately 60 patients in
the trial.
- Key endpoints include safety and PK, clinical chemistry and
biomarkers (e.g., bilirubin, lipids, liver enzymes, CK-18s, and
inflammatory cytokines) as well as liver imaging (e.g.,
MRI-PDFF).
- We expect to announce initial data from this study in the
second half of 2019.
- In the Company's previous Phase 1b NASH study, reported at the European
Association for the Study of the Liver (EASL) in April 2017, an exploratory biomarker analysis
demonstrated that a single oral dose of DUR-928 in NASH patients,
at both dose levels tested (50 mg and 200 mg), resulted in
statistically significant reductions from baseline of both
full-length and cleaved cytokeratin-18 (CK-18), bilirubin, hsCRP
and IL-18.
- Non-alcoholic fatty liver disease (NAFLD) is the most common
form of chronic liver disease in both children and adults. It is
estimated that NAFLD affects about 30% to 40% of adults and 10% of
children in the United States.
NASH, a more severe and progressive form of NAFLD, is one of the
most common chronic liver diseases worldwide, with an estimated
prevalence of more than 10% of adults in the United States, Europe, Japan
and other developed countries. No drug is currently approved
for NAFLD or NASH.
Psoriasis
- We are conducting a Phase 2a, randomized, double-blind,
vehicle-controlled proof-of-concept clinical trial, in which
DUR-928 is applied topically once-daily for four weeks in patients
with mild to moderate plaque psoriasis. The trial is being
conducted at multiple clinical sites in the U.S. Twenty
patients are planned to be enrolled to obtain approximately 15
evaluable patients. Patients serve as their own controls, applying
DUR-928 to the plaque on one arm and the vehicle to a similar
plaque on the other arm. After the treatment period, patients are
followed for an additional four weeks. The primary efficacy
endpoint is the change in local psoriasis scores from baseline in
the DUR-928-treated plaques compared to that in the vehicle-treated
plaques. Additional information on the trial design, including
eligibility criteria and site locations, can be found at
www.clinicaltrials.gov using the NCT Identifier
03837743.
- We began enrolling patients in March of 2019 and expect to
announce top line data from this study in the second half of
2019.
- We previously conducted an exploratory Phase 1b trial in psoriasis patients (9 evaluable
patients) in Australia. The trial was randomized,
double-blinded, placebo and self-controlled, using a micro-plaque
assay with intralesional injections of DUR-928. The results
were encouraging and warranted advancing into the current
proof-of-concept trial with topically applied DUR-928. In
support of the Phase 2a study, we have completed multiple
non-clinical safety studies for topically applied
DUR-928.
- Psoriasis is an inflammatory skin disease and an
immune-mediated condition that causes the body to make new skin
cells in days rather than weeks. Psoriasis affects an
estimated 7.5 million Americans. According to the
International Federation of Psoriasis Associations (IFPA), nearly
3% of the world's population, or about 125 million people, has some
form of psoriasis. Psoriasis causes itchiness and irritation and
may be painful. There is no cure, but currently approved treatment
can ease symptoms. Approximately 80% of
patients with psoriasis have
localized disease, which can be
treated with topical therapies. As such,
topical agents remain the mainstay of psoriasis treatment.
POSIMIR® (bupivacaine extended-release
solution) Post-Operative Pain Relief Depot. POSIMIR is our
investigational post-operative pain relief depot that utilizes our
patented SABER® technology and is designed to deliver
bupivacaine to provide up to 3 days of pain relief after
surgery.
- After a comprehensive review of the POSIMIR program in light of
the issues raised by the FDA in our communications with them,
including the Complete Response Letter (CRL), we prepared and
submitted a full response to the CRL in late June 2019 intending to address the issues raised
in the CRL and seeking FDA approval of POSIMIR.
- The FDA has agreed to file the submitted response to the CRL as
a complete Class 2 Resubmission and assigned a user fee goal date
of December 27, 2019.
- The effort to evaluate the program, develop a strategy for
filing the response, and the actual writing of key sections of the
response, has been under the direction of Dr. Lee Simon, who was formerly FDA's Division
Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug
Products.
- We believe that the completed inguinal hernia and subacromial
decompression (shoulder) clinical trials support the efficacy of
POSIMIR in post-operative pain and meet the requirements to be
considered as adequate and well-controlled pivotal clinical trials.
Both trials demonstrated a significant decrease in pain and opioid
use over the 0-72 hour period following surgery as compared to
placebo.
- We have completed 16 clinical trials in the POSIMIR program,
involving over 1,400 patients, over 850 of whom received POSIMIR
with the remainder in control groups. We believe this is a
sufficiently sized safety database. We believe that, with the
PERSIST safety data from over 380 patients included, we now have
sufficient data to address FDA's issues raised in the CRL and that
the data package meets the requirements for FDA
approval.
- POSIMIR has not been approved by the FDA for marketing in the
U.S. for any indication and there can be no assurance that FDA will
approve the planned submission described above.
Gilead Agreement. In July
2019, we entered into an agreement with Gilead Sciences,
Inc. (Gilead) granting Gilead the exclusive worldwide rights to
develop and commercialize a long-acting injectable HIV
investigational product utilizing our SABER technology. Gilead
also received exclusive access to the SABER platform for HIV and
Hepatitis B Virus (HBV) and the exclusive option to license
additional SABER-based products directed to HIV and HBV.
Under the terms of the agreement, Gilead made an upfront payment to
us of $25 million, with the potential
for up to an additional $75 million
in development and regulatory milestones, up to an additional
$70 million in sales based
milestones, as well as tiered royalties on product sales. Gilead
has the exclusive option to license additional SABER-based products
directed to HIV and HBV for an additional $150 million per product in upfront, development,
regulatory and sales based milestones as well as tiered royalties
on sales. The parties will collaborate on specified
development activities with Gilead controlling and funding the
development programs.
Indivior Agreement and PERSERIS™. In
September 2017, we entered into a
patent purchase agreement with an affiliate of Indivior PLC,
whereby we assigned certain of our U.S. patent rights to Indivior.
Under the terms of the agreement, Indivior paid us $12.5 million upfront and a $5 million milestone based on NDA approval of
PERSERIS (risperidone) extended-release injectable suspension for
the treatment of schizophrenia in adults. We also receive quarterly
earn-out payments based on a single digit percentage of U.S. net
sales for certain products covered by the patent rights, including
PERSERIS. The patent rights include granted patents extending into
at least 2026.
- According to its public disclosures, Indivior has stated
that:
-
- The PERSERIS commercial launch took place in the last week of
February 2019 with a field force of
50 representatives.
- As of Indivior's July 31, 2019
update on the first half of 2019:
-
- Net revenue was consistent with Indivior's expectations
- Managed care coverage is over 70% nationally, which is at
parity with established LAIs
- Sales key performance indicators (KPIs) (reach and frequency)
are on target
- Continued positive patient and HCP feedback
- Indivior previously announced a peak annual net revenue goal
for PERSERIS of $200 to $300 million.
- U.S. sales of long acting injectables to treat schizophrenia
were in excess of $3 billion in
2017.
- Full prescribing information for PERSERIS, including BOXED
WARNING, and Medication Guide can be found at
www.perseris.com.
Financing. In June
2019, we raised net proceeds of approximately $15.0 million in a registered offering of the
Company's common stock.
Earnings Conference Call
We will host a
conference call today at 4:30 p.m. Eastern
Time/1:30 p.m. Pacific Time to discuss second quarter
2019 results and provide a corporate update:
Toll Free:
|
877-407-0784
|
International:
|
201-689-8560
|
Conference
ID:
|
13692344
|
Webcast:
|
http://public.viavid.com/index.php?id=135202
|
A live audio webcast of the presentation will be also available
by accessing DURECT's homepage at www.durect.com and clicking
"Investors." If you are unable to participate during the live
webcast, the call will be archived on DURECT's website under "Event
Calendar" in the "Investors" section.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing
therapeutics based on its Epigenetic Regulator Program and
proprietary drug delivery platforms. DUR‑928, a new chemical
entity in Phase 2 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 such as alcoholic hepatitis (AH) and
acute kidney injury (AKI), chronic hepatic diseases such as
nonalcoholic steatohepatitis (NASH), and inflammatory skin
conditions such as psoriasis and atopic dermatitis. DURECT's
advanced oral and injectable delivery technologies are designed to
enable new indications and enhanced attributes for small-molecule
and biologic drugs. Key product candidates in this category
include POSIMIR® (bupivacaine extended-release
solution), an investigational locally-acting, non-opioid analgesic
intended to provide up to 3 days of continuous pain relief after
surgery, a long-acting injectable SABER-based HIV investigational
product being developed with Gilead, and ORADUR™-Methylphenidate ER
Capsules, approved as Methydur Sustained Release Capsules in
Taiwan, where it is indicated for
the treatment of attention deficit hyperactivity disorder
(ADHD). In addition, for the assignment of certain
patent rights, DURECT receives single digit sales-based earn-out
payments from U.S. net sales of Indivior's PERSERIS™
(risperidone) drug for schizophrenia, which was commercially
launched in February 2019. In July
2019 we executed an exclusive license agreement with Gilead
for a long-acting injectable HIV investigational product utilizing
DURECT's SABER® technology, entailing an upfront fee of
$25 million, up to $145 in additional milestone payments plus tiered
royalties and an exclusive option to license additional SABER-based
products directed to HIV and HBV for an additional
$150 million per product in upfront
and milestones plus royalties. For more information about
DURECT, please visit www.durect.com.
NOTE: POSIMIR®, SABER® and
ORADUR™ are trademarks of DURECT Corporation. Other
referenced trademarks belong to their respective owners. DUR-928
and POSIMIR 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
DURECT's drug candidates, including, but not limited to, the
potential use of DUR-928 to treat alcoholic hepatitis, hepatic and
renal diseases such as NASH, and inflammatory skin conditions such
as psoriasis and atopic dermatitis, the potential use of POSIMIR to
treat post-operative pain, the potential of the long-acting
injectable SABER-based investigational product being developed with
Gilead to treat HIV, the potential use of ORADUR-Methylphenidate to
treat ADHD, the potential for sales-based earn-out payments from
the sale of Indivior's PERSERIS to treat schizophrenia, and the
potential development of a long-acting injectable SABER-based HIV
product with Gilead and associated potential payments to DURECT 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 possibility that studies of
DUR-928 will not replicate results from earlier preclinical or
clinical trials, the risks that PERSERIS will not obtain market
acceptance and meaningful sales, as well as possible adverse events
associated with the use of PERSERIS, POSIMIR,
ORADUR-Methylphenidate, the long-acting injectable SABER-based HIV
investigational product being developed with Gilead, and DUR-928,
and delays and costs due to additional work or other requirements
imposed by regulatory agencies for continued development, approval
or sale of POSIMIR, the long-acting injectable SABER-based HIV
investigational product being developed with Gilead,
ORADUR-Methylphenidate and DUR-928. Further information
regarding these and other risks related to DURECT is included in
DURECT's Form 10-Q filed on May 8,
2019 under the heading "Risk Factors."
DURECT
CORPORATION
|
CONDENSED STATEMENTS
OF COMPREHENSIVE LOSS
|
(in thousands, except
per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
June
30
|
|
June
30
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
$
1,639
|
|
$
645
|
|
$
3,139
|
|
$
1,741
|
Product revenue,
net
|
2,346
|
|
2,768
|
|
4,977
|
|
5,160
|
|
Total
revenues
|
3,985
|
|
3,413
|
|
8,116
|
|
6,901
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
879
|
|
1,084
|
|
2,015
|
|
2,258
|
|
Research and
development
|
6,598
|
|
6,120
|
|
12,849
|
|
13,072
|
|
Selling, general and
administrative
|
3,278
|
|
2,816
|
|
6,732
|
|
6,010
|
Total operating
expenses
|
10,755
|
|
10,020
|
|
21,596
|
|
21,340
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(6,770)
|
|
(6,607)
|
|
(13,480)
|
|
(14,439)
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest and other
income
|
177
|
|
240
|
|
386
|
|
398
|
|
Interest and other
expense
|
(634)
|
|
(644)
|
|
(1,263)
|
|
(1,267)
|
Net other
expense
|
(457)
|
|
(404)
|
|
(877)
|
|
(869)
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
(7,227)
|
|
$
(7,011)
|
|
$
(14,357)
|
|
$
(15,308)
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
Basic
|
$
(0.04)
|
|
$
(0.04)
|
|
$
(0.09)
|
|
$
(0.10)
|
|
Diluted
|
$
(0.04)
|
|
$
(0.04)
|
|
$
(0.09)
|
|
$
(0.10)
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share
|
|
|
|
|
|
|
|
|
Basic
|
164,359
|
|
161,621
|
|
163,219
|
|
157,612
|
|
Diluted
|
164,359
|
|
161,621
|
|
163,219
|
|
157,612
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
$
(7,230)
|
|
$
(7,010)
|
|
$
(14,364)
|
|
$
(15,307)
|
|
|
DURECT
CORPORATION
|
|
|
CONDENSED BALANCE
SHEETS
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
June 30,
2019
|
|
December 31,
2018(1)
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
36,943
|
|
$
31,644
|
Short-term investments
|
|
996
|
|
2,671
|
Accounts receivable
|
|
2,142
|
|
1,757
|
Inventories, net
|
|
3,665
|
|
3,421
|
Prepaid expenses and other current assets
|
|
1,336
|
|
2,247
|
Total current
assets
|
|
45,082
|
|
41,740
|
|
|
|
|
|
Property and
equipment, net
|
|
533
|
|
605
|
Operating lease
right-of-use assets
|
|
6,717
|
|
-
|
Goodwill
|
|
6,399
|
|
6,399
|
Long-term restricted
Investments
|
|
150
|
|
150
|
Other long-term
assets
|
|
1,106
|
|
1,105
|
Total
assets
|
|
$
59,987
|
|
$
49,999
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
|
$
2,012
|
|
$
1,589
|
Accrued liabilities
|
|
4,377
|
|
4,668
|
Contract research liability
|
|
1,204
|
|
1,405
|
Term loan, current portion, net
|
|
972
|
|
-
|
Operating lease liabilities, current portion
|
|
2,014
|
|
-
|
Total current
liabilities
|
|
10,579
|
|
7,662
|
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
|
812
|
|
812
|
Operating lease
liabilities, noncurrent portion
|
|
5,143
|
|
-
|
Term loan, noncurrent
portion, net
|
|
19,838
|
|
20,533
|
Other long-term
liabilities
|
|
721
|
|
992
|
|
|
|
|
|
Stockholders'
equity
|
|
22,894
|
|
20,000
|
Total liabilities and
stockholders' equity
|
|
$
59,987
|
|
$
49,999
|
|
|
|
|
|
(1) Derived
from audited financial statements.
|
|
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SOURCE DURECT Corporation