CUPERTINO,
Calif., March 3, 2020
/PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced
financial results for the three months and year ended December 31, 2019 and provided a corporate
update.
- Total revenues were $10.7
million and net loss was $4.2
million for the three months ended December 31, 2019 as compared to total revenues
of $3.6 million and net loss of
$7.3 million for the three months
ended December 31, 2018.
- Total revenues were $29.6
million and net loss was $20.6
million for the year ended December
31, 2019, compared to total revenues of $18.6 million and net loss of $25.3 million for the year ended December 31, 2018.
- At December 31, 2019, cash
and investments were $64.8 million,
compared to cash and investments of $34.5
million at December 31,
2018. Debt at December
31, 2019 was $20.3 million,
compared to $20.5 million at
December 31, 2018.
"The highlight of the year for DURECT in 2019 was achieving
positive results from our DUR-928 Phase 2a alcoholic hepatitis (AH)
study, which were featured in multiple presentations at the Liver
Meeting® 2019, including a late-breaking oral
presentation by Dr. Tarek
Hassanein," stated James E.
Brown, D.V.M., President and CEO of DURECT. "In addition, we
have already exceeded our 60 patient enrollment target in the
ongoing NASH trial, and the last patient is scheduled to begin the
28-day dosing period next week. We are on track to announce
top-line NASH data mid-year. We are also making steady progress
toward starting a Phase 2b AH
clinical trial by mid-year. In January
2020, the FDA held an Advisory Committee meeting to discuss
our POSIMIR NDA resubmission. Subsequently, we have continued to
interact with FDA as they continue their review."
Potential major milestones in 2020:
- Initiation of Phase 2b trial of
DUR-928 in AH: mid-year
- Reporting top-line data from the DUR-928 one-month daily dose
trial in NASH: mid-year
- POSIMIR® FDA decision
- Commercial partnership if POSIMIR is approved
- New license and collaboration agreements
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, orally bioavailable, first-in-class small molecule,
which may have broad applicability in acute organ injuries such as
AH, and in chronic liver diseases such as non-alcoholic
steatohepatitis (NASH).
Clinical Trials
Alcoholic Hepatitis
(AH)
- During 2019, we completed a Phase 2a clinical trial of DUR-928
in patients with AH. The study results were presented as a
late-breaking oral presentation at The Liver Meeting®
2019 by Dr. Tarek Hassanein, one of
the trial's principal investigators. In a separate poster
presentation, Dr. Craig McClain
presented additional comparative data from the Phase 2a clinical
trial of DUR-928 and a control group of severe AH patients treated
with corticosteroids in a contemporaneous AH trial conducted at
University of Louisville. Additionally,
the DUR-928 results were selected for inclusion in the "Best of The
Liver Meeting" summary slide deck in the Alcohol-related Liver
Disease category. Inclusion in this slide deck is considered a
singular honor and indicates the high level with which the AASLD
review committee regarded this study.
- All 19 patients treated with DUR-928 in the AH trial survived
the 28-day follow-up period and there were no drug-related serious
adverse events. Patients treated with DUR-928 had a statistically
significant reduction from baseline in bilirubin at days 7 and 28,
and model of end-stage liver disease (MELD) at day 28. Lille scores were also statistically
significantly lower than those from a well-matched group of
patients in a contemporary trial as well as from several published
comparable historical control groups. Seventy four percent of all
DUR-928 treated patients and 67% of those with severe AH were
discharged from the hospital within four days of receiving a single
dose of DUR-928.
- DUR-928 AH Phase 2a trial design: The open-label, dose
escalation, multi-center study was designed to determine the
safety, pharmacokinetics and pharmacodynamic signals of DUR-928 in
AH patients following treatment. This included assessing liver
biochemistry, biomarkers, and prognostic scores such as the
Lille score. Final enrollment
included 19 patients with moderate and severe AH, who were
administered DUR-928 intravenously at three different doses. Eight
patients (four moderate and four severe) were dosed at 30 mg, seven
patients (three moderate and four severe) were dosed at 90 mg and
four patients (all severe) were dosed at 150 mg. After being
discharged on day two, one patient did not return for the scheduled
day 7 and day 28 follow-up visits (this patient did survive through
day 28); therefore Lille,
bilirubin and MELD data reported above are based on 18
patients.
- AH is an acute form of alcoholic liver disease (ALD) associated
with long-term heavy intake of alcohol, and often occurs after a
recent period of increased alcohol consumption. AH is typically
characterized by recent onset jaundice and hepatic failure. An
analysis of 77 studies published between 1971 and 2016, which
included data from a total of 8,184 patients, showed the overall
mortality from AH was 26% at 28 days. According to the most recent
data provided by the Agency for Healthcare Research and Quality
(AHRQ), a part of the US Department of Health and Human Services
(HHS), there were over 117,000 hospitalizations for patients with
alcoholic hepatitis in 2016. From a recent publication analyzing
the mortality and costs associated with alcoholic hepatitis, the
cost per patient is estimated at over $50,000 in the first year. ALD is one of the
leading causes of liver transplants in the U.S., costing over
$800,000 per patient.
- We are working with the FDA and our advisors to finalize the
design of a multi-center, international, randomized, double blind,
placebo-controlled Phase 2b clinical
trial of DUR-928 in AH patients. We are planning to initiate the
trial in mid-2020. Based on our current working assumptions related
to trial design, number of clinical trial sites and enrollment
rates, top-line data for this trial may be available in 2022.
Non-Alcoholic
Steatohepatitis (NASH)
- We have exceeded our 60 patient enrollment target in the
ongoing NASH trial, and the last patient is scheduled to begin the
28-day dosing period next week. The trial is a Phase 1b randomized and open-label clinical study being
conducted in the U.S. to evaluate safety, pharmacokinetics and
signals of biological activity (including clinical chemistry and
biomarkers as well as liver fat content and liver stiffness by MRI
and ultrasonic imaging, respectively) 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 or more patients per dose group for a total of
over 60 patients in the trial.
- We expect all patients to complete their dosing and follow up
visits in the first half of 2020 and expect to announce top-line
study results mid-year.
- 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 approximately 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 3-5% globally. No drug is currently
approved for NAFLD or NASH.
Psoriasis
- In January 2020, we
announced the results from a Phase 2a clinical trial of DUR-928 in
patients with mild to moderate plaque psoriasis. Twenty-two
patients completed the study, applying DUR-928 topically to the
plaque on one arm and the vehicle (placebo) to a similar plaque on
the other arm daily for 28 days. DUR-928 did not demonstrate a
benefit over vehicle (placebo) based on Investigator's Global
Assessment (IGA), or in any of the secondary analyses, including
Local Psoriasis Severity Index (LPSI). However, at the end
of the 4-week daily application period, plaques in both the DUR-928
and vehicle treatment groups were significantly improved over
baseline with respect to both IGA and LPSI scores. In fact, 90% of
plaques in both groups had at least a 1 point reduction in LPSI
score after the 4-week daily application period as compared to
baseline. Daily topical application of DUR-928 was well
tolerated with no meaningful differences in adverse events between
the treatment and vehicle (placebo) groups. Based on the top-line
data, we do not plan to continue development of topical DUR-928 in
psoriasis at this time and will focus our near- term development
activities on AH and NASH.
POSIMIR® (bupivacaine extended-release solution)
Post-Operative Pain Relief Depot. POSIMIR is the Company's
investigational post-operative pain relief depot that uses the
Company's 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 response to the CRL in June
2019. The FDA initially assigned a user fee goal date of
December 27, 2019, but subsequently
scheduled a meeting of the Anesthetic and Analgesic Drug Products
Advisory Committee (AADPAC) for January 16,
2020; a new user fee goal date has not been assigned. At the
meeting, six Advisory Committee members voted to recommend that the
efficacy, safety, and overall risk-benefit profile of POSIMIR
support approval, while six did not recommend approval based on the
information presented. Although the FDA considers the
recommendations of the Advisory Committee, the recommendations by
the panel are non-binding.
- Since the Advisory Committee meeting, we have continued to
interact with the FDA as they continue their review.
- The efforts to evaluate the program, develop a strategy for
filing the response, and preparing the response, have been under
the direction of Dr. Lee Simon, who
was formerly the FDA's Division Director of Analgesic,
Anti-inflammatory and Ophthalmologic Drug Products. Dr. Simon also
led our preparation efforts for the Advisory Committee
meeting.
- 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 Collaboration. The investigational
long-acting injectable HIV product using DURECT's SABER technology
under development with Gilead is currently being re-formulated and
will undergo additional pre-clinical development work.
Debt Amendment. In December
2019, the Company amended its existing $20 million term loan with Oxford Finance such
that principal payments will commence 18 months later than
previously scheduled (i.e., commencing December 1, 2021 rather than June 1, 2020) and the final maturity date has
been moved back by 18 months (i.e., from November 1, 2022 to May 1,
2024). The interest rate and final payment remain unchanged,
and the Company paid Oxford Finance an amendment fee of
$825,000.
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 fourth quarter
2019 results and provide a corporate update:
Toll Free:
|
877-407-0784
|
International:
|
201-689-8560
|
Conference
ID:
|
13698601
|
Webcast:
|
http://public.viavid.com/index.php?id=137885
|
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 committed to transforming
the treatment of acute organ injury and chronic liver diseases by
advancing novel and potentially lifesaving therapies based on its
endogenous epigenetic regulator program. DURECT's lead candidate,
DUR-928, has demonstrated the ability to regulate the expression of
genes involved in lipid metabolism, inflammatory responses and cell
survival. This drug candidate is currently in Phase 2 development
for the treatment of alcoholic hepatitis (AH) and Phase 1
development for the treatment of nonalcoholic steatohepatitis
(NASH). DURECT's proprietary drug delivery technologies are
designed to enable new indications and enhanced attributes for
small-molecule and biologic drugs. A key product candidate in this
category is POSIMIR® (bupivacaine extended-release
solution), an investigational locally-acting, non-opioid analgesic
intended to provide up to three days of continuous pain relief
after surgery. DURECT has also entered into an agreement with
Gilead Sciences to develop and commercialize a long-acting
injectable HIV investigational product using DURECT's
SABER® technology. For more information about DURECT, please
visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding clinical
development and plans for DUR-928, including plans to announce
top-line data from the Phase 1b NASH
trial by mid-year, and initiate a Phase 2b trial of DUR-928 in AH by mid-year, potential
regulatory approval of POSIMIR, potential commercial relationships
for POSIMIR if approved or other license and collaboration
agreements, and the potential benefits and uses of our drug
candidates, including the potential use of DUR-928 to treat
acute organ injuries such as AH and chronic liver diseases
such as NASH , 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 are
not started when anticipated, take longer to conduct than
anticipated, do not replicate the results from earlier clinical or
pre-clinical trials, or do not demonstrate the safety or efficacy
of DUR-928 in a statistically significant manner, the
risk that the FDA will not approve POSIMIR, the risk
that additional time and resources may be required for development,
testing and regulatory approval of DUR-928 or POSIMIR, potential
adverse effects arising from the testing or use of our drug
candidates, our potential failure to successfully re-formulate
the investigational long-acting injectable HIV product
under development with Gilead, 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 5, 2019 under the heading "Risk
Factors."
NOTE: POSIMIR® and SABER® are
trademarks of DURECT Corporation. Other referenced trademarks
belong to their respective owners. DUR-928 and POSIMIR are
investigational drug candidates under development and have not been
approved for commercialization by the U.S. Food and Drug
Administration or other health authorities for any indication.
DURECT
CORPORATION
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(in thousands,
except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Twelve months
ended
|
|
|
|
December
31
|
|
December
31
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
|
$
7,249
|
|
$
775
|
|
$ 18,129
|
|
$
8,207
|
Product revenue,
net
|
|
3,436
|
|
2,852
|
|
11,435
|
|
10,357
|
|
Total
revenues
|
|
10,685
|
|
3,627
|
|
29,564
|
|
18,564
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
|
1,397
|
|
1,093
|
|
4,143
|
|
4,263
|
|
Research and
development
|
|
9,454
|
|
5,887
|
|
30,209
|
|
25,501
|
|
Selling, general and
administrative
|
|
3,794
|
|
3,539
|
|
14,363
|
|
12,419
|
Total operating
expenses
|
|
14,645
|
|
10,519
|
|
48,715
|
|
42,183
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(3,960)
|
|
(6,892)
|
|
(19,151)
|
|
(23,619)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest and other
income
|
|
338
|
|
238
|
|
1,074
|
|
870
|
|
Interest and other
expense
|
|
(609)
|
|
(645)
|
|
(2,501)
|
|
(2,573)
|
Net other
expense
|
|
(271)
|
|
(407)
|
|
(1,427)
|
|
(1,703)
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ (4,231)
|
|
$ (7,299)
|
|
$(20,578)
|
|
$(25,322)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
Basic
|
|
$
(0.02)
|
|
$
(0.05)
|
|
$
(0.12)
|
|
$
(0.16)
|
|
Diluted
|
|
$
(0.02)
|
|
$
(0.05)
|
|
$
(0.12)
|
|
$
(0.16)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share
|
|
|
|
|
|
|
|
|
|
Basic
|
|
193,181
|
|
162,040
|
|
178,042
|
|
159,834
|
|
Diluted
|
|
193,181
|
|
162,040
|
|
178,042
|
|
159,834
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
$ (4,236)
|
|
$ (7,299)
|
|
$(20,581)
|
|
$(25,321)
|
DURECT
CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
December 31,
2019
|
|
December 31,
2018(1)
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
34,924
|
|
$
31,644
|
Short-term investments
|
|
29,750
|
|
2,671
|
Accounts receivable
|
|
2,313
|
|
1,757
|
Inventories, net
|
|
3,383
|
|
3,421
|
Prepaid expenses and other current assets
|
|
1,459
|
|
2,247
|
Total current
assets
|
|
71,829
|
|
41,740
|
|
|
|
|
|
Property and
equipment, net
|
|
469
|
|
605
|
Operating lease
right-of-use assets
|
|
6,066
|
|
-
|
Goodwill
|
|
6,399
|
|
6,399
|
Long-term restricted
Investments
|
|
150
|
|
150
|
Other long-term
assets
|
|
1,107
|
|
1,105
|
Total
assets
|
|
$
86,020
|
|
$
49,999
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
|
$
2,109
|
|
$
1,589
|
Accrued liabilities
|
|
6,284
|
|
4,668
|
Contract research liability
|
|
3,653
|
|
1,405
|
Deferred revenue, current portion
|
|
22,679
|
|
-
|
Operating lease liabilities, current portion
|
|
2,043
|
|
-
|
Total current
liabilities
|
|
36,768
|
|
7,662
|
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
|
812
|
|
812
|
Operating lease
liabilities, noncurrent portion
|
|
4,517
|
|
-
|
Term loan, noncurrent
portion, net
|
|
20,262
|
|
20,533
|
Other long-term
liabilities
|
|
801
|
|
992
|
|
|
|
|
|
Stockholders'
equity
|
|
22,860
|
|
20,000
|
Total liabilities and
stockholders' equity
|
|
$
86,020
|
|
$
49,999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Derived
from audited financial statements.
|
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SOURCE DURECT Corporation