CUPERTINO, Calif., Nov. 4, 2019 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced financial results for the three
months ended September 30, 2019 and
provided a corporate update.
- Total revenues were $10.8 million
and net loss was $2.0 million for the
three months ended September 30, 2019
as compared to total revenues of $8.0
million and net loss of $2.7
million for the three months ended September 30, 2018.
- At September 30, 2019, cash and
investments were $57.1 million,
compared to cash and investments of $34.5
million at December 31, 2018.
In September, DURECT earned a $10
million milestone under its agreement with Gilead; payment
of the milestone was received in October and is therefore not
reflected in the cash and investments figure as of September 30, 2019. Debt at September 30, 2019 was $21.0 million, which included partial accrual for
the final payment of our term loan.
"Recent progress continues on both our proprietary and partnered
clinical development programs, led by the completion of the DUR-928
Phase 2a alcoholic hepatitis study. The strength of the data from
this study is underscored by its selection as an oral late-breaking
presentation and for inclusion in the 'Best of The Liver Meeting'
summary slide deck at the upcoming Liver Meeting® 2019,"
stated James E. Brown, D.V.M.,
President and CEO of DURECT. "In addition, we completed
enrollment in the DUR-928 psoriasis trial and passed the half way
point for enrollment in the DUR-928 NASH trial. In September we
earned a $10 million development
milestone under our exclusive license agreement with Gilead for a
long-acting injectable HIV investigational product utilizing
DURECT's SABER® technology."
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 alcoholic hepatitis
(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)
- We completed the Phase 2a clinical trial of DUR-928 in patients
with alcoholic hepatitis (AH). The final enrollment for the trial
consists of 12 severe patients (Model for End-Stage Liver Disease
(MELD) 21-30) and 7 moderate patients (MELD 11-20) for a total of
19 AH patients. After being discharged on day 2, one patient did
not return for the scheduled day 7 and day 28 follow up visits;
therefore Lille, bilirubin and
MELD data reported below are based on 18 patients. Patients treated
with DUR-928 had statistically significant reductions from baseline
in bilirubin (day 7 and 28) and MELD (day 28), as well as
statistically significantly lower Lille scores, compared with a historical
control group (n=15) from a University of
Louisville (UL) AH study[1].
All 19 patients treated with DUR-928 survived the 28-day follow-up
period.
- The study results have been selected for an oral presentation
as part of the late-breaking session of The Liver
Meeting® 2019. Additionally, the results have been
selected for inclusion in the 'Best of The Liver Meeting' summary
slide deck in the alcohol-related liver disease category.
- Tarek Hassanein, M.D., one of
the trial's principal investigators, will deliver the oral
late-breaking presentation detailing trial results.
Oral Late-Breaking
Presentation Details:
|
|
Title:
|
Safety and Efficacy
of DUR-928: A Potential New Therapy for Acute
Alcoholic Hepatitis
|
Date:
|
Tuesday, November 12,
2019
|
Time:
|
8:30 a.m. Eastern
Time
|
Location:
|
Auditorium, Hynes
Convention Center
|
Session
Title:
|
Late-Breaking
Abstract Oral Session II
|
Presentation
Type:
|
Oral, Late-Breaking
Session
|
Publication
Number:
|
LO9
|
- In a separate poster presentation, Craig McClain, M.D., will present additional
comparative data from the Phase 2a clinical trial of DUR-928 and a
control group from a contemporaneous AH trial conducted at
University of Louisville.
Poster
Presentation Details:
|
|
Title:
|
DUR-928 Therapy of
Acute Alcoholic Hepatitis: A Pilot Study
|
Date:
|
Sunday, November 10,
2019
|
Time:
|
12:00 – 2:00 p.m.
Eastern Time
|
Presentation
Type:
|
Poster
Presentation
|
Location:
|
Hynes Convention
Center, Hall B
|
Publication
Number:
|
1376
|
- Lille scores are used in
clinical practice to help determine the prognosis and response for
AH patients after 7 days of treatment. The lower the Lille score, the better the prognosis is for
the AH patient. Patients with a Lille score below 0.45 have a 6-month survival
rate of 85% vs. those with Lille
scores of above 0.45, who have only a 25% 6-month survival rate
(Louvet A et al. Hepatology 2007; 45: 1348-54). In our study, the
median Lille score for the AH
patients treated with DUR-928 was 0.10. 89% (16/18) had a
Lille score below 0.45. The median
Lille score among the UL cohort of
15 patients treated with either supportive care or supportive care
with corticosteroids was 0.41, with 53% (8/15) having a
Lille score below 0.45.
- DUR-928 was well tolerated in all patients, with no
drug-related serious adverse events reported at any dose level.
Drug exposures were dose proportional and were not affected by the
severity of the disease.
- About the AH trial: Patients with moderate and severe AH were
treated with intravenously administered DUR-928 in this open label,
dose escalation multi-center U.S., Phase 2a clinical trial. Final
enrollment was 19 patients comprised of: 8 patients (4 moderate and
4 severe) dosed at 30 mg, 7 patients (3 moderate and 4 severe)
dosed at 90 mg and 4 patients (4 severe) dosed at 150 mg. The
objectives of this study included assessment of safety, PK and
pharmacodynamic (PD) signals, including liver biochemistry,
biomarkers, and prognostic scores, including the Lille score, following DUR-928 treatment.
- 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 (Journal of Hepatology 2019, vol. 70; 314-318). 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 (PLOS ONE |
https://doi.org/10.1371/journal.pone.0192393, February 14, 2018). 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 (Alcohol
2018:71:57-63). ALD is one of the leading causes of liver
transplants in the US, each of which cost over $800,000.
Non-Alcoholic Steatohepatitis (NASH)
- We have enrolled over half of the expected 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
(targeting 15 evaluable) for a total of approximately 60 patients
in the trial.
- Key endpoints include safety, PK, and signals of biological
activities, including clinical chemistry and biomarkers as well as
liver fat content by imaging.
- We expect to complete the study in the first half of 2020 and
announce top-line study results following completion of the
trial.
Psoriasis
- We have completed enrollment in 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. Over twenty
patients have been enrolled with the goal of obtaining
approximately 15 evaluable patients. Each patient serves as their
own control, applying DUR-928 to the plaque on one arm and the
vehicle (placebo) 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 the vehicle-treated plaques.
- We expect to announce top line data from this study by the end
of 2019.
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.
- In July 2019, the FDA agreed to
file the submitted response to the Complete Response Letter (CRL)
as a complete Class 2 Resubmission and initially assigned a user
fee goal date of December 27, 2019.
The FDA subsequently has tentatively scheduled an Advisory
Committee meeting for January 16,
2020; a new user fee goal date has not been assigned.
- The effort to evaluate the program, develop a strategy for
filing the response, and preparing 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. Dr. Simon is also leading our
preparation efforts for the Advisory Committee meeting.
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. In
September 2019, we earned the first
$10 million milestone payment under
this program, which was received in the fourth quarter of 2019.
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.
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 third quarter 2019 results and provide a corporate
update:
Toll Free:
|
877-407-0784
|
International:
|
201-689-8560
|
Conference
ID:
|
13695661
|
Webcast:
|
http://public.viavid.com/index.php?id=136610
|
A live audio webcast of the presentation will also be 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 AH and acute kidney injury (AKI),
chronic hepatic diseases such as 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, and a long-acting injectable SABER-based HIV
investigational product being developed with Gilead. For more
information about DURECT, please visit www.durect.com.
NOTE: POSIMIR® and SABER® 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 AH, hepatic and renal diseases
such as NASH and AKI, and inflammatory skin conditions such as
psoriasis and atopic dermatitis, the potential use of POSIMIR to
treat post-operative pain, planned clinical trial announcements for
the Phase 2a trial of DUR-928 in psoriasis in 2019 or for the Phase
1b trial in patients with NASH
following anticipated trial completion in 2020, 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 risk of delays in clinical
trials or adverse safety events from patients administered with
DUR-928, the risk that the ongoing clinical trials of DUR-928 in
NASH or psoriasis do not successfully achieve their endpoints, the
risk that placebo controlled studies of DUR-928 required for
regulatory approval will not replicate results from open
label clinical trials or trials with small numbers of patients or
historical controls, the risks that the long-acting injectable
SABER-based HIV investigational product being developed with Gilead
will not succeed or that Gilead will abandon this program, the risk
that the FDA Advisory Committee will not recommend approval of
POSIMIR or that the FDA will not approve POSIMIR, and the risk of
delays and costs due to additional work or other requirements
imposed by regulatory agencies for continued development, approval
or sale of any of our product candidates. Further information
regarding these and other risks related to DURECT is included in
DURECT's Form 10-Q filed on August 2,
2019 under the heading "Risk Factors" and in subsequent
reports that we file with the Securities and Exchange
Commission.
|
|
|
|
1 Our
advisor, Dr. Craig McClain from the University of Louisville (UL),
shared anonymized data from his study, in which 15 AH patients with
initial MELD scores ranging from 15-30 received either supportive
care alone (n=8) or supportive care with corticosteroids
(n=7).
|
DURECT
CORPORATION
|
CONDENSED STATEMENTS
OF COMPREHENSIVE LOSS
|
(in thousands, except
per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
September
30
|
|
September
30
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
$
7,741
|
|
$
5,691
|
|
$ 10,880
|
|
$
7,432
|
Product revenue,
net
|
3,022
|
|
2,345
|
|
7,999
|
|
7,505
|
|
Total
revenues
|
10,763
|
|
8,036
|
|
18,879
|
|
14,937
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
731
|
|
912
|
|
2,746
|
|
3,170
|
|
Research and
development
|
7,906
|
|
6,542
|
|
20,755
|
|
19,614
|
|
Selling, general and
administrative
|
3,837
|
|
2,870
|
|
10,569
|
|
8,880
|
Total operating
expenses
|
12,474
|
|
10,324
|
|
34,070
|
|
31,664
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(1,711)
|
|
(2,288)
|
|
(15,191)
|
|
(16,727)
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest and other
income
|
350
|
|
234
|
|
736
|
|
632
|
|
Interest and other
expense
|
(629)
|
|
(661)
|
|
(1,892)
|
|
(1,928)
|
Net other
expense
|
(279)
|
|
(427)
|
|
(1,156)
|
|
(1,296)
|
|
|
|
|
|
|
|
|
|
Net loss
|
$ (1,990)
|
|
$ (2,715)
|
|
$(16,347)
|
|
$(18,023)
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
Basic
|
$
(0.01)
|
|
$
(0.02)
|
|
$
(0.09)
|
|
$
(0.11)
|
|
Diluted
|
$
(0.01)
|
|
$
(0.02)
|
|
$
(0.09)
|
|
$
(0.11)
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss per share
|
|
|
|
|
|
|
|
|
Basic
|
192,039
|
|
162,002
|
|
172,939
|
|
159,091
|
|
Diluted
|
192,039
|
|
162,002
|
|
172,939
|
|
159,091
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
$ (1,981)
|
|
$ (2,715)
|
|
$(16,345)
|
|
$(18,022)
|
DURECT
CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
|
|
|
|
|
As of
|
|
As of
|
|
September 30,
2019
|
|
December 31,
2018(1)
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash equivalents
|
$
39,726
|
|
$
31,644
|
Short-term investments
|
17,235
|
|
2,671
|
Accounts receivable
|
12,193
|
|
1,757
|
Inventories, net
|
3,618
|
|
3,421
|
Prepaid expenses and other current assets
|
970
|
|
2,247
|
Total current
assets
|
73,742
|
|
41,740
|
|
|
|
|
Property and
equipment, net
|
462
|
|
605
|
Operating lease
right-of-use assets
|
6,397
|
|
-
|
Goodwill
|
6,399
|
|
6,399
|
Long-term restricted
Investments
|
150
|
|
150
|
Other long-term
assets
|
1,107
|
|
1,105
|
Total
assets
|
$
88,257
|
|
$
49,999
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable
|
$
1,501
|
|
$
1,589
|
Accrued liabilities
|
4,512
|
|
4,668
|
Contract research liability
|
2,089
|
|
1,405
|
Deferred revenue, current portion
|
27,582
|
|
-
|
Term loan, current portion, net
|
2,981
|
|
-
|
Operating lease liabilities, current portion
|
2,028
|
|
-
|
Total current
liabilities
|
40,693
|
|
7,662
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
2,033
|
|
812
|
Operating lease
liabilities, noncurrent portion
|
4,836
|
|
-
|
Term loan, noncurrent
portion, net
|
17,970
|
|
20,533
|
Other long-term
liabilities
|
719
|
|
992
|
|
|
|
|
Stockholders'
equity
|
22,006
|
|
20,000
|
Total liabilities and
stockholders' equity
|
$
88,257
|
|
$
49,999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Derived
from audited financial statements.
|
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SOURCE DURECT Corporation