- Webcast of Earnings Call Today,
August 4th at 4:30 p.m. ET
- Enrollment accelerating in the
AHFIRM trial
CUPERTINO, Calif., Aug. 4, 2022
/PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced
financial results for the three months ended June 30, 2022 and provided a corporate
update.
"We continue to see enrollment accelerating in the larsucosterol
(DUR-928) AHFIRM trial and are pleased to announce that we have
enrolled 170 patients to date. The second quarter continued
the recent positive enrollment trend, with more patients dosed than
in any prior quarter, reflecting the opening of additional clinical
trial sites and our ongoing efforts to work with existing sites to
recruit more patients with severe alcohol-associated hepatitis (AH)
that meet our enrollment criteria," stated James E. Brown, D.V.M., President and CEO of
DURECT.
Second Quarter and Recent Business Highlights:
- Continued progress in AHFIRM enrollment – DURECT
has enrolled 170 patients in the AHFIRM trial to date, which
exceeds 50% of the target enrollment for the 300-patient
trial. We now have over 60 AHFIRM study sites open at leading
hospitals in the U.S., Australia,
E.U. and U.K. We continue to expect to enroll the last
patient in the AHFIRM trial in mid-2023, which should enable
top-line results to be reported in the second half of 2023.
- FDA agreement on modified primary endpoint to include liver
transplant in addition to mortality – Through a Type C meeting
with the U.S. Food and Drug Administration (FDA), FDA has concurred
with DURECT's proposal to amend the primary endpoint of the ongoing
AHFIRM trial to be the reduction in mortality or liver transplant
at 90 days. A liver transplant represents a serious and
expensive medical event for patients and we believe that including
transplanted patients as well as mortality in the primary endpoint
better reflects the current state of care for AH
patients.
- Recent Patent Issuance covering POSIMIR – On
August 2, 2022, DURECT was issued a
new patent by the US Patent Office, extending US patent coverage
for POSIMIR to at least 2041. This event triggered an $8 million milestone payment due to DURECT under
our license agreement with Innocoll Pharmaceuticals Limited
(Innocoll). This payment is in addition to the $4 million upfront license fee received in
January 2022, and a $2 million milestone payment to be received upon
the first commercial sale of POSIMIR in the United States.
Financial Highlights for Q2 2022:
- Total revenues were $2.1 million
and net loss was $11.6 million for
the three months ended June 30, 2022
compared to total revenues of $2.3
million and net loss of $9.1
million for the three months ended June 30, 2021.
- At June 30, 2022, cash and
investments were $54.3 million,
compared to cash and investments of $70.0
million at December 31, 2021.
Total debt at June 30, 2022 was
$20.9 million, compared to
$20.6 million at December 31, 2021.
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
2022 results and provide a corporate update:
Thursday, August
4 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific
Time
|
Toll
Free:
|
1-800-285-6670
|
International:
|
713-481-1320
|
Conference
ID:
|
13729654
|
Webcast:
|
https://event.choruscall.com/mediaframe/webcast.html?webcastid=6RVdxB8I
|
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 the AHFIRM Trial
Enrollment is ongoing in our Phase 2b randomized, double-blind, placebo-controlled,
international, multi-center study in subjects with severe acute
alcohol-associated hepatitis (AH) to evaluate saFety
and effIcacy of laRsucosterol (DUR-928)
treatMent (AHFIRM). The study is comprised of three arms
targeting enrollment of 300 total patients, with approximately 100
patients in each arm: (1) Placebo plus supportive care, with or
without methylprednisolone capsules at the investigators'
discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90
mg). Patients in the larsucosterol arms receive the same supportive
care without steroids. In order to maintain blinding,
patients in the two active arms receive matching placebo capsules
if the investigator prescribes steroids. The primary outcome
measure will be the 90-Day incidence of mortality or liver
transplantation for patients treated with larsucosterol compared to
those treated with placebo. The Company is enrolling patients at
more than 60 clinical trial sites across the U.S., EU, U.K., and
Australia. Reflecting the
life-threatening nature of AH and the lack of therapeutic options,
the U.S. Food and Drug Administration (FDA) has granted
larsucosterol Fast Track Designation for the treatment of AH. We
believe a positive outcome in the AHFIRM trial could support a New
Drug Application filing. For more information, refer to
ClinicalTrials.gov Identifier: NCT04563026.
About Alcohol-associated Hepatitis
(AH)
AH is a life-threatening acute alcohol-associated liver disease
(ALD) often caused by chronic heavy alcohol use and a recent period
of increased alcohol consumption (i.e., a binge). It is
characterized by severe inflammation and destruction of liver
tissue (i.e., necrosis), potentially leading to life-threatening
complications including liver failure, acute renal injury and
multi-organ failure. There are no FDA approved therapies for AH and
a retrospective 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, 29% at 90 days
and 44% at 180 days. A subsequent global study published in
December 2021, which included 85
tertiary centers in 11 countries across 3 continents, prospectively
enrolled 2,581 AH patients with a median Model of End-Stage Liver
Disease (MELD) score of 23.5, reported mortality at 28 and 90 days
of 20% and 31%, respectively. Stopping alcohol consumption is not
sufficient for recovery in many moderate (defined as MELD scores of
11-20) and severe (defined as MELD scores >20) patients and the
use of treatments to reduce liver inflammation, such as
corticosteroids, are limited by contraindications and have been
shown to provide no survival benefit at 90 days or 1 year. While
liver transplantation is becoming more common for ALD patients,
including AH patients, the procedure often involves a long waiting
period, a burdensome selection process, costs exceeding
$875,000 on average, and patients
requiring lifelong immunosuppressive therapy to prevent organ
rejection.
About Larsucosterol
(DUR-928)
Larsucosterol is an endogenous sulfated oxysterol and an
epigenetic regulator. Epigenetic regulators are compounds that
regulate patterns of gene expression without modifying the DNA
sequence. DNA hypermethylation, an example of epigenetic
dysregulation, results in transcriptomic reprogramming and cellular
dysfunction, and has been found to be associated with many acute
(e.g., AH) or chronic diseases (e.g., NASH). As an inhibitor of DNA
methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation,
which subsequently regulates expression of genes that are involved
in cell signaling pathways associated with stress responses, cell
death and survival, and lipid biosynthesis. This may ultimately
lead to improved cell survival, reduced inflammation, and decreased
lipotoxicity. As an epigenetic regulator, the proposed mechanism of
action provides further scientific rationale for developing
larsucosterol for the treatment of acute organ injury and certain
chronic diseases.
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. Larsucosterol
(also known as DUR-928), DURECT's lead drug candidate, binds to and
inhibits the activity of DNA methyltransferases (DNMTs), epigenetic
enzymes which are elevated and associated with hypermethylation
found in alcohol-associated hepatitis (AH) patients. Larsucosterol
is in clinical development for the potential treatment of AH, for
which FDA has granted a Fast Track Designation; non-alcoholic
steatohepatitis (NASH) is also being explored. In addition,
POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid
analgesic utilizing the innovative SABER® platform technology, is
FDA-approved and has been exclusively licensed to Innocoll
Pharmaceuticals for development and commercialization in
the United States. For more
information about DURECT, please visit www.durect.com and
follow us on Twitter https://twitter.com/DURECTCorp.
DURECT Forward-Looking
Statements
This press release contains forward-looking statements,
including statements made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995, relating to:
our plans to complete enrollment of the AHFIRM trial in mid-2023
and report top-line results in the second half of 2023, the
expected commercial launch of POSIMIR by Innocoll and potential
future payments we may receive from Innocoll, the potential to
develop larsucosterol for NASH or other indications, and the
potential benefits, if any, of our product candidates. Actual
results may differ materially from those contained in the
forward-looking statements contained in this press release, and
reported results should not be considered as an indication of
future performance. The potential risks and uncertainties that
could cause actual results to differ from those projected include,
among other things, the risks that the AHFIRM trial takes longer to
conduct than anticipated due to COVID-19 or other factors, the risk
that ongoing and future clinical trials of larsucosterol do
not confirm the results from earlier clinical or pre-clinical
trials, or do not demonstrate the safety or efficacy of
larsucosterol in a statistically significant manner, risks
that Innocoll may not commercialize POSIMIR successfully, if at
all, 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 most recent Securities and
Exchange Commission (SEC) filings, including its annual report on
Form 10-K for the year ended December 31,
2021 and quarterly report on Form 10-Q for the quarter ended
June 30, 2022 when filed with the SEC
under the heading "Risk Factors." These reports are available
on our website www.durect.com under the "Investors" tab and on the
SEC's website at www.sec.gov. All information provided in this
press release and in the attachments is based on information
available to DURECT as of the date hereof, and DURECT assumes no
obligation to update this information as a result of future events
or developments, except as required by law.
NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals, Ltd.
in the U.S. and a trademark of DURECT Corporation outside of the
U.S. SABER® is a trademark of DURECT Corporation. Other
referenced trademarks belong to their respective
owners. Larsucosterol (DUR-928) is an investigational drug
candidate under development and has 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
|
|
Six months
ended
|
|
|
|
June
30
|
|
June
30
|
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
|
|
|
Collaborative research
and development and other revenue
|
$
606
|
|
$
735
|
|
$ 1,101
|
|
$ 1,309
|
Product revenue,
net
|
1,470
|
|
1,568
|
|
2,890
|
|
3,206
|
|
Total
revenues
|
2,076
|
|
2,303
|
|
3,991
|
|
4,515
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
393
|
|
359
|
|
728
|
|
711
|
|
Research and
development
|
8,817
|
|
7,433
|
|
17,028
|
|
15,408
|
|
Selling, general and
administrative
|
3,952
|
|
3,168
|
|
7,687
|
|
6,699
|
Total operating
expenses
|
13,162
|
|
10,960
|
|
25,443
|
|
22,818
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(11,086)
|
|
(8,657)
|
|
(21,452)
|
|
(18,303)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest and other
income
|
127
|
|
39
|
|
181
|
|
76
|
|
Interest and other
expense
|
(592)
|
|
(528)
|
|
(1,122)
|
|
(1,053)
|
Net other
expense
|
(465)
|
|
(489)
|
|
(941)
|
|
(977)
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(11,551)
|
|
$ (9,146)
|
|
$
(22,393)
|
|
$
(19,280)
|
|
|
|
|
|
|
|
|
|
|
Net change in
unrealized loss on available-for-sale securities, net of
reclassification
adjustments and taxes
|
4
|
|
13
|
|
$
(15)
|
|
$
4
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
$
(11,547)
|
|
$ (9,133)
|
|
$
(22,408)
|
|
$
(19,276)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
|
|
Basic
|
|
$ (0.05)
|
|
$
(0.04)
|
|
$ (0.10)
|
|
$
(0.09)
|
|
Diluted
|
|
$ (0.05)
|
|
$
(0.04)
|
|
$ (0.10)
|
|
$
(0.09)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
used in computing net loss per share
|
|
|
|
|
|
|
|
|
Basic
|
|
227,742
|
|
227,428
|
|
227,715
|
|
222,510
|
|
Diluted
|
|
227,742
|
|
227,428
|
|
227,715
|
|
222,510
|
DURECT
CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
June 30,
2022
|
|
December 31,
2021
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash
and cash equivalents
|
|
$
47,135
|
|
$
49,844
|
Short-term investments
|
|
6,977
|
|
19,966
|
Accounts receivable, net
|
|
1,204
|
|
6,477
|
Inventories, net
|
|
2,133
|
|
1,870
|
Prepaid expenses and other current assets
|
|
3,006
|
|
3,580
|
Total current
assets
|
|
60,455
|
|
81,737
|
|
|
|
|
|
Property and equipment,
net
|
|
222
|
|
227
|
Operating lease
right-of-use assets
|
|
2,722
|
|
3,446
|
Goodwill
|
|
6,169
|
|
6,169
|
Long-term restricted
Investments
|
|
150
|
|
150
|
Other long-term
assets
|
|
261
|
|
261
|
Total assets
|
|
$
69,979
|
|
$
91,990
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
|
$
3,230
|
|
$
1,311
|
Accrued liabilities
|
|
4,537
|
|
6,799
|
Deferred revenue, current portion
|
|
-
|
|
98
|
Term
loan, current portion, net
|
|
950
|
|
-
|
Operating lease liabilities, current portion
|
|
1,876
|
|
1,848
|
Total current
liabilities
|
|
10,593
|
|
10,056
|
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
|
812
|
|
812
|
Operating lease
liabilities, noncurrent portion
|
|
1,039
|
|
1,824
|
Term loan, noncurrent
portion, net
|
|
19,949
|
|
20,632
|
Other long-term
liabilities
|
|
882
|
|
884
|
|
|
|
|
|
Stockholders'
equity
|
|
36,704
|
|
57,782
|
Total liabilities and
stockholders' equity
|
|
$
69,979
|
|
$
91,990
|
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SOURCE DURECT Corporation