- Webcast of Earnings Call Today,
May 8th at 4:30 p.m. ET
- Topline data from AHFIRM trial expected
in 2H 2023
CUPERTINO, Calif., May 8, 2023
/PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced
financial results for the three months ended March 31, 2023 and provided a corporate
update.
"We are rapidly approaching the completion of enrollment in our
Phase 2b AHFIRM trial later this
quarter and remain on track to report topline data in the second
half of 2023. We are preparing to file an NDA for
larsucosterol in alcohol-associated hepatitis (AH) if the AHFIRM
trial outcome is positive and are in the early stages of commercial
launch planning in the U.S.," stated James
E. Brown, D.V.M., President and CEO of DURECT. "If
approved, larsucosterol would be the first FDA-approved treatment
for AH. We also are pleased that an article describing our
Phase 2a data in AH has been published online in The American
Journal of Gastroenterology. This peer-reviewed publication
provides further insight into the efficacy and safety of
larsucosterol in AH and underscores the insufficiency of current
treatment approaches for this highly lethal disease."
Recent Business Highlights:
- AHFIRM approaching completion - DURECT has enrolled
more than 285 patients in the AHFIRM trial to date, which exceeds
95% of the target enrollment for the 300-patient trial. We
have enrolled patients at leading hospitals in the U.S.,
Australia, E.U. and U.K.,
including prominent transplant centers. We continue to expect
to complete enrollment in the AHFIRM trial in the second quarter of
2023, which should enable topline data to be reported in the second
half of 2023.
- Peer-reviewed publication of Phase 2a trial of larsucosterol
in AH – Additional data from our previously completed Phase 2a
trial evaluating larsucosterol in AH was recently published online
by The American Journal of Gastroenterology. In addition to
previously reported safety and efficacy data from the 19-patient,
open label Phase 2a trial, the publication includes individual
patient data and additional liver biomarker data as well as
cross-study comparisons of severe AH patients from the Phase 2a
trial with two matching comparison arms from a contemporaneous
study conducted by the DASH (Defeat Alcoholic Steatohepatitis)
Consortium.
- Upcoming AH Key Opinion Leader (KOL) Event – DURECT
announced that it will be hosting a KOL event for investors on
May 16, 2023 at 12 p.m. ET in New York City. The event will
include presentations by Dr. Paul
Gaglio and Dr. Brett Fortune,
as well as members of our senior leadership team.
Financial Highlights for Q1 2023:
- Total revenues were $2.1 million
and net loss was $12.0 million for
the three months ended March 31, 2023
compared to total revenues of $1.9
million and net loss of $10.8
million for the three months ended March 31, 2022.
- At March 31, 2023, cash, cash
equivalents and investments were $44.4
million, compared to $43.6
million at December 31, 2022.
Debt at March 31, 2023 was
$21.3 million, compared to
$21.2 million at December 31, 2022.
- In February 2023, we completed a
registered direct offering of common stock and warrants with a
leading institutional healthcare investor and an existing
institutional investor. The offering raised net proceeds from
the financing of approximately $8.8
million.
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 first quarter
2023 results and provide a corporate update:
Monday, May 8 @
4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time
|
Toll Free:
|
1-877-869-3847
|
International:
|
201-689-8261
|
Conference ID:
|
13738577
|
Webcast:
|
https://event.choruscall.com/mediaframe/webcast.html?webcastid=nKLHIvLR
|
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 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
has enrolled patients at 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 an acute
form of alcohol-associated liver disease (ALD), associated with
long-term heavy intake of alcohol and often occurs after a recent
period of increased alcohol consumption (i.e., a binge). AH is
typically characterized by severe inflammation and destruction of
liver tissue (i.e., necrosis), potentially leading to
life-threatening complications including liver failure, acute
kidney 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 approximately 20% and 31%,
respectively. Stopping alcohol consumption is necessary, but
frequently 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
not been shown to improve survival at 90 days or one year, and have
demonstrated an increased risk of infection. While liver
transplantation is becoming more common for ALD patients, including
AH patients, the total number of such transplants is still
relatively small. Average charges for a liver transplant
exceed $875,000, and patients require
lifelong immunosuppressive therapy to prevent organ rejection.
About Larsucosterol
Larsucosterol is an endogenous
sulfated oxysterol and an epigenetic modulator. 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 modulates 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
modulator, 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, 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
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 the second quarter of 2023 and
report topline data in the second half of 2023, the potential FDA
approval of larsucosterol for the treatment of AH, the ability of a
positive outcome in the AHFIRM trial to support a New Drug
Application filing, our plans to commercialize larsucosterol if
approved, the commercialization of POSIMIR by Innocoll, the
potential to develop larsucosterol for AH, 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, the risk
that the FDA or other government agencies may require additional
clinical trials for larsucosterol before approving it for the
treatment of AH even if the results of the AHFIRM trial are
successful, risks that Innocoll may not commercialize POSIMIR
successfully, and risks related to the sufficiency of our cash
resources, our anticipated capital requirements and capital
expenditures, our need or desire for additional financing, our
ability to obtain capital to fund our operations and expenses and
our ability to continue to operate as a going concern. 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, 2022 and quarterly
report on Form 10-Q for the quarter ended March 31, 2023 when filed under the heading "Risk
Factors." These reports are available on our website
www.durect.comunder 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 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
|
|
|
|
March
31
|
|
|
|
2023
|
|
2022
|
|
|
|
|
|
|
Collaborative research
and development and other revenue
|
$
643
|
|
$
495
|
Product revenue,
net
|
1,411
|
|
1,420
|
|
Total
revenues
|
2,054
|
|
1,915
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Cost of product
revenues
|
388
|
|
335
|
|
Research and
development
|
8,593
|
|
8,211
|
|
Selling, general and
administrative
|
4,095
|
|
3,735
|
Total operating
expenses
|
13,076
|
|
12,281
|
|
|
|
|
|
|
Loss from
operations
|
(11,022)
|
|
(10,366)
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest and other
income
|
517
|
|
54
|
|
Change in fair value of
warrant liabilities
|
2,477
|
|
-
|
|
Interest and other
expenses
|
(726)
|
|
(530)
|
|
Issuance cost for
warrants
|
(1,200)
|
|
-
|
|
Loss on issuance of
warrants
|
(2,033)
|
|
-
|
Other income (expense),
net
|
(965)
|
|
(476)
|
|
|
|
|
|
|
Net loss
|
|
$
(11,987)
|
|
$
(10,842)
|
|
|
|
|
|
|
Net change in
unrealized loss on available-for-sale securities, net of
reclassification
adjustments and
taxes
|
$
6
|
|
$
(19)
|
|
|
|
|
|
|
Total comprehensive
loss
|
$
(11,981)
|
|
$
(10,861)
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
Basic
|
|
$
(0.50)
|
|
$
(0.48)
|
|
Diluted
|
|
$
(0.52)
|
|
$
(0.48)
|
|
|
|
|
|
|
Weighted-average shares
used in computing net loss per share
|
|
|
|
|
Basic
|
|
23,767
|
|
22,768
|
|
Diluted
|
|
23,940
|
|
22,768
|
|
|
|
|
|
|
|
|
|
DURECT
CORPORATION
|
|
|
|
CONDENSED BALANCE
SHEETS
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
|
March 31,
2023
|
|
December 31, 2022
(1)
|
|
|
|
(unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
39,296
|
|
$
43,483
|
|
Short-term investments
|
|
4,924
|
|
-
|
|
Short-term restricted Investments
|
|
150
|
|
-
|
|
Accounts receivable, net
|
|
1,401
|
|
3,423
|
|
Inventories, net
|
|
2,211
|
|
2,113
|
|
Prepaid expenses and other current assets
|
|
2,522
|
|
2,375
|
|
Total current
assets
|
|
50,504
|
|
51,394
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
144
|
|
188
|
|
Operating lease
right-of-use assets
|
|
1,532
|
|
1,943
|
|
Goodwill
|
|
6,169
|
|
6,169
|
|
Long-term restricted
Investments
|
|
-
|
|
150
|
|
Other long-term
assets
|
|
-
|
|
256
|
|
Total assets
|
|
$
58,349
|
|
$
60,100
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
2,006
|
|
$
3,106
|
|
Accrued liabilities
|
|
7,388
|
|
7,896
|
|
Term
loan, current portion, net
|
|
21,303
|
|
21,170
|
|
Deferred revenue, current portion
|
|
178
|
|
-
|
|
Operating lease liabilities, current portion
|
|
1,655
|
|
1,832
|
|
Warrant liabilities
|
|
9,556
|
|
-
|
|
Total current
liabilities
|
|
42,086
|
|
34,004
|
|
|
|
|
|
|
|
Operating lease
liabilities, noncurrent portion
|
|
-
|
|
260
|
|
Other long-term
liabilities
|
|
921
|
|
851
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
15,342
|
|
24,985
|
|
Total liabilities and
stockholders' equity
|
|
$
58,349
|
|
$
60,100
|
(1) Derived from
audited financial statements.
|
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SOURCE DURECT Corporation