CUPERTINO, Calif., March 7, 2022 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced financial results for
the three months and year ended December 31,
2021 and provided a corporate update.
"We are pleased with the progress made over the past few months
in the larsucosterol (DUR-928) AHFIRM trial, including opening
international sites and the enrollment rate of patients with severe
alcohol-associated hepatitis (AH)," stated James E. Brown, D.V.M., President and CEO of
DURECT. "We also signed a U.S. licensing agreement for
POSIMIR® with Innocoll Pharmaceuticals and look forward to their
anticipated launch in the second quarter of 2022."
Fourth Quarter and Recent Business Highlights:
- Continued progress in AHFIRM enrollment – DURECT has now
dosed over 100 patients in the Phase 2b AHFIRM clinical trial of larsucosterol in
severe AH. This includes dosing the first patient in Europe, with 51 global AHFIRM study sites now
open, an increase of 15 since our last earnings call. With this
progress, our estimated completion of enrollment remains on track
for mid-2023.
- Successful completion of POSIMIR licensing – DURECT
signed an exclusive U.S. licensing agreement for POSIMIR® with
Innocoll Pharmaceuticals in late 2021. Under the agreement, DURECT
will earn low to mid double-digit royalties from net sales of
POSIMIR and is eligible to receive up to $136 million in upfronts and milestones,
including the $4 million upfront
license fee received in January 2022,
and a $2 million milestone payment
upon the first commercial sale of POSIMIR, which is anticipated in
2Q22.
- Increasing awareness of AH market potential – In
collaboration with DURECT, Dr. Suthat Liangpunsakul presented a
poster at The Liver Meeting® 2021 showing increased
hospitalizations for AH in the U.S., highlighting both significant
comorbidities and high hospitalization costs of over $150,000 per hospitalization for those AH
patients who died during their hospital stay.
- Important addition to our team – In December 2021, DURECT strengthened its board of
directors with the appointment of Pete
Garcia, a seasoned financial executive in the
biopharmaceutical industry.
Financial highlights for Q4 and full year 2021:
- Total revenues were $7.3 million
and net loss from continuing operations was $7.0 million for the three months ended
December 31, 2021 compared to total
revenues of $2.2 million and net loss
from continuing operations of $8.8
million for the three months ended December 31, 2020. Total revenues were
$14.0 million and net loss from
continuing operations was $36.3
million for the year ended December
31, 2021, compared to total revenues of $30.1 million and net loss from continuing
operations of $14.3 million for the
year ended December 31, 2020.
- At December 31, 2021, cash and
investments were $70.0 million,
compared to cash, cash held in escrow and investments of
$56.9 million at December 31, 2020. Debt at December 31, 2021 was $20.6 million, compared to $20.8 million at December
31, 2020. At December 31,
2021, accounts receivable included $5.3 million due from Innocoll as a result of the
$4 million upfront fee and a
$1.3 million fee primarily to cover
manufacturing supplies and excipients and certain equipment
transferred to Innocoll; these funds were received in January 2022.
Upcoming Key Milestones:
- Complete opening of 60 or more global clinical trial sites
across the U.S., E.U., U.K., and Australia and continue acceleration of
enrollment in the Phase 2b AHFIRM
trial of larsucosterol in severe AH
- Provide an update on plans to expand clinical development of
larsucosterol in NASH and/or other indications
- Commercial launch of POSIMIR by our licensee, Innocoll
Pharmaceuticals; expected in Q2 2022
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
2021 results and provide a corporate update:
Monday, March 7
@ 4:30pm Eastern Time / 1:30 p.m. Pacific
Time
|
Toll
Free:
|
877-869-3847
|
International:
|
201-689-8261
|
Conference
ID:
|
13727525
|
Webcast:
|
https://themediaframe.com/mediaframe/webcast.html?webcastid=qrEvoVo0
|
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 standard of care (SOC) which
may include the use of methylprednisolone, a corticosteroid, at the
discretion of the treating physician; (2) larsucosterol (30 mg);
and (3) larsucosterol (90 mg). All patients in the trial
receive supportive care. The primary outcome measure is 90-day
survival rate for patients treated with larsucosterol compared to
those treated with placebo plus SOC. The Company is targeting
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 demonstration of a robust survival benefit in the AHFIRM
trial would support an NDA 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
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, 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 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 and
severe 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 alcoholic liver disease patients,
including for AH patients, the procedure involves a long waiting
period, a burdensome selection process, and costs more than
$875,000 on average.
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 Statement
The statements in this press release regarding plans to complete
enrollment of the AHFIRM trial in mid-2023, plans to increase the
number of clinical trial sites in the AHFIRM trial, the expected
commercial launch of POSIMIR by Innocoll and potential future
payments we may receive from Innocoll, and the potential to develop
larsucosterol for NASH or other indications 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 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 or the life-saving
potential 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 Form 10-Q
filed on November 3, 2021 and in our
annual report on Form 10-K for the year ended December 31, 2021 when filed with the Securities
and Exchange Commission under the heading "Risk Factors."
These reports are available on our website www.durect.com under the
"Investors" tab.
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) INCOME
|
(in thousands, except
per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Twelve months
ended
|
|
|
|
December 31,
2021
|
|
December 31,
2021
|
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020(1)
|
|
|
|
|
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
$
4,579
|
|
$
317
|
|
$
6,331
|
|
$
23,941
|
Product revenue,
net
|
2,718
|
|
1,890
|
|
7,646
|
|
6,170
|
|
Total
revenues
|
7,297
|
|
2,207
|
|
13,977
|
|
30,111
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
880
|
|
418
|
|
1,955
|
|
1,406
|
|
Research and
development
|
8,415
|
|
6,682
|
|
31,846
|
|
27,709
|
|
Selling, general and
administrative
|
4,514
|
|
3,413
|
|
14,449
|
|
13,611
|
Total operating
expenses
|
13,809
|
|
10,513
|
|
48,250
|
|
42,726
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(6,512)
|
|
(8,306)
|
|
(34,273)
|
|
(12,615)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest and other
income
|
46
|
|
40
|
|
156
|
|
517
|
|
Interest and other
expense
|
(542)
|
|
(547)
|
|
(2,148)
|
|
(2,237)
|
Net other
expense
|
(496)
|
|
(507)
|
|
(1,992)
|
|
(1,720)
|
Loss from continuing
operations
|
(7,008)
|
|
(8,813)
|
|
(36,265)
|
|
(14,335)
|
Income from
discontinued operations
|
-
|
|
13,173
|
|
-
|
|
13,753
|
Net (loss)
income
|
$
(7,008)
|
|
$
4,360
|
|
$
(36,265)
|
|
$
(582)
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per
share
|
|
|
|
|
|
|
|
|
Basic and
Diluted
|
|
|
|
|
|
|
|
|
Loss from Continuing operations
|
$
(0.03)
|
|
$
(0.04)
|
|
$
(0.16)
|
|
$
(0.07)
|
|
Income from discontinued operations
|
$
-
|
|
$
0.06
|
|
$
-
|
|
$
0.07
|
|
Net (loss) income per
common share, basic and diluted
|
$
(0.03)
|
|
$
0.02
|
|
$
(0.16)
|
|
$
(0.00)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net (loss) income per share
|
|
|
|
|
|
|
|
|
Basic
|
|
227,586
|
|
203,272
|
|
225,047
|
|
199,457
|
|
Diluted
|
|
227,586
|
|
211,497
|
|
225,047
|
|
199,457
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
(loss) income
|
$
(7,020)
|
|
$
4,337
|
|
$
(36,270)
|
|
$
(584)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Derived
from audited financial statements.
|
|
|
|
|
|
|
|
|
|
DURECT
CORPORATION
|
|
|
CONDENSED BALANCE
SHEETS
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
December 31,
2021
|
|
December 31,
2020(1)
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
49,844
|
|
$
21,312
|
Cash held in escrow
|
|
-
|
|
14,979
|
Short-term investments
|
|
19,966
|
|
19,421
|
Accounts receivable
|
|
6,477
|
|
940
|
Inventories
|
|
1,870
|
|
1,864
|
Prepaid expenses and other current assets
|
|
3,580
|
|
4,545
|
Total current
assets
|
|
81,737
|
|
63,061
|
|
|
|
|
|
Property and
equipment, net
|
|
227
|
|
251
|
Operating lease
right-of-use assets
|
|
3,446
|
|
4,749
|
Goodwill
|
|
6,169
|
|
6,169
|
Long-term
investments
|
|
-
|
|
1,000
|
Long-term restricted
Investments
|
|
150
|
|
150
|
Other long-term
assets
|
|
261
|
|
261
|
Total
assets
|
|
$
91,990
|
|
$
75,641
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
|
$
1,311
|
|
$
1,678
|
Accrued liabilities
|
|
6,799
|
|
6,346
|
Deferred revenue, current portion
|
|
98
|
|
-
|
Term loan, current portion, net
|
|
-
|
|
884
|
Operating lease liabilities, current portion
|
|
1,848
|
|
1,795
|
Total current
liabilities
|
|
10,056
|
|
10,703
|
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
|
812
|
|
812
|
Operating lease
liabilities, noncurrent portion
|
|
1,824
|
|
3,202
|
Term loan, noncurrent
portion, net
|
|
20,632
|
|
19,936
|
Other long-term
liabilities
|
|
884
|
|
873
|
|
|
|
|
|
Stockholders'
equity
|
|
57,782
|
|
40,115
|
Total liabilities and
stockholders' equity
|
|
$
91,990
|
|
$
75,641
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Derived
from audited financial statements.
|
|
|
|
|
View original
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SOURCE DURECT Corporation