CUPERTINO, Calif., May 4, 2021 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced financial results for
the three months ended March 31, 2021
and provided a corporate update.
Q1 2021 Accomplishments:
- Initiated patient dosing in the Phase 2b AHFIRM clinical study of DUR-928 in severe
Alcohol-associated Hepatitis (AH)
- FDA approval of POSIMIR in adults to produce post-surgical
analgesia for up to 72 hours following Arthroscopic Subacromial
Decompression
- Publication of DUR-928's mechanism of action
- Appointment of two highly experienced biopharmaceutical board
members
- Further strengthened our financial position by raising
$47.8 million in equity and ending Q1
with $97.2 million in cash and
investments
"We are pleased with progress made in opening clinical trial
sites in the U.S. and early enrollment in the AHFIRM trial, our
Phase 2b clinical trial designed to
evaluate the potential life-saving capability of DUR-928 in
patients with severe Alcohol-associated Hepatitis," stated James E.
Brown, D.V.M, President and CEO of DURECT. "We are also
in discussions with multiple potential POSIMIR partners with a goal
of enabling the partner to launch the product this
year."
Financial highlights for Q1 2021:
- Total revenues were $2.2 million
and net loss was $10.1 million for
the three months ended March 31, 2021
as compared to total revenues of $1.6
million and net loss of $9.9
million for the three months ended March 31, 2020.
- At March 31, 2021, cash and
investments were $97.2 million,
compared to cash, cash held in escrow and investments of
$56.9 million at December 31, 2020. Debt at March 31, 2021 was $21.0
million, compared to $20.8
million at December 31,
2020.
Update on Selected Programs:
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
alcohol-associated hepatitis (AH) as well as in chronic liver
diseases such as non-alcoholic steatohepatitis (NASH).
Clinical Development
Alcohol-associated Hepatitis (AH)
- Enrollment is ongoing in our Phase 2b study in subjects with severe acute AH
to evaluate saFety and effIcacy of DUR-928
treatMent (AHFIRM). AHFIRM is a randomized,
double-blind, placebo-controlled, international, multi-center Phase
2b study to evaluate the safety and
efficacy of DUR-928 in approximately 300 patients with severe AH.
The study is comprised of three arms targeting approximately 100
patients each: (1) Placebo plus standard of care (SOC, which may
include the use of methylprednisolone, a corticosteroid, at the
discretion of the treating physician); (2) DUR-928 (30 mg); and (3)
DUR-928 (90 mg). All patients in the trial receive supportive care.
Patients receive an intravenous (IV) dose of DUR-928 or placebo
(sterile water) on day 1 and a second IV dose on day 4 if they are
still hospitalized. The primary outcome measure is 90-day survival
rate for patients treated with DUR-928 compared to those treated
with placebo plus SOC. Secondary endpoints include 28-day survival,
the rate of adverse events, Lille
and MELD (prognostic scores) and time in the intensive care unit.
The Company is targeting approximately 50-60 clinical trial sites
in the U.S., U.K., Europe and
Australia.
- Reflecting the life-threatening nature of AH and the lack of
therapeutic options for this devastating condition, the FDA granted
DUR-928 Fast Track Designation for the treatment of AH in
December 2020. The FDA grants Fast
Track Designation to facilitate development and expedite the review
of therapies with the potential to treat a serious condition where
there is an unmet medical need. A therapeutic that receives Fast
Track Designation may benefit from early and frequent communication
with the agency in addition to a rolling submission of the
marketing application, with the objective of getting important new
therapies to patients more quickly.
- Given the high mortality rate in severe AH patients and the
absence of an approved therapeutic, we believe demonstration of a
robust survival benefit in the AHFIRM trial may support an NDA
filing.
- In March 2021, a peer-reviewed
research paper describing the binding sites and proposed mechanism
of action of DUR-928 was published in The Journal of Lipid
Research. The publication shows that DUR-928 (referred to in the
paper as 25HC3S) binds to and inhibits the activity of DNA
methyltransferases (DNMTs) DNMT-1, 3a and 3b, epigenetic regulating enzymes that add
methyl groups to DNA (a process called DNA methylation). As such,
by inhibiting DNMT activity, DUR-928 inhibits DNA methylation,
thereby regulating the expression of genes that modulate crucial
cellular activities, including those associated with cell death,
stress response, and lipid biosynthesis. These modulations may lead
to improved cell survival, and reduced lipid accumulation and
inflammation, as has been observed in various in vivo animal
models and in results from DURECT's completed clinical trials in
alcohol-associated hepatitis (AH) and non-alcoholic steatohepatitis
(NASH).
- During 2019, we completed a Phase 2a clinical trial of DUR-928
in patients with AH. All 19 patients treated with DUR-928 survived
the 28-day follow-up period, 74% of patients (14/19) were
discharged in ≤ 4 days after receiving a single dose of DUR-928,
and there were no drug-related serious adverse events.
- Alcohol-associated hepatitis (also called alcoholic hepatitis
or 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 a recent onset of jaundice and hepatic failure.
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 approximately
132,000 hospitalizations for patients with AH in 2018. From a 2018
publication analyzing the mortality and costs associated with AH,
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
$875,000 per patient. 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 and 29% at 90 days after admission.
Non-Alcoholic Steatohepatitis (NASH)
- In May 2020, we reported positive
topline results from a Phase 1b
randomized and open-label clinical study 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 imaging) of DUR-928 in
NASH patients with stage 1-3 fibrosis. In this 65-patient study,
reductions from baseline (pre-treatment) levels were seen in liver
enzymes, liver stiffness as measured by imaging, serum lipids and
biomarkers. Many of these reductions were statistically significant
and DUR-928 was well tolerated at all three doses evaluated.
- We will present additional data from this trial at an upcoming
medical conference and we are working with a number of disease
experts to determine next steps for DUR-928 in NASH.
- 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.
POSIMIR® (bupivacaine solution)
Post-Operative Pain Relief Depot. POSIMIR is DURECT's
post-operative pain relief depot that uses the Company's patented
SABER® technology that delivers bupivacaine to provide up to 3 days
of post-surgical analgesia.
- In February 2021, POSIMIR was
granted U.S. FDA approval in adults for administration into the
subacromial space under direct arthroscopic visualization to
produce post-surgical analgesia for up to 72 hours following
arthroscopic subacromial decompression. POSIMIR is the only
approved sustained-release bupivacaine product indicated for up to
72 hours of post-surgical analgesia from a single application.
- The approval was based on positive data from a randomized,
multicenter, assessor-blinded, placebo–controlled clinical trial in
patients undergoing arthroscopic subacromial decompression surgery
with an intact rotator cuff. The primary outcome measures were mean
pain intensity and total opioid rescue analgesia administered, both
evaluated over the first 72 hours after surgery versus placebo.
POSIMIR demonstrated a statistically significant improvement in
both primary outcome measures: a 1.3 point, or 20%, reduction in
mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67%
reduction in I.V. morphine-equivalent rescue opioid use, from a
median of 12 mg in the placebo group to 4 mg in the POSIMIR group
(p=0.01). In connection with this approval, the Company or its
licensee, will be required to conduct two postmarketing
non-clinical studies. Full Prescribing Information, including the
Boxed Warning, is available at www.POSIMIR.com.
- DURECT is in discussions with potential licensees of
commercialization rights to POSIMIR, for which DURECT currently
holds worldwide rights. Our goal is to put a commercial license in
place in time for the licensee to launch the product in Q4
2021.
- Subacromial decompression is a type of shoulder surgery used to
treat impingement syndrome, a common repetitive-use injury that
causes pain when the arm is raised over the head. The procedure is
typically performed arthroscopically, meaning that several small
incisions are made in the skin and muscle of the shoulder through
which a camera lens (arthroscope) and surgical instruments are
inserted during surgery. Arthroscopic subacromial decompression is
generally considered outpatient surgery, and most patients go home
within a few hours of surgery. The recovery period may extend from
weeks to months, but the most intense pain typically occurs during
the first 3 days after surgery and is often managed with oral
opioids. There are over 600,000 surgeries involving arthroscopic
subacromial decompression performed each year in the U.S.
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
2021 results and provide a corporate update:
Tuesday, May 4
@ 4:30pm Eastern Time / 1:30 p.m. Pacific
Time
|
Toll Free:
|
877-407-0784
|
International:
|
201-689-8560
|
Conference
ID:
|
13718713
|
Webcast:
|
http://public.viavid.com/index.php?id=144373
|
The conference call will also be available by webcast on
DURECT's homepage at www.durect.com under the "Investors"
tab. If you are unable to participate during the 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. DUR-928, the
company's lead drug candidate is in clinical development for the
potential treatment of alcohol-associated hepatitis (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 now FDA-approved. Full prescribing information
about POSIMIR, including the Boxed Warning, can be found at
www.posimir.com. 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 the potential for
DUR-928 to treat patients with AH and NASH, clinical trial plans,
the potential benefits of Fast Track Designation, the potential for
the AHFIRM trial to support an NDA filing for DUR-928, and plans to
seek a commercial licensee for POSIMIR and its commercial launch,
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
DUR-928 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 DUR-928 in a statistically
significant manner, the risk that Fast Track designation for
DUR-928 in AH may not actually lead to faster FDA review or an
approval, risks that we may not enter a commercial license for
POSIMIR on favorable terms, if at all, risks that we or a licensee
may not commercialize POSIMIR successfully, if at all, and risks
related to entering into new agreements or our ability to obtain
capital to fund operations and expenses. Further information
regarding these and other risks is included in DURECT's Form 10-K
filed on March 5, 2021 and in our
Form 10-Q for the quarter ended March 31,
2021 when filed with the Securities and Exchange
Commission under the heading "Risk Factors."
NOTE: POSIMIR® and SABER® are trademarks
of DURECT Corporation. Other referenced trademarks belong to
their respective owners. DUR-928 is an investigational drug
candidate under development and have not been approved for
commercialization by the U.S. Food and Drug Administration or other
health authorities for any indication. Full prescribing information
for POSIMIR, including its Boxed Warning, can be found at
www.POSIMIR.com.
DURECT
CORPORATION
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(in thousands,
except per share amounts)
|
(Unaudited)
|
|
|
|
Three months
ended
|
|
|
March
31
|
|
|
2021
|
|
2020
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
$
574
|
|
$
(30)
|
Product revenue,
net
|
1,638
|
|
1,625
|
|
Total
revenues
|
2,212
|
|
1,595
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Cost of product
revenues
|
352
|
|
396
|
|
Research and
development
|
7,975
|
|
7,587
|
|
Selling, general and
administrative
|
3,531
|
|
3,431
|
Total operating
expenses
|
11,858
|
|
11,414
|
|
|
|
|
|
Loss from
operations
|
(9,646)
|
|
(9,819)
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest and other
income
|
37
|
|
258
|
|
Interest and other
expense
|
(525)
|
|
(592)
|
Net other
expense
|
(488)
|
|
(334)
|
Loss from continuing
operations
|
(10,134)
|
|
(10,153)
|
Income from
discontinued operations
|
-
|
|
205
|
Net loss
|
$(10,134)
|
|
$ (9,948)
|
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
|
Basic and
diluted
|
|
|
|
|
Continuing operations
|
$
(0.05)
|
|
$
(0.05)
|
|
Discontinued operations
|
$
-
|
|
$
0.00
|
|
Net loss per common
share, basic and diluted
|
$
(0.05)
|
|
$
(0.05)
|
|
|
|
|
|
Weighted-average
shares used in computing net income (loss) per share, basic and
diluted
|
217,537
|
|
195,745
|
|
|
|
|
|
Total comprehensive
loss
|
$(10,143)
|
|
$ (9,963)
|
DURECT
CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
|
|
As of
|
|
As of
|
|
March 31,
2021
|
|
December 31,
2020(1)
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash equivalents
|
$
57,545
|
|
$
21,312
|
Cash held in escrow
|
-
|
|
14,979
|
Short-term investments
|
39,538
|
|
19,421
|
Accounts receivable
|
993
|
|
940
|
Inventories, net
|
1,955
|
|
1,864
|
Prepaid expenses and other current assets
|
4,780
|
|
4,545
|
Total current
assets
|
104,811
|
|
63,061
|
|
|
|
|
Property and
equipment, net
|
224
|
|
251
|
Operating lease
right-of-use assets
|
4,440
|
|
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
|
$
116,055
|
|
$
75,641
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable
|
$
2,150
|
|
$
1,678
|
Accrued liabilities
|
4,094
|
|
5,801
|
Contract research liability
|
384
|
|
545
|
Deferred revenue, current portion
|
373
|
|
-
|
Term loan, current portion, net
|
2,895
|
|
884
|
Operating lease liabilities, current portion
|
1,808
|
|
1,795
|
Total current
liabilities
|
11,704
|
|
10,703
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
812
|
|
812
|
Operating lease
liabilities, noncurrent portion
|
2,881
|
|
3,202
|
Term loan, noncurrent
portion, net
|
18,062
|
|
19,936
|
Other long-term
liabilities
|
873
|
|
873
|
|
|
|
|
Stockholders'
equity
|
81,723
|
|
40,115
|
Total liabilities and
stockholders' equity
|
$
116,055
|
|
$
75,641
|
|
(1) Derived
from audited financial statements.
|
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SOURCE DURECT Corporation