CUPERTINO, Calif., March 4, 2021 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced financial results for
the three months and year ended December 31,
2020 and provided a corporate update.
"We have achieved a number of important milestones over the past
few months, most significantly, initiating dosing in the DUR-928
AHFIRM trial in patients with severe alcohol-associated hepatitis
(AH) and obtaining Fast Track Designation for that indication,"
stated James E. Brown, D.V.M.,
President and CEO of DURECT. "We also obtained FDA approval for
POSIMIR® and took steps to strengthen our financial position, our
board and our management team as we advance the development of
DUR-928, a potentially life-saving therapy for patients with severe
AH."
Accomplishments since last earnings call:
- Initiated patient dosing in the Phase 2b AHFIRM clinical study of DUR-928 in severe
AH
- DUR-928 was granted FDA Fast Track Designation for the
treatment of AH
- FDA approval of POSIMIR in adults to produce post-surgical
analgesia for up to 72 hours following Arthroscopic Subacromial
Decompression
- Presented additional Safety Data and Efficacy Signals from the
Phase 1b NASH trial at The Liver
Meeting Digital Experience™ 2020
- Appointment of two highly experienced biopharmaceutical board
members
- Sale of the LACTEL Absorbable Polymers product line to Evonik
for $15 million in cash
- Further strengthened our financial position by raising
$47.8 million in equity since
December 31, 2020
Financial highlights for Q4 and full year 2020:
- On December 31, 2020, the Company
completed the sale of its LACTEL Absorbable Polymers product line
to Evonik Corporation for $15 million in cash, resulting in a
gain of approximately $12.8 million
which is reflected in net income and net loss for three and twelve
months ended December 31, 2020,
respectively. As a result of the sale, the operating results from
our LACTEL product line have been excluded from continuing
operations and presented as discontinued operations in the
accompanying Condensed Statements of Operations and Comprehensive
Income (Loss) and Condensed Balance Sheets for all periods
presented.
- Total revenues were $2.2 million
and net income was $4.4 million for
the three months ended December 31,
2020 as compared to total revenues of $9.0 million and net loss of $4.2 million for the three months ended
December 31, 2019. Total
revenues were $30.1 million and net
loss was $0.6 million for the year
ended December 31, 2020, compared to
total revenues of $25.1 million and
net loss of $20.6 million for the
year ended December 31,
2019.
- At December 31, 2020, cash, cash
held in escrow and investments were $56.9
million, compared to cash and investments of $64.8 million at December
31, 2019. In Q1 2021, DURECT raised net proceeds of
$47.8 million from an underwritten
public offering and other sales of equity. Debt at
December 31, 2020 was $20.8 million, compared to $20.3 million at December
31, 2019.
Major activities in 2021:
- Ramping up clinical trial sites and enrollment in the Phase
2b AHFIRM trial of DUR-928 in severe
AH
- Initiating ex-US dosing in the AHFIRM trial
- Commercial partnership discussions for POSIMIR, and potential
subsequent commercial launch
- Publication of the DUR-928 mechanism of action in a
peer-reviewed journal
- Determining next steps in NASH
- Potential new license and collaboration agreements
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, 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
Alcoholic Hepatitis (AH)
- We have begun dosing 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). 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. We are targeting 40-50 clinical
trial sites in the US, Europe and
Australia.
- 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.
- 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.
- Reflecting the life-threatening nature of AH and the lack of
therapeutic options for this devastating condition, the FDA
recently granted DUR-928 Fast Track Designation for the treatment
of AH. 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 can
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.
- 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 over
122,000 hospitalizations for patients with AH in 2017. The
cost per AH 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 average
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.
- Additional results, including biomarker data, were presented
through a poster at The Liver Meeting Digital Experience™ 2020 held
November 13-16, 2020.
COVID-19
Since we initiated our clinical trial of DUR-928 in patients
with COVID-19, several vaccines and therapeutics for COVID-19 have
been approved and are being deployed worldwide. Treatment
regimens for patients with COVID-19 have also evolved, the disease
landscape has changed and additional therapies have entered
clinical trials. Consequently, there have been a limited number of
patients eligible or willing to enroll in our trial, and we have
elected to discontinue the trial. The people and resources that
were supporting the COVID-19 trial are now being redirected to
support the AHFIRM trial.
POSIMIR® (bupivacaine solution)
- 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 partners regarding the
licensing of commercialization rights to POSIMIR, for which DURECT
currently holds worldwide rights.
- 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.
Sale of LACTEL Absorbable Polymers product line
- In December 2020, we sold our
LACTEL product line to Evonik for $15
million in cash. The gain from this sale was approximately
$12.8 million. This transaction is
part of our effort to focus on epigenetic regulation and the
development of DUR-928.
- The $15 million of cash was held
in escrow as of December 31, 2020 and
was released to DURECT's bank account in January 2021.
Important additions to our team
- In November 2020, we appointed
Dr. Norman Sussman as our Chief
Medical Officer. Dr. Sussman is a renowned hepatologist with
extensive clinical experience and expertise in the liver disease
field. He brings over 30 years of clinical research and development
experience in academia and industry and a proven track record in
clinical research of liver diseases.
- In January 2021, we appointed two
new members to our board of directors. Gail J. Maderis, MBA, and Mohammad Azab, MD, MSc, MBA, are industry
veterans with extensive drug development, clinical research and
medical affairs experience.
Strengthening our financial position
In Q1 2021, DURECT raised net proceeds of $47.8 million from an underwritten public
offering and other sales of equity.
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 2020 results and provide a corporate
update:
Thursday, March 4 @
4:30pm Eastern Time /
1:30 p.m. Pacific Time
Toll
Free:
|
877-407-0784
|
International:
|
201-689-8560
|
Conference
ID:
|
13715968
|
Webcast:
|
http://public.viavid.com/index.php?id=143367
|
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 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, plans to ramp up clinical trial sites
and enrollment and initiate ex-US trial sites in the Phase
2b AHFIRM trial, plans to seek a
commercialization partner for POSIMIR and its commercial launch,
and to enter into additional license and commercialization
agreements 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, risks that we may not enter a
commercialization partnership for POSIMIR on favorable terms, if at
all, risks that we or a third-party collaborator 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-Q filed on
November 3, 2020 and in our annual
report on Form 10-K for the year ended December 31, 2020 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® 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 has 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 INCOME (LOSS)
|
(in thousands, except
per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Twelve months
ended
|
|
|
|
December
31
|
|
December
31
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
Collaborative
research and development and other revenue
|
$
317
|
|
$
7,249
|
|
$
23,941
|
|
$
18,129
|
Product revenue,
net
|
|
1,890
|
|
1,746
|
|
6,170
|
|
6,945
|
|
Total
revenues
|
|
2,207
|
|
8,995
|
|
30,111
|
|
25,074
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
418
|
|
463
|
|
1,406
|
|
1,263
|
|
Research and
development
|
6,682
|
|
9,295
|
|
27,709
|
|
29,640
|
|
Selling, general and
administrative
|
3,413
|
|
3,705
|
|
13,611
|
|
14,115
|
Total operating
expenses
|
10,513
|
|
13,463
|
|
42,726
|
|
45,018
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(8,306)
|
|
(4,468)
|
|
(12,615)
|
|
(19,944)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest and other
income
|
40
|
|
338
|
|
517
|
|
1,074
|
|
Interest and other
expense
|
(547)
|
|
(610)
|
|
(2,237)
|
|
(2,501)
|
Net other
expense
|
|
(507)
|
|
(272)
|
|
(1,720)
|
|
(1,427)
|
Loss from continuing
operations
|
(8,813)
|
|
(4,740)
|
|
(14,335)
|
|
(21,371)
|
Income from
discontinued operations
|
13,173
|
|
509
|
|
13,753
|
|
793
|
Net income
(loss)
|
|
$
4,360
|
|
$
(4,231)
|
|
$
(582)
|
|
$
(20,578)
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
|
|
|
|
|
|
Continuing operations
|
$
(0.04)
|
|
$
(0.02)
|
|
$
(0.07)
|
|
$
(0.12)
|
|
Discontinued operations
|
$
0.06
|
|
$
0.00
|
|
$
0.07
|
|
$
0.00
|
|
Net income (loss) per
common share, basic and diluted
|
$
0.02
|
|
$
(0.02)
|
|
$
(0.00)
|
|
$
(0.12)
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net income (loss) per share
|
|
|
|
|
|
|
|
|
Basic
|
|
203,272
|
|
193,181
|
|
199,457
|
|
178,042
|
|
Diluted
|
|
211,497
|
|
193,181
|
|
199,457
|
|
178,042
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
income (loss)
|
$
4,337
|
|
$
(4,236)
|
|
$
(584)
|
|
$
(20,581)
|
|
|
DURECT
CORPORATION
|
|
|
CONDENSED BALANCE
SHEETS
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
As of
|
|
As of
|
|
|
December 31,
2020
|
|
December 31,
2019(1)
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
21,312
|
|
$
34,924
|
Cash held in escrow
|
|
14,979
|
|
-
|
Short-term investments
|
|
19,421
|
|
29,750
|
Accounts receivable
|
|
940
|
|
1,516
|
Inventories, net
|
|
1,864
|
|
1,919
|
Prepaid expenses and other current assets
|
|
4,545
|
|
1,424
|
Discontinued operations, current portion
|
|
-
|
|
2,296
|
Total current
assets
|
|
63,061
|
|
71,829
|
|
|
|
|
|
Property and
equipment, net
|
|
251
|
|
159
|
Operating lease
right-of-use assets
|
|
4,749
|
|
5,866
|
Goodwill
|
|
6,169
|
|
6,399
|
Long-term
investments
|
|
1,000
|
|
-
|
Long-term restricted
Investments
|
|
150
|
|
150
|
Other long-term
assets
|
|
261
|
|
1,085
|
Discontinued
operations, non-current portion
|
|
-
|
|
532
|
Total
assets
|
|
$
75,641
|
|
$
86,020
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable
|
|
$
1,678
|
|
$
1,982
|
Accrued liabilities
|
|
5,801
|
|
5,940
|
Contract research liability
|
|
545
|
|
3,653
|
Deferred revenue, current portion
|
|
-
|
|
22,679
|
Term loan, current portion, net
|
|
884
|
|
-
|
Operating lease liabilities, current portion
|
|
1,795
|
|
1,742
|
Discontinued operations, current portion
|
|
-
|
|
772
|
Total current
liabilities
|
|
10,703
|
|
36,768
|
|
|
|
|
|
Deferred revenue,
noncurrent portion
|
|
812
|
|
812
|
Operating lease
liabilities, noncurrent portion
|
|
3,202
|
|
4,356
|
Term loan, noncurrent
portion, net
|
|
19,936
|
|
20,262
|
Other long-term
liabilities
|
|
873
|
|
705
|
Discontinued
operations, non-current portion
|
|
-
|
|
257
|
|
|
|
|
|
Stockholders'
equity
|
|
40,115
|
|
22,860
|
Total liabilities and
stockholders' equity
|
|
$
75,641
|
|
$
86,020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Derived
from audited financial statements.
|
|
|
|
|
|
|
|
|
|
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SOURCE DURECT Corporation