DURECT Corporation Announces Fourth Quarter and Full Year 2019 Financial Results and Update of Programs
CUPERTINO, Calif., March 3, 2020 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months and year ended December 31, 2019 and provided a corporate update.
-- Total revenues were $10.7 million and net loss was $4.2 million for the
three months ended December 31, 2019 as compared to total revenues of
$3.6 million and net loss of $7.3 million for the three months ended
December 31, 2018.
-- Total revenues were $29.6 million and net loss was $20.6 million for the
year ended December 31, 2019, compared to total revenues of $18.6
million and net loss of $25.3 million for the year ended December 31,
2018.
-- At December 31, 2019, cash and investments were $64.8 million, compared
to cash and investments of $34.5 million at December 31, 2018. Debt at
December 31, 2019 was $20.3 million, compared to $20.5 million at
December 31, 2018.
"The highlight of the year for DURECT in 2019 was achieving positive results from our DUR-928 Phase 2a alcoholic hepatitis (AH) study, which were featured in multiple presentations at the Liver Meeting(®) 2019, including a late-breaking oral presentation by Dr. Tarek Hassanein," stated James E. Brown, D.V.M., President and CEO of DURECT. "In addition, we have already exceeded our 60 patient enrollment target in the ongoing NASH trial, and the last patient is scheduled to begin the 28-day dosing period next week. We are on track to announce top-line NASH data mid-year. We are also making steady progress toward starting a Phase 2b AH clinical trial by mid-year. In January 2020, the FDA held an Advisory Committee meeting to discuss our POSIMIR NDA resubmission. Subsequently, we have continued to interact with FDA as they continue their review."
Potential major milestones in 2020:
-- Initiation of Phase 2b trial of DUR-928 in AH: mid-year
-- Reporting top-line data from the DUR-928 one-month daily dose trial in
NASH: mid-year
-- POSIMIR(®) FDA decision
-- Commercial partnership if POSIMIR is approved
-- 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 AH, and in chronic liver diseases such as non-alcoholic steatohepatitis (NASH).
Clinical Trials
Alcoholic Hepatitis (AH)
-- During 2019, we completed a Phase 2a clinical trial of DUR-928 in
patients with AH. The study results were presented as a late-breaking
oral presentation at The Liver Meeting(®) 2019 by Dr. Tarek Hassanein,
one of the trial's principal investigators. In a separate poster
presentation, Dr. Craig McClain presented additional comparative data
from the Phase 2a clinical trial of DUR-928 and a control group of
severe AH patients treated with corticosteroids in a contemporaneous AH
trial conducted at University of Louisville. Additionally, the DUR-928
results were selected for inclusion in the "Best of The Liver Meeting"
summary slide deck in the Alcohol-related Liver Disease category.
Inclusion in this slide deck is considered a singular honor and
indicates the high level with which the AASLD review committee regarded
this study.
-- All 19 patients treated with DUR-928 in the AH trial survived the 28-day
follow-up period and there were no drug-related serious adverse events.
Patients treated with DUR-928 had a statistically significant reduction
from baseline in bilirubin at days 7 and 28, and model of end-stage
liver disease (MELD) at day 28. Lille scores were also statistically
significantly lower than those from a well-matched group of patients in
a contemporary trial as well as from several published comparable
historical control groups. Seventy four percent of all DUR-928 treated
patients and 67% of those with severe AH were discharged from the
hospital within four days of receiving a single dose of DUR-928.
-- DUR-928 AH Phase 2a trial design: The open-label, dose escalation,
multi-center study was designed to determine the safety,
pharmacokinetics and pharmacodynamic signals of DUR-928 in AH patients
following treatment. This included assessing liver biochemistry,
biomarkers, and prognostic scores such as the Lille score. Final
enrollment included 19 patients with moderate and severe AH, who were
administered DUR-928 intravenously at three different doses. Eight
patients (four moderate and four severe) were dosed at 30 mg, seven
patients (three moderate and four severe) were dosed at 90 mg and four
patients (all severe) were dosed at 150 mg. After being discharged on
day two, one patient did not return for the scheduled day 7 and day 28
follow-up visits (this patient did survive through day 28); therefore
Lille, bilirubin and MELD data reported above are based on 18 patients.
-- 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 recent onset jaundice and hepatic failure. 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.
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 117,000 hospitalizations for
patients with alcoholic hepatitis in 2016. From a recent publication
analyzing the mortality and costs associated with alcoholic hepatitis,
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 $800,000 per patient.
-- We are working with the FDA and our advisors to finalize the design of a
multi-center, international, randomized, double blind,
placebo-controlled Phase 2b clinical trial of DUR-928 in AH patients. We
are planning to initiate the trial in mid-2020. Based on our current
working assumptions related to trial design, number of clinical trial
sites and enrollment rates, top-line data for this trial may be
available in 2022.
Non-Alcoholic Steatohepatitis (NASH)
-- We have exceeded our 60 patient enrollment target in the ongoing NASH
trial, and the last patient is scheduled to begin the 28-day dosing
period next week. The trial is a Phase 1b randomized and open-label
clinical study being 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 MRI and ultrasonic imaging, respectively) of DUR-928 in
NASH patients with stage 1-3 fibrosis. DUR-928 (at doses of 50 mg QD,
150 mg QD or 300 mg BID) is administered orally for 28 consecutive days
with approximately 20 or more patients per dose group for a total of
over 60 patients in the trial.
-- We expect all patients to complete their dosing and follow up visits in
the first half of 2020 and expect to announce top-line study results
mid-year.
-- 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.
Psoriasis
-- In January 2020, we announced the results from a Phase 2a clinical trial
of DUR-928 in patients with mild to moderate plaque psoriasis.
Twenty-two patients completed the study, applying DUR-928 topically to
the plaque on one arm and the vehicle (placebo) to a similar plaque on
the other arm daily for 28 days. DUR-928 did not demonstrate a benefit
over vehicle (placebo) based on Investigator's Global Assessment (IGA),
or in any of the secondary analyses, including Local Psoriasis Severity
Index (LPSI). However, at the end of the 4-week daily application
period, plaques in both the DUR-928 and vehicle treatment groups were
significantly improved over baseline with respect to both IGA and LPSI
scores. In fact, 90% of plaques in both groups had at least a 1 point
reduction in LPSI score after the 4-week daily application period as
compared to baseline. Daily topical application of DUR-928 was well
tolerated with no meaningful differences in adverse events between the
treatment and vehicle (placebo) groups. Based on the top-line data, we
do not plan to continue development of topical DUR-928 in psoriasis at
this time and will focus our near- term development activities on AH and
NASH.
POSIMIR(®) (bupivacaine extended-release solution) Post-Operative Pain Relief Depot. POSIMIR is the Company's investigational post-operative pain relief depot that uses the Company's patented SABER technology and is designed to deliver bupivacaine to provide up to 3 days of pain relief after surgery.
-- After a comprehensive review of the POSIMIR program in light of the
issues raised by the FDA in our communications with them, including the
Complete Response Letter (CRL), we prepared and submitted a response to
the CRL in June 2019. The FDA initially assigned a user fee goal date of
December 27, 2019, but subsequently scheduled a meeting of the
Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) for
January 16, 2020; a new user fee goal date has not been assigned. At the
meeting, six Advisory Committee members voted to recommend that the
efficacy, safety, and overall risk-benefit profile of POSIMIR support
approval, while six did not recommend approval based on the information
presented. Although the FDA considers the recommendations of the
Advisory Committee, the recommendations by the panel are non-binding.
-- Since the Advisory Committee meeting, we have continued to interact with
the FDA as they continue their review.
-- The efforts to evaluate the program, develop a strategy for filing the
response, and preparing the response, have been under the direction of
Dr. Lee Simon, who was formerly the FDA's Division Director of
Analgesic, Anti-inflammatory and Ophthalmologic Drug Products. Dr. Simon
also led our preparation efforts for the Advisory Committee meeting.
-- POSIMIR has not been approved by the FDA for marketing in the U.S. for
any indication and there can be no assurance that FDA will approve the
planned submission described above.
Gilead Collaboration. The investigational long-acting injectable HIV product using DURECT's SABER technology under development with Gilead is currently being re-formulated and will undergo additional pre-clinical development work.
Debt Amendment. In December 2019, the Company amended its existing $20 million term loan with Oxford Finance such that principal payments will commence 18 months later than previously scheduled (i.e., commencing December 1, 2021 rather than June 1, 2020) and the final maturity date has been moved back by 18 months (i.e., from November 1, 2022 to May 1, 2024). The interest rate and final payment remain unchanged, and the Company paid Oxford Finance an amendment fee of $825,000.
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 2019 results and provide a corporate update:
Toll Free:
877-407-0784
International:
201-689-8560
Conference ID: 13698601
Webcast:
http://public.viavid.com/index.php?id=137885
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. DURECT's lead candidate, DUR-928, has demonstrated the ability to regulate the expression of genes involved in lipid metabolism, inflammatory responses and cell survival. This drug candidate is currently in Phase 2 development for the treatment of alcoholic hepatitis (AH) and Phase 1 development for the treatment of nonalcoholic steatohepatitis (NASH). DURECT's proprietary drug delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. A key product candidate in this category is POSIMIR(®) (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery. DURECT has also entered into an agreement with Gilead Sciences to develop and commercialize a long-acting injectable HIV investigational product using DURECT's SABER® technology. For more information about DURECT, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding clinical development and plans for DUR-928, including plans to announce top-line data from the Phase 1b NASH trial by mid-year, and initiate a Phase 2b trial of DUR-928 in AH by mid-year, potential regulatory approval of POSIMIR, potential commercial relationships for POSIMIR if approved or other license and collaboration agreements, and the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat acute organ injuries such as AH and chronic liver diseases such as NASH, 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 future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not replicate the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or POSIMIR, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to successfully re-formulate the investigational long-acting injectable HIV product under development with Gilead, our potential failure to maintain our collaborative agreements with third parties or consummate new collaborations 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 5, 2019 under the heading "Risk Factors."
NOTE: POSIMIR(®) and SABER(®) are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928 and POSIMIR are investigational drug candidates under development and have 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 Twelve months ended
December 31
December 31
2019 2018 2019 2018
Collaborative research and
development and other revenue $7,249 $775 $18,129 $8,207
Product revenue, net 3,436 2,852 11,435 10,357
Total revenues 10,685 3,627 29,564 18,564
Operating expenses:
Cost of product revenues 1,397 1,093 4,143 4,263
Research and development 9,454 5,887 30,209 25,501
Selling, general and administrative 3,794 3,539 14,363 12,419
Total operating expenses 14,645 10,519 48,715 42,183
Loss from operations (3,960) (6,892) (19,151) (23,619)
Other income (expense):
Interest and other income 338 238 1,074 870
Interest and other expense (609) (645) (2,501) (2,573)
Net other expense (271) (407) (1,427) (1,703)
Net loss $(4,231) $(7,299) $(20,578) $(25,322)
Net loss per share
Basic $(0.02) $(0.05) $(0.12) $(0.16)
Diluted $(0.02) $(0.05) $(0.12) $(0.16)
Weighted-average shares used in
computing net loss per share
Basic 193,181 162,040 178,042 159,834
Diluted 193,181 162,040 178,042 159,834
Total comprehensive loss $(4,236) $(7,299) $(20,581) $(25,321)
DURECT CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
As of
As of
December 31, 2019
December 31, 2018(1)
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $34,924 $31,644
Short-term investments 29,750 2,671
Accounts receivable 2,313 1,757
Inventories, net 3,383 3,421
Prepaid expenses and other current
assets 1,459 2,247
Total current assets 71,829 41,740
Property and equipment, net 469 605
Operating lease right-of-use assets 6,066
Goodwill 6,399 6,399
Long-term restricted Investments 150 150
Other long-term assets 1,107 1,105
Total assets $86,020 $49,999
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $2,109 $1,589
Accrued liabilities 6,284 4,668
Contract research liability 3,653 1,405
Deferred revenue, current portion 22,679
Operating lease liabilities, current
portion 2,043
Total current liabilities 36,768 7,662
Deferred revenue, noncurrent portion 812 812
Operating lease liabilities,
noncurrent portion 4,517
Term loan, noncurrent portion, net 20,262 20,533
Other long-term liabilities 801 992
Stockholders' equity 22,860 20,000
Total liabilities and stockholders'
equity $86,020 $49,999
(1) Derived from audited financial statements.
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