- Total revenues were
$8.0 million and net loss was$2.7 million for the three months endedSeptember 30, 2018 as compared to total revenues of$20.7 million and net income of$6.1 million for the three months endedSeptember 30, 2017 . The third quarter of 2018 included a$5 million milestone payment fromIndivior related to theFDA approval of PERSERIS™ (risperidone). The third quarter of 2017 included$12.5 million in revenues from the upfront payment related to a patent purchase agreement withIndivior . - At
September 30, 2018 , cash and investments were$41.5 million , compared to cash and investments of$36.9 million atDecember 31, 2017 . Debt atSeptember 30, 2018 was$19.9 million .
“During the third quarter, we benefited from two product approvals through corporate relationships, most notably U.S.
Update on Selected Programs:
Epigenetic Regulator Program. DUR-928, the lead product candidate in the Company’s Epigenetic Regulator Program, is an endogenous, first-in-class small molecule, which may have broad applicability in several hepatic and renal diseases such as NASH and PSC, in acute organ injuries such as AH and acute kidney injury (AKI), and in inflammatory skin disorders such as psoriasis and atopic dermatitis.
Ongoing Clinical Trials
Alcoholic Hepatitis (AH)
DURECT is conducting a Phase 2a clinical trial with intravenously administered DUR-928 in patients with AH. This is an open label, dose escalation, multi-center U.S. study, originally designed to be conducted in two sequential parts. Part A includes patients with moderate AH (as determined by the Model of End-Stage Liver Disease (MELD) scores, a common scoring system to assess the severity and prognosis of AH patients), and Part B includes patients with severe AH. Three dose levels (30, 90 and 150 mg) are planned for testing in Part A. Dose escalation occurs following review of safety and pharmacokinetic (PK) results of the prior dose level by a Dose Escalation Committee (DEC). The target number of patients for the study is 4-6 per dose group. The objectives of this study include safety, PK and pharmacodynamic (PD) signals, including liver biochemistry and biomarkers. Additional information on the trial design, including eligibility criteria and site locations, can be found at www.clinicaltrials.gov using the NCT Identifier NCT03432260.- The Company recently completed dosing for the low-dose 30 mg cohort (n=4) of Part A (moderate AH patients). After completing the safety and PK review by the DEC,
DURECT plans to commence the 90 mg cohort in Part A. - The Company has amended the protocol so that after the DEC completes its review,
DURECT can begin enrolling Part B (severe AH patients), starting with the low dose, while it simultaneously continues enrolling Part A (moderate AH patients). The Company believes enrolling Part A and B simultaneously will accelerate the overall timeline for the trial. Over the course of the trial, the clinical sites have encountered many severe AH patients who may have qualified for Part B but were deemed screen failures due to their MELD scores being too high for Part A. - AH is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of alcohol, and encompasses a spectrum that ranges from mild injury to severe, life threatening liver damage. The prevalence of AH is estimated to occur in 10-35% of heavy drinkers. According to an article in the
Journal of Clinical Gastroenterology (2015 July; 49(6): 506-511), there were over 320,000 hospitalizations related to alcoholic hepatitis in 2010, resulting in hospitalization costs of nearly$50,000 per patient.
Primary Sclerosing Cholangitis (PSC)
- The Company is currently conducting a Phase 2a clinical trial in PSC with orally administered DUR-928. This is a randomized, open label, multi-center study with two cohorts (10 mg and 50 mg), in which patients (n = 15-20 per cohort) receive daily oral dosing of DUR-928 for four weeks with follow-up for an additional four weeks. The objectives of this study include safety, PK and PD signals, including the percent change from baseline of serum alkaline phosphatase (ALP) and other biomarkers. Additional information on the trial design, including eligibility criteria and site locations, can be found at www.clinicaltrials.gov using the NCT Identifier NCT03394781. To date, five PSC patients have been dosed, and as such the Company is not able to provide meaningful interim data at this time. The Company plans to continue enrolling patients and will provide an update when enrollment has reached a critical mass for data analysis.
- PSC is a chronic liver disease characterized by a progression of cholestasis (decrease in bile flow) with inflammation and fibrosis of bile ducts. DUR-928 has been awarded orphan drug designation for the PSC indication.
Planned Clinical Trials
Psoriasis
- The Company is planning to conduct a Phase 2a proof-of-concept trial with topical DUR-928 in patients with mild to moderate plaque psoriasis beginning in the first quarter of 2019. This will be a multicenter, randomized, double-blind, vehicle-controlled clinical trial conducted in the U.S. Approximately 20 subjects will be enrolled to obtain about 15 evaluable subjects in the study. DUR-928 will be applied topically once-daily for four weeks. Patients will serve as their own controls, as each patient will have similar contralateral plaques. DUR-928 will be applied to one plaque and the vehicle control will be applied to the contralateral plaque daily for four weeks. Patients will be followed for an additional four weeks and the primary efficacy endpoint will be improvement in local psoriasis scores in the DUR-928-treated plaque compared to the vehicle-treated plaque.
- The Company observed activity of DUR-928 in a previous exploratory Phase 1b trial utilizing intralesional injections of DUR-928 in psoriasis patients. In support of the upcoming study, it has completed multiple non-clinical safety studies for topically applied DUR-928.
- Skin inflammatory disorders, such as psoriasis and atopic dermatitis, affect approximately 7.5 million and 32 million Americans, respectively. Most currently available topical treatments, typically as first line therapy, either slow down excessive skin cell proliferation or reduce inflammation. Steroids are the most commonly used topical anti-inflammatory agents because they reduce the swelling and redness of lesions.
Non-Alcoholic Steatohepatitis (NASH)
DURECT is planning to conduct a clinical trial in NASH patients with orally-administered DUR-928 beginning in the first half of 2019. Further details on study design and timing will be provided as the Company gets closer to initiation. In the Company’s previous Phase 1b NASH study, reported at theEuropean Association for the Study of the Liver (EASL) inApril 2017 , a reduction of certain biomarkers after a single oral dose of DUR-928 was observed. Exploratory biomarker analysis indicated that a single oral dose of DUR-928 in NASH patients resulted in statistically significant reductions from baseline of both full-length and cleaved cytokeratin-18 (CK-18), bilirubin, hsCRP and IL-18.
Indivior Agreement and PERSERIS. In
Under the terms of the agreement,
POSIMIR® (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is the Company’s investigational post-operative pain relief depot that utilizes the Company’s patented SABER technology and is designed to deliver bupivacaine to provide up to 3 days of pain relief after surgery.
In
Methydur Sustained Release Capsules (ORADUR®-methylphenidate ER Capsules). In
In
Debt amendment. In
Upcoming investor conference.
Earnings Conference Call
A live audio webcast of a conference call to discuss third quarter 2018 results and provide a corporate update will be broadcast live over the internet at
About
NOTE: ORADUR®, POSIMIR® and SABER® are trademarks of
DURECT Forward-Looking Statement
The statements in this press release regarding clinical development plans for DUR-928, including potential acceleration of the Phase 2a trial in AH, the initiation of a Phase 2a trial in psoriasis, plans for a clinical trial in patients with NASH, and the disclosure of data from the Phase 2a trial in PSC, potential future payments from
DURECT CORPORATION
|
|||||||||
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS |
|||||||||
(in thousands, except per share amounts) |
|||||||||
(unaudited) |
|||||||||
Three months ended |
Nine months ended |
||||||||
September 30 |
September 30 |
||||||||
2018 |
2017 |
2018 |
2017 |
||||||
Collaborative research and development and other revenue |
$ 5,691 |
$ 5,602 |
$ 7,432 |
$ 7,304 |
|||||
Product revenue, net |
2,345 |
2,644 |
7,505 |
9,828 |
|||||
Revenue from sale of intellectual property rights |
– |
12,500 |
– |
12,500 |
|||||
Total revenues |
8,036 |
20,746 |
14,937 |
29,632 |
|||||
Operating expenses: |
|||||||||
Cost of product revenues |
912 |
3,105 |
3,170 |
5,572 |
|||||
Research and development |
6,542 |
8,378 |
19,614 |
25,005 |
|||||
Selling, general and administrative |
2,870 |
3,138 |
8,880 |
9,862 |
|||||
Total operating expenses |
10,324 |
14,621 |
31,664 |
40,439 |
|||||
Income (Loss) from operations |
(2,288) |
6,125 |
(16,727) |
(10,807) |
|||||
Other income (expense): |
|||||||||
Interest and other income |
234 |
605 |
632 |
680 |
|||||
Interest and other expense |
(661) |
(619) |
(1,928) |
(1,803) |
|||||
Net other expense |
(427) |
(14) |
(1,296) |
(1,123) |
|||||
Net income (loss) |
$ (2,715) |
$ 6,111 |
$(18,023) |
$(11,930) |
|||||
Net income (loss) per share |
|||||||||
Basic |
$ (0.02) |
$ 0.04 |
$ (0.11) |
$ (0.08) |
|||||
Diluted |
$ (0.02) |
$ 0.04 |
$ (0.11) |
$ (0.08) |
|||||
Weighted-average shares used in computing net income (loss) per share |
|||||||||
Basic |
162,002 |
147,213 |
159,091 |
143,873 |
|||||
Diluted |
162,002 |
151,885 |
159,091 |
143,873 |
|||||
Total comprehensive income (loss) |
$ (2,715) |
$ 6,114 |
$(18,022) |
$(11,927) |
DURECT CORPORATION
|
||||
CONDENSED BALANCE SHEETS |
||||
(in thousands) |
||||
As of |
As of |
|||
September 30, 2018 |
December 31, 2017(1) |
|||
(unaudited) |
||||
ASSETS |
||||
Current assets: |
||||
Cash and cash equivalents |
$ 38,217 |
$ 29,375 |
||
Short-term investments |
3,090 |
7,384 |
||
Accounts receivable |
1,606 |
2,376 |
||
Inventories, net |
3,485 |
3,163 |
||
Prepaid expenses and other current assets |
2,870 |
3,060 |
||
Total current assets |
49,268 |
45,358 |
||
Property and equipment, net |
677 |
929 |
||
Goodwill |
6,399 |
6,399 |
||
Long-term restricted Investments |
150 |
150 |
||
Other long-term assets |
366 |
277 |
||
Total assets |
$ 56,860 |
$ 53,113 |
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||
Current liabilities: |
||||
Accounts payable |
$ 1,152 |
$ 1,520 |
||
Accrued liabilities |
5,200 |
5,511 |
||
Contract research liability |
1,375 |
834 |
||
Deferred revenue, current portion |
13 |
682 |
||
Term loan, current portion, net |
10,390 |
7,281 |
||
Total current liabilities |
18,130 |
15,828 |
||
Deferred revenue, noncurrent portion |
812 |
1,093 |
||
Term loan, noncurrent portion, net |
9,500 |
12,634 |
||
Other long-term liabilities |
2,324 |
2,070 |
||
Stockholders’ equity |
26,094 |
21,488 |
||
Total liabilities and stockholders’ equity |
$ 56,860 |
$ 53,113 |
||
(1) Derived from audited financial statements. |
View original content:http://www.prnewswire.com/news-releases/durect-corporation-announces-third-quarter-2018-financial-results-and-provides-corporate-update-300745947.html
SOURCE
Michael Arenberg, Chief Financial Officer, DURECT Corporation, 408-346-1052