- Total revenues were
$3.5 million and net loss was$8.8 million for the three months endedDecember 31, 2016 as compared to total revenues of$5.2 million and net loss of$5.8 million for the three months endedDecember 31, 2015 . - Total revenues were
$14.0 million and net loss was$34.5 million for the year endedDecember 31, 2016 , compared to total revenues of$19.1 million and net loss of$22.7 million for the year endedDecember 31, 2015 . - At
December 31, 2016 , cash and investments were$25.2 million , compared to cash and investments of$29.3 million atDecember 31, 2015 . Debt atDecember 31, 2016 was$19.9 million .
“For DUR-928, our novel epigenetic regulator which has potential for broad utility in metabolic disorders, acute organ injury and inflammatory conditions, we have completed six Phase 1 clinical trials to date, including dosing over 140 healthy volunteers and patients,” stated
Expected milestones in 2017:
- Reporting of DUR-928 Phase 1b and other data at scientific meetings, including the
AASLD Emerging Trends Conference (March) and EASL (April) - Commencing at least one Phase 2 trial with DUR-928, with primary sclerosing cholangitis (PSC) likely the first oral indication to be pursued
- Selecting lead topical formulations for DUR-928 that will be taken into a proof-of-concept clinical trial in psoriasis patients
- Completing enrollment in the Phase 3 POSIMIR clinical trial (PERSIST) in post-operative pain and announcing top-line results
- Potentially establishing a commercial partner for POSIMIR
- Reporting on top-line results from the Phase 3 trial with ORADUR®-Methylphenidate in
Taiwan conducted by our partnerOrient Pharma
Update on Selected Programs:
Epigenetic Regulator Program. DUR-928, our Epigenetic Regulator Program’s lead product candidate, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic steatohepatitis (NASH) and other disorders of the liver, in acute organ injuries such as acute kidney injury, and in autoimmune/inflammatory disorders such as psoriasis.
Oral Formulation
- Our first patient trial utilizing DUR-928 was an open-label, single-ascending-dose safety and pharmacokinetic (PK) Phase 1b trial in liver function impaired (NASH) patients and matched control subjects. This study was conducted in
Australia , evaluating single-dose levels (first a low dose and then a high dose) of orally administered DUR-928 in successive cohorts. Twenty subjects with NASH and 12 matched control subjects received DUR-928. - We observed a dose dependent reduction of certain biomarkers after a single oral dose of DUR-928. In both cohorts, IL-18, an inflammatory mediator implicated in both liver and kidney diseases, decreased hours after DUR-928 dosing, with the effect greater in the NASH patients. Full length CK-18 (a generalized cell death marker) and cleaved CK-18 (a cell apoptosis marker) were both greatly reduced after low and high doses of DUR-928, with the effect, again, more pronounced in NASH patients.
- An abstract for this study has been accepted and data from the study will be presented at the International Liver Congress™ 2017 organized by the
European Association for the Study of the Liver (EASL) inAmsterdam ,April 19-23, 2017 . - An abstract describing our two STAM™ NASH mouse model studies has been accepted at the
AASLD Emerging Trends Conference 2017: Emerging Trends in Non-alcoholic Fatty Liver Disease inWashington, DC . That data will be presented onMarch 17, 2017 . - We will be participating in and presenting at
4:40 pm at theH.C. Wainwright NASH Investor Conference taking place onApril 3, 2017 at theSt. Regis Hotel inNew York . - We are actively working towards a Phase 2 trial in Primary Sclerosing Cholangitis (PSC), with an oral formulation of DUR-928. PSC is a chronic liver disease characterized by a progressive cause of cholestasis (decrease in bile flow) with inflammation and fibrosis of bile ducts. It is an orphan medical condition for which there is no established medical treatment.
Injectable Formulation
- Our second Phase 1b study with DUR-928, also being conducted in
Australia , is an open-label, single-ascending-dose safety and pharmacokinetic study in patients with impaired kidney function (stage 3 and 4 chronic kidney disease) and matched control subjects. - This study is being conducted in successive cohorts evaluating single-dose levels (first a low dose and then a high dose) of DUR-928 administered by intramuscular injection. The low dose cohort consisted of 6 kidney function impaired patients and 3 matched control subjects.
- Data from the low dose cohort showed the PK parameters between the kidney function impaired patients and the matched control subjects were comparable. After a PK/safety review of this cohort, patients are now being enrolled in the high dose cohort, utilizing a dose four times larger than the low dose cohort.
- We are working closely with expert advisors to design Phase 2 trials in one or more indications with an injectable formulation of DUR-928.
Topical Formulation
- We conducted an initial exploratory Phase 1b trial in psoriasis patients (n = 9 evaluable patients) in Australia. The decision to proceed with clinical testing in psoriasis was based on the anti-inflammatory and cell survival properties of DUR-928, including the downregulation of IL-17, full length CK-18, cleaved CK-18, as well as the results of a psoriasis study with DUR-928 in mice.
- The Phase 1b trial was conducted with intradermal micro injections of DUR-928, and we feel the results warrant further investigation. As a result, we have developed several topical formulations of DUR-928 that we are evaluating for a topical application microplaque trial which we expect to commence this year. We believe that there is a large unmet medical need for new topical drugs for psoriasis for use prior to systemic biologic treatments which often have significant associated side effects.
POSIMIR (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to 3 days of pain relief after surgery. We are in negotiations with a number of potential partners regarding licensing development and commercialization rights to POSIMIR, for which we hold worldwide rights.
- We expect to finish dosing patients in PERSIST, a POSIMIR Phase 3 clinical trial consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery, in the third quarter of 2017 and to have top-line results this year.
- In a previous clinical trial of 50 patients in the same surgical model (laparoscopic cholecystectomy), POSIMIR was compared with the active control bupivacaine HCl, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024) and for the first 2 days after surgery (p=0.0198), using the same statistical methodology specified for the current trial. There can be no assurance that the PERSIST trial will replicate these results.
REMOXY® ER (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, the investigational drug REMOXY ER is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse.
- In
September 2016 ,Pain Therapeutics (our licensee) received a Complete Response Letter from theFDA for REMOXY ER. Based on its review, theFDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval. - We understand from its public disclosures that
Pain Therapeutics had a meeting with theFDA inFebruary 2017 to discuss the regulatory path forward for REMOXY ER, and thatPain Therapeutics will provide details of theFDA meeting after receipt of the final meeting minutes.
ORADUR-ADHD Program. ORADUR-Methylphenidate is an investigational drug that has the potential for rapid onset of action, long duration with once-a-day dosing, utilizes a small capsule size relative to the leading existing long-acting products on the market and incorporates our ORADUR anti-tampering technology.
Feasibility Projects and Other Activities. During the fourth quarter of 2016 and in 2017, we continued work on feasibility projects funded by large pharmaceutical companies as a means of demonstrating that our technologies can achieve the drug delivery objectives set forth by our collaborators and are worthy of further development.
Earnings Conference Call
A live audio webcast of a conference call to discuss fourth quarter 2016 results and provide a corporate update will be broadcast live over the internet at
About
NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of
DURECT Forward-Looking Statement
The statements in this press release regarding the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat NASH, other disorders of the liver, kidney diseases or psoriasis or other inflammatory conditions, the potential use of POSIMIR to treat pain, the potential abuse deterrent properties of REMOXY ER and the potential use of ORADUR-ADHD to treat ADHD, clinical trial plans for DUR-928, POSIMIR and our other product candidates (including timing and potential results), potential reporting of Phase 3 results for ORADUR-methylphenidate, potential regulatory approvals of POSIMIR and REMOXY ER, potential markets for our product candidates, potential plans to license commercialization rights for POSIMIR and
DURECT CORPORATION |
||||||||||
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS |
||||||||||
Three months ended |
Twelve months ended |
|||||||||
December 31 |
December 31 |
|||||||||
2016 |
2015 |
2016 |
2015 |
|||||||
Collaborative research and development and other revenue |
$ 738 |
$ 2,264 |
$ 1,880 |
$ 7,832 |
||||||
Product revenue, net |
2,779 |
2,903 |
12,145 |
11,292 |
||||||
Total revenues |
3,517 |
5,167 |
14,025 |
19,124 |
||||||
Operating expenses: |
||||||||||
Cost of product revenues |
955 |
993 |
5,290 |
3,905 |
||||||
Research and development |
7,992 |
6,658 |
29,274 |
24,317 |
||||||
Selling, general and administrative |
2,832 |
2,845 |
11,825 |
11,566 |
||||||
Total operating expenses |
11,779 |
10,496 |
46,389 |
39,788 |
||||||
Loss from operations |
(8,262) |
(5,329) |
(32,364) |
(20,664) |
||||||
Other income (expense): |
||||||||||
Interest and other income |
31 |
43 |
143 |
237 |
||||||
Interest and other expense |
(580) |
(559) |
(2,288) |
(2,236) |
||||||
Net other income (expense) |
(549) |
(516) |
(2,145) |
(1,999) |
||||||
Net loss |
$ (8,811) |
$ (5,845) |
$(34,509) |
$(22,663) |
||||||
Net loss per share |
||||||||||
Basic |
$ (0.06) |
$ (0.05) |
$ (0.26) |
$ (0.19) |
||||||
Diluted |
$ (0.06) |
$ (0.05) |
$ (0.26) |
$ (0.19) |
||||||
Weighted-average shares used in computing net loss per share |
||||||||||
Basic |
139,636 |
120,911 |
133,163 |
118,523 |
||||||
Diluted |
139,636 |
120,911 |
133,163 |
118,523 |
||||||
Total comprehensive loss |
$ (8,819) |
$ (5,925) |
$(34,498) |
$(22,764) |
DURECT CORPORATION |
|||||
CONDENSED BALANCE SHEETS |
|||||
(in thousands) |
|||||
As of |
As of |
||||
December 31, 2016 |
December 31, 2015(1) |
||||
(unaudited) |
|||||
ASSETS |
|||||
Current assets: |
|||||
Cash and cash equivalents |
$ 5,404 |
$ 3,583 |
|||
Short-term investments |
19,600 |
25,457 |
|||
Accounts receivable |
1,154 |
2,222 |
|||
Inventories |
3,782 |
3,917 |
|||
Prepaid expenses and other current assets |
2,486 |
3,142 |
|||
Total current assets |
32,426 |
38,321 |
|||
Property and equipment, net |
1,297 |
1,566 |
|||
Goodwill |
6,399 |
6,399 |
|||
Long-term restricted Investments |
150 |
250 |
|||
Other long-term assets |
236 |
236 |
|||
Total assets |
$ 40,508 |
$ 46,772 |
|||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|||||
Current liabilities: |
|||||
Accounts payable |
$ 2,086 |
$ 1,286 |
|||
Accrued liabilities |
5,060 |
4,970 |
|||
Contract research liability |
783 |
575 |
|||
Deferred revenue, current portion |
968 |
616 |
|||
Term loan, current portion, net |
19,853 |
– |
|||
Total current liabilities |
28,750 |
7,447 |
|||
Deferred revenue, noncurrent portion |
1,879 |
2,269 |
|||
Term loan, noncurrent portion, net |
– |
19,684 |
|||
Other long-term liabilities |
1,541 |
2,489 |
|||
Stockholders’ equity |
8,338 |
14,883 |
|||
Total liabilities and stockholders’ equity |
$ 40,508 |
$ 46,772 |
(1) Derived from audited financial statements. |
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/durect-corporation-announces-fourth-quarter-and-full-year-2016-financial-results-and-update-of-programs-300423515.html
SOURCE
Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936; Matthew Duffy, Managing Director, LifeSci Advisors, 212-915-0685