PR Newswire
CUPERTINO, Calif., May 10, 2017
CUPERTINO, Calif., May 10, 2017 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended March 31, 2017 and provided a corporate update.
"We are very pleased to have a company with the market presence and resources of Sandoz to commercialize POSIMIR® in the United States," stated James E. Brown, D.V.M., President and CEO of DURECT. "Recent enrollment rates for PERSIST, the POSIMIR pivotal Phase 3 clinical trial in post-operative pain, are ahead of schedule and support completion of dosing in the second quarter of 2017, which would position us to announce top-line results in the fourth quarter of this year. We were also pleased to present at a major scientific meeting the results from our Phase 1b NASH study in which we observed promising decreases in certain cell death markers, an improvement of a key biomarker of liver function, and decreases in certain biomarkers associated with inflammation, in each case from a single oral dose of DUR-928, the lead molecule in our Epigenetic Regulator Program."
Update on Selected Programs:
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.
Epigenetic Regulator Program. DUR-928, the lead product candidate in our Epigenetic Regulator Program, 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 skin disorders such as psoriasis.
Oral Administration
Injectable Administration
Topical Administration
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.
ORADUR-ADHD Program. ORADUR-Methylphenidate is an investigational drug that has the potential for rapid onset of action and 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. Orient Pharma, our licensee in defined Asian and South Pacific countries, has completed dosing a Phase 3 study in Taiwan and anticipates obtaining top-line results from that study in the second quarter of 2017. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan.
Earnings Conference Call
A live audio webcast of a conference call to discuss first quarter 2017 results and provide a corporate update will be broadcast live over the internet at 4:30 p.m. Eastern Time on May 10 and is available by accessing DURECT's homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT's website under Audio Archive in the "Investor Relations" section.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury, chronic metabolic diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other liver diseases with both broad and orphan populations, and inflammatory skin conditions such as psoriasis. DURECT's advanced oral, injectable, and transdermal delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR® technology. For more information, please visit www.durect.com.
NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. POSIMIR, DUR-928, REMOXY ER and ORADUR-Methylphenidate are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
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 POSIMIR and ORADUR-methylphenidate, potential regulatory approvals of POSIMIR and REMOXY ER, potential markets for our product candidates, potential closing of the agreement with Sandoz for POSIMIR and potential payments under that agreement, and Pain Therapeutics' plans for REMOXY ER 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 do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, that the PERSIST clinical trial of POSIMIR will take longer to conduct than anticipated or result in data that will not support a successful NDA resubmission or product approval, that Pain Therapeutics may not be able to adequately address all of FDA's concerns regarding the REMOXY ER NDA or that there could be a delay in addressing such concerns, the potential that FDA may not grant regulatory approval of POSIMIR or REMOXY ER, the risks of obtaining marketplace acceptance of POSIMIR or REMOXY ER, if approved, the risk of delays in the commencement, enrollment or completion of other clinical trials, the risk that prior clinical trials (including prior trials of POSIMIR in laparoscopic cholecystectomy patients and Phase 1b trials of DUR-928) will not be confirmed in subsequent trials, the potential failure of clinical trials to meet their intended endpoints, the risk that Pain Therapeutics or Orient Pharma will discontinue development of REMOXY ER or ORADUR-Methylphenidate, respectively, or be delayed in development or regulatory submissions, the risk that the Sandoz agreement for POSIMIR will not close or that future milestones under that agreement will not be achieved, the risk of adverse decisions by regulatory agencies or delays and additional costs due to requirements imposed by regulatory agencies, additional time and resources that may be required for development, testing and regulatory approval of DUR-928, potential adverse effects arising from the testing or use of our drug candidates, 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-K filed on March 29, 2017 under the heading "Risk Factors."
DURECT CORPORATION | |||||||
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CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | |||||||
(in thousands, except per share amounts) | |||||||
(unaudited) | |||||||
| | | | | | | |
| | | | | | | |
| | | Three months ended | | | ||
| | | March 31 | | | ||
| | | 2017 | | 2016 | | |
| | | | | | | |
Collaborative research and development and other revenue | $ 434 | | $ 419 | | | ||
Product revenue, net | 4,133 | | 3,189 | | | ||
| Total revenues | 4,567 | | 3,608 | | | |
| | | | | | | |
Operating expenses: | | | | | | ||
| Cost of product revenues | 1,543 | | 1,242 | | | |
| Research and development | 7,548 | | 6,625 | | | |
| Selling, general and administrative | 3,043 | | 3,062 | | | |
Total operating expenses | 12,134 | | 10,929 | | | ||
| | | | | | | |
Loss from operations | (7,567) | | (7,321) | | | ||
| | | | | | | |
Other income (expense): | | | | | | ||
| Interest and other income | 36 | | 27 | | | |
| Interest and other expense | (583) | | (558) | | | |
Net other income (expense) | (547) | | (531) | | | ||
| | | | | | | |
Net loss | | $ (8,114) | | $ (7,852) | | | |
| | | | | | | |
Net loss per share | | | | | | ||
| Basic | | $ (0.06) | | $ (0.06) | | |
| Diluted | | $ (0.06) | | $ (0.06) | | |
| | | | | | | |
Weighted-average shares used in computing net loss per share | | | | | | ||
| Basic | | 141,815 | | 122,149 | | |
| Diluted | | 141,815 | | 122,149 | | |
| | | | | | | |
Total comprehensive loss | $ (8,116) | | $ (7,835) | | |
DURECT CORPORATION | ||||
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CONDENSED BALANCE SHEETS | ||||
(in thousands) | ||||
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| | As of | | As of |
| | March 31, 2017 | | December 31, 2016(1) |
| | (unaudited) | | |
ASSETS | | | | |
Current assets: | | | | |
Cash and cash equivalents | | $ 4,272 | | $ 5,404 |
Short-term investments | | 12,406 | | 19,600 |
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