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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Durect Corp | NASDAQ:DRRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.04 | 4.04% | 1.03 | 1.05 | 1.15 | 1.19 | 0.9712 | 1.02 | 177,793 | 00:35:28 |
CUPERTINO, Calif., Nov. 4, 2019 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended September 30, 2019 and provided a corporate update.
"Recent progress continues on both our proprietary and partnered clinical development programs, led by the completion of the DUR-928 Phase 2a alcoholic hepatitis study. The strength of the data from this study is underscored by its selection as an oral late-breaking presentation and for inclusion in the 'Best of The Liver Meeting' summary slide deck at the upcoming Liver Meeting® 2019," stated James E. Brown, D.V.M., President and CEO of DURECT. "In addition, we completed enrollment in the DUR-928 psoriasis trial and passed the half way point for enrollment in the DUR-928 NASH trial. In September we earned a $10 million development milestone under our exclusive license agreement with Gilead for a long-acting injectable HIV investigational product utilizing DURECT's SABER® technology."
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, first-in-class small molecule, which may have broad applicability in acute organ injuries such as alcoholic hepatitis (AH) and acute kidney injury (AKI), in chronic liver diseases such as non-alcoholic steatohepatitis (NASH), and in inflammatory skin disorders such as psoriasis and atopic dermatitis.
Clinical Trials
Alcoholic Hepatitis (AH)
Oral Late-Breaking Presentation Details: | |
Title: | Safety and Efficacy of DUR-928: A Potential New Therapy for Acute |
Date: | Tuesday, November 12, 2019 |
Time: | 8:30 a.m. Eastern Time |
Location: | Auditorium, Hynes Convention Center |
Session Title: | Late-Breaking Abstract Oral Session II |
Presentation Type: | Oral, Late-Breaking Session |
Publication Number: | LO9 |
Poster Presentation Details: | |
Title: | DUR-928 Therapy of Acute Alcoholic Hepatitis: A Pilot Study |
Date: | Sunday, November 10, 2019 |
Time: | 12:00 – 2:00 p.m. Eastern Time |
Presentation Type: | Poster Presentation |
Location: | Hynes Convention Center, Hall B |
Publication Number: | 1376 |
Non-Alcoholic Steatohepatitis (NASH)
Psoriasis
POSIMIR® (bupivacaine extended-release solution) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER® technology and is designed to deliver bupivacaine to provide up to 3 days of pain relief after surgery.
Gilead Agreement. In July 2019, we entered into an agreement with Gilead Sciences, Inc. (Gilead) granting Gilead the exclusive worldwide rights to develop and commercialize a long-acting injectable HIV investigational product utilizing our SABER technology. Gilead also received exclusive access to the SABER platform for HIV and Hepatitis B Virus (HBV) and the exclusive option to license additional SABER-based products directed to HIV and HBV. Under the terms of the agreement, Gilead made an upfront payment to us of $25 million, with the potential for up to an additional $75 million in development and regulatory milestones, up to an additional $70 million in sales-based milestones, as well as tiered royalties on product sales. In September 2019, we earned the first $10 million milestone payment under this program, which was received in the fourth quarter of 2019. Gilead has the exclusive option to license additional SABER-based products directed to HIV and HBV for an additional $150 million per product in upfront, development, regulatory and sales-based milestones as well as tiered royalties on sales. The parties will collaborate on specified development activities with Gilead controlling and funding the development programs.
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 third quarter 2019 results and provide a corporate update:
Toll Free: | 877-407-0784 |
International: | 201-689-8560 |
Conference ID: | 13695661 |
Webcast: | http://public.viavid.com/index.php?id=136610 |
A live audio webcast of the presentation will also be 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 actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 2 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 such as AH and acute kidney injury (AKI), chronic hepatic diseases such as NASH, and inflammatory skin conditions such as psoriasis and atopic dermatitis. DURECT's advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. Key product candidates in this category include POSIMIR® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery, and a long-acting injectable SABER-based HIV investigational product being developed with Gilead. For more information about DURECT, please visit www.durect.com.
NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928 and POSIMIR 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 DURECT's drug candidates, including, but not limited to, the potential use of DUR-928 to treat AH, hepatic and renal diseases such as NASH and AKI, and inflammatory skin conditions such as psoriasis and atopic dermatitis, the potential use of POSIMIR to treat post-operative pain, planned clinical trial announcements for the Phase 2a trial of DUR-928 in psoriasis in 2019 or for the Phase 1b trial in patients with NASH following anticipated trial completion in 2020, and the potential development of a long-acting injectable SABER-based HIV product with Gilead and associated potential payments to DURECT 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 risk of delays in clinical trials or adverse safety events from patients administered with DUR-928, the risk that the ongoing clinical trials of DUR-928 in NASH or psoriasis do not successfully achieve their endpoints, the risk that placebo controlled studies of DUR-928 required for regulatory approval will not replicate results from open label clinical trials or trials with small numbers of patients or historical controls, the risks that the long-acting injectable SABER-based HIV investigational product being developed with Gilead will not succeed or that Gilead will abandon this program, the risk that the FDA Advisory Committee will not recommend approval of POSIMIR or that the FDA will not approve POSIMIR, and the risk of delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of any of our product candidates. Further information regarding these and other risks related to DURECT is included in DURECT's Form 10-Q filed on August 2, 2019 under the heading "Risk Factors" and in subsequent reports that we file with the Securities and Exchange Commission.
1 Our advisor, Dr. Craig McClain from the University of Louisville (UL), shared anonymized data from his study, in which 15 AH patients with initial MELD scores ranging from 15-30 received either supportive care alone (n=8) or supportive care with corticosteroids (n=7). |
DURECT CORPORATION | |||||||||
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | |||||||||
(in thousands, except per share amounts) | |||||||||
(unaudited) | |||||||||
Three months ended | Nine months ended | ||||||||
September 30 | September 30 | ||||||||
2019 | 2018 | 2019 | 2018 | ||||||
Collaborative research and development and other revenue | $ 7,741 | $ 5,691 | $ 10,880 | $ 7,432 | |||||
Product revenue, net | 3,022 | 2,345 | 7,999 | 7,505 | |||||
Total revenues | 10,763 | 8,036 | 18,879 | 14,937 | |||||
Operating expenses: | |||||||||
Cost of product revenues | 731 | 912 | 2,746 | 3,170 | |||||
Research and development | 7,906 | 6,542 | 20,755 | 19,614 | |||||
Selling, general and administrative | 3,837 | 2,870 | 10,569 | 8,880 | |||||
Total operating expenses | 12,474 | 10,324 | 34,070 | 31,664 | |||||
Loss from operations | (1,711) | (2,288) | (15,191) | (16,727) | |||||
Other income (expense): | |||||||||
Interest and other income | 350 | 234 | 736 | 632 | |||||
Interest and other expense | (629) | (661) | (1,892) | (1,928) | |||||
Net other expense | (279) | (427) | (1,156) | (1,296) | |||||
Net loss | $ (1,990) | $ (2,715) | $(16,347) | $(18,023) | |||||
Net loss per share | |||||||||
Basic | $ (0.01) | $ (0.02) | $ (0.09) | $ (0.11) | |||||
Diluted | $ (0.01) | $ (0.02) | $ (0.09) | $ (0.11) | |||||
Weighted-average shares used in computing net loss per share | |||||||||
Basic | 192,039 | 162,002 | 172,939 | 159,091 | |||||
Diluted | 192,039 | 162,002 | 172,939 | 159,091 | |||||
Total comprehensive loss | $ (1,981) | $ (2,715) | $(16,345) | $(18,022) |
DURECT CORPORATION | |||
CONDENSED BALANCE SHEETS | |||
(in thousands) | |||
As of | As of | ||
September 30, 2019 | December 31, 2018(1) | ||
(unaudited) | |||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 39,726 | $ 31,644 | |
Short-term investments | 17,235 | 2,671 | |
Accounts receivable | 12,193 | 1,757 | |
Inventories, net | 3,618 | 3,421 | |
Prepaid expenses and other current assets | 970 | 2,247 | |
Total current assets | 73,742 | 41,740 | |
Property and equipment, net | 462 | 605 | |
Operating lease right-of-use assets | 6,397 | - | |
Goodwill | 6,399 | 6,399 | |
Long-term restricted Investments | 150 | 150 | |
Other long-term assets | 1,107 | 1,105 | |
Total assets | $ 88,257 | $ 49,999 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 1,501 | $ 1,589 | |
Accrued liabilities | 4,512 | 4,668 | |
Contract research liability | 2,089 | 1,405 | |
Deferred revenue, current portion | 27,582 | - | |
Term loan, current portion, net | 2,981 | - | |
Operating lease liabilities, current portion | 2,028 | - | |
Total current liabilities | 40,693 | 7,662 | |
Deferred revenue, noncurrent portion | 2,033 | 812 | |
Operating lease liabilities, noncurrent portion | 4,836 | - | |
Term loan, noncurrent portion, net | 17,970 | 20,533 | |
Other long-term liabilities | 719 | 992 | |
Stockholders' equity | 22,006 | 20,000 | |
Total liabilities and stockholders' equity | $ 88,257 | $ 49,999 | |
(1) Derived from audited financial statements. |
View original content:http://www.prnewswire.com/news-releases/durect-corporation-announces-third-quarter-2019-financial-results-and-update-of-programs-300950989.html
SOURCE DURECT Corporation
Copyright 2019 PR Newswire
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