PR Newswire
CUPERTINO, Calif., Aug. 3, 2020
CUPERTINO, Calif., Aug. 3, 2020 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended June 30, 2020 and provided a corporate update.
"We continued to make progress in our clinical programs investigating DUR-928, our lead epigenetic regulator, during the second quarter. We were pleased to report positive topline data from our Phase 1b NASH trial and we look forward to presenting additional data from the trial at a future scientific meeting," stated James E. Brown, D.V.M., President and CEO of DURECT. "We also initiated a Phase 2 trial of DUR-928 in COVID-19 patients with acute liver or kidney injury and are finalizing our preparations to initiate the Phase 2b trial with DUR-928 in alcoholic hepatitis in the upcoming months. The review of our New Drug Application (NDA) for POSIMIR is also ongoing and we continue to respond to the Agency's requests for information."
Update on Selected Programs:
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 alcoholic hepatitis (AH) and coronavirus disease 2019 (COVID-19) patients with acute liver or kidney injury as well as in chronic liver diseases such as non-alcoholic steatohepatitis (NASH).
Clinical Development
Alcoholic Hepatitis (AH)
Non-Alcoholic Steatohepatitis (NASH)
Median at Day 28 * p < 0.05 ** p < 0.01 *** p < 0.001 | All Subjects | Patients with ≥ 10% Reduction in MRI-PDFF | |||||
50 mg QD (n=21-23) | 150 mg QD (n=20-21) | 300 mg BID (n=20-21) | 50 mg QD (n=9) | 150 mg QD (n=8) | 300 mg BID (n=9) | ||
Liver Enzymes | ALT | -16%* | -10% | -17%*** | -21%** | -19%* | -32%*** |
AST | -14% | -9% | -18%** | -24%** | -21% | -39%*** | |
GGT | -6% | -1% | -8%* | -13%*** | -16%* | -14% | |
Imaging | MRI-PDFF | -7% | -7% | -4% | -18%*** | -19%*** | -23%*** |
FibroScan | -10%** | -9% | -1% | -7% | -9%** | -9% | |
Serum Lipids | LDL-C | -6% | -11%* | -7% | -7% | -11% | -8%* |
Non-HDL-C | -8% | -5% | -1% | -10% | -8%* | -12%* | |
Triglycerides | -13%* | -3% | -2% | -9% | 0% | -8% | |
24% reduction in serum triglycerides in patients with elevated baseline triglycerides (≥200 mg/dL; n=16) across all dose groups at day 28 from baseline (p <0.01) |
ALT (alanine aminotransferase); AST (aspartate aminotransferase); GGT (gamma-glutamyl transferase); LDL-C ( Low-Density Lipoprotein – Cholesterol); Non-HDL-C (Total cholesterol excluding High-Density Lipoprotein-Cholesterol); QD (once a day); BID (twice a day); MRI-PDFF (Magnetic Resonance Imaging - Proton Density Fat Fraction) is a non-invasive measure of the proportion of liver tissue which is composed of fat; FibroScan is a specialized ultrasound machine that measures the stiffness of liver tissue. |
COVID-19
POSIMIR® (bupivacaine extended-release solution) Post-Operative Pain Relief Depot. POSIMIR is DURECT'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.
Conference Call
We will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss second quarter 2020 results and provide a corporate update:
Monday, August 3 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time
Toll Free: 877-407-0784
International: 201-689-8560
Conference ID: 13706541
Webcast: http://public.viavid.com/index.php?id=140595
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 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 is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival. This drug candidate is currently in Phase 2 development for the treatment of alcoholic hepatitis (AH) and the treatment of COVID-19 patients with acute liver or kidney injury as well as 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. One late-stage 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. 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 announcing further data from the Phase 1b NASH trial, initiating a Phase 2b trial of DUR-928 in AH in the second half of 2020, plans to enroll patents in a Phase 2 study in hospitalized COVID-19 infected patients with acute liver or kidney injury, potential regulatory approval of POSIMIR, 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 COVID-19 patients with acute liver or kidney injury as well as 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 generate similar positive results as generated in 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 of disruptions to our business operations resulting from the COVID-19 pandemic, 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 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 May 11, 2020 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 INCOME (LOSS) | |||||||||
(in thousands, except per share amounts) | |||||||||
(unaudited) | |||||||||
Three months ended | Six months ended | ||||||||
June 30 | June 30 | ||||||||
2020 | 2019 | 2020 | 2019 | ||||||
Collaborative research and development and other revenue | $ 23,347 | $ 1,639 | $ 23,317 | $ 3,139 | |||||
Product revenue, net | 2,497 | 2,346 | 5,302 | 4,977 | |||||
Total revenues | 25,844 | 3,985 | 28,619 | 8,116 | |||||
Operating expenses: | |||||||||
Cost of product revenues | 964 | 879 | 2,196 | 2,015 | |||||
Research and development | 6,686 | 6,598 | 14,403 | 12,849 | |||||
Selling, general and administrative | 3,439 | 3,278 | 6,879 | 6,732 | |||||
Total operating expenses | 11,089 | 10,755 | 23,478 | 21,596 | |||||
Income (loss) from operations | 14,755 | (6,770) | 5,141 | (13,480) | |||||
Other income (expense): | |||||||||
Interest and other income | 135 | 177 | 393 | 386 | |||||
Interest and other expense | (552) | (634) | (1,144) | (1,263) | |||||
Net other expense | (417) | (457) | (751) | (877) | |||||
Net income (loss) | $ 14,338 | $ (7,227) | $ 4,390 | $ (14,357) | |||||
Net Income (loss) per share | |||||||||
Basic | $ 0.07 | $ (0.04) | $ 0.02 | $ (0.09) | |||||
Diluted | $ 0.07 | $ (0.04) | $ 0.02 | $ (0.09) | |||||
Weighted-average shares used in computing net income (loss) per share | |||||||||
Basic | 196,866 | 164,359 | 196,306 | 163,219 | |||||
Diluted | 207,477 | 164,359 | 206,111 | 163,219 | |||||
Total comprehensive income (loss) | $ 14,427 | $ (7,230) | $ 4,464 | $ (14,364) |
DURECT CORPORATION | |||||
CONDENSED BALANCE SHEETS | |||||
(in thousands) | |||||
As of | As of | ||||
June 30, 2020 | December 31, 2019(1) | ||||
(unaudited) | |||||
ASSETS | |||||
Current assets: | |||||
Cash and cash equivalents | $ 18,446 | $ 34,924 | |||
Short-term investments | 32,699 | 29,750 | |||
Accounts receivable | 1,997 | 2,313 | |||
Inventories, net | 3,460 | 3,383 | |||
Prepaid expenses and other current assets | 3,481 | 1,459 | |||
Total current assets | 60,083 | 71,829 | |||
Property and equipment, net | 476 | 469 | |||
Operating lease right-of-use assets | 5,372 | 6,066 | |||
Goodwill | 6,399 | 6,399 | |||
Long-term restricted Investments | 150 | 150 | |||
Other long-term assets | 283 | 1,107 | |||
Total assets | $ 72,763 | $ 86,020 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
Current liabilities: | |||||
Accounts payable | $ 2,015 | $ 2,109 | |||
Accrued liabilities | 3,692 | 6,284 | |||
Contract research liability | 2,572 | 3,653 | |||
Deferred revenue, current portion | - | 22,679 | |||
Operating lease liabilities, current portion | 2,073 | 2,043 | |||
Total current liabilities | 10,352 | 36,768 | |||
Deferred revenue, noncurrent portion | 812 | 812 | |||
Operating lease liabilities, noncurrent portion | 3,827 | 4,517 | |||
Term loan, noncurrent portion, net | 20,539 | 20,262 | |||
Other long-term liabilities | 891 | 801 | |||
Stockholders' equity | 36,342 | 22,860 | |||
Total liabilities and stockholders' equity | $ 72,763 | $ 86,020 | |||
(1) Derived from audited financial statements. |
View original content:http://www.prnewswire.com/news-releases/durect-corporation-announces-second-quarter-2020-financial-results-and-update-of-programs-301104991.html
SOURCE DURECT Corporation
We use cookies to tailor your experience, measure site performance and present relevant offers and advertisements. By clicking ‘Accept’ or any content on this site, you agree that cookies can be placed on your browser. You can view our privacy policy to learn more.
If you would like to get more data, alerts and access to Real Vision videos, join us as an Insider Tracking Advantage Ultra member