PR Newswire
CUPERTINO, Calif., July 29, 2021
CUPERTINO, Calif., July 29, 2021 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended June 30, 2021 and provided a corporate update.
Q2 2021 Accomplishments:
We expanded the number of U.S. clinical trial sites to 26 in the Phase 2b AHFIRM clinical study of DUR-928 in severe alcohol-associated hepatitis (AH), and we are enrolling at a good rate. We have now opened about 75% of the U.S. sites we plan to open. We expect to open our first ex-U.S. clinical sites (in the UK, Europe and Australia) in the coming months. In addition, we presented further encouraging DUR-928 clinical data from the completed NASH Phase 1b trial showing trends for reduction in insulin resistance and liver fibrosis biomarkers. Data from a Pharmacokinetic trial in patients with moderate and severe liver impairment showed a reduction in an important apoptosis biomarker with no adverse events or dose-limiting toxicity in these severely ill liver patients. We were also invited to present at the 2021 Epigenetic Therapeutic Targets Virtual Summit, which is for leading companies in the field of Epigenetics to present to their peers. To our knowledge, we were the only presenter utilizing an epigenetic regulator to restore function in injured cells as opposed to most who are using epigenetics to kill cancer cells. Our presentation was well received.
"Executing on the AHFIRM trial to the highest level of quality and in a timely fashion is our highest priority and we are pleased with the progress made this quarter," stated James E. Brown, D.V.M, President and CEO of DURECT. "Discussions with potential POSIMIR partners are ongoing."
Financial highlights for Q2 2021:
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 alcohol-associated hepatitis (AH) as well as in chronic liver diseases such as non-alcoholic steatohepatitis (NASH).
Clinical Development
Alcohol-associated Hepatitis (AH)
Non-Alcoholic Steatohepatitis (NASH)
POSIMIR® (bupivacaine solution) Post-Operative Pain Relief Depot. POSIMIR is DURECT's post-operative pain relief depot that uses the Company's patented SABER® technology that delivers bupivacaine to provide up to 3 days of post-surgical analgesia.
Debt Amendment. In May 2021, the Company amended its existing $20 million term loan with Oxford Finance such that principal payments will commence 18 months later than previously scheduled (i.e., commencing June 1, 2023 rather than December 1, 2021) and the final maturity date has been moved back by 16 months (i.e., from May 1, 2024 to September 1, 2025). The interest rate and final payment remain unchanged, and the Company paid Oxford Finance an amendment fee of $712,500.
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 2021 results and provide a corporate update:
Thursday, July 29 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time
Toll Free: 877-407-0784
International: 201-689-8560
Conference ID: 13721980
Webcast: http://public.viavid.com/index.php?id=145979
The conference call will also be available by webcast on DURECT's homepage at www.durect.com under the "Investors" tab. If you are unable to participate during the 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. DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcohol-associated hepatitis (AH) for which FDA has granted a Fast Track Designation; non-alcoholic steatohepatitis (NASH) is also being explored. In addition, POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is FDA-approved. Full prescribing information about POSIMIR, including the Boxed Warning, can be found at www.posimir.com. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential for DUR-928 to treat patients with AH and NASH, clinical trial plans, the potential benefits of Fast Track Designation, the potential for the AHFIRM trial to support an NDA filing for DUR-928 in AH, plans to develop DUR-928 in NASH, and plans to seek a commercial licensee for POSIMIR and its commercial launch, 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 the AHFIRM trial takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that ongoing and future clinical trials of DUR-928 do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the life-saving potential of DUR-928 in a statistically significant manner, the risk that Fast Track designation for DUR-928 in AH may not actually lead to faster FDA review or an approval, risks that biomarker data in earlier trials of DUR-928 may not predict clinical efficacy, risks that we may not enter a commercial license for POSIMIR on favorable terms, if at all, risks that we or a licensee may not commercialize POSIMIR successfully, if at all, and risks related to entering into new agreements or 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 May 5, 2021 and in our Form 10-Q for the quarter ended June 30, 2021 when filed with the Securities and Exchange Commission under the heading "Risk Factors."
NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928 is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. Full prescribing information for POSIMIR, including its Boxed Warning, can be found at www.posimir.com.
DURECT CORPORATION
| |||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME | |||||||||
(in thousands, except per share amounts) | |||||||||
(unaudited) | |||||||||
Three months ended | Six months ended | ||||||||
June 30 | June 30 | ||||||||
2021 | 2020 | 2021 | 2020 | ||||||
Collaborative research and development and other revenue | $ 735 | $ 23,347 | $ 1,309 | $ 23,317 | |||||
Product revenue, net | 1,568 | 1,151 | 3,206 | 2,776 | |||||
Total revenues | 2,303 | 24,498 | 4,515 | 26,093 | |||||
Operating expenses: | |||||||||
Cost of product revenues | 359 | 253 | 711 | 649 | |||||
Research and development | 7,433 | 6,567 | 15,408 | 14,154 | |||||
Selling, general and administrative | 3,168 | 3,337 | 6,699 | 6,768 | |||||
Total operating expenses | 10,960 | 10,157 | 22,818 | 21,571 | |||||
(Loss) income from operations | (8,657) | 14,341 | (18,303) | 4,522 | |||||
Other income (expense): | |||||||||
Interest and other income | 39 | 135 | 76 | 393 | |||||
Interest and other expense | (528) | (552) | (1,053) | (1,144) | |||||
Net other expense | (489) | (417) | (977) | (751) | |||||
(Loss) income from continuing operations | (9,146) | 13,924 | (19,280) | 3,771 | |||||
Income from discontinued operations | - | 414 | - | 619 | |||||
Net (loss) income | $ (9,146) | $ 14,338 | $ (19,280) | $ 4,390 | |||||
Net (loss) income per share | |||||||||
Basic and Diluted | |||||||||
(Loss) income from Continuing operations | $ (0.04) | $ 0.07 | $ (0.09) | $ 0.02 | |||||
Income from discontinued operations | $ - | $ 0.00 | $ - | $ 0.00 | |||||
Weighted-average shares used in computing net (loss) income per share | |||||||||
Basic | 227,428 | 196,866 | 222,510 | 196,306 | |||||
Diluted | 227,428 | 207,477 | 222,510 | 206,111 | |||||
Total comprehensive (loss) income | $ (9,133) | $ 14,427 | $ (19,276) | $ 4,464 |
DURECT CORPORATION
| ||||
CONDENSED BALANCE SHEETS | ||||
(in thousands) | ||||
As of | As of | |||
June 30, 2021 | December 31, 2020(1) | |||
(unaudited) | ||||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 56,073 | $ 21,312 | ||
Cash held in escrow | - | 14,979 | ||
Short-term investments | 32,357 | 19,421 | ||
Accounts receivable | 816 | 940 | ||
Inventories, net | 1,918 | 1,864 | ||
Prepaid expenses and other current assets | 4,192 | 4,545 | ||
Total current assets | 95,356 | 63,061 | ||
Property and equipment, net | 211 | 251 | ||
Operating lease right-of-use assets | 4,120 | 4,749 | ||
Goodwill | 6,169 | 6,169 | ||
Long-term investments | - | 1,000 | ||
Long-term restricted Investments | 150 | 150 | ||
Other long-term assets | 261 | 261 | ||
Total assets | $ 106,267 | $ 75,641 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities: | ||||
Accounts payable | $ 1,086 | $ 1,678 | ||
Accrued liabilities | 5,114 | 5,801 | ||
Contract research liability | 192 | 545 | ||
Deferred revenue, current portion | 5 | - | ||
Term loan, current portion, net | - | 884 | ||
Operating lease liabilities, current portion | 1,821 | 1,795 | ||
Total current liabilities | 8,218 | 10,703 | ||
Deferred revenue, noncurrent portion | 812 | 812 | ||
Operating lease liabilities, noncurrent portion | 2,542 | 3,202 | ||
Term loan, noncurrent portion, net | 20,360 | 19,936 | ||
Other long-term liabilities | 873 | 873 | ||
Stockholders' equity | 73,462 | 40,115 | ||
Total liabilities and stockholders' equity | $ 106,267 | $ 75,641 | ||
(1) Derived from audited financial statements. |
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SOURCE DURECT Corporation
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