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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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.16 | 1.05 | 1.16 | 0 | 12:00:00 |
CUPERTINO, Calif., May 4, 2021 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended March 31, 2021 and provided a corporate update.
Q1 2021 Accomplishments:
"We are pleased with progress made in opening clinical trial sites in the U.S. and early enrollment in the AHFIRM trial, our Phase 2b clinical trial designed to evaluate the potential life-saving capability of DUR-928 in patients with severe Alcohol-associated Hepatitis," stated James E. Brown, D.V.M, President and CEO of DURECT. "We are also in discussions with multiple potential POSIMIR partners with a goal of enabling the partner to launch the product this year."
Financial highlights for Q1 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.
Conference Call
We will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss first quarter 2021 results and provide a corporate update:
Tuesday, May 4 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time | |
Toll Free: | 877-407-0784 |
International: | 201-689-8560 |
Conference ID: | 13718713 |
Webcast: | http://public.viavid.com/index.php?id=144373 |
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 now 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, 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 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 March 5, 2021 and in our Form 10-Q for the quarter ended March 31, 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 have 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 | ||||
(in thousands, except per share amounts) | ||||
(Unaudited) | ||||
Three months ended | ||||
March 31 | ||||
2021 | 2020 | |||
Collaborative research and development and other revenue | $ 574 | $ (30) | ||
Product revenue, net | 1,638 | 1,625 | ||
Total revenues | 2,212 | 1,595 | ||
Operating expenses: | ||||
Cost of product revenues | 352 | 396 | ||
Research and development | 7,975 | 7,587 | ||
Selling, general and administrative | 3,531 | 3,431 | ||
Total operating expenses | 11,858 | 11,414 | ||
Loss from operations | (9,646) | (9,819) | ||
Other income (expense): | ||||
Interest and other income | 37 | 258 | ||
Interest and other expense | (525) | (592) | ||
Net other expense | (488) | (334) | ||
Loss from continuing operations | (10,134) | (10,153) | ||
Income from discontinued operations | - | 205 | ||
Net loss | $(10,134) | $ (9,948) | ||
Net income (loss) per share | ||||
Basic and diluted | ||||
Continuing operations | $ (0.05) | $ (0.05) | ||
Discontinued operations | $ - | $ 0.00 | ||
Net loss per common share, basic and diluted | $ (0.05) | $ (0.05) | ||
Weighted-average shares used in computing net income (loss) per share, basic and diluted | 217,537 | 195,745 | ||
Total comprehensive loss | $(10,143) | $ (9,963) |
DURECT CORPORATION | |||
CONDENSED BALANCE SHEETS | |||
(in thousands) | |||
As of | As of | ||
March 31, 2021 | December 31, 2020(1) | ||
(unaudited) | |||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 57,545 | $ 21,312 | |
Cash held in escrow | - | 14,979 | |
Short-term investments | 39,538 | 19,421 | |
Accounts receivable | 993 | 940 | |
Inventories, net | 1,955 | 1,864 | |
Prepaid expenses and other current assets | 4,780 | 4,545 | |
Total current assets | 104,811 | 63,061 | |
Property and equipment, net | 224 | 251 | |
Operating lease right-of-use assets | 4,440 | 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 | $ 116,055 | $ 75,641 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 2,150 | $ 1,678 | |
Accrued liabilities | 4,094 | 5,801 | |
Contract research liability | 384 | 545 | |
Deferred revenue, current portion | 373 | - | |
Term loan, current portion, net | 2,895 | 884 | |
Operating lease liabilities, current portion | 1,808 | 1,795 | |
Total current liabilities | 11,704 | 10,703 | |
Deferred revenue, noncurrent portion | 812 | 812 | |
Operating lease liabilities, noncurrent portion | 2,881 | 3,202 | |
Term loan, noncurrent portion, net | 18,062 | 19,936 | |
Other long-term liabilities | 873 | 873 | |
Stockholders' equity | 81,723 | 40,115 | |
Total liabilities and stockholders' equity | $ 116,055 | $ 75,641 |
(1) Derived from audited financial statements. |
View original content:http://www.prnewswire.com/news-releases/durect-corporation-announces-first-quarter-2021-financial-results-and-update-of-programs-301283764.html
SOURCE DURECT Corporation
Copyright 2021 PR Newswire
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