1. CUPERTINO, Calif., Sept. 15, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that Dr. James E. Brown, President and CEO, Michael H. Arenberg, Chief Financial Officer, Dr. Norman Sussman, Chief Medical Officer, and Dr. WeiQi Lin, Executive Vice President of R&D, will be participating in a fireside chat hosted by Francois Brisebois, Managing Director, Senior Biotechnology Research Analyst at Oppenheimer & Co. Inc.

    Presentation details are as follows:

    Oppenheimer's Fall Healthcare Life Sciences & MedTech Summit

    Date:

    September 22, 2021

    Time:

    2:05 P.M. to 2:45 P.M. Eastern Standard Time

    Format:

    Fireside chat hosted by Francois Brisebois

    Webcast:

    https://wsw.com/webcast/oppenheimer16/drrx/2816864

    The webcast link of the presentation

    CUPERTINO, Calif., Sept. 15, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that Dr. James E. Brown, President and CEO, Michael H. Arenberg, Chief Financial Officer, Dr. Norman Sussman, Chief Medical Officer, and Dr. WeiQi Lin, Executive Vice President of R&D, will be participating in a fireside chat hosted by Francois Brisebois, Managing Director, Senior Biotechnology Research Analyst at Oppenheimer & Co. Inc.

    Presentation details are as follows:

    Oppenheimer's Fall Healthcare Life Sciences & MedTech Summit

    Date:

    September 22, 2021

    Time:

    2:05 P.M. to 2:45 P.M. Eastern Standard Time

    Format:

    Fireside chat hosted by Francois Brisebois

    Webcast:

    https://wsw.com/webcast/oppenheimer16/drrx/2816864

    The webcast link of the presentation will also be available by accessing DURECT's homepage at www.durect.com and clicking on "Event Calendar" under the "Investors" section.

    Management will also be available for virtual 1x1 meetings during the conference. If you would like to request a meeting, please contact Oppenheimer directly.

    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. The Company is conducting a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM, evaluating DUR-928's life saving potential compared to the current standard of care in patients with severe AH. 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, NASH, and other diseases, multiple acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR 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 clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of DUR-928, including AHFIRM, 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, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, 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 July 30, 2021 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.

     

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  2. CUPERTINO, Calif., Sept. 7, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that James E. Brown, President, CEO, Michael H. Arenberg, Chief Financial Officer, Dr. Norman Sussman, Chief Medical Officer and Dr. WeiQi Lin, Executive Vice President of R&D will be participating in a fireside chat hosted by Ed Arce of H.C. Wainwright, at the H.C. Wainwright 23rd Annual Global Investment Conference. A recording of the fireside chat will be available on-demand starting at 7:00 A.M. Eastern Standard Time on September 13, 2021. 

    Presentation details are as follows:

    H.C. Wainwright 23rd Annual Global Investment Conference

    Date:

    September 13-15, 2021

    Time:

    Recording will be available on-demand starting at 7:00 A.M. (ET) on September

    CUPERTINO, Calif., Sept. 7, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that James E. Brown, President, CEO, Michael H. Arenberg, Chief Financial Officer, Dr. Norman Sussman, Chief Medical Officer and Dr. WeiQi Lin, Executive Vice President of R&D will be participating in a fireside chat hosted by Ed Arce of H.C. Wainwright, at the H.C. Wainwright 23rd Annual Global Investment Conference. A recording of the fireside chat will be available on-demand starting at 7:00 A.M. Eastern Standard Time on September 13, 2021. 

    Presentation details are as follows:

    H.C. Wainwright 23rd Annual Global Investment Conference

    Date:

    September 13-15, 2021

    Time:

    Recording will be available on-demand starting at 7:00 A.M. (ET) on September 13, 2021

    Format:

    Fireside chat hosted by Ed Arce

    Webcast:

    https://journey.ct.events/view/7394db61-b64c-464f-abec-9307b55521c8

    The webcast link of the presentation will also be available by accessing DURECT's homepage at www.durect.com and clicking on "Event Calendar" under the "Investors" section.

    Management will also be available for virtual 1x1 meetings during the conference. If you would like to request a meeting, please contact meetings@hcwco.com.

    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. The Company is conducting a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM, evaluating DUR-928's life saving potential compared to the current standard of care in patients with severe AH. 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, NASH, and other diseases, multiple acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR 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 clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of DUR-928, including AHFIRM, 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, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, 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 July 30, 2021 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.

     

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  3. 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…

    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:

    • Total revenues were $2.3 million and net loss was $9.1 million for the three months ended June 30, 2021 as compared to total revenues of $24.5 million and net income of $14.3 million for the three months ended June 30, 2020. Total revenues and net income for the three months ended June 30, 2020 included the recognition of $23.1 million in deferred revenue related to the termination of a license agreement during that period.
    • At June 30, 2021, cash and investments were $88.6 million, compared to cash, cash held in escrow and investments of $56.9 million at December 31, 2020. Debt at June 30, 2021 was $20.4 million, compared to $20.8 million at December 31, 2020.

    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)

    • Enrollment is ongoing in our Phase 2b study in subjects with severe acute AH to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM).  AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH.  The study is comprised of three arms targeting enrollment of approximately 100 patients each: (1) Placebo plus standard of care (SOC, which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician); (2) DUR-928 (30 mg); and (3) DUR-928 (90 mg).  All patients in the trial receive supportive care. The primary outcome measure is 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC.  The Company is targeting approximately 50 to 60 clinical trial sites in the U.S., U.K., E.U. and Australia.
    • Given the high mortality rate in severe AH patients and the absence of an approved therapeutic, we believe demonstration of a robust survival benefit in the AHFIRM trial would support an NDA filing.
    • Reflecting the life-threatening nature of AH and the lack of therapeutic options for this devastating condition, the FDA granted DUR-928 Fast Track Designation for the treatment of AH in December 2020.
    • In March 2021, a peer-reviewed research paper describing the binding sites and proposed mechanism of action of DUR-928 was published in The Journal of Lipid Research. The publication shows that DUR-928 (referred to in the paper as 25HC3S) binds to and inhibits the activity of DNA methyltransferases (DNMTs) DNMT-1, 3a and 3b, epigenetic regulating enzymes that add methyl groups to DNA (a process called DNA methylation). As such, by inhibiting DNMT activity, DUR-928 inhibits DNA methylation, thereby regulating the expression of genes that modulate crucial cellular activities, including those associated with cell death, stress response, and lipid biosynthesis. These modulations may lead to improved cell survival, and reduced lipid accumulation and inflammation, as has been observed in various in vivo animal models and in results from DURECT's completed clinical trials in alcohol-associated hepatitis (AH) and non-alcoholic steatohepatitis (NASH).
    • In July 2021 we presented DUR-928's mechanism of action, the previously reported positive results from our Phase 2a clinical study in alcohol-associated hepatitis (AH), and an overview of the AHFIRM trial at the 2021 Epigenetic Therapeutic Targets Virtual Summit.
    • In the Phase 2a clinical trial of DUR-928 in patients with AH, all 19 patients treated with DUR-928 survived the 28-day follow-up period, 74% of patients (14/19) were discharged in ≤ 4 days after receiving a single dose of DUR-928, and there were no drug-related serious adverse events.
    • Alcohol-associated hepatitis (also called alcoholic hepatitis or AH) is an acute form of alcoholic liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by a recent onset of jaundice and hepatic failure. According to the most recent data provided by the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were approximately 132,000 hospitalizations for patients with AH in 2018. From a 2018 publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $875,000 per patient. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days and 29% at 90 days after admission.

    Non-Alcoholic Steatohepatitis (NASH)

    • In June 2021, we presented new data showing additional signals of potential efficacy from the NASH Phase 1b study of DUR-928 at the 2021 International Liver Conference (EASL) . This was a randomized and open-label clinical study conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity of DUR-928 in NASH patients with stage 1-3 fibrosis. Subjects in the 50 mg and 150 mg groups had 22% and 18% median reductions (not statistically significant) of homeostatic model assessment (HOMA-IR) from baseline, respectively, after 4 weeks of daily oral dosing of DUR-928. NASH subjects also had improvement from baseline in liver stiffness, assessed by transient elastography (TE), magnetic resonance elastography (MRE) and the liver fibrosis marker pro-C3. Positive topline results from this study were previously reported in May 2020.
    • We have also conducted a Phase 1b open-label, multi-center U.S. study to evaluate the safety, tolerability, and pharmacokinetics (PK) of DUR-928 in subjects with moderate (Child-Pugh B scores, n=10) and severe (Child-Pugh C scores, n=7) hepatic function impairment (HI), and matched control subjects (MCS, n=10) with normal hepatic functions. Each subject received a single oral dose of 200 mg DUR-928. Results from this study were presented at the International Liver Conference 2021 (EASL) in June 2021. DUR-928 was safe and well-tolerated by all moderate and severe HI subjects with no adverse events and no dose-limiting toxicity reported throughout the study. As expected, clearance of DUR-928 was decreased in HI subjects compared to MCS with normal hepatic function, resulting in a 4-10 fold higher drug exposure (Cmax and AUC) in HI subjects. Additionally, a single oral dose of 200 mg of DUR-928 in subjects with HI resulted in statistically significant median reductions from baseline of the apoptosis biomarker M30 (cCK-18) at 12 hours post-dose.
    • We are working with a number of disease experts to determine next steps for DUR-928 in 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.

    • In February 2021, POSIMIR was granted U.S. FDA approval in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.
    • The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. POSIMIR demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opioid use, from a median of 12 mg in the placebo group to 4 mg in the POSIMIR group (p=0.01). In connection with this approval, the Company or its licensee, will be required to conduct two postmarketing non-clinical studies. Full Prescribing Information, including the Boxed Warning, is available at www.POSIMIR.com.
    • DURECT is in discussions with potential commercial partners for POSIMIR, for which DURECT currently holds worldwide rights.

    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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  4. CUPERTINO, Calif., July 22, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will report its second quarter 2021 financial results and host a conference call after the market close on Thursday, July 29, 2021.

    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

    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…

    CUPERTINO, Calif., July 22, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will report its second quarter 2021 financial results and host a conference call after the market close on Thursday, July 29, 2021.

    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

    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. The Company is conducting a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM, evaluating DUR-928's life saving potential compared to the current standard of care in patients with severe AH. 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, NASH, and other diseases, multiple acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR 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 clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of DUR-928, including AHFIRM, 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, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, 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 5, 2021 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.

     

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  5. CUPERTINO, Calif., July 14, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present at the Epigenetic Therapeutic Targets Summit, being held virtually July 13-15, 2021. 

    Our President and Chief Executive Officer, James E. Brown, D.V.M., will discuss the mechanism of action of our lead drug candidate and epigenetic regulator (DUR-928), the previously reported positive results from our Phase 2a clinical study in alcohol-associated hepatitis (AH), in addition to providing an overview of our ongoing randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 hospitalized subjects with severe AH .

    Presentation Details:

    CUPERTINO, Calif., July 14, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present at the Epigenetic Therapeutic Targets Summit, being held virtually July 13-15, 2021. 

    Our President and Chief Executive Officer, James E. Brown, D.V.M., will discuss the mechanism of action of our lead drug candidate and epigenetic regulator (DUR-928), the previously reported positive results from our Phase 2a clinical study in alcohol-associated hepatitis (AH), in addition to providing an overview of our ongoing randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 hospitalized subjects with severe AH .

    Presentation Details:

    Title:                   DUR-928, DNMTs and Alcohol-Associated Hepatitis

    Presenter:          James Brown, D.V.M., President and CEO of DURECT

    Date/Time:         July 15, 2021, 1 p.m. EST

    A copy of the presentation will be available on DURECT's corporate website here at the conclusion of the conference.

    About DUR-928

    DUR-928 is an endogenous sulfated oxysterol and an epigenetic regulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been found to be associated with many acute (e.g., AH) or chronic diseases (e.g., NASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), DUR-928 inhibits DNA methylation, which subsequently regulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic regulator, the proposed mechanism of action provides further scientific rationale for developing DUR-928 for the treatment of acute organ injury and certain chronic diseases.

    About Epigenetic Regulation

    Epigenetic regulation influences the expression of genes through the silencing or initiation of gene activity without modifying the DNA sequence. For instance, methylation of cytosine nucleotides in promoter regions of DNA, facilitated by DNA methyltransferases (DNMTs), will generally result in downregulation of gene expression, while demethylation generally results in upregulation. DNA methylation/demethylation can thus regulate the expression of relevant genes, especially clusters of master genes that further modulate crucial cellular activities.

    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. The Company is conducting a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM, evaluating DUR-928's lifesaving potential compared to the current standard of care in patients with severe AH. 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, NASH, and other diseases, such as acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR 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 clinical trial of DUR-928 in AH (AHFIRM) takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of DUR-928, including AHFIRM, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the lifesaving potential of DUR-928 in a statistically significant manner, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, 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 5, 2021 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.

     

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  6. CUPERTINO, Calif., June 9, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present two posters at the 2021 International Liver Conference (EASL) to be held virtually June 23-26, 2021. 

    The first poster will discuss additional efficacy signals from a Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients. Previously reported data showed that DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD, and 300mg BID (600mg/day) with overall improvement from baseline observed in liver enzymes, serum lipid profiles, liver fat by imaging, and  biomarkers of liver health. The poster will feature additional efficacy signal data including liver stiffness by…

    CUPERTINO, Calif., June 9, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present two posters at the 2021 International Liver Conference (EASL) to be held virtually June 23-26, 2021. 

    The first poster will discuss additional efficacy signals from a Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients. Previously reported data showed that DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD, and 300mg BID (600mg/day) with overall improvement from baseline observed in liver enzymes, serum lipid profiles, liver fat by imaging, and  biomarkers of liver health. The poster will feature additional efficacy signal data including liver stiffness by transient elastography (TE) and magnetic resonance elastography (MRE), liver fibrosis marker, pro-C3, and ELF scores, as well as insulin resistance (HOMA-IR).

    A second poster will provide data from a Phase 1 study assessing the safety, tolerability, pharmacokinetics (PK) of DUR-928 in subjects with moderate (Child-Pugh B scores) and severe (Child-Pugh C scores) hepatic impairment (HI), who received a single oral dose of 200mg DUR-928.

    Poster Presentation Details:

    Title:        

    Efficacy Signals of 4-Week Oral DUR-928 in NASH Subjects

    Poster #:             

    1198

    Presenter:         

    Eric Lawitz, M.D., Vice President, Scientific and Research Development, Texas Liver Institute

    Date/Time:        

    June 24-26, 2021





    Poster Presentation Details:

    Title:            

    Safety and pharmacokinetics of DUR-928 in hepatic function impaired subjects

    Session:              

    668

    Presenter:         

    Jaymin Shah, Ph.D., Executive Director, Clinical Pharmacology and Pharmacokinetics at DURECT

    Date/Time:        

    June 24-26, 2021

    Copies of the posters will be available on DURECT's corporate website here at the conclusion of the conference.

    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. The Company is conducting a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM, evaluating DUR-928's lifesaving potential compared to the current standard of care in patients with severe AH. 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, NASH, and other diseases, multiple acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR 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 clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of DUR-928, including AHFIRM, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the lifesaving potential of DUR-928 in a statistically significant manner, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, 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 5, 2021 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.

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  7. 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:

    • Initiated patient dosing in the Phase 2b AHFIRM clinical study of DUR-928 in severe Alcohol-associated Hepatitis (AH)
    • FDA approval of POSIMIR in adults to produce post-surgical analgesia for up to 72 hours following Arthroscopic Subacromial Decompression
    • Publication of DUR-928's mechanism of action
    • Appointment of two highly experienced biopharmaceutical board members
    • Further strengthened our financial position by raising $47.8 million in equity and ending Q1 with $97.2 million in cash and investments

    "We are pleased with progress made…

    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:

    • Initiated patient dosing in the Phase 2b AHFIRM clinical study of DUR-928 in severe Alcohol-associated Hepatitis (AH)
    • FDA approval of POSIMIR in adults to produce post-surgical analgesia for up to 72 hours following Arthroscopic Subacromial Decompression
    • Publication of DUR-928's mechanism of action
    • Appointment of two highly experienced biopharmaceutical board members
    • Further strengthened our financial position by raising $47.8 million in equity and ending Q1 with $97.2 million in cash and investments

    "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:

    • Total revenues were $2.2 million and net loss was $10.1 million for the three months ended March 31, 2021 as compared to total revenues of $1.6 million and net loss of $9.9 million for the three months ended March 31, 2020.
    • At March 31, 2021, cash and investments were $97.2 million, compared to cash, cash held in escrow and investments of $56.9 million at December 31, 2020. Debt at March 31, 2021 was $21.0 million, compared to $20.8 million at December 31, 2020.

    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)

    • Enrollment is ongoing in our Phase 2b study in subjects with severe acute AH to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM). AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study is comprised of three arms targeting approximately 100 patients each: (1) Placebo plus standard of care (SOC, which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician); (2) DUR-928 (30 mg); and (3) DUR-928 (90 mg). All patients in the trial receive supportive care. Patients receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure is 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores) and time in the intensive care unit. The Company is targeting approximately 50-60 clinical trial sites in the U.S., U.K., Europe and Australia.
    • Reflecting the life-threatening nature of AH and the lack of therapeutic options for this devastating condition, the FDA granted DUR-928 Fast Track Designation for the treatment of AH in December 2020. The FDA grants Fast Track Designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track Designation may benefit from early and frequent communication with the agency in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly.
    • Given the high mortality rate in severe AH patients and the absence of an approved therapeutic, we believe demonstration of a robust survival benefit in the AHFIRM trial may support an NDA filing.
    • In March 2021, a peer-reviewed research paper describing the binding sites and proposed mechanism of action of DUR-928 was published in The Journal of Lipid Research. The publication shows that DUR-928 (referred to in the paper as 25HC3S) binds to and inhibits the activity of DNA methyltransferases (DNMTs) DNMT-1, 3a and 3b, epigenetic regulating enzymes that add methyl groups to DNA (a process called DNA methylation). As such, by inhibiting DNMT activity, DUR-928 inhibits DNA methylation, thereby regulating the expression of genes that modulate crucial cellular activities, including those associated with cell death, stress response, and lipid biosynthesis. These modulations may lead to improved cell survival, and reduced lipid accumulation and inflammation, as has been observed in various in vivo animal models and in results from DURECT's completed clinical trials in alcohol-associated hepatitis (AH) and non-alcoholic steatohepatitis (NASH).
    • During 2019, we completed a Phase 2a clinical trial of DUR-928 in patients with AH. All 19 patients treated with DUR-928 survived the 28-day follow-up period, 74% of patients (14/19) were discharged in ≤ 4 days after receiving a single dose of DUR-928, and there were no drug-related serious adverse events.
    • Alcohol-associated hepatitis (also called alcoholic hepatitis or AH) is an acute form of alcoholic liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by a recent onset of jaundice and hepatic failure. According to the most recent data provided by the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were approximately 132,000 hospitalizations for patients with AH in 2018. From a 2018 publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $875,000 per patient. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days and 29% at 90 days after admission.

    Non-Alcoholic Steatohepatitis (NASH)

    • In May 2020, we reported positive topline results from a Phase 1b randomized and open-label clinical study conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity (including clinical chemistry and biomarkers as well as liver fat content and liver stiffness by imaging) of DUR-928 in NASH patients with stage 1-3 fibrosis. In this 65-patient study, reductions from baseline (pre-treatment) levels were seen in liver enzymes, liver stiffness as measured by imaging, serum lipids and biomarkers. Many of these reductions were statistically significant and DUR-928 was well tolerated at all three doses evaluated.
    • We will present additional data from this trial at an upcoming medical conference and we are working with a number of disease experts to determine next steps for DUR-928 in NASH.
    • Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in both children and adults. It is estimated that NAFLD affects approximately 30% to 40% of adults and 10% of children in the United States. NASH, a more severe and progressive form of NAFLD, is one of the most common chronic liver diseases worldwide, with an estimated prevalence of 3-5% globally. No drug is currently approved for NAFLD or 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.

    • In February 2021, POSIMIR was granted U.S. FDA approval in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. POSIMIR is the only approved sustained-release bupivacaine product indicated for up to 72 hours of post-surgical analgesia from a single application.
    • The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. POSIMIR demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opioid use, from a median of 12 mg in the placebo group to 4 mg in the POSIMIR group (p=0.01). In connection with this approval, the Company or its licensee, will be required to conduct two postmarketing non-clinical studies. Full Prescribing Information, including the Boxed Warning, is available at www.POSIMIR.com.
    • DURECT is in discussions with potential licensees of commercialization rights to POSIMIR, for which DURECT currently holds worldwide rights. Our goal is to put a commercial license in place in time for the licensee to launch the product in Q4 2021.
    • Subacromial decompression is a type of shoulder surgery used to treat impingement syndrome, a common repetitive-use injury that causes pain when the arm is raised over the head. The procedure is typically performed arthroscopically, meaning that several small incisions are made in the skin and muscle of the shoulder through which a camera lens (arthroscope) and surgical instruments are inserted during surgery. Arthroscopic subacromial decompression is generally considered outpatient surgery, and most patients go home within a few hours of surgery. The recovery period may extend from weeks to months, but the most intense pain typically occurs during the first 3 days after surgery and is often managed with oral opioids. There are over 600,000 surgeries involving arthroscopic subacromial decompression performed each year in the U.S.

    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.

     

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  8. CUPERTINO, Calif., April 27, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will report its first quarter 2021 financial results and host a conference call after the market close on Tuesday, May 4, 2021.

    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

    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…

    CUPERTINO, Calif., April 27, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will report its first quarter 2021 financial results and host a conference call after the market close on Tuesday, May 4, 2021.

    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

    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. The Company is conducting a double-blind, placebo-controlled Phase 2b clinical trial called AHFIRM, evaluating DUR-928's life saving potential compared to the current standard of care in patients with severe AH. 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, NASH, and other diseases, multiple acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR 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 clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of DUR-928, including AHFIRM, 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, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, 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 5, 2021 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.

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  9. CUPERTINO, Calif., March 9, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the publication of a peer-reviewed research paper describing the binding sites and proposed mechanism of action of its lead drug candidate, an endogenous sulfated oxysterol and epigenetic regulator, DUR-928, in The Journal of Lipid Research.

    DUR-928 is an endogenous sulfated oxysterol that acts as an epigenetic regulator, a compound that regulates patterns of gene expression without modifying the DNA sequence. The publication shows that DUR-928 (referred to in the paper as 25HC3S) binds to and inhibits the activity of DNA methyltransferases (DNMTs), DNMT-1, 3a and 3b, epigenetic regulating enzymes that add methyl groups to DNA (a process called…

    CUPERTINO, Calif., March 9, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the publication of a peer-reviewed research paper describing the binding sites and proposed mechanism of action of its lead drug candidate, an endogenous sulfated oxysterol and epigenetic regulator, DUR-928, in The Journal of Lipid Research.

    DUR-928 is an endogenous sulfated oxysterol that acts as an epigenetic regulator, a compound that regulates patterns of gene expression without modifying the DNA sequence. The publication shows that DUR-928 (referred to in the paper as 25HC3S) binds to and inhibits the activity of DNA methyltransferases (DNMTs), DNMT-1, 3a and 3b, epigenetic regulating enzymes that add methyl groups to DNA (a process called DNA methylation). As such, by inhibiting DNMT activity, DUR-928 inhibits DNA methylation, thereby regulating the expression of genes that modulate crucial cellular activities, including those associated with cell death, stress response, and lipid biosynthesis.  These modulations may lead to improved cell survival, and reduced lipid accumulation and inflammation, as has been observed in various in vivo animal models and in results from DURECT's completed clinical trials in alcohol-associated hepatitis (AH) and non-alcoholic steatohepatitis (NASH).

    "DNA hypermethylation, an example of epigenetic dysregulation, has been reported to be associated with certain diseases, like AH and NASH, a life-threatening acute liver disease characterized by lipid accumulation, severe inflammation and liver cell death, with an average 90-day mortality rate of 29%," said Norman Sussman, MD, FAASLD, Chief Medical Officer of DURECT. "DUR-928 has already demonstrated promising efficacy signals in a Phase 2a study in patients with AH and encouraging data in a Phase 1b study in patients with NASH. The proposed mechanism of action of DUR-928 in this publication provides a further scientific rationale for evaluating DUR-928 as a therapeutic agent for AH and NASH."

    James E. Brown, D.V.M., President and Chief Executive Officer of DURECT, added, "We are focused on progressing our ongoing Phase 2b trial of DUR-928 in AH (AHFIRM), and in parallel, exploring additional indications that could benefit from DUR-928's mechanism of action."

    In a Phase 2a clinical trial in patients with AH, 100% of patients treated with DUR-928 survived the 28-day follow-up period compared to a 26% historical average 28-day mortality rate. 74% of patients treated with DUR-928 were discharged within 4 days or less of treatment after one dose. In a Phase 1b trial, patients with NASH treated with DUR-928 experienced significant improvements in biomarkers of liver function and liver health, including liver enzymes and serum lipid profiles. A reduction in liver fat of more than 10% was observed in 43% of these patients.

    The publication, entitled, "25-hydroxycholesterol 3-sulfate is an endogenous ligand of DNA methyltransferases in hepatocytes" is available online herehttps://www.jlr.org/article/S0022-2275(21)00045-6/fulltext

    About DUR-928

    DUR-928 is an endogenous sulfated oxysterol and an epigenetic regulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence.  DNA hypermethylation (an example of epigenetic dysregulation), results in transcriptomic reprogramming and cellular dysfunction, and has been found to be associated with many acute (e.g. AH) or chronic diseases (e.g. NASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), DUR-928 inhibits DNA methylation , which subsequently regulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic regulator, the proposed mechanism of action provides further scientific rationale for developing DUR-928 for the treatment of multiple acute organ injury and certain chronic diseases.

    About Epigenetic Regulation

    Epigenetic regulation influences the expression of genes through the silencing or initiation of gene activity without modifying the DNA sequence. For instance, methylation of cytosine nucleotides in promoter regions of DNA, facilitated by DNA methyltransferases (DNMTs), will generally result in downregulation of gene expression, while demethylation results in upregulation. DNA methylation/demethylation can thus regulate the expression of relevant genes, especially clusters of master genes that further modulate crucial cellular activities.

    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, NASH, and other diseases, multiple acute organ injury, ongoing and planned clinical trials of DUR-928, and the commercial potential of POSIMIR 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 clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that 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, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, 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 5, 2021 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.

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  10. CUPERTINO, Calif., March 4, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced financial results for the three months and year ended December 31, 2020 and provided a corporate update.  

    "We have achieved a number of important milestones over the past few months, most significantly, initiating dosing in the DUR-928 AHFIRM trial in patients with severe alcohol-associated hepatitis (AH) and obtaining Fast Track Designation for that indication," stated James E. Brown, D.V.M., President and CEO of DURECT. "We also obtained FDA approval for POSIMIR® and took steps to strengthen our financial position, our board and our management team as we advance the development of DUR-928, a potentially life-saving therapy for patients with severe…

    CUPERTINO, Calif., March 4, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced financial results for the three months and year ended December 31, 2020 and provided a corporate update.  

    "We have achieved a number of important milestones over the past few months, most significantly, initiating dosing in the DUR-928 AHFIRM trial in patients with severe alcohol-associated hepatitis (AH) and obtaining Fast Track Designation for that indication," stated James E. Brown, D.V.M., President and CEO of DURECT. "We also obtained FDA approval for POSIMIR® and took steps to strengthen our financial position, our board and our management team as we advance the development of DUR-928, a potentially life-saving therapy for patients with severe AH."

    Accomplishments since last earnings call:

    • Initiated patient dosing in the Phase 2b AHFIRM clinical study of DUR-928 in severe AH
    • DUR-928 was granted FDA Fast Track Designation for the treatment of AH
    • FDA approval of POSIMIR in adults to produce post-surgical analgesia for up to 72 hours following Arthroscopic Subacromial Decompression
    • Presented additional Safety Data and Efficacy Signals from the Phase 1b NASH trial at The Liver Meeting Digital Experience™ 2020
    • Appointment of two highly experienced biopharmaceutical board members
    • Sale of the LACTEL Absorbable Polymers product line to Evonik for $15 million in cash
    • Further strengthened our financial position by raising $47.8 million in equity since December 31, 2020

    Financial highlights for Q4 and full year 2020:

    • On December 31, 2020, the Company completed the sale of its LACTEL Absorbable Polymers product line to Evonik Corporation for $15 million in cash, resulting in a gain of approximately $12.8 million which is reflected in net income and net loss for three and twelve months ended December 31, 2020, respectively. As a result of the sale, the operating results from our LACTEL product line have been excluded from continuing operations and presented as discontinued operations in the accompanying Condensed Statements of Operations and Comprehensive Income (Loss) and Condensed Balance Sheets for all periods presented.
    • Total revenues were $2.2 million and net income was $4.4 million for the three months ended December 31, 2020 as compared to total revenues of $9.0 million and net loss of $4.2 million for the three months ended December 31, 2019.   Total revenues were $30.1 million and net loss was $0.6 million for the year ended December 31, 2020, compared to total revenues of $25.1 million and net loss of $20.6 million for the year ended December 31, 2019. 
    • At December 31, 2020, cash, cash held in escrow and investments were $56.9 million, compared to cash and investments of $64.8 million at December 31, 2019. In Q1 2021, DURECT raised net proceeds of $47.8 million from an underwritten public offering and other sales of equity.  Debt at December 31, 2020 was $20.8 million, compared to $20.3 million at December 31, 2019. 

    Major activities in 2021:

    • Ramping up clinical trial sites and enrollment in the Phase 2b AHFIRM trial of DUR-928 in severe AH
    • Initiating ex-US dosing in the AHFIRM trial
    • Commercial partnership discussions for POSIMIR, and potential subsequent commercial launch
    • Publication of the DUR-928 mechanism of action in a peer-reviewed journal
    • Determining next steps in NASH
    • Potential new license and collaboration agreements

    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, 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

    Alcoholic Hepatitis (AH)

    • We have begun dosing in our Phase 2b study in subjects with severe acute AH to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM).  AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH.  The study is comprised of three arms targeting approximately 100 patients each: (1) Placebo plus standard of care (SOC, which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician); (2) DUR-928 (30 mg); and (3) DUR-928 (90 mg). Patients receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized.  The primary outcome measure is 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC.  Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores), and time in the intensive care unit.  We are targeting 40-50 clinical trial sites in the US, Europe and Australia.
    • Given the high mortality rate in severe AH patients and the absence of an approved therapeutic, we believe demonstration of a robust survival benefit in the AHFIRM trial may support an NDA filing. 
    • During 2019, we completed a Phase 2a clinical trial of DUR-928 in patients with AH.  All 19 patients treated with DUR-928 survived the 28-day follow-up period, 74% of patients (14/19) were discharged in ≤ 4 days after receiving a single dose of DUR-928, and there were no drug-related serious adverse events.  
    • Reflecting the life-threatening nature of AH and the lack of therapeutic options for this devastating condition, the FDA recently granted DUR-928 Fast Track Designation for the treatment of AH.  The FDA grants Fast Track Designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need.  A therapeutic that receives Fast Track Designation can benefit from early and frequent communication with the agency in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly.
    • Alcohol-associated hepatitis (also called alcoholic hepatitis or AH) is an acute form of alcoholic liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption.  AH is typically characterized by a recent onset of jaundice and hepatic failure.  According to the most recent data provided by the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 122,000 hospitalizations for patients with AH in 2017.  The cost per AH patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $875,000 per patient.  An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the average overall mortality from AH was 26% at 28 days and 29% at 90 days after admission.

    Non-Alcoholic Steatohepatitis (NASH)

    • In May 2020, we reported positive topline results from a Phase 1b randomized and open-label clinical study conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity (including clinical chemistry and biomarkers as well as liver fat content and liver stiffness by imaging) of DUR-928 in NASH patients with stage 1-3 fibrosis.   In this 65-patient study, reductions from baseline (pre-treatment) levels were seen in liver enzymes, liver stiffness as measured by imaging, serum lipids and biomarkers.  Many of these reductions were statistically significant and DUR-928 was well tolerated at all three doses evaluated. 
    • Additional results, including biomarker data, were presented through a poster at The Liver Meeting Digital Experience™ 2020 held November 13-16, 2020. 

    COVID-19

    Since we initiated our clinical trial of DUR-928 in patients with COVID-19, several vaccines and therapeutics for COVID-19 have been approved and are being deployed worldwide.  Treatment regimens for patients with COVID-19 have also evolved, the disease landscape has changed and additional therapies have entered clinical trials. Consequently, there have been a limited number of patients eligible or willing to enroll in our trial, and we have elected to discontinue the trial. The people and resources that were supporting the COVID-19 trial are now being redirected to support the AHFIRM trial.

    POSIMIR® (bupivacaine solution)

    • In February 2021, POSIMIR was granted U.S. FDA approval in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.  POSIMIR is the only approved sustained-release bupivacaine product indicated for up to 72 hours of post-surgical analgesia from a single application. 
    • The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. POSIMIR demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opioid use, from a median of 12 mg in the placebo group to 4 mg in the POSIMIR group (p=0.01). In connection with this approval, the Company or its licensee, will be required to conduct two postmarketing non-clinical studies.  Full Prescribing Information, including the Boxed Warning, is available at www.POSIMIR.com
    • DURECT is in discussions with potential partners regarding the licensing of commercialization rights to POSIMIR, for which DURECT currently holds worldwide rights. 
    • Subacromial decompression is a type of shoulder surgery used to treat impingement syndrome, a common repetitive-use injury that causes pain when the arm is raised over the head. The procedure is typically performed arthroscopically, meaning that several small incisions are made in the skin and muscle of the shoulder through which a camera lens (arthroscope) and surgical instruments are inserted during surgery. Arthroscopic subacromial decompression is generally considered outpatient surgery, and most patients go home within a few hours of surgery. The recovery period may extend from weeks to months, but the most intense pain typically occurs during the first 3 days after surgery and is often managed with oral opioids. There are over 600,000 surgeries involving arthroscopic subacromial decompression performed each year in the U.S.

    Sale of LACTEL Absorbable Polymers product line

    • In December 2020, we sold our LACTEL product line to Evonik for $15 million in cash. The gain from this sale was approximately $12.8 million. This transaction is part of our effort to focus on epigenetic regulation and the development of DUR-928.
    • The $15 million of cash was held in escrow as of December 31, 2020 and was released to DURECT's bank account in January 2021.

    Important additions to our team

    • In November 2020, we appointed Dr. Norman Sussman as our Chief Medical Officer.  Dr. Sussman is a renowned hepatologist with extensive clinical experience and expertise in the liver disease field. He brings over 30 years of clinical research and development experience in academia and industry and a proven track record in clinical research of liver diseases.
    • In January 2021, we appointed two new members to our board of directors.  Gail J. Maderis, MBA, and Mohammad Azab, MD, MSc, MBA, are industry veterans with extensive drug development, clinical research and medical affairs experience.

    Strengthening our financial position

    In Q1 2021, DURECT raised net proceeds of $47.8 million from an underwritten public offering and other sales of equity. 

    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 fourth quarter 2020 results and provide a corporate update:

    Thursday, March 4 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

    Toll Free:              

    877-407-0784

    International:           

    201-689-8560

    Conference ID:        

    13715968

    Webcast:               

    http://public.viavid.com/index.php?id=143367

    A live audio webcast of the presentation will be also 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. 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, plans to ramp up clinical trial sites and enrollment and initiate ex-US trial sites in the Phase 2b AHFIRM trial, plans to seek a commercialization partner for POSIMIR and its commercial launch, and to enter into additional license and commercialization agreements 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, risks that we may not enter a commercialization partnership for POSIMIR on favorable terms, if at all,  risks that we or a third-party collaborator 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-Q filed on November 3, 2020 and in our annual report on Form 10-K for the year ended December 31, 2020 when filed with the Securities and Exchange Commission under the heading "Risk Factors."  These reports are available on our website www.durect.com under the "Investors" tab.

    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 INCOME (LOSS)

    (in thousands, except per share amounts)

    (unaudited)















































    Three months ended



    Twelve months ended







     December 31 



     December 31 







    2020



    2019



    2020



    2019





















    Collaborative research and development and other revenue

    $        317



    $      7,249



    $   23,941



    $    18,129

    Product revenue, net



    1,890



    1,746



    6,170



    6,945



    Total revenues



    2,207



    8,995



    30,111



    25,074





















    Operating expenses:



















    Cost of product revenues 

    418



    463



    1,406



    1,263



    Research and development

    6,682



    9,295



    27,709



    29,640



    Selling, general and administrative 

    3,413



    3,705



    13,611



    14,115

    Total operating expenses

    10,513



    13,463



    42,726



    45,018





















    Loss from operations



    (8,306)



    (4,468)



    (12,615)



    (19,944)





















    Other income (expense):



















    Interest and other income

    40



    338



    517



    1,074



    Interest and other expense

    (547)



    (610)



    (2,237)



    (2,501)

    Net other expense



    (507)



    (272)



    (1,720)



    (1,427)

    Loss from continuing operations

    (8,813)



    (4,740)



    (14,335)



    (21,371)

    Income from discontinued operations

    13,173



    509



    13,753



    793

    Net income (loss)



    $     4,360



    $     (4,231)



    $      (582)



    $   (20,578)





















    Net income (loss) per share

















    Basic and diluted

















        Continuing operations

    $     (0.04)



    $       (0.02)



    $     (0.07)



    $       (0.12)



        Discontinued operations

    $       0.06



    $        0.00



    $       0.07



    $        0.00



    Net income (loss) per common share, basic and diluted

    $       0.02



    $       (0.02)



    $     (0.00)



    $       (0.12)





















    Weighted-average shares used in computing net income (loss) per share

















    Basic 



    203,272



    193,181



    199,457



    178,042



    Diluted



    211,497



    193,181



    199,457



    178,042





















    Total comprehensive income (loss)

    $     4,337



    $     (4,236)



    $      (584)



    $   (20,581)

     





    DURECT CORPORATION





    CONDENSED BALANCE SHEETS





    (in thousands)















    As of



    As of





    December 31, 2020



    December 31, 2019(1)





    (unaudited)





    ASSETS









    Current assets:









        Cash and cash equivalents



    $                              21,312



    $                              34,924

        Cash held in escrow



    14,979



    -

        Short-term investments



    19,421



    29,750

        Accounts receivable



    940



    1,516

        Inventories, net



    1,864



    1,919

        Prepaid expenses and other current assets



    4,545



    1,424

        Discontinued operations, current portion



    -



    2,296

    Total current assets



    63,061



    71,829











    Property and equipment, net



    251



    159

    Operating lease right-of-use assets



    4,749



    5,866

    Goodwill



    6,169



    6,399

    Long-term investments 



    1,000



    -

    Long-term restricted Investments



    150



    150

    Other long-term assets



    261



    1,085

    Discontinued operations, non-current portion



    -



    532

    Total assets



    $                              75,641



    $                              86,020











    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









        Accounts payable



    $                                1,678



    $                                1,982

        Accrued liabilities



    5,801



    5,940

        Contract research liability



    545



    3,653

        Deferred revenue, current portion



    -



    22,679

        Term loan, current portion, net



    884



    -

        Operating lease liabilities, current portion



    1,795



    1,742

        Discontinued operations, current portion



    -



    772

    Total current liabilities



    10,703



    36,768











    Deferred revenue, noncurrent portion



    812



    812

    Operating lease liabilities, noncurrent portion



    3,202



    4,356

    Term loan, noncurrent portion, net



    19,936



    20,262

    Other long-term liabilities



    873



    705

    Discontinued operations, non-current portion



    -



    257











    Stockholders' equity



    40,115



    22,860

    Total liabilities and stockholders' equity 



    $                              75,641



    $                              86,020









































    (1)  Derived from audited financial statements.



















    Cision View original content:http://www.prnewswire.com/news-releases/durect-corporation-announces-fourth-quarter-and-full-year-2020-financial-results-and-update-of-programs-301241036.html

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  11. CUPERTINO, Calif., March 3, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will partipate in three upcoming investor conferences, taking place in March 2021.  All conferences will take place virtually.

    Details are as follow:

    H.C. Wainwright Life Sciences Conference: March 9 – 10

    Presentation Date:

    March 9

    Time:

    Available on demand from 7:00 am (EST)

    Webcast:

    Register Here



    ROTH Conference: March 15 – 17

    Presentation Date:

    March 5

    Time:

    Available on demand from 5:00 pm (EST)

    Webcast:

    Register Here



    Oppenheimer & Co. Healthcare Conference: March 16 – 18

    Presentation Date:

    March 17

    Time:

    11:20 a.m. EST

    Webcast:

    Register Here

    The webcast links and replay links of the presentations will also be available by accessing…

    CUPERTINO, Calif., March 3, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will partipate in three upcoming investor conferences, taking place in March 2021.  All conferences will take place virtually.

    Details are as follow:

    H.C. Wainwright Life Sciences Conference: March 9 – 10

    Presentation Date:

    March 9

    Time:

    Available on demand from 7:00 am (EST)

    Webcast:

    Register Here





    ROTH Conference: March 15 – 17

    Presentation Date:

    March 5

    Time:

    Available on demand from 5:00 pm (EST)

    Webcast:

    Register Here





    Oppenheimer & Co. Healthcare Conference: March 16 – 18

    Presentation Date:

    March 17

    Time:

    11:20 a.m. EST

    Webcast:

    Register Here

    The webcast links and replay links of the presentations will also be available by accessing DURECT's homepage at www.durect.com and clicking on the "Investors" tab. If you are unable to participate during conferences, the calls 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; COVID-19 and non-alcoholic steatohepatitis (NASH) are 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, NASH, COVID-19, or other acute organ injury and chronic liver diseases, plans for clinical development of DUR-928, and the commercial potential of POSIMIR 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 clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, or that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that 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, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, 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 with the SEC on November 3, 2020 and the Prospectus Supplement filed on February 5, 2021 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.

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  12. CUPERTINO, Calif., Feb. 25, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will report its fourth quarter and year ended December 31, 2020 financial results and host a conference call after the market close on Thursday, March 4, 2021.

    Thursday, March 4 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

    Toll Free:

    877-407-0784

    International: 

    201-689-8560

    Conference ID: 

    13715968

    Webcast: 

    http://public.viavid.com/index.php?id=143367

    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…

    CUPERTINO, Calif., Feb. 25, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will report its fourth quarter and year ended December 31, 2020 financial results and host a conference call after the market close on Thursday, March 4, 2021.

    Thursday, March 4 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

    Toll Free:

    877-407-0784

    International: 

    201-689-8560

    Conference ID: 

    13715968

    Webcast: 

    http://public.viavid.com/index.php?id=143367

    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; COVID-19 and non-alcoholic steatohepatitis (NASH) are 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, NASH, COVID-19, or other acute organ injury and chronic liver diseases, plans for clinical development of DUR-928, and the commercial potential of POSIMIR 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 clinical trial of DUR-928 in AH takes longer to conduct than anticipated due to COVID-19 or other factors, or that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that 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, risks that we or a third-party licensee may not commercialize POSIMIR successfully, if at all, 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 November 3, 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 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.

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  13. CUPERTINO, Calif., Feb. 4, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) ("DURECT"), 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, today announced the pricing of its underwritten public offering of 17,708,333 shares of its common stock (the "Offering") for gross proceeds of approximately $42,500,000, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by DURECT. The offering is expected to close on or about February 8, 2021, subject to customary closing conditions. In addition, DURECT has granted the underwriter…

    CUPERTINO, Calif., Feb. 4, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) ("DURECT"), 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, today announced the pricing of its underwritten public offering of 17,708,333 shares of its common stock (the "Offering") for gross proceeds of approximately $42,500,000, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by DURECT. The offering is expected to close on or about February 8, 2021, subject to customary closing conditions. In addition, DURECT has granted the underwriter for the Offering a 30-day option to purchase up to an additional 2,656,249 shares of its common stock.

    Cantor Fitzgerald & Co. is acting as the sole book running manager for the Offering.

    The underwriter may offer the shares from time to time for sale in one or more transactions on the Nasdaq Capital Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On February 3, 2021, the last sale price of the shares as reported on the Nasdaq Capital Market was $2.87 per share.

    DURECT intends to use the net proceeds of the Offering for general corporate purposes, which may include clinical trials, research and development activities, capital expenditures, selling, general and administrative costs, facilities expansion, and to meet working capital needs.

    The Offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226518) previously filed by DURECT with the Securities and Exchange Commission (the "SEC") on September 28, 2019 and declared effective by the SEC on October 9, 2018. The Offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement describing the terms of the Offering and the accompanying prospectus have been filed with the SEC. Before you invest, you should read the registration statement, the preliminary prospectus, the documents that DURECT has filed with the SEC that are incorporated by reference into the registration statement, and the other documents DURECT has filed with the SEC for more complete information about DURECT and the Offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: prospectus@cantor.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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, COVID-19 patients, and non-alcoholic steatohepatitis (NASH). DURECT's proprietary drug delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is now FDA-approved.

    Forward Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Offering, regarding the potential uses and benefits of POSIMIR, the potential for DUR-928 to treat patients with AH, NASH, COVID-19, or other acute organ injury and chronic liver diseases, and plans for clinical development of DUR-928.  These forward-looking statements are only predictions based upon management's current information and expectations, are subject to known and unknown risks, and involve a number of uncertainties. Actual events and results may differ materially from those projected in such forward-looking statements as a result of various factors, including market risks and uncertainties and the satisfaction of customary closing conditions for an offering of securities, as well as potential risks and uncertainties that POSIMIR will not achieve a successful commercial launch, that the clinical trial of DUR-928 in AH is delayed due to COVID-19 or other factors or that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that clinical trials of DUR-928 take longer to conduct than anticipated, 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, and risks related to our ability to obtain capital to fund operations and expenses. For a discussion of these and other factors, please refer to DURECT's Annual Report on Form 10-K for the year ended December 31, 2019, DURECT's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as DURECT's subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made, and DURECT undertakes no obligation to revise or update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    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.

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    SOURCE DURECT Corporation

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  14. CUPERTINO, Calif., Feb. 3, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) ("DURECT"), 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, today announced that it is commencing an underwritten public offering of its common stock (the "Offering"). All of the shares to be sold in the Offering will be sold by DURECT, subject to customary closing conditions. In addition, DURECT intends to grant the underwriter for the Offering a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

    Cantor Fitzgerald…

    CUPERTINO, Calif., Feb. 3, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) ("DURECT"), 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, today announced that it is commencing an underwritten public offering of its common stock (the "Offering"). All of the shares to be sold in the Offering will be sold by DURECT, subject to customary closing conditions. In addition, DURECT intends to grant the underwriter for the Offering a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

    Cantor Fitzgerald & Co. is acting as the sole book running manager for the Offering.

    The Offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226518) previously filed by DURECT with the Securities and Exchange Commission (the "SEC") on September 28, 2019 and declared effective by the SEC on October 9, 2018. The Offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the Offering will be filed with the SEC. Before you invest, you should read the registration statement, the preliminary prospectus, the documents that DURECT has filed with the SEC that are incorporated by reference into the registration statement, and the other documents DURECT has filed with the SEC for more complete information about DURECT and the offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: prospectus@cantor.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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, COVID-19 patients, and non-alcoholic steatohepatitis (NASH). DURECT's proprietary drug delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is now FDA-approved.

    Forward Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Offering, regarding the potential uses and benefits of POSIMIR, the potential for DUR-928 to treat patients with AH, NASH, COVID-19, or other acute organ injury and chronic liver diseases, and plans for clinical development of DUR-928.  These forward-looking statements are only predictions based upon management's current information and expectations, are subject to known and unknown risks, and involve a number of uncertainties. Actual events and results may differ materially from those projected in such forward-looking statements as a result of various factors, including market risks and uncertainties and the satisfaction of customary closing conditions for an offering of securities, as well as potential risks and uncertainties that POSIMIR will not achieve a successful commercial launch, that the clinical trial of DUR-928 in AH is delayed due to COVID-19 or other factors or that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that clinical trials of DUR-928 take longer to conduct than anticipated, 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, and risks related to our ability to obtain capital to fund operations and expenses. For a discussion of these and other factors, please refer to DURECT's Annual Report on Form 10-K for the year ended December 31, 2019, DURECT's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as DURECT's subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made, and DURECT undertakes no obligation to revise or update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    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.

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  15. CUPERTINO, Calif., Feb. 2, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that the U.S. Food and Drug Administration (FDA) has approved POSIMIR® (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated…

    CUPERTINO, Calif., Feb. 2, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that the U.S. Food and Drug Administration (FDA) has approved POSIMIR® (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. POSIMIR demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opioid use, from a median of 12 mg in the placebo group to 4 mg in the POSIMIR group (p=0.01). Please see important safety information including the Boxed Warning below and the POSIMIR full prescribing information.

    "We are excited to announce the approval of POSIMIR, a novel, non-opioid, sustained-release local analgesic for the treatment of post-surgical pain following arthroscopic subacromial decompression surgery," said James E. Brown, President and CEO of DURECT. "This FDA approval provides an important new option to help orthopedic surgeons in their efforts to minimize opioid use while managing acute pain for up to 72 hours after this painful surgery."

    "In my experience, POSIMIR was easy to administer into the subacromial space under arthroscopic guidance, where it can directly address the source of postsurgical pain," said Sten Rasmussen, MD CBE PhD, Associate Professor, Department of Orthopaedic Surgery, Aalborg University Hospital, and Professor and Head of the Department of Clinical Medicine, Aalborg University, Denmark, a principal investigator in the POSIMIR registration trial. "A non-opioid product providing up to three days of local analgesia would be a significant benefit to patients."

    "The first 72 hours after surgery are typically when patients experience the most severe postsurgical pain," said T J Gan, MD MHS FRCA MBA, Professor and Distinguished Endowed Chair, Department of Anesthesiology at Stony Brook University Renaissance School of Medicine. "So, a new sustained-release product providing continuous analgesia during this critical period is a welcome addition to the armamentarium for anesthesiologists and surgeons, especially as we aim to reduce the use of postsurgical opioids whenever possible."

    About POSIMIR

    POSIMIR (bupivacaine solution) for infiltration use is a novel and proprietary product that combines the strength of 660 mg of bupivacaine base with the innovative SABER® platform technology, enabling continuous sustained delivery of a non-opioid local analgesic over 3 days in adults. POSIMIR contains more bupivacaine than any other approved single-dose sustained-release bupivacaine product. At the end of surgery, POSIMIR is administered into the subacromial space under direct arthroscopic visualization, where it continuously releases bupivacaine for 72 hours or more. DURECT is in discussions with potential partners regarding the licensing of commercialization rights to POSIMIR, for which DURECT holds worldwide rights. 

    About Subacromial Decompression Shoulder Surgery

    Subacromial decompression is a type of shoulder surgery used to treat impingement syndrome, a common repetitive-use injury that causes pain when the arm is raised over the head. The procedure is typically performed arthroscopically, meaning that several small incisions are made in the skin and muscle of the shoulder through which a camera lens (arthroscope) and surgical instruments are inserted during surgery. Arthroscopic subacromial decompression is generally considered outpatient surgery, and most patients go home within a few hours of surgery. The recovery period may extend from weeks to months, but the most intense pain typically occurs during the first 3 days after surgery and is often managed with oral opioids. There are over 600,000 surgeries involving arthroscopic subacromial decompression performed each year in the U.S.

    Postmarketing Requirements

    In connection with this approval, the Company or its licensee, will be required to conduct two postmarketing non-clinical studies.

    Indications and Usage

    POSIMIR (bupivacaine solution) for infiltration use is indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.

    Limitations of Use

    Safety and effectiveness have not been established in other surgical procedures, including soft tissue surgical procedures, other orthopedic procedures, including for intra-articular administration, and boney procedures, or when used for neuraxial or peripheral nerve blockade.

    Full Prescribing Information, including the Boxed Warning, is available at www.POSIMIR.com

    Important Safety Information

    BOXED WARNING: Risk of Potential Adverse Embolic Effects Resulting From Inadvertent Intravascaular Injection. Inadvertent intravascular injection could cause POSIMIR droplets to be deposited in the pulmonary and other capillary beds.  Administer POSIMIR into the subacromial space at the end of arthroscopic shoulder surgery. Direct arthroscopic visualization must be used to confirm proper placement of the needle tip before injecting POSIMIR.

    In POSIMIR clinical studies, no inadvertent intravascular injections were observed. Do not inject POSIMIR intravascularly.

    POSIMIR is contraindicated in patients with a known hypersensitivity to any amide local anesthetic, or other components of POSIMIR, as well as in patients undergoing obstetrical paracervical block anesthesia. There is a risk of joint cartilage necrosis with unapproved intra-articular use of POSIMIR. Unintended intravascular injection of POSIMIR may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. As with other local anesthetics, patients should be monitored for central nervous system, cardiovascular, and allergic reactions. Avoid additional use of local anesthetics within 168 hours following administration of POSIMIR. Cases of methemoglobinemia have been reported in association with use of local anesthetics. There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. POSIMIR should be used cautiously in patients with impaired hepatic and cardiovascular function. Adverse events reported with an incidence greater than or equal to 10% and greater than control following POSIMIR administration in shoulder surgery were dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, and vomiting. Adverse events reported with an incidence greater than or equal to 10% and greater than control following POSIMIR administration in soft tissue surgical procedures were anemia, bradycardia, constipation, C-reactive protein increased, diarrhea, dizziness, dysgeusia, headache, nausea, oropharyngeal pain, post-procedural contusion (bruising), procedural pain, pruritus, pyrexia, somnolence, surgical site bleeding, visible bruising and vomiting.

    To report SUSPECTED ADVERSE REACTIONS, contact DURECT Corporation at 1-844-767-4647 or FDA at 1–800–FDA-1088 or www.fda.gov/medwatch.

    Conference Call

    The DURECT management team will host a conference call to discuss the contents of this press release today at 4:30pm ET / 1:30pm PT:

    Toll Free: 877-407-0784

    International: 201-689-8560

    Conference ID: 13716187

    Webcast: http://public.viavid.com/index.php?id=143426

    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, COVID-19 patients, and non-alcoholic steatohepatitis (NASH). DURECT's proprietary drug delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. 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 uses and benefits of POSIMIR, prospects of obtaining a commercialization partner for POSIMIR, as well as the potential for DUR-928 to treat patients with AH, NASH, COVID-19, or other acute organ injury and chronic liver diseases, and plans for clinical development of DUR-928 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 DURECT will not reach agreement with a commercialization partner for POSIMIR and that POSIMIR will not achieve a successful commercial launch, that the clinical trial of DUR-928 in AH is delayed due to COVID-19 or other factors or that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that clinical trials of DUR-928 take longer to conduct than anticipated, 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, 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 November 3, 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 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.

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  16. CUPERTINO, Calif., Jan. 25, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it has dosed the first patient in its AHFIRM randomized, double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in severe alcohol-associated hepatitis (AH) patients.

    "We are excited to have begun dosing severe AH patients in the AHFIRM trial. There are no approved therapies indicated for treatment of AH and the average mortality rate in AH clinical trials at 90 days after admission to the hospital is 29%," stated James E. Brown, D.V.M., President and CEO of DURECT. "In our completed Phase 2a AH trial, all 19 patients dosed with DUR-928 survived the 28-day study period. In this much larger, placebo-controlled…

    CUPERTINO, Calif., Jan. 25, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it has dosed the first patient in its AHFIRM randomized, double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in severe alcohol-associated hepatitis (AH) patients.

    "We are excited to have begun dosing severe AH patients in the AHFIRM trial. There are no approved therapies indicated for treatment of AH and the average mortality rate in AH clinical trials at 90 days after admission to the hospital is 29%," stated James E. Brown, D.V.M., President and CEO of DURECT. "In our completed Phase 2a AH trial, all 19 patients dosed with DUR-928 survived the 28-day study period. In this much larger, placebo-controlled Phase 2b AHFIRM trial, we are evaluating DUR-928's lifesaving potential in severe AH patients at 90 days compared to a control group that will receive placebo and standard of care.  We believe that demonstration of a robust survival benefit in this trial may support an NDA filing."

    About the AHFIRM Clinical Trial - Phase 2b study in subjects with Alcohol-associated Hepatitis to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM)

    AHFIRM is a Phase 2b clinical trial evaluating the potential life-saving capacity of DUR-928 in patients with severe AH. AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC.  Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores), and time in the intensive care unit. The Company is targeting 40-50 clinical trial sites in the US and Europe. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026

    About Alcohol-Associated Hepatitis (AH)

    Alcohol-Associated Hepatitis (also called Alcoholic Hepatitis or AH) is an acute form of alcohol-associated liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by recent onset jaundice and hepatic failure. According to the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 122,000 hospitalizations for patients with AH in 2017. From a recent publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $800,000 per patient. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days after admission.

    About DUR-928

    DURECT's lead drug 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.

    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 being developed for the potential treatment of alcohol-associated hepatitis (AH) for which FDA has granted a Fast Track Designation, COVID-19 patients, and non-alcoholic 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 sustained-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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement  

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat AH, plans for the AHFIRM trial and the potential for this Phase 2b trial to support an NDA, the potential use of DUR-928 to treat COVID-19 patients or NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 will take longer to conduct than anticipated, will not confirm the results from earlier clinical or pre-clinical trials, or will not demonstrate the safety or efficacy or the life saving potential of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates 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 November 3, 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.

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  17. CUPERTINO, Calif., Jan. 5, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the appointment of two new members to its board of directors, Gail J. Maderis, MBA and Mohammad Azab, M.D., M. Sc., MBA, two senior industry veterans with extensive drug development, clinical research and medical affairs experience.

    "We are pleased to welcome Ms. Maderis and Dr. Azab to our board as we continue to enhance our board in line with our maturing company," stated James E. Brown, D.V.M., President and Chief Executive Officer of DURECT. "Their extensive expertise will be valuable as we continue to advance our clinical pipeline and create value for our shareholders, in particular as we advance the Phase 2b AHFIRM study of our lead candidate…

    CUPERTINO, Calif., Jan. 5, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the appointment of two new members to its board of directors, Gail J. Maderis, MBA and Mohammad Azab, M.D., M. Sc., MBA, two senior industry veterans with extensive drug development, clinical research and medical affairs experience.

    "We are pleased to welcome Ms. Maderis and Dr. Azab to our board as we continue to enhance our board in line with our maturing company," stated James E. Brown, D.V.M., President and Chief Executive Officer of DURECT. "Their extensive expertise will be valuable as we continue to advance our clinical pipeline and create value for our shareholders, in particular as we advance the Phase 2b AHFIRM study of our lead candidate DUR-928 for the treatment of alcohol-associated hepatitis (AH) and plan for other indications with DUR-928."

    Ms. Maderis stated, "Clinical data from DURECT's lead clinical asset DUR-928 in AH and non-alcoholic steatohepatitis (NASH) look very promising and show the potential of DUR-928 for the treatment of multiple organ injury and chronic liver diseases. I am eager to work with the DURECT board and management team to bring additional perspective as the company advances its clinical pipeline and explores additional opportunities for DUR-928 to fulfill unmet needs."

    Dr. Azab added, "I am excited to be joining the DURECT board as the company advances DUR-928 in the AHFIRM trial and gets closer to potentially offering a life-saving therapy to people affected by this life-threating condition. I look forward to working with the team and providing guidance as DURECT continues to advance DUR-928 through development and eventually, to potential approval and commercialization."

    Gail Maderis has served as President and CEO of Antiva Biosciences, a venture funded biopharma company developing topical therapies to treat the pre-cancerous lesions caused by HPV, since 2015.  From 2009 to 2015, she led BayBio, the industry organization representing and supporting Northern California's life science community. From 2003 to 2009, she served as President and CEO of Five Prime Therapeutics, Inc., a protein discovery and development company. Prior to FivePrime, Ms. Maderis held senior executive positions at Genzyme Corporation, including founder and president of Genzyme Molecular Oncology. She also practiced management and strategy consulting with Bain & Co. She serves on the corporate boards of Allarity Therapeutics and Valitor, Inc., as well as on the non-profit boards of BIO (Emerging Company and Health Sections), CLSI, The Termeer Foundation and the University of California Berkeley Foundation Board of Trustees. She received a BS in business from UC Berkeley and an MBA from Harvard Business School.

    Dr. Mohammad Azab served as President and Chief Medical Officer of Astex Pharmaceuticals, Inc. since 2014 after holding the position of Chief Medical Officer there since 2009.  As of November 2020, upon retirement from his management role, Dr. Azab has served as the Chair of the Board of Directors for Astex Pharmaceuticals, Inc, which is a wholly owned subsidiary of Otsuka Pharmaceuticals, focused on the discovery and development of drugs in oncology and other therapeutic areas. Previously, Dr. Azab served as President and CEO of Intradigm Corporation, a developer of siRNA cancer therapeutics. Prior to this, Dr. Azab served as Executive Vice President of Research and Development, and Chief Medical Officer of QLT Inc., and in several drug development leadership positions at Astra Zeneca in the United Kingdom and Sanofi Pharmaceuticals in France. During his carrier he has led or has been involved with the development of 8 approved drugs, 7 in Oncology and one in Ophthalmology.  Dr. Azab holds his medical degree (MB ChB) from Cairo University and an M.B.A. from the Richard Ivey School of Business, University of Western Ontario. He received post-graduate training and degrees in oncology research from the University of Paris-Sud and biostatistics from the University of Pierre et Marie Curie in Paris, France. Dr. Azab has more than 30 years of experience in clinical research, global drug development, and business management and led the global development of several drugs currently approved in oncology and other therapeutic areas. Currently, he also serves on the board of directors of Xenon Pharmaceuticals Inc. 

    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, COVID-19 patients with acute liver or kidney injury, and non-alcoholic 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 sustained-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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat AH and other acute organ injuries, including in COVID-19 patients, as well as chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 start of the AHFIRM trial or other trials will be delayed due to COVID-19 or other factors, that the AHFIRM trial will take longer than expected and may not replicate results from earlier trials, that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that clinical trials of DUR-928 do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 November 3, 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.

     

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  18. CUPERTINO, Calif., Jan. 4, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that the sale of the LACTEL product line to Evonik closed and the $15 million payment was received on December 31, 2020.

    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, COVID-19 patients with acute liver or kidney injury, and non-alcoholic steatohepatitis…

    CUPERTINO, Calif., Jan. 4, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that the sale of the LACTEL product line to Evonik closed and the $15 million payment was received on December 31, 2020.

    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, COVID-19 patients with acute liver or kidney injury, and non-alcoholic 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 sustained-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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat AH and other acute organ injuries, including in COVID-19 patients, as well as chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 start of the AHFIRM trial or other trials will be delayed due to COVID-19 or other factors, that the AHFIRM trial will take longer than expected and may not replicate results from earlier trials, that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that clinical trials of DUR-928 do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 November 3, 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.

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  19. CUPERTINO, Calif., Dec. 21, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will participate in the forthcoming H.C. Wainwright BioConnect 2021 Conference and Annual LifeSci Advisors Corporate Access Event. Both conferences will take place virtually. 

    H.C. Wainwright BioConnect 2021 Conference (January 11-14)

    DURECT management will provide a corporate update. The session time is on-demand, beginning Monday January 11 starting 6:00 am (EST). To register  and view the presentation, please click here.

    LifeSci Advisors Corporate Access Event (January 6-8 and 11-14)

    Management will be available for virtual 1on1 meetings with institutional investors and sell side analysts. To register for this event and request a meeting…

    CUPERTINO, Calif., Dec. 21, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will participate in the forthcoming H.C. Wainwright BioConnect 2021 Conference and Annual LifeSci Advisors Corporate Access Event. Both conferences will take place virtually. 

    H.C. Wainwright BioConnect 2021 Conference (January 11-14)

    DURECT management will provide a corporate update. The session time is on-demand, beginning Monday January 11 starting 6:00 am (EST). To register  and view the presentation, please click here.

    LifeSci Advisors Corporate Access Event (January 6-8 and 11-14)

    Management will be available for virtual 1on1 meetings with institutional investors and sell side analysts. To register for this event and request a meeting, please click here.

    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 Fast Track Designation, COVID-19 patients with acute liver or kidney injury, and non-alcoholic 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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat AH and other acute organ injuries, including in COVID-19 patients, as well as chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 start of the AHFIRM trial or other trials will be delayed due to COVID-19 or other factors, that the AHFIRM trial will take longer than expected and may not replicate results from earlier trials, that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that clinical trials of DUR-928 do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 November 3, 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.

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  20. CUPERTINO, Calif., Dec. 16, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to DUR-928 for the treatment of alcoholic hepatitis (AH, also known as alcohol-associated hepatitis). AH is an acute, life-threatening form of alcohol-associated liver disease (ALD). DUR-928 is the lead investigational product candidate in DURECT's Epigenetic Regulator program.  

    "Fast Track Designation highlights the life-threatening nature of AH and the lack of therapeutic options for this devastating condition," said Norman L. Sussman, M.D., Chief Medical Officer of DURECT Corporation. "As an endogenous epigenetic regulator, DUR-928 is a new class of therapeutics…

    CUPERTINO, Calif., Dec. 16, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to DUR-928 for the treatment of alcoholic hepatitis (AH, also known as alcohol-associated hepatitis). AH is an acute, life-threatening form of alcohol-associated liver disease (ALD). DUR-928 is the lead investigational product candidate in DURECT's Epigenetic Regulator program.  

    "Fast Track Designation highlights the life-threatening nature of AH and the lack of therapeutic options for this devastating condition," said Norman L. Sussman, M.D., Chief Medical Officer of DURECT Corporation. "As an endogenous epigenetic regulator, DUR-928 is a new class of therapeutics. We are very encouraged by the promising clinical data from our Phase 2a trial in which 100% of AH patients treated with DUR-928 survived the 28-day follow-up period compared to a 26% historical 28-day death rate. We look forward to initiating our Phase 2b trial shortly and working with the FDA to bring DUR-928 to the many patients in need as soon as possible."

    The FDA grants Fast Track Designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track Designation can benefit from early and frequent communication with the agency in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly.

    About Alcoholic Hepatitis (AH)

    AH is an acute form of alcohol-associated liver disease (ALD) that may occur after months or years of excess alcohol consumption, often after a recent period of intense consumption.   AH is typically characterized by recent onset jaundice and hepatic failure. According to the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 122,000 hospitalizations for patients with AH in 2017. From a recent publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $800,000 per patient.

    About DUR-928

    DURECT's lead drug 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.

    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 alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and non-alcoholic 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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat AH and other acute organ injuries, including in COVID-19 patients, as well as chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 start of the AHFIRM trial or other trials will be delayed due to COVID-19 or other factors, that the AHFIRM trial will take longer than expected and may not replicate results from earlier trials, that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that clinical trials of DUR-928 do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 November 3, 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.

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  21. CUPERTINO, Calif., Dec. 7, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it has signed an agreement to sell its LACTEL Absorbable Polymer (LACTEL) product line to Evonik, a global leader in specialty chemicals.

    Under the terms of the agreement, Evonik will pay DURECT $15 million in exchange for certain assets and liabilities associated with LACTEL product line based in Birmingham, Alabama, plus an additional potential payment based on full year EBITDAS results. The transaction is expected to close by Q1 2021 pending the satisfaction of certain customary closing conditions. An offer will be extended to each of the 15 employees of DURECT located in Birmingham, Alabama, which are associated with the LACTEL® business…

    CUPERTINO, Calif., Dec. 7, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it has signed an agreement to sell its LACTEL Absorbable Polymer (LACTEL) product line to Evonik, a global leader in specialty chemicals.

    Under the terms of the agreement, Evonik will pay DURECT $15 million in exchange for certain assets and liabilities associated with LACTEL product line based in Birmingham, Alabama, plus an additional potential payment based on full year EBITDAS results. The transaction is expected to close by Q1 2021 pending the satisfaction of certain customary closing conditions. An offer will be extended to each of the 15 employees of DURECT located in Birmingham, Alabama, which are associated with the LACTEL® business to transition to Evonik.

    "It has been a pleasure working with the highly motivated and talented LACTEL team. We have confidence that Evonik will apply its resources and commitment to excellence to enable the LACTEL product line and supporting team members to thrive," said James E. Brown, President and CEO of DURECT. "This deal makes strategic sense for DURECT as we continue to focus on epigenetic regulation and the development of DUR-928 for alcohol-associated hepatitis and other acute organ injury and chronic liver diseases. We wish all of our LACTEL colleagues the very best going forward."

    "The acquisition of the LACTEL® business will strengthen both our innovation growth field Healthcare Solutions and Evonik's position as a globally leading CDMO for drug delivery solutions," says Johann-Caspar Gammelin, Head of the Nutrition & Care Division of Evonik. "The acquisition of the LACTEL® business marks a consequential step in the growth agenda of the life-science division Nutrition & Care. The LACTEL® business will benefit from fast-growing markets such as advanced drug delivery, biomaterials for tissue engineering, and the 3D printing of implantable medical devices."

    Evonik is one of the world leaders in specialty chemicals. The company is active in more than 100 countries around the world and generated sales of €13.1 billion and an operating profit (adjusted EBITDA) of €2.15 billion in 2019. Evonik goes far beyond chemistry to create innovative, profitable and sustainable solutions for customers. The focus of Evonik's Nutrition & Care division is on health and quality of life. It develops differentiated solutions for active pharmaceutical ingredients, medical devices, nutrition for humans and animals, personal care, cosmetics, and household cleaning. In these resilient end markets, the division generated sales of around €2.9 billion in 2019 with about 5,300 employees.

    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), COVID-19 patients with acute liver or kidney injury, and 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 sustained-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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding the agreement to sell the LACTEL product line to Evonik and potential additional payments, clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH,  and the potential use of POSIMIR to provide pain relief after surgery 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 closing of the sale of the LACTEL product line fails to close as anticipated or that additional payments are not earned, that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from 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 or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 November 3, 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.

     

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  22. CUPERTINO, Calif., Nov. 13, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today presented additional safety data and efficacy signals from its Phase 1b clinical trial of DUR-928 in nonalcoholic steatohepatitis (NASH) patients in a poster presentation at The AASLD Liver Meeting Digital Experience ™ (TLMdX) 2020.

    "The additional safety and efficacy data presented, including improvements in multiple biomarkers of liver health such as a significant reduction in cytokeratin-18 among the patients who also experienced at least a 10% reduction in liver fat, continue to strengthen the promising profile of DUR-928 for NASH," stated Eric Lawitz, M.D., Texas Liver Institute, University of Texas Health San Antonio and principal investigator of the…

    CUPERTINO, Calif., Nov. 13, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today presented additional safety data and efficacy signals from its Phase 1b clinical trial of DUR-928 in nonalcoholic steatohepatitis (NASH) patients in a poster presentation at The AASLD Liver Meeting Digital Experience ™ (TLMdX) 2020.

    "The additional safety and efficacy data presented, including improvements in multiple biomarkers of liver health such as a significant reduction in cytokeratin-18 among the patients who also experienced at least a 10% reduction in liver fat, continue to strengthen the promising profile of DUR-928 for NASH," stated Eric Lawitz, M.D., Texas Liver Institute, University of Texas Health San Antonio and principal investigator of the study. "Together with previously reported overall global reduction from baseline of liver enzymes, liver fat, stiffness as measured by imaging and serum lipids, this additional biomarker data suggests that epigenetic modulation by DUR-928 is worthy of further study in NASH patients."

    James E. Brown, D.V.M., President and CEO of DURECT, added, "The safety and efficacy profiles demonstrated with DUR-928 not only in this NASH trial but in our Phase 2a trial in alcoholic hepatitis, demonstrate potential of this epigenetic regulator to treat multiple acute organ injury and chronic liver diseases. We look forward to continuing the evaluation of DUR-928 in our clinical studies and potentially bringing a life-saving treatment option to patients in need."

    Data presented at The Liver Meeting further demonstrated that DUR-928 was well tolerated at all three doses (50mg, 150mg, and 600mg) with no serious adverse events reported.

    Improvements in Biomarkers Data Summary (Day 28 vs Baseline)

    % change from baseline at the end of dosing (median at day 28)

    Biomarker

    Daily Dose (mg)



    50

    150

    600

    Cytokeratin 18 M30

    -14.6

    -8.6

    -16.1

    Cytokeratin 18 M65

    -18.1

    -9.9

    -35.0

    C Reactive Protein

    -13.9

    -11.8

    1.7

    Plasminogen Activator

    Inhibitor-1

    -13.5

    -13.7

    -8.2

    Interleukin 1 Beta

    -0.1

    -0.6

    -0.2

    Interleukin 6

    -6.0

    1.7

    5.4

    Interleukin 12

    0.0

    0.0

    0.0

    Interleukin 17

    -1.3

    -16.4

    -0.8

    Interleukin 18

    -8.9

    -5.0

    -2.1

    Tumor Necrosis Factor

    -3.2

    -2.9

    -7.9

    Bile Acid

    0.0

    0.0

    1.6

    Adiponectin

    -1.6

    -3.8

    3.9

    Adiponectin, HMW

    0.0

    1.0

    1.0

    Biomarker Data Along With Previously Reported Improvements in Liver Enzymes, Imaging and Serum Levels (Day 28 vs Baseline)

    * Indicates p-value <0.05; ** indicates p < 0.01; *** indicates p <0.001

    Median

    at Day 28

    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%

    Biomarkers

    CK-18, M30

    -14.6%

    -8.6%

    -16.1%

    -22.8%***

    -3.8%

    -42.1%*

    CK-18, M65

    -18.1%

    -9.9%

    -35.0%

    -28.1%***

    -8.7%

    -55.8%*

    ALT (alanine aminotransferase); AST (aspartate aminotransferase); GGT (gamma-glutamyl transferase); 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. LDL-C ( Low-Density Lipoprotein – Cholesterol); Non-HDL-C (Total cholesterol excluding High-Density Lipoprotein-Cholesterol); QD (once a day); BID (twice a day); CK-18 (cytokeritin 18)

    Additionally, in subjects with baseline triglyceride (TG) levels ≥200mg/dL (n=16), there was a 24% reduction at the end of the 4-week dosing period (p<0.01). 

    About DUR-928 Phase 1b Trial

    The study was a randomized, open label, multi center US study to evaluate safety, pharmacokinetics and signals of biological activity of DUR-928 in NASH patients with stage 1-3 fibrosis. A total of 65 patients completed the study. DUR-928 was orally administered daily at 50 mg (n=23), 150 mg (n=21), or 600 mg (300 mg BID (n=21)). Patients in this trial were dosed daily for 4 weeks and followed up for an additional 4 weeks.

    About DUR-928

    DURECT's lead drug 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.

    About NASH

    Nonalcoholic steatohepatitis (NASH) is the most severe and progressive form of nonalcoholic fatty liver disease (NAFLD) and the most common chronic liver disease worldwide, with an estimated prevalence of more than 10% of adults in the United States, Europe, Japan, and other developed countries, expected to double by 2030. No drug is currently approved for treatment of NAFLD or NASH.

    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 alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and 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 sustained-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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, the life saving potential of DUR-928, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, 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 the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 November 3, 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.

     

     

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  23. CUPERTINO, Calif., Nov. 10, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that Norman Sussman, MD, FAASLD, newly appointed Chief Medical Officer, will host a webinar on the treatment landscape and unmet medical need in treating patients with alcoholic hepatitis (AH), as well as information on DURECT' investigational drug candidate, DUR-928, being developed for the treatment of AH. The webinar will be held on Friday, November 20, 2020 at 1:00 pm Eastern Time.  Dr. Sussman will be available to answer questions following the formal presentations.

    To register for the event, please click here.

    DURECT is evaluating DUR-928 in the AHFRIM trial, a double-blind, placebo-controlled Phase 2b Trial in Alcoholic Hepatitis to Evaluate…

    CUPERTINO, Calif., Nov. 10, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that Norman Sussman, MD, FAASLD, newly appointed Chief Medical Officer, will host a webinar on the treatment landscape and unmet medical need in treating patients with alcoholic hepatitis (AH), as well as information on DURECT' investigational drug candidate, DUR-928, being developed for the treatment of AH. The webinar will be held on Friday, November 20, 2020 at 1:00 pm Eastern Time.  Dr. Sussman will be available to answer questions following the formal presentations.

    To register for the event, please click here.

    DURECT is evaluating DUR-928 in the AHFRIM trial, a double-blind, placebo-controlled Phase 2b Trial in Alcoholic Hepatitis to Evaluate Safety and EfFIcacy of DUR-928 TreatMent.

    DUR-928 is an endogenous sulfated oxysterol, 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.

    Norman L. Sussman, MD, FAASLD, joined DURECT as Chief Medical Officer in November 2020. He has extensive clinical experience and expertise in the field of liver disease and brings over 30 years of clinical research and development experience in academia and industry. Prior to joining DURECT he was an Associate Professor of Medicine and Surgery at Baylor College of Medicine and a faculty member of Baylor College of Medicine intermittently since 1985. During that time, he served as a Principal Investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman gained leadership experience in industry as the founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as Director of the telehealth program, Project ECHO®, at Baylor St. Luke's Medical Center.

    Dr. Sussman received his MBBCh from the University of the Witwatersrand in Johannesburg, South Africa. He then completed his residency at St. Louis University Hospital and his post-doctoral fellowship at Washington University. He is Board Certified in Internal Medicine, Gastroenterology, and Transplant Hepatology. Dr. Sussman is also a Fellow of the American Association of the Study of Liver Disease, which is a designation that recognizes his superior level of professional achievement in the field of hepatology.

    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 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 sustained-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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, the life saving potential of DUR-928, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, 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 the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 November 3, 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.

     

     

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  24. CUPERTINO, Calif., Nov. 2, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced financial results for the three months ended September 30, 2020 and provided a corporate update.

    • Total revenues were $2.7 million and net loss was $9.3 million for the three months ended September 30, 2020 as compared to total revenues of $10.8 million and net loss of $2.0 million for the three months ended September 30, 2019.
    • At September 30, 2020, cash and investments were $49.8 million, compared to cash and investments of $51.3 million at June 30, 2020 and $64.8 million at December 31, 2019. Debt at September 30, 2020 was $20.7 million, compared to $20.3 million at December 31, 2019.

    "We are pleased with the progress made in our development of…

    CUPERTINO, Calif., Nov. 2, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced financial results for the three months ended September 30, 2020 and provided a corporate update.

    • Total revenues were $2.7 million and net loss was $9.3 million for the three months ended September 30, 2020 as compared to total revenues of $10.8 million and net loss of $2.0 million for the three months ended September 30, 2019.
    • At September 30, 2020, cash and investments were $49.8 million, compared to cash and investments of $51.3 million at June 30, 2020 and $64.8 million at December 31, 2019. Debt at September 30, 2020 was $20.7 million, compared to $20.3 million at December 31, 2019.

    "We are pleased with the progress made in our development of DUR-928 for the indications of Alcoholic Hepatitis, COVID-19 and NASH," stated James E. Brown, D.V.M, President and CEO of DURECT.  "We expect dosing to begin shortly in AHFIRM, our Phase 2b clinical trial evaluating the potential life-saving capacity of DUR-928 in patients with severe Alcoholic Hepatitis.  We initiated dosing in our Phase 2a trial of DUR-928 in COVID-19 patients in September and also will be presenting additional data from our Phase 1b NASH trial at The Liver Meeting Digital Experience™ 2020 in mid-November.  We have had continuing correspondence with the FDA regarding the POSIMIR NDA and believe they are making progress with their review. And last but not least, we are excited to welcome Dr. Norman Sussman as our Chief Medical Officer."

    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)

    • We expect to begin dosing soon in our Phase 2b study in subjects with severe acute Alcoholic Hepatitis to evaluate safety and efFIcacy of DUR-928 treatMent (AHFIRM). AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores) and time in the intensive care unit. The Company is targeting 40-45 clinical trial sites in the US and Europe.
    • Given the high mortality rate in severe AH patients and the absence of an approved therapeutic, demonstration of a robust survival benefit in the AHFIRM trial may support an NDA filing.
    • During 2019, we completed a Phase 2a clinical trial of DUR-928 in patients with AH. All 19 patients treated with DUR-928 survived the 28-day follow-up period, 74% of patients (14/19) were discharged in ≤ 4 days after receiving a single dose of DUR-928, and there were no drug-related serious adverse events.
    • AH is an acute form of alcoholic liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by a recent onset of jaundice and hepatic failure. According to the most recent data provided by the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 122,000 hospitalizations for patients with AH in 2017. From a recent publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $800,000 per patient. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days after admission.

    Non-Alcoholic Steatohepatitis (NASH)

    • In May 2020, we reported positive topline results from a Phase 1b randomized and open-label clinical study conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity (including clinical chemistry and biomarkers as well as liver fat content and liver stiffness by imaging) of DUR-928 in NASH patients with stage 1-3 fibrosis. A total of 65 patients completed the study. DUR-928 was orally administered daily at 50 mg (n=23), 150 mg (n=21), or 600 mg (300 mg BID (n=21)) for 4 weeks. At the end of dosing, patients were followed up for an additional 4 weeks.
    • Reductions from baseline (pre-treatment) levels were seen in liver enzymes, liver stiffness as measured by imaging, and serum lipids. Many of these reductions were statistically significant. The Company believes that these results , i.e., multiple important parameters moving in the same desirable direction, especially given the short treatment course of four weeks, is a promising indication of DUR-928's potential in NASH.
    • DUR-928 was well tolerated at all three doses evaluated. There were no serious adverse events reported during the study. Pharmacokinetic (PK) parameters after repeat dosing were comparable to those after a single dose (from a prior study), indicating no accumulation after repeat dosing.
    • Additional results, including biomarker data, will be presented through a poster at The Liver Meeting Digital Experience™ 2020 being held November 13-16, 2020.
    • Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in both children and adults. It is estimated that NAFLD affects approximately 30% to 40% of adults and 10% of children in the United States. NASH, a more severe and progressive form of NAFLD, is one of the most common chronic liver diseases worldwide, with an estimated prevalence of 3-5% globally. No drug is currently approved for NAFLD or NASH.

    COVID-19

    • We have initiated dosing in a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the safety and efficacy of DUR-928 in hospitalized COVID-19 patients with acute liver or kidney injury.
    • A total of approximately 80 patients are planned to be enrolled into two study treatment groups in a 3:1 (DUR-928: placebo) ratio. Patients will receive a dose of 150 mg of DUR-928 or placebo by intravenous infusion on day 1 and day 4 in combination with standard of care therapy, which will be determined by the principal investigator (PI) at each clinical trial site. The primary efficacy endpoint is a composite of survival and being free of acute organ failure (free of mechanical ventilation, free of liver failure events and free of renal replacement therapy) at day 28. Patients will be followed for 60 days. Any drug product(s) determined by the FDA to be safe and effective for the treatment of COVID-19 while the trial is ongoing may be offered, at each PI's discretion, to any remaining and future patients in this trial.
    • COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus (SARS-COV-2). The rapid spread of the disease has resulted in a pandemic with millions of confirmed cases and over one million deaths worldwide. While most cases result in mild symptoms, including fever, cough and shortness of breath, some rapidly progress into acute respiratory distress syndrome (ARDS), multi-organ failure, and death. Many of these patients experience severe systemic inflammation that results in acute injuries in multiple organs including the liver and/or the kidney. Organ injury may also occur in hospitalized COVID-19 patients as the result of other complications of the viral infection. In a study of 1,059 adult cases of confirmed hospitalized COVID-19, 62% of patients presented with at least one elevated liver enzyme. In another study, 36.6% of 5,449 patients admitted with COVID-19 had or developed acute kidney injury (AKI).

    POSIMIR® (bupivacaine 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.

    • We have continued to communicate with the FDA regarding their review of the POSIMIR NDA and believe they are making progress on their review.

    Methydur® Sustained Release Capsules (ORADUR®-Methylphenidate). Our partner, Orient Pharma, has informed us that they launched Methydur Sustained Release Capsules commercially in Taiwan in September 2020.

    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 2020 results and provide a corporate update:

    Monday, November 2 @ 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

    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.  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 plans to begin dosing soon in our Phase 2b study in subjects with acute Alcoholic Hepatitis, announce further data from the Phase 1b NASH trial, and 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, 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 AHFIRM trial does not support NDA filing, the risk that the FDA will not approve POSIMIR or will require a commercially limiting label, 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 August 4, 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. Methydur Sustained Release Capsules have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities other than in Taiwan for any indication.

    DURECT CORPORATION



    CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

    (in thousands, except per share amounts)

    (unaudited)























    Three months ended



    Nine months ended





     September 30 



     September 30 





    2020



    2019



    2020



    2019



















    Collaborative research and development and other revenue

    $     306



    $  7,741



    $23,623



    $ 10,880

    Product revenue, net

    2,377



    3,022



    7,679



    7,999



    Total revenues

    2,683



    10,763



    31,302



    18,879



















    Operating expenses:

















    Cost of product revenues 

    1,065



    731



    3,261



    2,746



    Research and development

    7,009



    7,906



    21,412



    20,755



    Selling, general and administrative 

    3,479



    3,837



    10,358



    10,569

    Total operating expenses

    11,553



    12,474



    35,031



    34,070



















    Loss from operations

    (8,870)



    (1,711)



    (3,729)



    (15,191)



















    Other income (expense):

















    Interest and other income

    84



    350



    477



    736



    Interest and other expense

    (546)



    (629)



    (1,690)



    (1,892)

    Net other expense

    (462)



    (279)



    (1,213)



    (1,156)



















    Net loss

    $ (9,332)



    $ (1,990)



    $ (4,942)



    $(16,347)



















    Net loss per share

















    Basic 

    $   (0.05)



    $   (0.01)



    $   (0.02)



    $    (0.09)



    Diluted

    $   (0.05)



    $   (0.01)



    $   (0.02)



    $    (0.09)



















    Weighted-average shares used in computing net loss per share

















    Basic 

    201,877



    192,039



    198,176



    172,939



    Diluted

    201,877



    192,039



    198,176



    172,939



















    Total comprehensive loss

    $ (9,385)



    $ (1,981)



    $ (4,921)



    $(16,345)

     

    DURECT CORPORATION



    CONDENSED BALANCE SHEETS

    (in thousands)















    As of



    As of





    September 30, 2020



    December 31, 2019(1)





    (unaudited)





    ASSETS









    Current assets:









        Cash and cash equivalents



    $                18,670



    $                   34,924

        Short-term investments



    29,943



    29,750

        Accounts receivable



    1,492



    2,313

        Inventories, net



    3,628



    3,383

        Prepaid expenses and other current assets



    3,134



    1,459

    Total current assets



    56,867



    71,829











    Property and equipment, net



    430



    469

    Operating lease right-of-use assets



    5,048



    6,066

    Goodwill



    6,399



    6,399

    Long-term investments 



    1,000



    -

    Long-term restricted Investments



    150



    150

    Other long-term assets



    261



    1,107

    Total assets



    $                70,155



    $                   86,020











    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









        Accounts payable



    $                  1,106



    $                     2,109

        Accrued liabilities



    4,665



    6,284

        Contract research liability



    1,746



    3,653

        Deferred revenue, current portion



    -



    22,679

        Operating lease liabilities, current portion



    2,039



    2,043

    Total current liabilities



    9,556



    36,768











    Deferred revenue, noncurrent portion



    812



    812

    Operating lease liabilities, noncurrent portion



    3,508



    4,517

    Term loan, noncurrent portion, net



    20,679



    20,262

    Other long-term liabilities



    902



    801











    Stockholders' equity



    34,698



    22,860

    Total liabilities and stockholders' equity 



    $                70,155



    $                   86,020



    (1)  Derived from audited financial statements.

     

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  25. CUPERTINO, Calif., Nov. 2, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX), a biopharmaceutical company focused on the development of treatments for acute organ injury and chronic liver diseases, today announced it has appointed Norman Sussman, M.D. as its Chief Medical Officer, effective immediately. In this new role, Dr. Sussman will oversee the clinical development of DURECT's pipeline including multiple indications for its lead investigational drug candidate DUR-928.

    "We are excited to welcome Dr. Sussman as our Chief Medical Officer as we continue to advance DUR-928 through clinical development for the treatment of alcoholic hepatitis (AH), nonalcoholic steatohepatitis (NASH), and other indications," stated James E. Brown, D.V.M…

    CUPERTINO, Calif., Nov. 2, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX), a biopharmaceutical company focused on the development of treatments for acute organ injury and chronic liver diseases, today announced it has appointed Norman Sussman, M.D. as its Chief Medical Officer, effective immediately. In this new role, Dr. Sussman will oversee the clinical development of DURECT's pipeline including multiple indications for its lead investigational drug candidate DUR-928.

    "We are excited to welcome Dr. Sussman as our Chief Medical Officer as we continue to advance DUR-928 through clinical development for the treatment of alcoholic hepatitis (AH), nonalcoholic steatohepatitis (NASH), and other indications," stated James E. Brown, D.V.M., President and Chief Executive Officer of DURECT. "Dr. Sussman is a renowned hepatologist with a proven track record in clinical research of liver diseases. We believe he will provide critical support in advancing our clinical programs and we look forward to his contributions."

    Dr. Sussman commented, "I am delighted to be joining DURECT at this exciting time for the company as it prepares to initiate dosing in a potentially pivotal Phase 2b trial in AH and continues to advance clinical programs for other indications involving acute organ injury and chronic liver diseases. DUR-928 is an epigenetic regulator with a unique mechanism of action that has potential to transform the treatment of these diseases. I look forward to leveraging my clinical experience as I join a talented and dedicated team at DURECT working to bring desperately needed, potentially life-saving therapies to patients with no good therapeutic options."

    Dr. Sussman has extensive clinical experience and expertise in the liver disease field and brings over 30 years of clinical research and development experience in academia and industry. He joins DURECT from Baylor College of Medicine, where he was an Associate Professor of Medicine and Surgery. Dr. Sussman has been a faculty member of Baylor College of Medicine intermittently since 1985. During this time, he has served as a Principal Investigator for research focused on the assessment and management of acute liver failure and artificial liver support. Dr. Sussman has also had leadership experience in industry as the founder and Vice President of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc from 1993 to 1995. Most recently, he has also served in senior leadership roles as a member of the Baylor Faculty Senate and as Director of the telehealth program, Project ECHO®, at Baylor St. Luke's Medical Center.

    Dr. Sussman received his MBBCh from the University of the Witwatersrand in Johannesburg, South Africa. He then completed his residency at St. Louis University Hospital and his post-doctoral fellowship at Washington University. He is Board Certified in Internal Medicine, Gastroenterology, and Transplant Hepatology. Dr. Sussman is also a Fellow of the American Association of the Study of Liver Disease, which is a designation that recognizes his superior level of professional achievement in the field of hepatology.

    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 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 sustained-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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, the life saving potential of DUR-928, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, 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 the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 August 4, 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.

     

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  26. CUPERTINO, Calif., Oct. 27, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will report third quarter 2020 financial results and host a conference call after the market close on Monday, November 2, 2020.

    Monday, November 2 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

    Toll Free:                             877-407-0784

    International:                        201-689-8560

    Conference ID:                    13712508

    Webcast:                              http://public.viavid.com/index.php?id=142231

    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 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 sustained-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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, the life saving potential of DUR-928, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, 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 the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 August 4, 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.

     

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  27. CUPERTINO, Calif., Oct. 26, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will partipate in the ROTH Capital Healthcare Event, "Covid-19 Therapeutics in Development," taking place on Wednesday, October 28, 2020.  The ROTH Healthcare and Biotechnology team are hosting the webinar to discuss key therapies in development to treat COVID disease. 

    The Webinar includes three sessions: "Immune Modulators to Ameliorate COVID Disease 1," "Direct Antivirals and Other Agents Against SARS-CoV2 Virus," and "Indirect Antivirals Against SARS-CoV2 Virus."

    To register for the event, please click here.

    Wednesday, October 28th @ 10:30am – 11:50am Eastern Time

    Session Title:

    Direct Antivirals and Other Agents Against SARS-CoV2

    CUPERTINO, Calif., Oct. 26, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will partipate in the ROTH Capital Healthcare Event, "Covid-19 Therapeutics in Development," taking place on Wednesday, October 28, 2020.  The ROTH Healthcare and Biotechnology team are hosting the webinar to discuss key therapies in development to treat COVID disease. 

    The Webinar includes three sessions: "Immune Modulators to Ameliorate COVID Disease 1," "Direct Antivirals and Other Agents Against SARS-CoV2 Virus," and "Indirect Antivirals Against SARS-CoV2 Virus."

    To register for the event, please click here.

    Wednesday, October 28th @ 10:30am – 11:50am Eastern Time

    Session Title:

    Direct Antivirals and Other Agents Against SARS-CoV2 Virus

    Participants: 

    Tarek Hassanein, M.D., F.A.C.P., F.A.C.G., A.G.A.F., F.A.A.S.L.D., Professor of Medicine at University of California San Diego School of Medicine



    Durect Corporation (DRRX)



    Aridis Pharmaceuticals (ARDS)



    Hepion Pharmaceuticals (HEPA)



    CohBar Inc (CWBR)



    Beyond Air (XAIR)

    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 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 sustained-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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, the life saving potential of DUR-928, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, 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 the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 August 4, 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.

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    SOURCE DURECT Corporation

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  28. AVROBIO, Inc. (NASDAQ:AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced the appointment of Gail M. Farfel, Ph.D., to its Board of Directors. Dr. Farfel brings more than 25 years of pharmaceutical development and regulatory experience in rare diseases with both large and small pharmaceutical companies.

    "Gail's deep experience in rare disease, with a focus on neuroscience, and her expertise in leading global product development and regulatory approvals is highly relevant to our growing pipeline of investigational gene therapies that target lysosomal disorders, devastating disorders that impact both the body and brain," said Geoff MacKay, president and CEO of…

    AVROBIO, Inc. (NASDAQ:AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced the appointment of Gail M. Farfel, Ph.D., to its Board of Directors. Dr. Farfel brings more than 25 years of pharmaceutical development and regulatory experience in rare diseases with both large and small pharmaceutical companies.

    "Gail's deep experience in rare disease, with a focus on neuroscience, and her expertise in leading global product development and regulatory approvals is highly relevant to our growing pipeline of investigational gene therapies that target lysosomal disorders, devastating disorders that impact both the body and brain," said Geoff MacKay, president and CEO of AVROBIO. "We're delighted to welcome Gail to the AVROBIO board. Her experience in advancing therapies from early development through commercialization provides us with additional expertise as we continue to advance our pipeline of investigational gene therapies for the treatment of rare lysosomal disorders."

    Dr. Farfel has been executive vice president and global chief development officer at Zogenix, Inc., a rare disease company, since July 2015. At Zogenix, Dr. Farfel leads all product development activities, including preclinical and clinical development, and regulatory strategy. Prior to joining Zogenix, Dr. Farfel was chief clinical and regulatory officer of Marinus Pharmaceuticals, establishing and overseeing clinical, medical and regulatory strategies for adult and pediatric seizure disorders, including a pediatric epileptic orphan disease. Previously, Dr. Farfel was vice president, therapeutic area head for neuroscience clinical development and medical affairs at Novartis Pharmaceuticals Corporation, where she oversaw a portfolio of products for multiple sclerosis, Alzheimer's disease and Parkinson's disease.

    Dr. Farfel began her career in pharmaceutical drug development at Pfizer Inc., where she worked in clinical development and global medical affairs, directing programs through all stages of clinical development and regulatory submissions.

    Dr. Farfel has authored more than 50 scientific articles in the areas of neuropsychopharmacology and drug effects. She currently serves on the board of directors of DURECT Corporation (NASDAQ:DRRX) and is a director on the Board of the American Society for Experimental Neurotherapeutics. She holds a Ph.D. in neuropsychopharmacology from the University of Chicago, where she received the Ginsburg Prize for Dissertation Excellence and is a director on the Medical and Biological Sciences Alumni Board. Dr. Farfel also holds a bachelor's degree in biochemistry from the University of Virginia.

    About AVROBIO

    Our vision is to bring personalized gene therapy to the world. We aim to halt, reverse or prevent disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing preclinical programs in Hunter syndrome and Pompe disease. AVROBIO is powered by the plato® gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.

    Forward-Looking Statement

    This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as "aims," "anticipates," "believes," "could," "designed to," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected benefits from the appointment of Dr. Farfel to our board of directors, the expected benefits, timing and results of our implementation of our gene therapy programs, as well as the expected benefits of our plato platform.

    Any forward-looking statements in this press release are based on AVROBIO's current expectations, estimates and projections about our industry as well as management's current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIO's product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned preclinical or clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not successfully recruit or enroll a sufficient number of patients for our clinical trials, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIO's product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, risks relating to clinical trial and business interruptions resulting from the COVID-19 outbreak or similar public health crises, including that such interruptions may materially delay our development timeline and/or increase our development costs or that data collection efforts may be impaired or otherwise impacted by such crises, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIO's actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled "Risk Factors" in AVROBIO's most recent Quarterly Report, as well as discussions of potential risks, uncertainties and other important factors in AVROBIO's subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

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  29. CUERTINO, Calif., Oct. 5, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present a poster at The AASLD Liver Meeting Digital Experience ™ (TLMdX) 2020, to be held virtually on November 13-16, 2020. 

    Topline results from the 4-week Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients were released previously, showing an overall improvement from baseline in liver enzymes, liver stiffness, and serum lipid profiles. At day 28, 43% of patients showed ≥ 10% liver fat reduction from baseline as measured by magnetic resonance imaging - proton density fat fraction (MRI-PDFF). Daily oral dosing of DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD…

    CUERTINO, Calif., Oct. 5, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it will present a poster at The AASLD Liver Meeting Digital Experience ™ (TLMdX) 2020, to be held virtually on November 13-16, 2020. 

    Topline results from the 4-week Phase 1b clinical study of orally administered DUR-928 in nonalcoholic steatohepatitis (NASH) patients were released previously, showing an overall improvement from baseline in liver enzymes, liver stiffness, and serum lipid profiles. At day 28, 43% of patients showed ≥ 10% liver fat reduction from baseline as measured by magnetic resonance imaging - proton density fat fraction (MRI-PDFF). Daily oral dosing of DUR-928 was well tolerated at all three doses evaluated, 50mg QD, 150mg QD, and 300mg BID (600mg/day).  Additional safety and efficacy data will be presented in the poster.

    Poster Presentation Details:

    Title: 

    Safety and Efficacy Signals of 4-Week Oral DUR-928 in NASH Subjects

    Session: 

    NAFLD and NASH: Therapeutics - Pharmacologic and Other 

    Presenter: 

    Eric Lawitz, M.D., Vice President, Scientific and Research Development, Texas Liver Institute

    Date/Time: 

    The poster will be available for viewing by attendees of the Liver Meeting throughout the entire meeting and will transition to LiverLearning® after the meeting concludes

    About DUR-928

    DURECT's lead drug 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.

    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 alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and 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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from 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 or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 August 4, 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.

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  30. CUPERTINO, Calif., Sept. 30, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) announced today that James E. Brown, President, CEO, Michael H. Arenberg, Chief Financial Officer, and Dr. WeiQi Lin, Executive Vice President of R&D will be participating in a fireside chat hosted by Ed Arce of H. C. Wainwright on Monday, October 5, 2020 from 2:30 p.m. to 3:00 p.m. EDT / 11:30 a.m. to noon PDT

    A live webcast of the presentation will be available by accessing https://journey.ct.events/view/e7ded313-1d06-476a-971c-b76dce8a6457

    The live webcast of the presentation will also be available by accessing DURECT's homepage at www.durect.com and clicking on the "Investors" tab. 

    About DURECT Corporation

    DURECT is a biopharmaceutical company committed…

    CUPERTINO, Calif., Sept. 30, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) announced today that James E. Brown, President, CEO, Michael H. Arenberg, Chief Financial Officer, and Dr. WeiQi Lin, Executive Vice President of R&D will be participating in a fireside chat hosted by Ed Arce of H. C. Wainwright on Monday, October 5, 2020 from 2:30 p.m. to 3:00 p.m. EDT / 11:30 a.m. to noon PDT

    A live webcast of the presentation will be available by accessing https://journey.ct.events/view/e7ded313-1d06-476a-971c-b76dce8a6457

    The live webcast of the presentation will also be available by accessing DURECT's homepage at www.durect.com and clicking on the "Investors" tab. 

    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 alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and nonalcoholic steatohepatitis (NASH). 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. 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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from 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 or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 August 4, 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.

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  31. CUPERTINO, Calif., Sept. 23, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it has dosed the first patient in its randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the safety and efficacy of DUR-928 in hospitalized COVID-19 patients with acute liver or kidney injury. The primary efficacy endpoint is a composite of survival and being free of acute organ failure at Day 28. The company plans to enroll approximately 80 patients in multiple study sites across the U.S.

    "We are excited to have begun dosing DUR-928 in this population of hospitalized COVID-19 patients with the additional complications of acute liver or kidney injury. These patients are at risk of multi-organ failure and death…

    CUPERTINO, Calif., Sept. 23, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it has dosed the first patient in its randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the safety and efficacy of DUR-928 in hospitalized COVID-19 patients with acute liver or kidney injury. The primary efficacy endpoint is a composite of survival and being free of acute organ failure at Day 28. The company plans to enroll approximately 80 patients in multiple study sites across the U.S.

    "We are excited to have begun dosing DUR-928 in this population of hospitalized COVID-19 patients with the additional complications of acute liver or kidney injury. These patients are at risk of multi-organ failure and death, similar to hospitalized patients with AH," stated James E. Brown, D.V.M., President and CEO of DURECT.  "Based on the positive clinical results of DUR-928 in hospitalized AH patients from our Phase 2a trial and our preclinical data in multi-organ failure models, we believe that DUR-928, in combination with standard of care, has the potential to help these COVID-19 patients."

    About the Phase 2 Trial

    This Phase 2, randomized, double-blind, placebo-controlled, multi-center study is designed to evaluate safety and efficacy of DUR-928 in COVID-19 patients with acute liver or kidney injury. A total of approximately 80 patients are planned to be enrolled into two study treatment groups in a 3:1 (DUR-928: placebo) ratio. Patients will receive a dose of 150 mg of DUR-928 or placebo by intravenous infusion on day 1 and day 4 in combination with standard of care therapy, which will be determined by the principal investigator (PI) at each clinical trial site. The primary efficacy endpoint is a composite of survival and being free of acute organ failure (free of mechanical ventilation, free of liver failure events and free of renal replacement therapy) at day 28. Patients will be followed for 60 days. Should any drug product be determined by the FDA to be safe and effective for the treatment of COVID-19 while the trial is ongoing, such treatments may be offered, at each PI's discretion, to any remaining and future patients in this trial.   For more information, refer to ClinicalTrials.gov Identifier: NCT04447404

    About COVID-19

    COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus (SARS-COV-2). The rapid spread of the disease has resulted in a pandemic with millions of confirmed cases and hundreds of thousands of deaths worldwide. While most cases result in mild symptoms, including fever, cough and shortness of breath, some rapidly progress into acute respiratory distress syndrome (ARDS), multi-organ failure, and death.  Many of these patients experience a rapid elevation of inflammation-inducing signaling molecules (cytokine storm) that trigger acute injuries in multiple organs including the liver and the kidney. Organ injury may also occur in hospitalized COVID-19 patients as the result of other complications of the viral infection. In a study of 1,059 adult cases of confirmed hospitalized COVID-19, 62% of patients presented with at least one elevated liver enzyme. In another study, 36.6% of 5,449 patients admitted with COVID-19 had or developed acute kidney injury (AKI).

    About DUR-928

    DURECT's lead drug 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.

    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 alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and 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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from 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 or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 August 4, 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.

     

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  32. CUPERTINO, Calif., Sept. 22, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the study design for the Phase 2b AHFIRM clinical trial of DUR-928 in severe alcoholic hepatitis (AH) patients.

    AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile…

    CUPERTINO, Calif., Sept. 22, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the study design for the Phase 2b AHFIRM clinical trial of DUR-928 in severe alcoholic hepatitis (AH) patients.

    AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC.  Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores) and time in the intensive care unit. The Company is targeting 40-45 clinical trial sites in the US and Europe and anticipates trial initiation in October.

    "We are pleased to announce the design and pending initiation of this important clinical trial," stated James E. Brown, D.V.M., President and CEO of DURECT.  "Following on the very encouraging results from our Phase 2a AH trial, we believe that the Phase 2b AHFIRM trial will provide a robust evaluation of the safety and potential life-saving capacity of DUR-928 in severe AH patients, who desperately need an effective therapy."

    About Alcoholic Hepatitis (AH)

    AH is an acute form of alcoholic liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by recent onset jaundice and hepatic failure. According to the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 117,000 hospitalizations for patients with AH in 2016. From a recent publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $800,000 per patient.

    About DUR-928

    DURECT's lead drug 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.

    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 alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and 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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat AH and other acute organ injuries, including in COVID-19 patients, as well as chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 start of the AHFIRM trial or other trials will be delayed due to COVID-19 or other factors, that the AHFIRM trial will take longer than expected and may not replicate results from earlier trials, that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that clinical trials of DUR-928 do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 August 4, 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.

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  33. CUPERTINO, Calif., Sept. 10, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will participate in the HC Wainwright 22nd Annual Global Investment Conference, Cantor Fitzgerald Virtual Global Healthcare Conference and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit.

    HC Wainwright 22nd Annual Global Investment Conference

    Date                     Monday, September 14

    Time:                    2:30-2:50 PM EDT (Fireside Chat with Ed Arce)

    Webcast:              https://wsw.com/webcast/hcw7/drrx/1628192

    Cantor Fitzgerald Virtual Global Healthcare Conference

    Date                      Tuesday, September 15

    Time                     10-10:30am EDT (Fireside Chat with Ellie Merle)

    Webcast:              https://www.webcaster4.com/Webcast/Page/2495/37207

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date:                     Tuesday, September 22

    Time:                    11:40am-12:20pm EDT (Fireside chat with Francois Brisebois)

    Webcast:              https://wsw.com/webcast/oppenheimer5/drrx/2751264

    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 in clinical development for the potential treatment of alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and 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 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 and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from 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 or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties 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 August 4, 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.

     

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  34. CUPERTINO, Calif., Aug. 27, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the presentation of pharmacokinetic (PK) data from a Phase 2a study of DUR-928 in alcoholic hepatitis (AH) at the Digital International Liver Congress™ 2020 (EASL), taking place on August 27-29.  DUR-928 was well tolerated at all doses tested in 19 AH patients, including 12 severe AH patients. These PK data, together with other available information for the drug, have been used to inform dose selection in the Company's upcoming Phase 2b study of DUR-298 in AH, planned to begin in the second half of 2020.   

    DURECT's Phase 2a AH study was an open-label, multi-center, dose escalation safety, PK and pharmacodynamic (PD) trial which evaluated doses…

    CUPERTINO, Calif., Aug. 27, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the presentation of pharmacokinetic (PK) data from a Phase 2a study of DUR-928 in alcoholic hepatitis (AH) at the Digital International Liver Congress™ 2020 (EASL), taking place on August 27-29.  DUR-928 was well tolerated at all doses tested in 19 AH patients, including 12 severe AH patients. These PK data, together with other available information for the drug, have been used to inform dose selection in the Company's upcoming Phase 2b study of DUR-298 in AH, planned to begin in the second half of 2020.   

    DURECT's Phase 2a AH study was an open-label, multi-center, dose escalation safety, PK and pharmacodynamic (PD) trial which evaluated doses of 30, 90, or 150 mg of DUR-928 administered by intravenous infusion for 2 hours on Day 1 and Day 4 (if still hospitalized), with patients followed for 28 days.

    Key results presented include:

    • Mean baseline laboratory characteristics and prognostic scores: 
      • Bilirubin 14.2 mg/dL, (upper limit of normal is 1.2 mg/dL)
      • MELD (Model for End-Stage Liver Disease) score 22.3, (≥21 is severe)
      • Maddrey's Discriminant Function 53.4 (≥32 is severe AH)
    • Drug exposure for DUR-928 (as measured by both AUC and Cmax) was dose proportional and comparable between moderate and severe AH patients.  
    • Due to the severe liver injury in AH patients, the systemic clearance of DUR-928 was reduced resulting in an approximately 2-fold higher Cmax in these AH patients compared to healthy subjects.

    As previ