DRRX DURECT Corporation

1.85
-0.03  -2%
Previous Close 1.88
Open 1.86
52 Week Low 1.52
52 Week High 2.96
Market Cap $420,323,447
Shares 227,201,863
Float 200,497,819
Enterprise Value $412,223,502
Volume 741,004
Av. Daily Volume 2,612,593
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Drug Pipeline

Drug Stage Notes
DUR-928
COVID-19 Patients with Acute Liver or Kidney Injury
Phase 2
Phase 2
Phase 2 trial to be discontinued due to limited number of patients eligible or willing to enroll.
POSIMIR
Post-operative pain relief
Approved
Approved
FDA approval announced February 2, 2021.
DUR-928 (AHFIRM)
Alcoholic hepatitis (AH)
Phase 2b
Phase 2b
Phase 2b initiation of dosing announced January 25, 2021.
DUR-928
Nonalcoholic steatohepatitis (NASH)
Phase 1b
Phase 1b
Phase 1b top-line data released May 26, 2020. Additional data presented at AASLD November 13-16, 2020.
DUR-928
Psoriasis
Phase 2a
Phase 2a
Phase 2 top-line data did not meet endpoints - January 2, 2020.
RBP-7000
Schizophrenia
Approved
Approved
FDA Approval announced July 27, 2018.
Posidur
Post-operative pain relief
CRL
CRL
CRL issued February 12, 2014.

Latest News

  1. 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.

    Cision View original content:http://www.prnewswire.com/news-releases/durect-corporation-announces-publication-of-dur-928s-mechanism-of-action-301243414.html

    SOURCE DURECT Corporation

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  2. 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

    SOURCE DURECT Corporation

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  3. 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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    SOURCE DURECT Corporation

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  4. 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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  5. 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: . 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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