Fourth Quarter Highlighted by Presentation of Positive DUR-928 Phase 2a Alcoholic Hepatitis Data at the Liver Meeting 2019

Live Webcast of Earnings Call Today at 4:30 p.m. Eastern Time

CUPERTINO, Calif., March 3, 2020 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months and year ended December 31, 2019 and provided a corporate update.

"The highlight of the year for DURECT in 2019 was achieving positive results from our DUR-928 Phase 2a alcoholic hepatitis (AH) study, which were featured in multiple presentations at the Liver Meeting 2019, including a late-breaking oral presentation by Dr. Tarek Hassanein," stated James E. Brown, D.V.M., President and CEO of DURECT. "In addition, we have already exceeded our 60 patient enrollment target in the ongoing NASH trial, and the last patient is scheduled to begin the 28-day dosing period next week. We are on track to announce top-line NASH data mid-year. We are also making steady progress toward starting a Phase 2b AH clinical trial by mid-year. In January 2020, the FDA held an Advisory Committee meeting to discuss our POSIMIR NDA resubmission. Subsequently, we have continued to interact with FDA as they continue their review."

Potential major milestones in 2020:

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 AH, and in chronic liver diseases such as non-alcoholic steatohepatitis (NASH).

Clinical Trials

Alcoholic Hepatitis (AH)

Non-Alcoholic Steatohepatitis (NASH)

Psoriasis

POSIMIR (bupivacaine extended-release solution) Post-Operative Pain Relief Depot. POSIMIR is the Company'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.

Gilead Collaboration. Theinvestigational long-acting injectable HIV product using DURECT's SABER technology under development with Gilead is currently being re-formulated and will undergo additional pre-clinical development work.

Debt Amendment. In December 2019, 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 December 1, 2021 rather than June 1, 2020) and the final maturity date has been moved back by 18 months (i.e., from November 1, 2022 to May 1, 2024). The interest rate and final payment remain unchanged, and the Company paid Oxford Finance an amendment fee of $825,000.

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 2019 results and provide a corporate update:

A live audio webcast of the presentation will be also available by accessing DURECT's homepage at http://www.durect.com and clicking "Investors." If you are unable to participate during the live webcast, the call will be archived on DURECT's website under "Event Calendar" in the "Investors" section.

About DURECT Corporation

DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. DURECT's lead candidate, DUR-928, has demonstrated the ability to regulate the expression of genes involved in lipid metabolism, inflammatory responses and cell survival. This drug candidate is currently in Phase 2 development for the treatment of alcoholic hepatitis (AH) and 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. A key 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. DURECT has also entered into an agreement with Gilead Sciences to develop and commercialize a long-acting injectable HIV investigational product using DURECT's SABERtechnology. For more information about DURECT, please visit http://www.durect.com.

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DURECT Forward-Looking Statement

The statements in this press release regarding clinical development and plans for DUR-928, including plans to announce top-line data from the Phase 1b NASH trial by mid-year, and initiate a Phase 2b trial of DUR-928 in AH by mid-year, potential regulatory approval of POSIMIR, potential commercial relationships for POSIMIR if approved or other license and collaboration agreements, and the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat acute organ injuries such as AH and 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 replicate 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, 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 successfully re-formulate the investigational long-acting injectable HIV product under development with Gilead, 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 November 5, 2019 under the heading "Risk Factors."

NOTE: POSIMIR and SABER are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928 and POSIMIR are investigational drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.

DURECT CORPORATION

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except per share amounts)

(unaudited)

Three months ended

Twelve months ended

December 31

December 31

2019

2018

2019

2018

Collaborative research and development and other revenue

$ 7,249

$ 775

$ 18,129

$ 8,207

Product revenue, net

3,436

2,852

11,435

10,357

Total revenues

10,685

3,627

29,564

18,564

Operating expenses:

Cost of product revenues

1,397

1,093

4,143

4,263

Research and development

9,454

5,887

30,209

25,501

Selling, general and administrative

3,794

3,539

14,363

12,419

Total operating expenses

14,645

10,519

48,715

42,183

Loss from operations

(3,960)

(6,892)

(19,151)

(23,619)

Other income (expense):

Interest and other income

338

238

1,074

870

Interest and other expense

(609)

(645)

(2,501)

(2,573)

Net other expense

(271)

(407)

(1,427)

(1,703)

Net loss

$ (4,231)

$ (7,299)

$(20,578)

$(25,322)

Net loss per share

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DURECT Corporation Announces Fourth Quarter and Full Year 2019 Financial Results and Update of Programs - Yahoo Finance