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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Durect Corp | NASDAQ:DRRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.38 | 28.15% | 1.73 | 1.73 | 1.78 | 1.77 | 1.331 | 1.34 | 565,903 | 01:00:00 |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported)
(Exact name of Registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
(Address of principal executive offices) (Zip code)
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Title of Each Class |
Trading Symbol |
Name of Each Exchange on Which Registered |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. Results of Operations and Financial Condition.
On May 13, 2024, DURECT Corporation, a Delaware corporation (“DURECT”), announced its first quarter 2024 financial results. This Current Report is filed to disclose nonpublic information required to be disclosed by Regulation FD. A copy of DURECT’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.
The information concerning financial results in this Form 8-K and in Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information concerning financial results in this Form 8-K and in Exhibit 99.1 shall not be incorporated into any registration statement or other document filed with the Securities and Exchange Commission by the company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DURECT Corporation |
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Date: May 13, 2024 |
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By: |
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/s/ James E. Brown |
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James E. Brown Chief Executive Officer
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3
Exhibit 99.1
DURECT Corporation Reports First Quarter 2024 Financial Results and Business Update
- FDA Feedback Supports Single Pivotal Trial for Approval of Larsucosterol in Alcohol-Associated Hepatitis
- Webcast of Earnings Call Today, May 13th at 4:30 p.m. ET
CUPERTINO, Calif., May 13, 2024 /PRNewswire / -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended March 31, 2024 and provided a business update.
“We are pleased that the feedback from the U.S. Food and Drug Administration (FDA) supports the advancement of larsucosterol into a single pivotal Phase 3 clinical trial which, if successful, may serve as the basis for a New Drug Application (NDA) in alcohol-associated hepatitis (AH),” stated James E. Brown, D.V.M., President and CEO of DURECT. “We are in the process of designing the registrational Phase 3 trial incorporating the FDA’s comments and insights gained from our Phase 2b AHFIRM trial. In addition, we are excited about the upcoming presentation at the European Association for the Study of the Liver (EASL) Congress 2024, which will be the first presentation of the AHFIRM data at a medical conference. We expect to provide additional details on our planned Phase 3 protocol and present new analyses from AHFIRM later in the year.”
Business Update:
Financial Highlights for Q1 2024:
Earnings Conference Call
We will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss the first quarter 2024 results and provide a corporate update:
Monday, May 13 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time
Toll Free: 1-877-407-0790
International: 1-201-689-8560
Conference ID: 13746111
Webcast: https://callme.viavid.com/viavid/?callme=true&passcode=13740526&h=true&info=company-email&r=true&B=6
A live audio webcast of the presentation will be also available by accessing DURECT’s homepage at www.durect.com on the “Events” page, under the “Investors” section. If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under the same section, following the completion of the call.
About the AHFIRM Trial
AHFIRM was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study conducted in subjects with severe alcohol-associated hepatitis (AH) to evaluate the saFety and effIcacy of laRsucosterol treatMent (AHFIRM). The study was comprised of three arms and enrolled 307 patients, with approximately 100 patients in each arm: (1) Placebo, which consists of standard of care, with or without methylprednisolone capsules at the investigators’ discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. The primary outcome measure was the 90-Day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo, and the key secondary endpoint was 90-Day survival. The Company enrolled patients at clinical trial sites across the U.S., EU, U.K., and Australia. In November 2023, the Company announced topline data for the AHFIRM Trial. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation for the treatment of AH. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026.
About Alcohol-associated Hepatitis (AH)
AH is an acute form of alcohol-associated liver disease (ALD) associated with long-term heavy alcohol intake, often following a recent period of increased consumption (i.e., a binge). AH is typically characterized by severe inflammation and liver cell damage, potentially leading to life-threatening complications including liver failure, acute kidney injury and multi-organ failure. There are no FDA approved therapies for AH, and a retrospective analysis of 77 studies published between 1971 and 2016, which included data from 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median Model of End-Stage Liver Disease (MELD) score of 23.5, reported mortality at 28 and 90 days of approximately 20% and 31%, respectively. Stopping alcohol consumption is necessary, but frequently not sufficient for recovery in many moderate (defined as MELD scores of 11-20) and severe (defined as MELD scores >20) patients, and therapies that reduce liver inflammation, such as corticosteroids, are limited by contraindications, have not been shown to improve survival at 90 days or one year, and have demonstrated an increased risk of infection. While liver transplantation is becoming more common for ALD patients, including AH patients, the total number of such transplants is still relatively small, and limited by organ availability. Average charges for a liver transplant exceed $875,000, and patients require lifelong immunosuppressive therapy to prevent organ rejection.
About Larsucosterol
Larsucosterol is an endogenous sulfated oxysterol and an epigenetic modulator. 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 reported in many acute (e.g., AH) and chronic diseases (e.g., MASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently modulates 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 modulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases.
About DURECT Corporation
DURECT is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury and cancer. Larsucosterol, DURECT’s lead drug candidate, binds to and inhibits the activity of DNA methyltransferases (DNMTs), epigenetic enzymes that are elevated and associated with hypermethylation found in alcohol-associated hepatitis (AH) patients. Larsucosterol is in clinical development for the potential treatment of AH, for which FDA has granted a Fast Track Designation; metabolic dysfunction-associated steatohepatitis (MASH) 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 and is exclusively licensed to Innocoll Pharmaceuticals for sale and distribution in the United States. For more information about DURECT, please visit www.durect.com and follow us on X (formerly Twitter) at https://x.com/DURECTCorp.
DURECT Forward-Looking Statements
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, relating to: the potential for a single Phase 3 trial of larsucosterol, if successful, to support an NDA filing, and the potential uses and benefits of laruscosterol in patients with AH and potentially other indications. Actual results may differ materially from those contained in the forward-looking statements contained in this press release, and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from those projected include, among other things, the risk that future clinical trials of larsucosterol are delayed or do not confirm the results from subset analyses of the AHFIRM trial, including geographic or other segmentation, or of earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of larsucosterol in a statistically significant manner; the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving larsucosterol for the treatment of AH, and that larsucosterol may never be approved; risks that Innocoll may not commercialize POSIMIR successfully; and risks related to the sufficiency of our cash resources, our anticipated capital requirements, our need or desire for additional financing, our ability to continue to meet the minimum bid price for continued listing on Nasdaq, our ability to obtain capital to fund our operations and expenses, and our ability to continue to operate as a going concern. Further information regarding these and other risks is included in DURECT’s most recent Securities and Exchange Commission (SEC) filings, including its annual report on Form 10-K for the year ended December 31, 2023 and quarterly report on Form 10-Q for the quarter ended March 31, 2024, when filed, under the heading “Risk Factors.” These reports are available on our website www.durect.com under the “Investors” tab and on the SEC’s website at www.sec.gov. All information provided in this press release and in the attachments is based on information available to DURECT as of the date hereof, and DURECT assumes no obligation to update this information as a result of future events or developments, except as required by law.
NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals, Ltd. in the U.S. and a trademark of DURECT Corporation outside of the U.S. SABER® is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners. Larsucosterol 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.
DURECT CORPORATION
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share amounts)
(Unaudited)
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Three months ended |
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2024 |
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2023 |
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Collaborative research and development and other revenue |
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$ |
496 |
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$ |
643 |
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Product revenue, net |
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1,331 |
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1,411 |
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Total revenues |
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1,827 |
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2,054 |
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Operating expenses: |
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Cost of product revenues |
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289 |
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388 |
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Research and development |
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4,119 |
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8,593 |
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Selling, general and administrative |
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3,136 |
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4,095 |
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Total operating expenses |
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7,544 |
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13,076 |
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Loss from operations |
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(5,717 |
) |
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(11,022 |
) |
Other income (expense): |
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Interest and other income |
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321 |
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517 |
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Interest and other expenses |
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(529 |
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(726 |
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Change in fair value of warrant liabilities |
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(1,718 |
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2,477 |
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Issuance cost for warrants |
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— |
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(1,200 |
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Loss on issuance of warrants |
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— |
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(2,033 |
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Other income (expense), net |
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(1,926 |
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(965 |
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Net loss |
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(7,643 |
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(11,987 |
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Net change in unrealized gain on available-for-sale securities, net of reclassification adjustments and taxes |
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4 |
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6 |
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Total comprehensive loss |
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$ |
(7,639 |
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$ |
(11,981 |
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Net loss per share |
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Basic |
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$ |
(0.25 |
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$ |
(0.50 |
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Diluted |
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$ |
(0.25 |
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$ |
(0.52 |
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Weighted-average shares used in computing net loss per share |
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Basic |
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30,637 |
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23,767 |
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Diluted |
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30,637 |
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23,940 |
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DURECT CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
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As of |
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As of |
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31-Mar-24 |
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December 31, 2023 (1) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
19,252 |
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$ |
28,400 |
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Short-term Investments |
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2,187 |
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1,280 |
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Accounts receivable, net |
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1,020 |
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1,261 |
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Inventories, net |
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2,398 |
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2,219 |
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Prepaid expenses and other current assets |
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1,228 |
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1,511 |
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Total current assets |
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26,085 |
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34,671 |
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Property and equipment, net |
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58 |
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91 |
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Operating lease right-of-use assets |
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3,631 |
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3,980 |
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Goodwill |
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6,169 |
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6,169 |
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Long-term restricted investments |
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150 |
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150 |
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Other long-term assets |
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128 |
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128 |
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Total assets |
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$ |
36,221 |
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$ |
45,189 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
782 |
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$ |
1,777 |
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Accrued liabilities |
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5,105 |
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5,966 |
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Term loan, current portion, net |
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14,612 |
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16,663 |
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Operatinglease liabilities, current portion |
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1,298 |
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1,381 |
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Warrant liabilities |
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2,942 |
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1,224 |
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Total current liabilities |
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24,739 |
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27,011 |
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Operating lease liabilities, non-current portion |
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2,466 |
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2,702 |
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Other long-term liabilities |
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716 |
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693 |
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Stockholders’ equity |
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8,300 |
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14,783 |
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Total liabilities and stockholders’ equity |
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$ |
36,221 |
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$ |
45,189 |
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(1) Derived from audited financial statements.
SOURCE: DURECT Corporation |
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Investor Relations |
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Media Contact (DURECT) |
Ashley R. Robinson |
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Mollie Godbout |
LifeSci Advisors |
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LifeSci Communications |
arr@lifesciadvisors.com |
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mgodbout@lifescicomms.com |
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Document and Entity Information |
May 13, 2024 |
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Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | May 13, 2024 |
Title of 12(b) Security | Common Stock $0.0001 par value per share |
Security Exchange Name | NASDAQ |
Trading Symbol | DRRX |
Entity Registrant Name | DURECT CORP |
Entity Central Index Key | 0001082038 |
Entity Emerging Growth Company | false |
Entity File Number | 000-31615 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 94-3297098 |
Entity Address, Address Line One | 10240 Bubb Road |
Entity Address, City or Town | Cupertino |
Entity Address, State or Province | CA |
Entity Address, Postal Zip Code | 95014 |
City Area Code | (408) |
Local Phone Number | 777-1417 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
1 Year Durect Chart |
1 Month Durect Chart |
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