DURECT Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Rhea-AI Summary
DURECT (DRRX) reported its Q4 and full year 2024 financial results, highlighting key developments in its larsucosterol program for alcohol-associated hepatitis (AH). The company's Phase 2b AHFIRM trial results were published in NEJM Evidence in January 2025, with additional data presented at The Liver Meeting 2024.
Financial highlights include: Q4 2024 revenue of $0.5M with net income of $7.8M, compared to Q4 2023 revenue of $0.9M and net loss of $1.4M. Full year 2024 showed revenue of $2.0M with a net loss of $7.9M, versus 2023 revenue of $2.6M and net loss of $27.6M. Cash position stood at $12.0M as of December 31, 2024.
The company sold its ALZET product line for $17.5M to Lafayette Instrument Co. and used the proceeds to repay its term loan with Oxford Finance DURECT is planning a Phase 3 trial for larsucosterol in severe AH, pending sufficient funding.
Positive
- Sale of ALZET product line for $17.5M strengthened balance sheet
- Full repayment of term loan with Oxford Finance
- Publication of Phase 2b AHFIRM trial results in prestigious NEJM Evidence
- Significant reduction in net loss from $27.6M in 2023 to $7.9M in 2024
Negative
- Revenue declined from $2.6M in 2023 to $2.0M in 2024
- Q4 revenue decreased from $0.9M in 2023 to $0.5M in 2024
- Cash position decreased from $29.8M to $12.0M year-over-year
- Phase 3 trial initiation contingent on securing additional funding
News Market Reaction
On the day this news was published, DRRX declined NaN%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Larsucosterol Phase 2b AHFIRM trial results published in NEJM Evidence in January 2025
Additional AHFIRM data presented in November 2024 at The Liver Meeting 2024 that informed the design of planned Phase 3 trial in alcohol-associated hepatitis (AH)
Webcast of earnings call today, March 26 at 4:30 p.m. ET
"We recently achieved significant accomplishments that reinforced our plans for continuing development of larsucosterol for AH and strengthened our balance sheet," stated James E. Brown, D.V.M., President and CEO of DURECT. "We are excited that NEJM Evidence published the results of our Phase 2b AHFIRM trial in January 2025. Publication in such a highly regarded, peer reviewed journal provides additional validation of the potential value of larsucosterol as a treatment for AH. We have incorporated these results, together with the additional AHFIRM data presented at The Liver Meeting 2024, into our planned Phase 3 trial design. Additionally, in the fourth quarter we completed the sale of the ALZET product line and used the proceeds to repay the entirety of our term loan. By strengthening our balance sheet, this transaction furthers our strategic goal of advancing development of larsucosterol for AH. Our primary focus continues to be initiating the Phase 3 trial of larsucosterol for severe AH, contingent on securing sufficient funding. We are engaged in active dialogue to explore all options for funding the continued development of larsucosterol, including potential business development and financing transactions."
Recent business highlights and updates:
- DURECT is planning a registrational Phase 3 trial to evaluate the safety and efficacy of larsucosterol for the treatment of patients with severe AH. The trial will be a randomized, double-blind, placebo-controlled, multi-center study conducted in the
U.S. The primary endpoint will be 90-day survival. The trial design incorporates feedback received from theU.S. Food and Drug Administration (FDA) during a Type B meeting that took place in 2024 under Breakthrough Therapy Designation (BTD) as well as learnings from the prior Phase 2b AHFIRM trial in AH. DURECT's goal is to begin the trial in 2025, subject to obtaining sufficient funding, with topline results expected within two years of trial initiation. - Results from the AHFIRM Phase 2b trial were published in NEJM Evidence in January 2025. In addition to highlighting the key findings from this study, the article also included new trial data, including subgroup analyses that explain regional differences in patient populations and in AH treatment regimens. Variations in time from hospitalization to first dose highlighted the importance of timely treatment in patients with severe AH. The full article can be accessed here. Top line data from AHFIRM were previously announced in November 2023.
- DURECT delivered an oral and two poster presentations at The Liver Meeting 2024, organized by the American Association for the Study of Liver Diseases (AASLD), in November 2024, in
San Diego, California . These presentations showcased additional data from the Phase 2b AHFIRM trial. The data further support the design of the Company's planned Phase 3 trial of larsucosterol, including the importance of timely treatment in driving clinical outcomes. - In November 2024, DURECT sold its ALZET® line of osmotic pumps to Lafayette Instrument Co. (LIC), a portfolio company of Branford Castle Partners II, L.P., a North-American focused private equity firm. DURECT received
$17.5 million
Financial Highlights for the Fourth Quarter and Full Year 2024:
- Total revenues were
$0.5 million $7.8 million $0.9 million $1.4 million $2.0 million $7.9 million $2.6 million $27.6 million - As of December 31, 2024, cash, cash equivalents and investments were
$12.0 million $29.8 million
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 Fourth Quarter and Full Year 2024 results and provide a corporate update:
Toll Free: | 1-877-407-0784 |
International: | 1-201-689-8560 |
Call Me: | https://callme.viavid.com/viavid/?callme=true&passcode=13740526&h=true&info=company-email&r=true&B=6 |
Participants can use guest dial-in numbers above to reach an operator or they can click the Call meTM link for instant telephone access to the event (dial-out). The Call meTM link will be made active 15 minutes prior to the scheduled start time.
The live audio webcast of the presentation will be also available on 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 consisted 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
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
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. Larsucosterol, DURECT's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH has also been explored. 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: our plans to conduct a Phase 3 clinical trial of larsucosterol, the ability of the Phase 3 trial to be successful and, if successful, to support a New Drug Application filing, the sufficiency of our capital requirements (including our sale of the our ALZET product line) to further our strategic goal and our ability to secure sufficient funding for a Phase 3 trial of larsucosterol, our expectations for timing of topline results from a Phase trial of larsucosterol and the potential uses of larsucosterol to treat 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 we do not raise sufficient capital to commence or complete the Phase 3 clinical trial of larsucosterol in patients with AH or continue to fund our operations, the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving larsucosterol for the treatment of AH, the risk that Breakthrough Therapy designation does not expedite the process for FDA approval and that larsucosterol may never be approved; and risks related to the sufficiency of our cash resources, our anticipated capital requirements, our ability to regain the minimum bid price for continued listing on Nasdaq, 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 filings, including its annual report on Form 10-K for the year ended December 31, 2024, when filed, and quarterly report on Form 10-Q for the quarter ended September 30, 2024, 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 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: Larsucosterol is an investigational drug candidate under development and has not been approved for commercialization by the
DURECT CORPORATION | |||||
CONDENSED BALANCE SHEETS | |||||
(in thousands) | |||||
As of | As of | ||||
December 31, 2024 | December 31, 2023 (1) | ||||
(unaudited) | |||||
ASSETS | |||||
Current assets: | |||||
Cash and cash equivalents | $ 11,011 | $ 28,400 | |||
Short-term Investments | 792 | 1,280 | |||
Accounts receivable, net | 453 | 618 | |||
Inventories, net | 106 | 132 | |||
Prepaid expenses and other current assets | 813 | 1,465 | |||
Discontinued operations - current assets | - | 2,777 | |||
Total current assets | 13,175 | 34,672 | |||
Property and equipment, net | 41 | 88 | |||
Operating lease right-of-use assets | 2,135 | 3,079 | |||
Goodwill | 2,725 | 6,169 | |||
Long-term restricted Investments | 150 | 150 | |||
Other long-term assets | 123 | 123 | |||
Discontinued operations - non-current assets | - | 908 | |||
Total assets | $ 18,349 | $ 45,189 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
Current liabilities: | |||||
Accounts payable | $ 309 | $ 1,723 | |||
Accrued liabilities | 4,321 | 5,810 | |||
Term loan, current portion, net | - | 16,663 | |||
Operating lease liabilities, current portion | 1,082 | 1,171 | |||
Warrant liabilities | 1,548 | 1,224 | |||
Discontinued operations - current liabilities | - | 420 | |||
Total current liabilities | 7,260 | 27,011 | |||
Operating lease liabilities, noncurrent portion | 1,124 | 1,967 | |||
Other long-term liabilities | 384 | 594 | |||
Discontinued operations - non-current liabilities | - | 834 | |||
Stockholders' equity | 9,581 | 14,783 | |||
Total liabilities and stockholders' equity | $ 18,349 | $ 45,189 | |||
(1) Derived from audited financial statements. | |||||
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 | ||||||||
2024 | 2023 | 2024 | 2023 | ||||||
Collaborative research and development and other revenue | $ 425 | $ 620 | $ 1,896 | $ 2,277 | |||||
Product revenue, net | 28 | 274 | 135 | 313 | |||||
Total revenues | 453 | 894 | 2,031 | 2,590 | |||||
Operating expenses: | |||||||||
Cost of product revenues | 22 | 238 | 78 | 268 | |||||
Research and development | 1,853 | 5,615 | 10,383 | 29,351 | |||||
Selling, general and administrative | 1,993 | 2,220 | 10,032 | 12,653 | |||||
Total operating expenses | 3,868 | 8,073 | 20,493 | 42,272 | |||||
Loss from operations | (3,415) | (7,179) | (18,462) | (39,682) | |||||
Other income (expense): | |||||||||
Interest and other income | 111 | 449 | 821 | 2,129 | |||||
Change in fair value of warrant liabilities | 1,589 | 4,982 | (323) | 13,583 | |||||
Issuance cost for warrants | - | - | - | (1,627) | |||||
Loss on issuance of warrants | - | - | - | (2,033) | |||||
Other income (expense), net | 1,700 | 5,431 | 498 | 12,052 | |||||
Loss from continuing operations | (1,715) | (1,748) | (17,964) | (27,630) | |||||
Income from discontinued operations | 9,469 | 307 | 10,090 | 6 | |||||
Net income (loss) | $ 7,754 | $ (1,441) | $ (7,874) | $ (27,624) | |||||
Net change in unrealized gain (loss) on available-for-sale securities, net of reclassification adjustments and taxes | $ (1) | $ (2) | $ 13 | $ (1) | |||||
Total comprehensive income (loss) | $ 7,753 | $ (1,443) | $ (7,861) | $ (27,625) | |||||
Net loss per share, basic | |||||||||
Loss from continuing operations | $ (0.06) | $ (0.06) | $ (0.58) | $ (1.05) | |||||
Income from discontinued operations | $ 0.31 | $ 0.01 | $ 0.33 | $ - | |||||
Net income (loss) per common share | $ 0.25 | $ (0.05) | $ (0.25) | $ (1.05) | |||||
Net loss per share, diluted | |||||||||
Loss from continuing operations | $ (0.06) | $ (0.11) | $ (0.58) | $ (1.20) | |||||
Income from discontinued operations | $ 0.30 | $ 0.01 | $ 0.33 | $ - | |||||
Net income (loss) per common share | $ 0.24 | $ (0.10) | $ (0.25) | $ (1.20) | |||||
Weighted-average shares used in computing net income (loss) per share | |||||||||
Basic | 31,041 | 29,464 | 30,940 | 26,256 | |||||
Diluted | 31,366 | 30,046 | 30,940 | 26,520 | |||||
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SOURCE DURECT Corporation
FAQ
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