DURECT Corporation Reports Third Quarter 2024 Financial Results and Provides Business Update
DURECT (DRRX) reported Q3 2024 financial results with total revenues of $1.9 million and a net loss of $4.3 million. The company's cash position stood at $10.5 million as of September 30, 2024, down from $29.8 million at year-end 2023. DURECT is preparing for a Phase 3 trial of larsucosterol in severe alcohol-associated hepatitis, pending sufficient funding. The trial will focus on 90-day survival as the primary endpoint, with topline results expected within two years of initiation. Additionally, Innocoll Pharmaceuticals is terminating its POSIMIR® license agreement, effective May 2025.
DURECT (DRRX) ha riportato i risultati finanziari del terzo trimestre 2024 con ricavi totali di $1,9 milioni e una perdita netta di $4,3 milioni. La posizione di cassa dell'azienda era di $10,5 milioni al 30 settembre 2024, in calo rispetto ai $29,8 milioni della fine dell'anno 2023. DURECT si sta preparando per un trial di Fase 3 di larsucosterolo per la grave epatite associata all'alcol, in attesa di finanziamenti sufficienti. Il trial si concentrerà sulla sopravvivenza a 90 giorni come obiettivo primario, con risultati preliminari attesi entro due anni dall'inizio. Inoltre, Innocoll Pharmaceuticals sta terminando il suo accordo di licenza POSIMIR®, a partire da maggio 2025.
DURECT (DRRX) informó los resultados financieros del tercer trimestre de 2024 con ingresos totales de $1.9 millones y una pérdida neta de $4.3 millones. La posición de efectivo de la empresa se situó en $10.5 millones al 30 de septiembre de 2024, una disminución respecto a $29.8 millones al final de 2023. DURECT se está preparando para un ensayo de Fase 3 de larsucosterol en hepatitis grave relacionada con el alcohol, a la espera de financiación suficiente. El ensayo se centrará en la supervivencia a 90 días como objetivo principal, con resultados preliminares esperados dentro de dos años después de iniciar. Además, Innocoll Pharmaceuticals está terminando su acuerdo de licencia POSIMIR®, efectivo a partir de mayo de 2025.
DURECT (DRRX)는 2024년 3분기 재무 결과를 발표했으며, 전체 수익은 $1.9 백만이고 순손실은 $4.3 백만입니다. 회사의 현금 위치는 2024년 9월 30일 기준 $10.5 백만 이었으며, 2023년 연말의 $29.8 백만에서 감소했습니다. DURECT는 알코올 관련 중증 간염에 대한 larsucosterol의 3상 시험을 준비하고 있으며, 충분한 자금 조달을 기다리고 있습니다. 이 시험은 90일 생존을 주요 목표로 하고 있으며, 시작 후 2년 이내에 주요 결과가 예상됩니다. 또한, Innocoll Pharmaceuticals는 2025년 5월부터 효력을 발생하는 POSIMIR® 라이센스 계약을 종료할 예정입니다.
DURECT (DRRX) a annoncé les résultats financiers du troisième trimestre 2024, avec des revenus totaux de $1,9 million et une perte nette de $4,3 millions. La position de trésorerie de l'entreprise s'élevait à $10,5 millions au 30 septembre 2024, en baisse par rapport à $29,8 millions à la fin de l'année 2023. DURECT se prépare à un essai de Phase 3 de larsucostérol pour l'hépatite sévère associée à l'alcool, en attente de financements suffisants. L'essai se concentrera sur la survie à 90 jours comme critère principal, avec des résultats préliminaires attendus dans les deux ans suivant le démarrage. De plus, Innocoll Pharmaceuticals met fin à son accord de licence POSIMIR®, effectif à partir de mai 2025.
DURECT (DRRX) hat die Finanzergebnisse für das dritte Quartal 2024 bekannt gegeben, mit Gesamterlösen von $1,9 Millionen und einem Nettoverlust von $4,3 Millionen. Die Liquiditätsposition des Unternehmens betrug am 30. September 2024 $10,5 Millionen, ein Rückgang von $29,8 Millionen zum Jahresende 2023. DURECT bereitet sich auf eine Phase-3-Studie von larsucosterol bei schwerer alkoholassoziierter Hepatitis vor, in Erwartung ausreichender Finanzierung. Die Studie wird sich auf die 90-Tage-Überlebensrate als primäres Endpunkt konzentrieren, wobei die Ergebnisse voraussichtlich innerhalb von zwei Jahren nach Beginn erwartet werden. Zusätzlich kündigt Innocoll Pharmaceuticals die Beendigung ihres POSIMIR®-Lizenzvertrags an, der im Mai 2025 wirksam wird.
- FDA agreed that a single Phase 3 trial may be sufficient for NDA submission
- Breakthrough Therapy Designation (BTD) status for larsucosterol
- Revenue increased to $1.9M from $1.7M year-over-year
- Debt reduced to $10.5M from $16.7M since December 2023
- Net loss increased to $4.3M from $3.0M year-over-year
- Cash position declined significantly to $10.5M from $29.8M since December 2023
- Loss of Innocoll Pharmaceuticals as POSIMIR® licensing partner
- Phase 3 trial initiation dependent on securing additional funding
Insights
The Q3 2024 results reveal concerning financial metrics for DURECT Total revenues of
The company's ability to initiate its important Phase 3 trial for larsucosterol hinges on securing additional funding, which may prove challenging given the current financial position. While debt reduction to
The planned Phase 3 trial for larsucosterol in severe alcohol-associated hepatitis (AH) shows promise with its streamlined design. The focus on 90-day survival as the primary endpoint is strategically sound, given the current
However, the two-year timeline to topline results, coupled with funding uncertainties, presents significant execution risks. The upcoming presentations at The Liver Meeting 2024 will be important for validating the Phase 2b AHFIRM trial data and supporting the Phase 3 trial design.
- Seeking to initiate Phase 3 registrational trial for larsucosterol with topline results expected within two years of initiation
- Webcast of Earnings Call Today, November 13 at 4:30 p.m. ET
"We remain focused on preparations for the Phase 3 trial for larsucosterol in severe alcohol-associated hepatitis (AH), including discussions with
Recent business highlights and updates:
- DURECT announced details on the design of its planned registrational Phase 3 trial to evaluate the safety and efficacy of larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (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 we received from theU.S. FDA during a Type B meeting held under Breakthrough Therapy Designation (BTD) as well as learnings from our prior Phase 2b AHFIRM trial in AH. DURECT's goal is to begin the trial as soon as possible, subject to obtaining sufficient funding, with topline results expected within two years of trial initiation. - DURECT plans to deliver an oral and two poster presentations at The Liver Meeting 2024, organized by the American Association for the Study of Liver Diseases (AASLD), to be held November 15-19, 2024 in
San Diego, California . These presentations will showcase additional data from the completed Phase 2b AHFIRM trial which evaluated larsucosterol for the treatment of alcohol-associated hepatitis (AH). The data further support the design of the Company's planned Phase 3 trial of larsucosterol, including the importance of timely treatment in clinical outcomes. Top line data from AHFIRM were previously announced in November 2023. - On November 8, 2024, DURECT received notice that Innocoll Pharmaceuticals is terminating its license agreement for POSIMIR® (bupivacaine solution), effective in May 2025. Innocoll has committed to transfer all data and know-how related to POSIMIR to DURECT, and the company is evaluating next steps with respect to the commercialization of POSIMIR.
Financial Highlights for Q3 2024:
- Total revenues were
$1.9 million $4.3 million $1.7 million $3.0 million - Cash, cash equivalents and investments were
$10.5 million $29.8 million $10.5 million $16.7 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 Third Quarter 2024 results and provide a corporate update:
Toll Free: | 1-877-407-0784 |
International: | 1-201-689-8560 |
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Participants can use guest dial-in numbers above to reach an operator or they can click the Call me™ link for instant telephone access to the event (dial-out). The Call me™ 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 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
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 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. 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 Company's ability to commence a Phase 3 trial of larsucosterol and report top-line data within two years of initiation, the potential for a single Phase 3 trial of larsucosterol, if successful, to support an NDA filing, and the potential uses and benefits of larsucosterol 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 risks that the Company is unable to raise sufficient capital to commence the Phase 3 trial of larsucosterol in AH, trial enrollment or completion takes longer than anticipated, 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; 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 September 30, 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
DURECT CORPORATION | |||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||
(in thousands, except per share amounts) | |||||||||
(unaudited) | |||||||||
Three months ended | Nine months ended | ||||||||
September 30 | September 30 | ||||||||
2024 | 2023 | 2024 | 2023 | ||||||
Collaborative research and development and other revenue | $ 369 | $ 506 | $ 1,471 | $ 1,657 | |||||
Product revenue, net | 1,558 | 1,238 | 4,454 | 4,222 | |||||
Total revenues | 1,927 | 1,744 | 5,925 | 5,879 | |||||
Operating expenses: | |||||||||
Cost of product revenues | 513 | 312 | 1,158 | 1,059 | |||||
Research and development | 2,164 | 7,199 | 8,530 | 23,738 | |||||
Selling, general and administrative | 3,217 | 3,790 | 9,325 | 11,712 | |||||
Total operating expenses | 5,894 | 11,301 | 19,013 | 36,509 | |||||
Loss from operations | (3,967) | (9,557) | (13,088) | (30,630) | |||||
Other income (expense): | |||||||||
Interest and other income | 163 | 653 | 711 | 1,681 | |||||
Interest and other expenses | (364) | (700) | (1,338) | (2,175) | |||||
Change in fair value of warrant liabilities | (117) | 7,016 | (1,913) | 8,601 | |||||
Issuance cost for warrants | - | (427) | - | (1,627) | |||||
Loss on issuance of warrants | - | - | - | (2,033) | |||||
Other income (expense), net | (318) | 6,542 | (2,540) | 4,447 | |||||
Net loss | $ (4,285) | $ (3,015) | $ (15,628) | $ (26,183) | |||||
Net change in unrealized gain (loss) on available-for-sale securities, net of reclassification adjustments and taxes | $ 7 | $ (6) | $ 14 | $ 1 | |||||
Total comprehensive loss | $ (4,278) | $ (3,021) | $ (15,614) | $ (26,182) | |||||
Net loss per share | |||||||||
Basic | $ (0.14) | $ (0.11) | $ (0.51) | $ (1.04) | |||||
Diluted | $ (0.14) | $ (0.01) | $ (0.51) | $ (1.07) | |||||
Weighted-average shares used in computing net loss per share | |||||||||
Basic | 31,039 | 27,211 | 30,906 | 25,175 | |||||
Diluted | 31,039 | 27,511 | 30,906 | 25,433 | |||||
DURECT CORPORATION | ||||
CONDENSED BALANCE SHEETS | ||||
(in thousands) | ||||
As of | As of | |||
September 30, 2024 | December 31, 2023 (1) | |||
(unaudited) | ||||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 9,086 | $ 28,400 | ||
Short-term Investments | 1,290 | 1,280 | ||
Accounts receivable, net | 1,016 | 1,261 | ||
Inventories, net | 2,376 | 2,219 | ||
Prepaid expenses and other current assets | 657 | 1,511 | ||
Total current assets | 14,425 | 34,671 | ||
Property and equipment, net | 52 | 91 | ||
Operating lease right-of-use assets | 3,142 | 3,980 | ||
Goodwill | 6,169 | 6,169 | ||
Long-term restricted Investments | 150 | 150 | ||
Other long-term assets | 128 | 128 | ||
Total assets | $ 24,066 | $ 45,189 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities: | ||||
Accounts payable | $ 498 | $ 1,777 | ||
Accrued liabilities | 4,798 | 5,966 | ||
Term loan, current portion, net | 10,466 | 16,663 | ||
Operating lease liabilities, current portion | 1,308 | 1,381 | ||
Warrant liabilities | 3,137 | 1,224 | ||
Total current liabilities | 20,207 | 27,011 | ||
Operating lease liabilities, noncurrent portion | 1,966 | 2,702 | ||
Other long-term liabilities | 676 | 693 | ||
Stockholders' equity | 1,217 | 14,783 | ||
Total liabilities and stockholders' equity | $ 24,066 | $ 45,189 | ||
(1) Derived from audited financial statements. | ||||
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SOURCE DURECT Corporation
FAQ
What were DURECT 's (DRRX) Q3 2024 financial results?
What is the status of DRRX's larsucosterol Phase 3 trial?
What happened to DRRX's POSIMIR license agreement?
